<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03300336</url>
  </required_header>
  <id_info>
    <org_study_id>QUX 16-015</org_study_id>
    <nct_id>NCT03300336</nct_id>
  </id_info>
  <brief_title>Optimizing Function and Independence Through STRIDE</brief_title>
  <acronym>STRIDE</acronym>
  <official_title>Optimizing Function and Independence Through STRIDE (QUE 16-170)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optimizing Function and Independence Through STRIDE aims to implement the STRIDE inpatient&#xD;
      hospital mobility program at 8 VAMC sites in a stepped-wedge design and evaluate patient&#xD;
      outcomes before and after the program is implemented, as well as the efficacy of a usual vs&#xD;
      enhanced implementation design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Purpose. A key contributor to hospital-associated disability is immobility during&#xD;
      hospitalization. While fewer than 5% of patients have physician orders for bed rest,&#xD;
      hospitalized older adults spend only 3% of their time standing or walking. The hazards of&#xD;
      immobility in the hospital have been recognized for more than two decades, but there are&#xD;
      currently no VA-system wide approaches to address this important gap in clinical care.&#xD;
&#xD;
      STRIDE is a supervised inpatient walking program developed by an interdisciplinary team of&#xD;
      investigators, clinicians and administrators at the Durham VA and funded by the VHA Office of&#xD;
      GEC. STRIDE consists of a one-time gait and balance assessment conducted by a physical&#xD;
      therapist, followed by daily supervised walks by a recreation therapy assistant for the&#xD;
      duration of the hospital stay. Program evaluation has demonstrated high satisfaction among&#xD;
      Veteran participants and reduced need for post-acute institutional care. As a result, the&#xD;
      Durham VAMC funded STRIDE as a permanent program that currently serves over 650 Veterans&#xD;
      annually, and the VHA Office of GEC funded a dissemination grant to launch the program at&#xD;
      another medical center. The investigators' initial experience with STRIDE implementation&#xD;
      suggests interprofessional relationships and team dynamics are key determinants to the&#xD;
      success of a new hospital-based clinical program that requires collaborative processes&#xD;
      involving multiple disciplines.&#xD;
&#xD;
      As part of the investigators' Optimizing Function and Independence QUERI, the investigators&#xD;
      plan to implement the STRIDE clinical program at 8 VAMC sites in a stepped-wedge design with&#xD;
      sites randomized to implementation strategy and start date.&#xD;
&#xD;
      Objectives. The investigators plan to conduct an evaluation to examine the impact of STRIDE&#xD;
      on patient outcomes.&#xD;
&#xD;
      Key questions: Do STRIDE participants have fewer discharges to skilled nursing facilities and&#xD;
      shorter lengths of stay? Do STRIDE participants have better physical function and higher&#xD;
      health-related quality of life at 30 days post-discharge? What is the value of STRIDE from&#xD;
      the Veteran's perspective? The investigators also plan to conduct a mixed method evaluation&#xD;
      that examines implementation outcomes and provider team experience that will not be reported&#xD;
      here.&#xD;
&#xD;
      Methodology. The investigators will compare patients discharged from sites before and after&#xD;
      the STRIDE program is implemented to assess discharge to skilled nursing facilities and&#xD;
      length of stay (approx. n=2000). A subset of patients participating in the STRIDE program and&#xD;
      a comparison group will be surveyed 30 days post-hospital discharge to assess outcomes&#xD;
      including health status, physical function, and quality of life. A subset of patients will be&#xD;
      interviewed one week post-discharge to gain feedback about the STRIDE program and perceived&#xD;
      benefits of a hospital inpatient mobility program.&#xD;
&#xD;
      In 2023, the following updates were made after results were initially uploaded to clinical&#xD;
      trials as follows: primary outcome description and results were modified to reflect discharge&#xD;
      to skilled nursing facility versus discharge to home and modifications were made to the&#xD;
      sample and discharge to skilled nursing home and length of stay outcomes due to receipt of&#xD;
      more complete data sources for use to determine eligibility and to assess the primary&#xD;
      outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 29, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Stepped Wedge Cluster Randomized Trial - a form of crossover design with unidirectional crossover (from control to experimental) but with randomization of when each cluster undertakes the transition. In the stepped wedge design, there is a staggered roll-out of the intervention, where the time and sequence of clusters that will start the intervention at each period determined by random allocation.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Patients Discharged to Skilled Nursing Facility</measure>
    <time_frame>Assessed at hospital discharge, an average of 7 days</time_frame>
    <description>Discharge to skilled nursing facility (versus home) will be assessed via administrative data pulls and chart review (not patient report).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Length of Stay (Days)</measure>
    <time_frame>Assessed at hospital discharge, an average of 7 days</time_frame>
