xml: <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/NCT05964205</url>
    </required_header>
    <id_info>
      <org_study_id>23-626</org_study_id>
      <nct_id>NCT05964205</nct_id>
    </id_info>
    <brief_title>Analysis of a Stepped-Wedge Implementation of the PT-PENCIL Tool</brief_title>
    <acronym>PT-PENCIL Tool</acronym>
    <official_title>Analysis of a Stepped-Wedge Implementation of the PT-PENCIL Tool</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Joshua Johnson DPT PhD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Learning Health Systems Rehabilitation Research Network</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Cleveland Clinic</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Despite the need to evolve, the fact that physical therapists are a constrained resource&#xD;
        prompts the need for care prioritization that is optimally targeted. It is currently unclear&#xD;
        which patients need physical therapist intervention in the hospital, and how much physical&#xD;
        therapy is necessary, in order to achieve a functional status that is adequate to discharge&#xD;
        home. We have developed a patient-level clinical decision support tool to guide optimal&#xD;
        treatment frequency. This tool-the Physical Therapy Frequency Clinical Decision Support Tool,&#xD;
        or &quot;PT-PENCIL&quot;-is based on a statistical model that predicts discharge home relative to the&#xD;
        frequency of physical therapist treatment.&#xD;
  &#xD;
        The primary goals of this study are to assess the implementation strategy for the PT-PENCIL&#xD;
        and analyze its effect on improving the proportion of patients who discharge home.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction and Aims Most patients prefer to discharge from the hospital to their own home,&#xD;
        but 11% of all hospitalized patients-and 22.4% of patients with Medicare-require discharge to&#xD;
        a post-acute care facility. Hospital systems are increasingly incentivized to facilitate&#xD;
        discharge home since a post-acute care facility stay is costly. Post-acute care is most often&#xD;
        necessitated by a patient's functional decline during hospitalization. Physical therapists,&#xD;
        whose primary treatment objective is generally to improve functional independence, could&#xD;
        therefore play a crucial role in promoting improvements in functional status sufficient to&#xD;
        enable a greater number of discharges to home.&#xD;
  &#xD;
        In current practice, however, physical therapists in acute care hospitals do not generally&#xD;
        address patients' function-related deficits. They do not generally have the opportunity to do&#xD;
        so, since the Inpatient Prospective Payment System incentivizes short hospital stays. Nor&#xD;
        have they needed to, since post-acute care facilities have become the primary setting for&#xD;
        patients to regain functional independence. In this environment, physical therapists-a&#xD;
        constrained resource in most hospitals primarily play a consultative role in which they&#xD;
        evaluate functional status during a single visit in order to provide a recommendation for&#xD;
        appropriate post-acute rehabilitation needs. With greater focus on ensuring value across the&#xD;
        care continuum, healthcare systems are now striving to maintain short hospital stays, but&#xD;
        also limit post-acute care utilization. This will require patients to achieve greater&#xD;
        functional independence as quickly as possible within their hospital stay. Thus, the role of&#xD;
        physical therapists in acute care hospitals must evolve.&#xD;
  &#xD;
        Intervention&#xD;
  &#xD;
        Despite the need to evolve, the fact that physical therapists are a constrained resource&#xD;
        prompts the need for care prioritization that is optimally targeted. It is currently unclear&#xD;
        which patients need physical therapist intervention in the hospital, and how much physical&#xD;
        therapy is necessary, in order to achieve a functional status that is adequate to discharge&#xD;
        home. We have developed a patient-level clinical decision support tool to guide optimal&#xD;
        treatment frequency. This tool-the Physical Therapy Frequency Clinical Decision Support Tool,&#xD;
        or &quot;PT-PENCIL&quot;-is based on a statistical model that predicts discharge home relative to the&#xD;
        frequency of physical therapist treatment. The primary goals of this study are to assess the&#xD;
        development and implementation strategy for the PT-PENCIL and analyze its effect on improving&#xD;
        the proportion of patients who discharge home.&#xD;
  &#xD;
        The PT-PENCIL will include two solutions integrated into the electronic health record (Epic).&#xD;
        For both, Epic will use the underlying statistical model to identify patients for whom daily&#xD;
        physical therapy may be indicated in order to facilitate a discharge to home. For such&#xD;
        patients, an Epic best practice advisory (BPA) alert will appear on the screen, which will&#xD;
        prompt therapists to consider a visit on the next day.&#xD;
  &#xD;
        The second Epic-integrated solution is an indicator column on the patient lists maintained by&#xD;
        therapists, which will identify patients who would benefit from daily PT (a green dot), those&#xD;
        who would not (a red dot), and those for whom the PT-PENCIL did not run in Epic.&#xD;
  &#xD;
        PT-PENCIL will be implemented into clinical care by means of a pilot hybrid type 2 design,&#xD;
        informed by the PRISM (Practical, Robust Implementation and Sustainability Model) and RE-AIM&#xD;
        (reach, effectiveness, adoption, implementation, and maintenance) frameworks. We will&#xD;
