<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/NCT02979353</url>
  </required_header>
  <id_info>
    <org_study_id>R01AG053264-01</org_study_id>
    <secondary_id>R01AG053264</secondary_id>
    <nct_id>NCT02979353</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy</brief_title>
  <acronym>Shed-Meds</acronym>
  <official_title>A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy Transferred From the Hospital to Skilled Nursing Facilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized, controlled trial will evaluate the effects of an intervention to reduce&#xD;
      exposure to medications among hospitalized older adults discharged to skilled nursing&#xD;
      facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as&#xD;
      defined by dose reductions and stopped medications, based on a combination of clinical&#xD;
      criteria and patient preferences. The investigators will evaluate the effects of the&#xD;
      intervention on the total number of medications prescribed to patients at hospital and SNF&#xD;
      discharge and at home 90-days after SNF discharge along with the prevalence of eight&#xD;
      geriatric syndromes, medication adherence, and health status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, controlled trial will evaluate the effects of an intervention to reduce&#xD;
      exposure to medications among hospitalized older adults discharged to skilled nursing&#xD;
      facilities (SNFs). This study will be conducted in one university-affiliated hospital and 14&#xD;
      area SNFs to enroll approximately 1,300 total participants across five project years.&#xD;
      Patients discharged to SNF represent the largest segment of Medicare beneficiaries discharged&#xD;
      to post-acute care services and are a particularly high risk group for loss of independence&#xD;
      and other poor clinical outcomes. This investigative team recently completed a Centers for&#xD;
      Medicare and Medicaid Services (CMS) Innovation Award, which provides strong preliminary data&#xD;
      related to the prevalence of polypharmacy and the relationship between polypharmacy and&#xD;
      geriatric syndromes (e.g., medications associated with falls) in this patient population.&#xD;
      Based on these data, the investigators developed a structured deprescribing intervention&#xD;
      protocol (&quot;Shed-Meds&quot;) coupled with standardized screening assessments for eight geriatric&#xD;
      syndromes to be implemented in the hospital and continued during the SNF stay. The goal of&#xD;
      the intervention is to safely deprescribe medications, as defined by dose reductions and&#xD;
      stopped medications, based on a combination of clinical criteria and patient preferences.&#xD;
      This trial will evaluate the effects of this intervention on medication exposure, medication&#xD;
      adherence, geriatric syndromes, and health status across the care transitions from hospital&#xD;
      to SNF to home to include a 90-day follow-up period after SNF discharge. The overarching&#xD;
      hypothesis is that reducing medications for older patients across the continuum of care will&#xD;
      favorably impact geriatric syndromes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Number of Medications</measure>
    <time_frame>Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC</time_frame>
    <description>The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug</measure>
    <time_frame>Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC</time_frame>
    <description>A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic &amp; Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic &amp; Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">372</enrollment>
  <condition>Polypharmacy</condition>
  <condition>Care Transitions</condition>
  <condition>Geriatric Syndromes</condition>
  <arm_group>
    <arm_group_label>Shed-Meds: A Patient-Centered Deprescribing Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Shed-Meds: A Patient-Centered Deprescribing Intervention</intervention_name>
    <description>The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.</description>
    <arm_group_label>Shed-Meds: A Patient-Centered Deprescribing Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized at Vanderbilt University Medical Center&#xD;
&#xD;
          -  Medicare-eligible&#xD;
&#xD;
          -  Discharged from VUMC to a post acute care facility&#xD;
&#xD;
          -  Has polypharmacy as defined by &gt; 5 medications&#xD;
&#xD;
          -  Able to self-consent or has a proxy (surrogate)&#xD;
&#xD;
          -  Speaks English (due to interview-based assessments)&#xD;
&#xD;
          -  Primary home residence within one of 9 surrounding counties (due to home visit during&#xD;
             follow-up phase)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Resides in long-term care&#xD;
&#xD;
          -  Is currently on hospice or otherwise has a limited life expectancy (&lt; 6 months).&#xD;
&#xD;
          -  Enrolled in a clinical drug trial&#xD;
&#xD;
          -  Has Stage IV Cancer Diagnosis&#xD;
&#xD;
          -  Incarcerated or homeless&#xD;
&#xD;
          -  Unable to self-consent and does not have a surrogate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra F Simmons, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Kripalani S, Mixon AS, Simmons SF. Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):223-231. doi: 10.1001/jamainternmed.2022.6545.</citation>
    <PMID>36745422</PMID>
  </reference>
  <reference>
    <citation>Kim JL, Lewallen KM, Hollingsworth EK, Shah AS, Simmons SF, Vasilevskis EE. Patient-Reported Barriers and Enablers to Deprescribing Recommendations During a Clinical Trial (Shed-MEDS). Gerontologist. 2023 Mar 21;63(3):523-533. doi: 10.1093/geront/gnac100.</citation>
    <PMID>35881109</PMID>
  </reference>
  <reference>
    <citation>Hollingsworth EK, Shah AS, Shotwell MS, Simmons SF, Vasilevskis EE. Older Patient and Surrogate Attitudes Toward Deprescribing During the Transition From Acute to Post-Acute Care. J Appl Gerontol. 2022 Mar;41(3):788-797. doi: 10.1177/07334648211015756.</citation>
    <PMID>35164584</PMID>
  </reference>
  <reference>
    <citation>Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Simmons SF, Vasilevskis EE. Sources of medication omissions among hospitalized older adults with polypharmacy. J Am Geriatr Soc. 2022 Apr;70(4):1180-1189. doi: 10.1111/jgs.17629. Epub 2021 Dec 30.</citation>
    <PMID>34967444</PMID>
  </reference>
  <results_reference>
    <citation>Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Bell SP, Kripalani S, Schnelle JF, Simmons SF; Shed-MEDS Team. A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial. BMC Health Serv Res. 2019 Mar 14;19(1):165. doi: 10.1186/s12913-019-3995-3.</citation>
    <PMID>30871561</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>April 11, 2023</results_first_submitted>
  <results_first_submitted_qc>June 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2023</results_first_posted>
  <last_update_submitted>June 26, 2023</last_update_submitted>
  <last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Sandra Simmons</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified data may be shared, per written request and completion of formal data sharing agreement approved by the institution</ipd_description>
  </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>October 17, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT02979353/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT02979353/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Shed-Meds: A Patient-Centered Deprescribing Intervention</title>
          <description>Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.&#xD;
Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="186"/>
                <participants group_id="P2" count="186"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Hospital Phase</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="181"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Post-Acute Care Phase</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