    <description>Hospital length of stay will be assessed via administrative data pulls (not patient report)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Physical Function - Disability</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Disability Component. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Physical Function - Limitations</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Limitations Component -Instrumental Role Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Physical Function</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Function Component - Basic Lower Extremity Functioning Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion Highly Satisfied With Care</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of satisfaction with care will be measured with the Consumer Assessment of Healthcare Providers and Systems (CAHPS)-based item &quot;Would you recommend this hospital to other Veterans if they needed care for a condition such as yours?&quot; Responses were categorized into two categories: highly satisfied (responses of &quot;Definitely Yes&quot;) and less satisfied (responses of &quot;Probably Yes&quot;, &quot;Probably No&quot;, and &quot;Definitely No&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Utility</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of health utility, a health-related quality of life measure, will be assessed with the ICEpop CAPability measure for adults (ICECAP-A). Tariff values for an overall state are calculated by summing the values across the individual attributes (Feeling settled and secure; Love, friendship and support; Being independent; Achievement and progress; and Enjoyment and pleasure). Tariff values can range from 0 to 1, with higher values reflecting greater quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of health-related quality of life will be measured by the Euroqol (EQ-5D). Response profiles are mapped to a score via a crosswalk. Scores range from -0.109 to 1.0, with higher scores reflecting a higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility in the Environment</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of mobility in the environment will be assessed by the Life Space Questionnaire. The composite score incorporates use of equipment, need for personal help, and frequency of movement. Scores range from 0-120 with higher scores reflecting greater mobility.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sleep</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of sleep functioning will be assessed with the sleep subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 32.0 to 73.3. Higher scores indicate more sleep disturbance.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Participants Self-reporting at Least One Fall</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Veterans self-reporting at least one fall in the 30 days since discharge from an eligible hospitalization, as queried during a telephone survey.</description>
  </other_outcome>
  <other_outcome>
    <measure>PROMIS-29 Pain Subscale</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of pain will be assessed with the pain subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 41.6 to 75.6. Higher scores indicate higher (worse) pain interference.</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression</measure>
    <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
    <description>Analysis of depression will be assessed with the Center for Epidemiologic Studies Depression Scale (CESD-10). Scores range from 0-30, with higher scores reflecting more depressive symptoms</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13857</enrollment>
  <condition>Early Ambulation</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implementation of STRIDE program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Pre-implementation before STRIDE program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>STRIDE</intervention_name>
    <description>Implementation of STRIDE inpatient hospital mobility program</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion/Exclusion listed here apply to subset of patients providing consent for telephone&#xD;
        interviews:&#xD;
&#xD;
          -  Able and willing to provide informed consent (does not lack decision-making capacity)&#xD;
&#xD;
          -  Discharged from a participating hospital within the preceding 30 days&#xD;
&#xD;
          -  Age &gt;= 60&#xD;
&#xD;
          -  Index admission for medical illness&#xD;
&#xD;
          -  Community-dwelling (i.e. not in a nursing home or institutional care) prior to&#xD;
             hospital visit&#xD;
&#xD;
          -  Ability to ambulate safely and independently (does not need help walking across a&#xD;
             small room)&#xD;
&#xD;
          -  Valid telephone number in the medical record&#xD;
&#xD;
          -  Admitted to a STRIDE ward and discharged from a STRIDE ward&#xD;
&#xD;
          -  Index hospital stay was in a ward identified to participate in the STRIDE program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient deceased&#xD;
&#xD;
          -  Index hospital stay was &lt; 2 business days&#xD;
&#xD;
          -  Currently hospitalized&#xD;
&#xD;
          -  Current high-risk suicide flag in medical record&#xD;
&#xD;
          -  Diagnosis of cognitive impairment or dementia&#xD;
&#xD;
          -  Difficulty with or unable to communicate on the telephone, or no telephone access&#xD;
&#xD;
          -  Discharged to another hospital or acute care setting&#xD;
&#xD;
          -  Transferred into index hospital from another hospital&#xD;
&#xD;
          -  Bedrest order not lifted for at least 2 days on STRIDE ward&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan N. Hastings, MD MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Courtney H Van Houtven, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Virginia Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705-3875</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.queri.research.va.gov/programs/function.cfm</url>
    <description>Function QUERI program</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>April 16, 2021</results_first_submitted>
  <results_first_submitted_qc>June 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2021</results_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Walking</keyword>
  <keyword>Inpatients</keyword>
  <keyword>Veterans</keyword>
  <keyword>Early Ambulation</keyword>
  <keyword>Quality of Life</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format.&#xD;
Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication.&#xD;
No data or statistical code that could lead to re-identification of individuals will be released.&#xD;
Data will be stored &amp; maintained in an approved, secured location as described in the VA Research Data Inventory Form.&#xD;