        accomplish the following primary specific aims:&#xD;
  &#xD;
        Aim 1: Analyze the effect of using the PT-PENCIL on the proportion of patients discharged&#xD;
        home.&#xD;
  &#xD;
        Aim 2: Assess the reach, adoption, acceptability, appropriateness, and feasibility of the&#xD;
        PT-PENCIL.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>30 Days</target_duration>
    <primary_outcome>
      <measure>Effectiveness of evaluation on discharge home vs facility</measure>
      <time_frame>Day of hospital discharge</time_frame>
      <description>Whether or not the patient was discharged home (vs. a facility)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reach</measure>
      <time_frame>Measured over the 24-week trial period</time_frame>
      <description>The number of patients for whom the PT-PENCIL algorithm ran in the EHR</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adoption</measure>
      <time_frame>Measured over the 24-week trial period</time_frame>
      <description>The number of therapists who acknowledge the PT-PENCIL best practice advisory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of PT-Pencil</measure>
      <time_frame>Measured at baseline and conclusion of 24-week trial</time_frame>
      <description>The rating of acceptability amongst physical therapists completing the Acceptability of the Intervention Measure (AIM) higher scores indicates greater acceptability. The scale ranges from 1-5.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Appropriateness of PT-Pencil</measure>
      <time_frame>Measured at baseline and conclusion of 24-week trial</time_frame>
      <description>The rating of appropriateness amongst physical therapists completing the Intervention Appropriateness Measure (IAM) higher scores indicates greater appropriateness. The scale ranges from 1-5.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility Rate of PT-Pencil</measure>
      <time_frame>Measured at baseline and conclusion of 24-week trial</time_frame>
      <description>The rating of feasibility amongst physical therapists completing the Feasibility of the Intervention Measure (FIM) higher scores indicates greater feasibility. The scale ranges from 1-5.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">9704</enrollment>
    <condition>Physical Therapy Evaluation</condition>
    <arm_group>
      <arm_group_label>PT-PENCIL cohort</arm_group_label>
      <description>patients discharged from the hospital while the PT-PENCIL was active</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control cohort</arm_group_label>
      <description>patients discharged from the hospital while the PT-PENCIL was not active</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electronic clinical decision support tool</intervention_name>
      <description>Electronic clinical decision support tool</description>
      <arm_group_label>PT-PENCIL cohort</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Physical Therapists at CCF Main, Fairview, &amp; Hillcrest hospitals who are being trained on&#xD;
          the use and implementation of the PT-PENCIL tool for general clinical care.&#xD;
  &#xD;
          Patients (SOC data) who are seen by physical therapists at CCF Main, Fairview, &amp; Hillcrest&#xD;
          hospitals during the study time period, who may or may not (dependent on the pilot&#xD;
          stepped-wedge design, see protocol) have the PT-PENCIL tool utilized in their care.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Admitted for at least one overnight&#xD;
  &#xD;
            -  Total ICU LOS &lt; 48 hours&#xD;
  &#xD;
            -  Primary medical service is any of: cardiology, vascular medicine, cardiac surgery,&#xD;
               thoracic surgery, vascular surgery, dermatology, endocrinology, hepatology, internal&#xD;
               medicine, obstetrics/gynecology, pulmonology, nephrology, urology, colorectal surgery,&#xD;
               general surgery, neurology, neurosurgery&#xD;
  &#xD;
          Exclusion&#xD;
  &#xD;
          - Individuals under the age of 18.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joshua Johnson, DPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Corey Jefferson, BS</last_name>
      <phone>216 445-4711</phone>
      <email>jefferc@ccf.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Donayja Harris, BS</last_name>
      <phone>2164132425</phone>
      <email>harrisD47@ccf.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cleveland Clinic</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Corey Jefferson, BS</last_name>
        <phone>216-445-4711</phone>
        <email>jefferc@ccf.org</email>
      </contact>
      <contact_backup>
        <last_name>Donayja Harris, BS</last_name>
        <phone>2164132425</phone>
      </contact_backup>
      <investigator>
        <last_name>Joshua Johnson, DPT</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>Joshua Johnson DPT PhD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964205
  org study id: 23-626
  nct id: NCT05964205
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Despite the need to evolve, the fact that physical therapists are a constrained resource
        prompts the need for care prioritization that is optimally targeted. It is currently unclear
        which patients need physical therapist intervention in the hospital, and how much physical
        therapy is necessary, in order to achieve a functional status that is adequate to discharge
        home. We have developed a patient-level clinical decision support tool to guide optimal
        treatment frequency. This tool-the Physical Therapy Frequency Clinical Decision Support Tool,
        or "PT-PENCIL"-is based on a statistical model that predicts discharge home relative to the
        frequency of physical therapist treatment.
  