                <participants group_id="P2" count="142"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>7-Day Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="133"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>60-Day Follow-Up</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="71"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Hospital Discharge to Non-Partner PAC or Non- PAC Location</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transfer to Hospice Care</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Shed-Meds: A Patient-Centered Deprescribing Intervention</title>
          <description>Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.&#xD;
Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.</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="186"/>
            <count group_id="B2" value="186"/>
            <count group_id="B3" value="372"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="186"/>
                    <count group_id="B2" value="186"/>
                    <count group_id="B3" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.4" lower_limit="69.5" upper_limit="85.3"/>
                    <measurement group_id="B2" value="76.9" lower_limit="66.9" upper_limit="84.6"/>
                    <measurement group_id="B3" value="76.8" lower_limit="69.1" upper_limit="84.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="186"/>
                    <count group_id="B2" value="186"/>
                    <count group_id="B3" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="229"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="186"/>
                    <count group_id="B2" value="186"/>
                    <count group_id="B3" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                    <measurement group_id="B2" value="182"/>
                    <measurement group_id="B3" value="368"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="186"/>
                    <count group_id="B2" value="186"/>
                    <count group_id="B3" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="158"/>
                    <measurement group_id="B2" value="155"/>
                    <measurement group_id="B3" value="313"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="186"/>
                    <count group_id="B2" value="186"/>
                    <count group_id="B3" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Number of Medications at Enrollment</title>
          <units>Medications</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="186"/>
                    <count group_id="B2" value="186"/>
                    <count group_id="B3" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.0" lower_limit="19.2" upper_limit="29.0"/>
                    <measurement group_id="B2" value="23.0" lower_limit="19.0" upper_limit="29.0"/>
                    <measurement group_id="B3" value="23.0" lower_limit="19.0" upper_limit="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anticholinergic and Sedative Drug Burden Index</title>
          <description>A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic &amp; Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic &amp; Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="186"/>
                    <count group_id="B2" value="186"/>
                    <count group_id="B3" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.1" lower_limit="2.9" upper_limit="5.4"/>
                    <measurement group_id="B2" value="4.5" lower_limit="3.1" upper_limit="6.3"/>
                    <measurement group_id="B3" value="4.2" lower_limit="2.9" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vulnerable Elders Survey 13 (VES-13)</title>
          <description>The Vulnerable Elders Survey 13 (VES-13) is a self-rating of functional health status, and it consists of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The total score ranges from 0 to 10. A score &gt;=3 was considered to show impairment (i.e., worse outcome).</description>
          <population>The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="157"/>
                    <count group_id="B2" value="153"/>
                    <count group_id="B3" value="310"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7" lower_limit="3" upper_limit="8"/>
                    <measurement group_id="B2" value="7" lower_limit="3" upper_limit="8"/>
                    <measurement group_id="B3" value="7" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Adherence to Refills and Medications Scale (ARMS)</title>
          <description>Trained research staff administered the Adherence to Refills and Medication Scale (ARMS). Participants indicate the extent of their adherence on a 4-point Likert-like scale. Responses range from 1=&quot;none of the time&quot; to 4=&quot;all of the time,&quot; and are summed to produce an overall adherence score ranging from 12-48, with lower values indicating better adherence (better outcome).</description>
          <population>The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="141"/>
                    <count group_id="B2" value="136"/>
                    <count group_id="B3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14" lower_limit="13" upper_limit="16"/>
                    <measurement group_id="B2" value="15" lower_limit="13" upper_limit="18"/>
                    <measurement group_id="B3" value="15" lower_limit="13" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Number of Medications</title>
        <description>The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.</description>
        <time_frame>Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC</time_frame>
        <population>Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The &quot;number analyzed&quot; below for each time point reflects the number of participants who completed that particular study time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Shed-Meds: A Patient-Centered Deprescribing Intervention</title>
            <description>Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.&#xD;
Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Medications</title>
          <description>The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.</description>
          <population>Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The &quot;number analyzed&quot; below for each time point reflects the number of participants who completed that particular study time point.</population>
          <units>Medications</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hospital Discharge (approximately 3 days after study enrollment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="12" upper_limit="18"/>
                    <measurement group_id="O2" value="16" lower_limit="12" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Acute Care Discharge (approximately 31 days after study enrollment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="10" upper_limit="16"/>
                    <measurement group_id="O2" value="15" lower_limit="12" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="9" upper_limit="16"/>
                    <measurement group_id="O2" value="14" lower_limit="11" upper_limit="18"/>
                  </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>Statistical Analysis 1 applies to the Hospital Discharge timepoint (average 3 days after study enrollment)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 2 applies to the Post-Acute Care Discharge time point (occurred on average 31 days after study enrollment)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 3 applies to the 90 Day Follow-Up After PAC Discharge (occurred, on average, 122 days after study enrollment)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug</title>
        <description>A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic &amp; Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic &amp; Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome).</description>
        <time_frame>Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC</time_frame>
        <population>Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The &quot;number analyzed&quot; below for each time point reflects the number of participants who completed that particular study time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Shed-Meds: A Patient-Centered Deprescribing Intervention</title>