The study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study publication.&#xD;
Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.</ipd_description>
    <ipd_time_frame>Available upon request.</ipd_time_frame>
    <ipd_access_criteria>Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03300336/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Pre-implementation before STRIDE program</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7134"/>
                <participants group_id="P2" count="6723"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7134"/>
                <participants group_id="P2" count="6723"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patient-hospitalizations</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Pre-implementation before STRIDE program</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7134"/>
            <count group_id="B2" value="6723"/>
            <count group_id="B3" value="13857"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>patient hospitalizations</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9070"/>
            <count group_id="B2" value="8167"/>
            <count group_id="B3" value="17237"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>patient hospitalizations</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.0" spread="8.6"/>
                    <measurement group_id="B2" value="72.8" spread="8.8"/>
                    <measurement group_id="B3" value="72.9" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>patient hospitalizations</units>
          <param>Count of Units</param>
          <units_analyzed>patient hospitalizations</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="308"/>
                    <measurement group_id="B2" value="213"/>
                    <measurement group_id="B3" value="521"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8762"/>
                    <measurement group_id="B2" value="7954"/>
                    <measurement group_id="B3" value="16716"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>patient hospitalizations</units>
          <param>Count of Units</param>
          <units_analyzed>patient hospitalizations</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="435"/>
                    <measurement group_id="B3" value="592"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8751"/>
                    <measurement group_id="B2" value="7626"/>
                    <measurement group_id="B3" value="16377"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>patient hospitalizations</units>
          <param>Count of Units</param>
          <units_analyzed>patient hospitalizations</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2468"/>
                    <measurement group_id="B2" value="2418"/>
                    <measurement group_id="B3" value="4886"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6206"/>
                    <measurement group_id="B2" value="5417"/>
                    <measurement group_id="B3" value="11623"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>patient hospitalizations</units>
          <param>Number</param>
          <units_analyzed>patient hospitalizations</units_analyzed>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9070"/>
                    <measurement group_id="B2" value="8167"/>
                    <measurement group_id="B3" value="17237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients Discharged to Skilled Nursing Facility</title>
        <description>Discharge to skilled nursing facility (versus home) will be assessed via administrative data pulls and chart review (not patient report).</description>
        <time_frame>Assessed at hospital discharge, an average of 7 days</time_frame>
        <population>Discharge to skilled nursing facility was analyzed for the first hospitalization for each patient during the study period. Patients can be in both intervention and usual care groups if hospitalized during the respective intervention and usual care time periods; however, for this outcome patients will be analyzed in only one group, based upon the earliest of their hospitalizations if had more than one.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Discharged to Skilled Nursing Facility</title>
          <description>Discharge to skilled nursing facility (versus home) will be assessed via administrative data pulls and chart review (not patient report).</description>
          <population>Discharge to skilled nursing facility was analyzed for the first hospitalization for each patient during the study period. Patients can be in both intervention and usual care groups if hospitalized during the respective intervention and usual care time periods; however, for this outcome patients will be analyzed in only one group, based upon the earliest of their hospitalizations if had more than one.</population>
          <units>proportion of patients</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6141"/>
                <count group_id="O2" value="6722"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.02"/>
                    <measurement group_id="O2" value="0.20" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline timepoints), and a site-level random effect. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <p_value_desc>a priori threshold for statistical significance p &lt;.05</p_value_desc>
            <method>generalized linear model</method>
            <method_desc>generalized linear model with a logit link and a binomial distribution</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Odds in intervention numerator vs odds in usual care denominator</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospital Length of Stay (Days)</title>
        <description>Hospital length of stay will be assessed via administrative data pulls (not patient report)</description>
        <time_frame>Assessed at hospital discharge, an average of 7 days</time_frame>
        <population>Length of stay was analyzed for the first hospitalization for each patient during the study period. Patients can be in both intervention and usual care groups if hospitalized during the respective intervention and usual care time periods; however, for this outcome patients will be analyzed in only one group, based upon the earliest of their hospitalizations if had more than one.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay (Days)</title>