        The primary goals of this study are to assess the implementation strategy for the PT-PENCIL
        and analyze its effect on improving the proportion of patients who discharge home.
  Introduction and Aims Most patients prefer to discharge from the hospital to their own home,
        but 11% of all hospitalized patients-and 22.4% of patients with Medicare-require discharge to
        a post-acute care facility. Hospital systems are increasingly incentivized to facilitate
        discharge home since a post-acute care facility stay is costly. Post-acute care is most often
        necessitated by a patient's functional decline during hospitalization. Physical therapists,
        whose primary treatment objective is generally to improve functional independence, could
        therefore play a crucial role in promoting improvements in functional status sufficient to
        enable a greater number of discharges to home.
  
        In current practice, however, physical therapists in acute care hospitals do not generally
        address patients' function-related deficits. They do not generally have the opportunity to do
        so, since the Inpatient Prospective Payment System incentivizes short hospital stays. Nor
        have they needed to, since post-acute care facilities have become the primary setting for
        patients to regain functional independence. In this environment, physical therapists-a
        constrained resource in most hospitals primarily play a consultative role in which they
        evaluate functional status during a single visit in order to provide a recommendation for
        appropriate post-acute rehabilitation needs. With greater focus on ensuring value across the
        care continuum, healthcare systems are now striving to maintain short hospital stays, but
        also limit post-acute care utilization. This will require patients to achieve greater
        functional independence as quickly as possible within their hospital stay. Thus, the role of
        physical therapists in acute care hospitals must evolve.
  
        Intervention
  
        Despite the need to evolve, the fact that physical therapists are a constrained resource
        prompts the need for care prioritization that is optimally targeted. It is currently unclear
        which patients need physical therapist intervention in the hospital, and how much physical
        therapy is necessary, in order to achieve a functional status that is adequate to discharge
        home. We have developed a patient-level clinical decision support tool to guide optimal
        treatment frequency. This tool-the Physical Therapy Frequency Clinical Decision Support Tool,
        or "PT-PENCIL"-is based on a statistical model that predicts discharge home relative to the
        frequency of physical therapist treatment. The primary goals of this study are to assess the
        development and implementation strategy for the PT-PENCIL and analyze its effect on improving
        the proportion of patients who discharge home.
  
        The PT-PENCIL will include two solutions integrated into the electronic health record (Epic).
        For both, Epic will use the underlying statistical model to identify patients for whom daily
        physical therapy may be indicated in order to facilitate a discharge to home. For such
        patients, an Epic best practice advisory (BPA) alert will appear on the screen, which will
        prompt therapists to consider a visit on the next day.
  
        The second Epic-integrated solution is an indicator column on the patient lists maintained by
        therapists, which will identify patients who would benefit from daily PT (a green dot), those
        who would not (a red dot), and those for whom the PT-PENCIL did not run in Epic.
  
        PT-PENCIL will be implemented into clinical care by means of a pilot hybrid type 2 design,
        informed by the PRISM (Practical, Robust Implementation and Sustainability Model) and RE-AIM
        (reach, effectiveness, adoption, implementation, and maintenance) frameworks. We will
        accomplish the following primary specific aims:
  
        Aim 1: Analyze the effect of using the PT-PENCIL on the proportion of patients discharged
        home.
  
        Aim 2: Assess the reach, adoption, acceptability, appropriateness, and feasibility of the
        PT-PENCIL.
  observational model: Cohort
  time perspective: Other
  measure: Effectiveness of evaluation on discharge home vs facility
  time frame: Day of hospital discharge
  description: Whether or not the patient was discharged home (vs. a facility)
  measure: Reach
  time frame: Measured over the 24-week trial period
  description: The number of patients for whom the PT-PENCIL algorithm ran in the EHR
  measure: Adoption
  time frame: Measured over the 24-week trial period
  description: The number of therapists who acknowledge the PT-PENCIL best practice advisory
  measure: Acceptability of PT-Pencil
  time frame: Measured at baseline and conclusion of 24-week trial
  description: The rating of acceptability amongst physical therapists completing the Acceptability of the Intervention Measure (AIM) higher scores indicates greater acceptability. The scale ranges from 1-5.
  measure: Appropriateness of PT-Pencil
  time frame: Measured at baseline and conclusion of 24-week trial
  description: The rating of appropriateness amongst physical therapists completing the Intervention Appropriateness Measure (IAM) higher scores indicates greater appropriateness. The scale ranges from 1-5.
  measure: Feasibility Rate of PT-Pencil
  time frame: Measured at baseline and conclusion of 24-week trial
  description: The rating of feasibility amongst physical therapists completing the Feasibility of the Intervention Measure (FIM) higher scores indicates greater feasibility. The scale ranges from 1-5.
  arm group label: PT-PENCIL cohort
  description: patients discharged from the hospital while the PT-PENCIL was active
  arm group label: Control cohort
  description: patients discharged from the hospital while the PT-PENCIL was not active
  intervention type: Other
  intervention name: Electronic clinical decision support tool
  description: Electronic clinical decision support tool
  arm group label: PT-PENCIL cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Joshua Johnson, DPT
  role: Principal Investigator
  affiliation: The Cleveland Clinic
  last name: Corey Jefferson, BS
  phone: 216 445-4711
  email: jefferc@ccf.org
  last name: Donayja Harris, BS
  phone: 2164132425
  email: harrisD47@ccf.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
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  responsible party type: Sponsor-Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: Joshua Johnson DPT PhD
  investigator title: Principal Investigator
  sharing ipd: Undecided