            <description>Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.&#xD;
Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug</title>
          <description>A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic &amp; Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic &amp; Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome).</description>
          <population>Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The &quot;number analyzed&quot; below for each time point reflects the number of participants who completed that particular study time point.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hospital Discharge (approximately 3 days after study enrollment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="1.5" upper_limit="3.4"/>
                    <measurement group_id="O2" value="2.9" lower_limit="1.9" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Acute Care Discharge (approximately 31 days after study enrollment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="1.3" upper_limit="3.1"/>
                    <measurement group_id="O2" value="2.7" lower_limit="1.5" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90-Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="2.8"/>
                    <measurement group_id="O2" value="2.3" lower_limit="1.3" upper_limit="3.7"/>
                  </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>Statistical Analysis 1 applies to the Hospital Discharge time point (occurred, on average, 3 days after study enrollment)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 2 applies to Post-Acute Care Discharge time point (occurred, on average, 31 days after study enrollment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.00001</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 3 applies to 90-Day Follow Up After PAC Discharge time point (occurred, on average, 122 after study enrollment).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days.</time_frame>
      <desc>The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.</desc>
      <group_list>
        <group group_id="E1">
          <title>Shed-Meds: A Patient-Centered Deprescribing Intervention</title>
          <description>Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.&#xD;
Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (12.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="186"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="186"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemias (NEC)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Spleen Disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>White Blood Cell Disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart Failure</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="186"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Cardiac Arrhythmias</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="186"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Motility and Defecation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Exocrine Pancreas Conditions</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Signs &amp; Symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Stenosis &amp; Obstructions</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General System Disorders (NEC)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Device Issues</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Gallbladder Disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="186"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infections</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="186"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Infections - Pathogen Unspecified</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="186"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Bacterial Infections Disorders</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="186"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Sepsis - Pathogen unspecified</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="186"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Fungal Infection Disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Viral Infectious Disorders</sub_title>
                <description>COVID-19</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="186"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Bone &amp; Joint Fractures</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Cerebral Injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Poisoning &amp; Toxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Procedural Related Injuries &amp; Complications</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haematology Investigations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Electrolyte and Fluid Balance Conditions</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Glucose Metabolism Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Calcium Metabolic Disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Phosphorous Metabolism Disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint Disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Plasma Cell Neoplasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Central Nervous System Vascular Disorders</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="186"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Seizures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Peripheral Neuropathies</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental Disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Depressive Disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Anxiety Disorders &amp; Symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Delusion Symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="186"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Urinary Tract Signs &amp; Symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Male Reproductive Tract Infections &amp; Inflammations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="186"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Bronchial Disorders (excludes neoplasms)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Pleural Disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Pulmonary Hypertensions</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular Hypotensive Disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Vascular Hypertensive Disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Embolism &amp; Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
              </event>
              <event>
                <sub_title>Vascular Haemorrhagic Disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (12.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="186"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="186"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="186"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="186"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="186"/>
              </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>Sandra F Simmons, PhD, Principle Investigator</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>615-343-6729</phone>
      <email>sandra.simmons@vumc.org</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/NCT02979353
org study id: R01AG053264-01
secondary id: R01AG053264
nct id: NCT02979353
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized, controlled trial will evaluate the effects of an intervention to reduce
      exposure to medications among hospitalized older adults discharged to skilled nursing
      facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as
      defined by dose reductions and stopped medications, based on a combination of clinical
      criteria and patient preferences. The investigators will evaluate the effects of the
      intervention on the total number of medications prescribed to patients at hospital and SNF
      discharge and at home 90-days after SNF discharge along with the prevalence of eight
      geriatric syndromes, medication adherence, and health status.