          <description>Hospital length of stay will be assessed via administrative data pulls (not patient report)</description>
          <population>Length of stay was analyzed for the first hospitalization for each patient during the study period. Patients can be in both intervention and usual care groups if hospitalized during the respective intervention and usual care time periods; however, for this outcome patients will be analyzed in only one group, based upon the earliest of their hospitalizations if had more than one.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6141"/>
                <count group_id="O2" value="6722"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.92" spread="0.21"/>
                    <measurement group_id="O2" value="6.58" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline time points), a site-level random effect and random effects for each of the time periods. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.25</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>generalized linear model</method>
            <method_desc>generalized linear model with a log link and negative binomial distribution.</method_desc>
            <param_type>rate ratio</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
            <estimate_desc>The rate ratio compares the intervention rate in the numerator vs the usual care rate in the denominator</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Physical Function - Disability</title>
        <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Disability Component. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Physical Function - Disability</title>
          <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Disability Component. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.31" spread="1.55"/>
                    <measurement group_id="O2" value="65.99" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.52</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.70</ci_lower_limit>
            <ci_upper_limit>5.33</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Physical Function - Limitations</title>
        <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Limitations Component -Instrumental Role Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Physical Function - Limitations</title>
          <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Limitations Component -Instrumental Role Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.67" spread="1.84"/>
                    <measurement group_id="O2" value="64.12" spread="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.66</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.14</ci_lower_limit>
            <ci_upper_limit>6.25</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Physical Function</title>
        <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Function Component - Basic Lower Extremity Functioning Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Patient telephone survey 30 days post discharge</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Physical Function</title>
          <description>Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Function Component - Basic Lower Extremity Functioning Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.</description>
          <population>Patient telephone survey 30 days post discharge</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.88" spread="1.64"/>
                    <measurement group_id="O2" value="68.40" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect.. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 14 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.81</p_value>
            <p_value_desc>a priori threshold for significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.74</ci_lower_limit>
            <ci_upper_limit>3.70</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion Highly Satisfied With Care</title>
        <description>Analysis of satisfaction with care will be measured with the Consumer Assessment of Healthcare Providers and Systems (CAHPS)-based item &quot;Would you recommend this hospital to other Veterans if they needed care for a condition such as yours?&quot; Responses were categorized into two categories: highly satisfied (responses of &quot;Definitely Yes&quot;) and less satisfied (responses of &quot;Probably Yes&quot;, &quot;Probably No&quot;, and &quot;Definitely No&quot;).</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion Highly Satisfied With Care</title>
          <description>Analysis of satisfaction with care will be measured with the Consumer Assessment of Healthcare Providers and Systems (CAHPS)-based item &quot;Would you recommend this hospital to other Veterans if they needed care for a condition such as yours?&quot; Responses were categorized into two categories: highly satisfied (responses of &quot;Definitely Yes&quot;) and less satisfied (responses of &quot;Probably Yes&quot;, &quot;Probably No&quot;, and &quot;Definitely No&quot;).</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>proportion of patients</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="0.04"/>
                    <measurement group_id="O2" value="0.84" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care: 0 out of 227 Missing data due to item nonresponse in intervention: 5 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.74</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>generalized linear model</method>
            <method_desc>generalized linear model with a logit link and a binomial distribution</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>2.32</ci_upper_limit>
            <estimate_desc>Odds in intervention numerator vs odds in usual care denominator</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Utility</title>
        <description>Analysis of health utility, a health-related quality of life measure, will be assessed with the ICEpop CAPability measure for adults (ICECAP-A). Tariff values for an overall state are calculated by summing the values across the individual attributes (Feeling settled and secure; Love, friendship and support; Being independent; Achievement and progress; and Enjoyment and pleasure). Tariff values can range from 0 to 1, with higher values reflecting greater quality of life.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Patients completing a telephone survey 30 days post discharge</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Health Utility</title>
          <description>Analysis of health utility, a health-related quality of life measure, will be assessed with the ICEpop CAPability measure for adults (ICECAP-A). Tariff values for an overall state are calculated by summing the values across the individual attributes (Feeling settled and secure; Love, friendship and support; Being independent; Achievement and progress; and Enjoyment and pleasure). Tariff values can range from 0 to 1, with higher values reflecting greater quality of life.</description>
          <population>Patients completing a telephone survey 30 days post discharge</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="0.02"/>
                    <measurement group_id="O2" value="0.80" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care: 14 out of 227 Missing data due to item nonresponse in intervention: 33 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.40</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health-related Quality of Life</title>
        <description>Analysis of health-related quality of life will be measured by the Euroqol (EQ-5D). Response profiles are mapped to a score via a crosswalk. Scores range from -0.109 to 1.0, with higher scores reflecting a higher quality of life.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Health-related Quality of Life</title>
          <description>Analysis of health-related quality of life will be measured by the Euroqol (EQ-5D). Response profiles are mapped to a score via a crosswalk. Scores range from -0.109 to 1.0, with higher scores reflecting a higher quality of life.</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.02"/>
                    <measurement group_id="O2" value="0.73" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care: 7 out of 227 Missing data due to item nonresponse in intervention: 23 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mobility in the Environment</title>
        <description>Analysis of mobility in the environment will be assessed by the Life Space Questionnaire. The composite score incorporates use of equipment, need for personal help, and frequency of movement. Scores range from 0-120 with higher scores reflecting greater mobility.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Mobility in the Environment</title>
          <description>Analysis of mobility in the environment will be assessed by the Life Space Questionnaire. The composite score incorporates use of equipment, need for personal help, and frequency of movement. Scores range from 0-120 with higher scores reflecting greater mobility.</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.81" spread="3.26"/>
                    <measurement group_id="O2" value="58.01" spread="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 4 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.83</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.38</ci_lower_limit>
            <ci_upper_limit>7.98</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Sleep</title>
        <description>Analysis of sleep functioning will be assessed with the sleep subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 32.0 to 73.3. Higher scores indicate more sleep disturbance.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep</title>
          <description>Analysis of sleep functioning will be assessed with the sleep subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 32.0 to 73.3. Higher scores indicate more sleep disturbance.</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.79" spread="0.98"/>
                    <measurement group_id="O2" value="50.33" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention: 6 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.25</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.05</ci_lower_limit>
            <ci_upper_limit>3.96</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Participants Self-reporting at Least One Fall</title>
        <description>Veterans self-reporting at least one fall in the 30 days since discharge from an eligible hospitalization, as queried during a telephone survey.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Self-reporting at Least One Fall</title>
          <description>Veterans self-reporting at least one fall in the 30 days since discharge from an eligible hospitalization, as queried during a telephone survey.</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>proportion of patients</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.02"/>
                    <measurement group_id="O2" value="0.16" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 3 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.59</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>generalized linear model</method>
            <method_desc>generalized linear model with a logit link and a binomial distribution</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.99</ci_upper_limit>
            <estimate_desc>Odds in intervention numerator vs odds in usual care denominator</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PROMIS-29 Pain Subscale</title>
        <description>Analysis of pain will be assessed with the pain subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 41.6 to 75.6. Higher scores indicate higher (worse) pain interference.</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS-29 Pain Subscale</title>
          <description>Analysis of pain will be assessed with the pain subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 41.6 to 75.6. Higher scores indicate higher (worse) pain interference.</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.46" spread="0.96"/>
                    <measurement group_id="O2" value="55.47" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care: 11 out of 227 Missing data due to item nonresponse in intervention: 20 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.47</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.71</ci_lower_limit>