This randomized, controlled trial will evaluate the effects of an intervention to reduce
      exposure to medications among hospitalized older adults discharged to skilled nursing
      facilities (SNFs). This study will be conducted in one university-affiliated hospital and 14
      area SNFs to enroll approximately 1,300 total participants across five project years.
      Patients discharged to SNF represent the largest segment of Medicare beneficiaries discharged
      to post-acute care services and are a particularly high risk group for loss of independence
      and other poor clinical outcomes. This investigative team recently completed a Centers for
      Medicare and Medicaid Services (CMS) Innovation Award, which provides strong preliminary data
      related to the prevalence of polypharmacy and the relationship between polypharmacy and
      geriatric syndromes (e.g., medications associated with falls) in this patient population.
      Based on these data, the investigators developed a structured deprescribing intervention
      protocol ("Shed-Meds") coupled with standardized screening assessments for eight geriatric
      syndromes to be implemented in the hospital and continued during the SNF stay. The goal of
      the intervention is to safely deprescribe medications, as defined by dose reductions and
      stopped medications, based on a combination of clinical criteria and patient preferences.
      This trial will evaluate the effects of this intervention on medication exposure, medication
      adherence, geriatric syndromes, and health status across the care transitions from hospital
      to SNF to home to include a 90-day follow-up period after SNF discharge. The overarching
      hypothesis is that reducing medications for older patients across the continuum of care will
      favorably impact geriatric syndromes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Total Number of Medications
time frame: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC
description: The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.
measure: Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug
time frame: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC
description: A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic & Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic & Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome).
arm group label: Shed-Meds: A Patient-Centered Deprescribing Intervention
arm group type: Experimental
description: Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.
arm group label: Control Group
arm group type: No Intervention
description: Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified.
intervention type: Behavioral
intervention name: Shed-Meds: A Patient-Centered Deprescribing Intervention
description: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.
arm group label: Shed-Meds: A Patient-Centered Deprescribing Intervention
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Sandra F Simmons, PhD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
citation: Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Kripalani S, Mixon AS, Simmons SF. Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):223-231. doi: 10.1001/jamainternmed.2022.6545.
PMID: 36745422
citation: Kim JL, Lewallen KM, Hollingsworth EK, Shah AS, Simmons SF, Vasilevskis EE. Patient-Reported Barriers and Enablers to Deprescribing Recommendations During a Clinical Trial (Shed-MEDS). Gerontologist. 2023 Mar 21;63(3):523-533. doi: 10.1093/geront/gnac100.
PMID: 35881109
citation: Hollingsworth EK, Shah AS, Shotwell MS, Simmons SF, Vasilevskis EE. Older Patient and Surrogate Attitudes Toward Deprescribing During the Transition From Acute to Post-Acute Care. J Appl Gerontol. 2022 Mar;41(3):788-797. doi: 10.1177/07334648211015756.
PMID: 35164584
citation: Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Simmons SF, Vasilevskis EE. Sources of medication omissions among hospitalized older adults with polypharmacy. J Am Geriatr Soc. 2022 Apr;70(4):1180-1189. doi: 10.1111/jgs.17629. Epub 2021 Dec 30.
PMID: 34967444
citation: Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Bell SP, Kripalani S, Schnelle JF, Simmons SF; Shed-MEDS Team. A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial. BMC Health Serv Res. 2019 Mar 14;19(1):165. doi: 10.1186/s12913-019-3995-3.
PMID: 30871561
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Sandra Simmons
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: Deidentified data may be shared, per written request and completion of formal data sharing agreement approved by the institution
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 