            <ci_upper_limit>3.69</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Depression</title>
        <description>Analysis of depression will be assessed with the Center for Epidemiologic Studies Depression Scale (CESD-10). Scores range from 0-30, with higher scores reflecting more depressive symptoms</description>
        <time_frame>30 days following hospital discharge, hospital stay an average of 6 days</time_frame>
        <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Pre-implementation before STRIDE program</description>
          </group>
        </group_list>
        <measure>
          <title>Depression</title>
          <description>Analysis of depression will be assessed with the Center for Epidemiologic Studies Depression Scale (CESD-10). Scores range from 0-30, with higher scores reflecting more depressive symptoms</description>
          <population>Veterans completing a telephone survey 30 days after discharge from an eligible hospitalization. While Veterans may have multiple eligible hospitalizations, in the study framework Veterans can only be surveyed once.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.04" spread="0.57"/>
                    <measurement group_id="O2" value="9.11" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.&#xD;
Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention group: 7 out of 399&#xD;
Estimated means and standard errors are provided in Outcome Measure Data table.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.94</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.76</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
            <estimate_desc>Estimated difference calculated as intervention minus control</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months post discharge, hospital stay an average of 7 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Implementation of STRIDE program&#xD;
STRIDE: Implementation of STRIDE inpatient hospital mobility program</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Pre-implementation before STRIDE program</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7134"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6723"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7134"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6723"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7134"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6723"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>S. Nicole Hastings</name_or_title>
      <organization>HSRD ADAPT</organization>
      <phone>919-286-6936</phone>
      <email>susan.hastings@va.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03300336
org study id: QUX 16-015
nct id: NCT03300336
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Optimizing Function and Independence Through STRIDE aims to implement the STRIDE inpatient
      hospital mobility program at 8 VAMC sites in a stepped-wedge design and evaluate patient
      outcomes before and after the program is implemented, as well as the efficacy of a usual vs
      enhanced implementation design.
Background/Purpose. A key contributor to hospital-associated disability is immobility during
      hospitalization. While fewer than 5% of patients have physician orders for bed rest,
      hospitalized older adults spend only 3% of their time standing or walking. The hazards of
      immobility in the hospital have been recognized for more than two decades, but there are
      currently no VA-system wide approaches to address this important gap in clinical care.

      STRIDE is a supervised inpatient walking program developed by an interdisciplinary team of
      investigators, clinicians and administrators at the Durham VA and funded by the VHA Office of
      GEC. STRIDE consists of a one-time gait and balance assessment conducted by a physical
      therapist, followed by daily supervised walks by a recreation therapy assistant for the
      duration of the hospital stay. Program evaluation has demonstrated high satisfaction among
      Veteran participants and reduced need for post-acute institutional care. As a result, the
      Durham VAMC funded STRIDE as a permanent program that currently serves over 650 Veterans
      annually, and the VHA Office of GEC funded a dissemination grant to launch the program at
      another medical center. The investigators' initial experience with STRIDE implementation
      suggests interprofessional relationships and team dynamics are key determinants to the
      success of a new hospital-based clinical program that requires collaborative processes
      involving multiple disciplines.

      As part of the investigators' Optimizing Function and Independence QUERI, the investigators
      plan to implement the STRIDE clinical program at 8 VAMC sites in a stepped-wedge design with
      sites randomized to implementation strategy and start date.

      Objectives. The investigators plan to conduct an evaluation to examine the impact of STRIDE
      on patient outcomes.

      Key questions: Do STRIDE participants have fewer discharges to skilled nursing facilities and
      shorter lengths of stay? Do STRIDE participants have better physical function and higher
      health-related quality of life at 30 days post-discharge? What is the value of STRIDE from
      the Veteran's perspective? The investigators also plan to conduct a mixed method evaluation
      that examines implementation outcomes and provider team experience that will not be reported
      here.

      Methodology. The investigators will compare patients discharged from sites before and after
      the STRIDE program is implemented to assess discharge to skilled nursing facilities and
      length of stay (approx. n=2000). A subset of patients participating in the STRIDE program and
      a comparison group will be surveyed 30 days post-hospital discharge to assess outcomes
      including health status, physical function, and quality of life. A subset of patients will be
      interviewed one week post-discharge to gain feedback about the STRIDE program and perceived
      benefits of a hospital inpatient mobility program.

      In 2023, the following updates were made after results were initially uploaded to clinical
      trials as follows: primary outcome description and results were modified to reflect discharge
      to skilled nursing facility versus discharge to home and modifications were made to the
      sample and discharge to skilled nursing home and length of stay outcomes due to receipt of
      more complete data sources for use to determine eligibility and to assess the primary
      outcome.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Stepped Wedge Cluster Randomized Trial - a form of crossover design with unidirectional crossover (from control to experimental) but with randomization of when each cluster undertakes the transition. In the stepped wedge design, there is a staggered roll-out of the intervention, where the time and sequence of clusters that will start the intervention at each period determined by random allocation.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of Patients Discharged to Skilled Nursing Facility
time frame: Assessed at hospital discharge, an average of 7 days
description: Discharge to skilled nursing facility (versus home) will be assessed via administrative data pulls and chart review (not patient report).
measure: Hospital Length of Stay (Days)
time frame: Assessed at hospital discharge, an average of 7 days
description: Hospital length of stay will be assessed via administrative data pulls (not patient report)
measure: Patient Physical Function - Disability
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Disability Component. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.
measure: Patient Physical Function - Limitations
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Limitations Component -Instrumental Role Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.
measure: Patient Physical Function
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of physical function will be measured by the Late Life Function and Disability Instrument (LL-FDI) - Function Component - Basic Lower Extremity Functioning Domain. Raw scores transformed to scaled scores ranging from 0-100, with higher scores reflecting higher functioning.
measure: Proportion Highly Satisfied With Care
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of satisfaction with care will be measured with the Consumer Assessment of Healthcare Providers and Systems (CAHPS)-based item "Would you recommend this hospital to other Veterans if they needed care for a condition such as yours?" Responses were categorized into two categories: highly satisfied (responses of "Definitely Yes") and less satisfied (responses of "Probably Yes", "Probably No", and "Definitely No").
measure: Health Utility
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of health utility, a health-related quality of life measure, will be assessed with the ICEpop CAPability measure for adults (ICECAP-A). Tariff values for an overall state are calculated by summing the values across the individual attributes (Feeling settled and secure; Love, friendship and support; Being independent; Achievement and progress; and Enjoyment and pleasure). Tariff values can range from 0 to 1, with higher values reflecting greater quality of life.
measure: Health-related Quality of Life
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of health-related quality of life will be measured by the Euroqol (EQ-5D). Response profiles are mapped to a score via a crosswalk. Scores range from -0.109 to 1.0, with higher scores reflecting a higher quality of life.
measure: Mobility in the Environment
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of mobility in the environment will be assessed by the Life Space Questionnaire. The composite score incorporates use of equipment, need for personal help, and frequency of movement. Scores range from 0-120 with higher scores reflecting greater mobility.
measure: Sleep
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of sleep functioning will be assessed with the sleep subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 32.0 to 73.3. Higher scores indicate more sleep disturbance.
measure: Proportion of Participants Self-reporting at Least One Fall
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Veterans self-reporting at least one fall in the 30 days since discharge from an eligible hospitalization, as queried during a telephone survey.
measure: PROMIS-29 Pain Subscale
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of pain will be assessed with the pain subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Raw scores converted to t-scores ranging from 41.6 to 75.6. Higher scores indicate higher (worse) pain interference.
measure: Depression
time frame: 30 days following hospital discharge, hospital stay an average of 6 days
description: Analysis of depression will be assessed with the Center for Epidemiologic Studies Depression Scale (CESD-10). Scores range from 0-30, with higher scores reflecting more depressive symptoms
arm group label: Intervention
arm group type: Experimental
description: Implementation of STRIDE program
arm group label: Usual Care
arm group type: No Intervention
description: Pre-implementation before STRIDE program
intervention type: Behavioral
intervention name: STRIDE
description: Implementation of STRIDE inpatient hospital mobility program
arm group label: Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Susan N. Hastings, MD MHSc
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
last name: Courtney H Van Houtven, PhD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
last name: Virginia Wang, PhD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
facility: 
country: United States
url: https://www.queri.research.va.gov/programs/function.cfm
description: Function QUERI program
responsible party type: Sponsor
sharing ipd: Yes
ipd description: A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format.
Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication.
No data or statistical code that could lead to re-identification of individuals will be released.
Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form.
The study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study publication.
Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.
ipd time frame: Available upon request.
ipd access criteria: Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 