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/NCT06001775</url>
    </required_header>
    <id_info>
      <org_study_id>FY22_Pilot1_Carnahan</org_study_id>
      <secondary_id>15345</secondary_id>
      <secondary_id>Pro00063400</secondary_id>
      <secondary_id>U54AG063546</secondary_id>
      <nct_id>NCT06001775</nct_id>
    </id_info>
    <brief_title>Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia</brief_title>
    <acronym>IN-TX-PPC</acronym>
    <official_title>Embedded Clinical Trial of Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indiana University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Indiana University</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>
        The goal of this pragmatic, embedded clinical trial is to analyze the implementation of&#xD;
        Patient Priorities Care in primary care and geriatrics clinics with patients living with&#xD;
        dementia or mild cognitive impairment. This study aims are:&#xD;
  &#xD;
          -  demonstrate the feasibility of using the electronic health record to identify a diverse&#xD;
             cohort of eligible patient and patient-care partner dyads who will engage in a Patient&#xD;
             Priorities Care conversation with a trained facilitator.&#xD;
  &#xD;
          -  demonstrate feasibility of pragmatically assessing clinical outcomes using the&#xD;
             electronic health record, including a) number of days at home, b) total medications, and&#xD;
             c) new referrals to specialist physicians.&#xD;
  &#xD;
          -  examine key feasibility measures across racial, ethnic, and socioeconomic subgroups.&#xD;
  &#xD;
        Participants will receive a packet of information about Patient Priorities Care from their&#xD;
        primary care clinic, in advance of their next upcoming clinic appointment. Individuals who&#xD;
        receive a packet will have the opportunity to engage in a conversation about what matters&#xD;
        most to them and what their priorities are, with trained facilitators at the clinic.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients with documentation of Patient Priorities Care discussion in the electronic health record</measure>
      <time_frame>Baseline</time_frame>
      <description>We will use a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identification of a care partner</measure>
      <time_frame>2 months pre and 2 months post baseline</time_frame>
      <description>Identification of a care partner for 50% of eligible persons living with dementia and mild cognitive impairment. Care partners will be identified based on information provided by the patient, the electronic health record, and the clinical team.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability</measure>
      <time_frame>Baseline and up to 2 months post baseline</time_frame>
      <description>We will utilize Sekhon et al's Theoretical Framework of Acceptability (TFA) to qualitatively assess acceptability, which includes meeting definitions outlined within the framework, represented by seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appropriateness</measure>
      <time_frame>Baseline and up to 2 months post baseline</time_frame>
      <description>We will assess appropriateness via qualitative exit interviews with patients, care partners, and clinicians.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of the intervention using Proctor et al as a guide</measure>
      <time_frame>Baseline and up to 2 months post baseline</time_frame>
      <description>Feasibility will be assessed qualitatively using the description provided by Proctor et al as a guide.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fidelity to the intervention</measure>
      <time_frame>Baseline and up to 2 months post baseline</time_frame>
      <description>Fidelity will be assessed when select charts are reviewed for adherence to the protocol.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Potential for future adoption of Patient Priorities Care intervention</measure>
      <time_frame>Baseline and up to 2 months post baseline</time_frame>
      <description>We will assess potential for future adoption of the intervention via qualitative exit interviews with patients, care partners, and clinicians.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patient days at home</measure>
      <time_frame>2 months pre and 2 months post baseline</time_frame>
      <description>We will use the electronic health record to assess for hospital visits, emergency room visits, or nursing home admissions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of total medications</measure>
      <time_frame>2 months pre and 2 months post baseline</time_frame>
      <description>We will use the electronic health record to assess the medication list total at 2 months pre and post baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of new referrals to specialist physicians</measure>
      <time_frame>2 months pre and 2 months post baseline</time_frame>
      <description>We will use the electronic health record to assess referrals to specialists at 2 months pre and post baseline</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Dementia</condition>
    <condition>Mild Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients (and their care partners when available) will receive a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) will initiate a Patient Priorities Care conversation with the patient or patient care partner dyad. This conversation will be documented in the Electronic Health Record.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patient Priorities Care</intervention_name>
      <description>According to patientprioritiescare.org a Patient Priorities Care conversation helps to align healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare.</description>
      <arm_group_label>Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patient Inclusion Criteria&#xD;
  &#xD;
          Patients must meet all of the following criteria to participate in this study:&#xD;
  &#xD;
            -  40 years or older&#xD;
  &#xD;
                 -  English-speaking at both Indiana sites or English and/or Spanish speaking at the&#xD;
                    University of Texas site&#xD;
  &#xD;
                 -  Receiving care with a participating physician&#xD;
  &#xD;
                 -  Has a scheduled outpatient care visit within 1-2 months (60 days)&#xD;
  &#xD;
                 -  Individual has a diagnosis of MCI or dementia&#xD;
  &#xD;
          Definition: To identify individuals with dementia and MCI, we will use two or more&#xD;
          instances of use of an ICD-10 code for either diagnosis in the EHR within 24 months.&#xD;
          Typically, we would include instances of these billing codes within a year of each other&#xD;
          but, due to the COVID-19 pandemic, recognize that there may be less frequent clinical&#xD;
          visits and less robust billing. Diagnostic codes include:&#xD;
  &#xD;
          • F01.50, F01.51, F02.80, F02.81, F03.90, G30.0, G30.1, G30.8, G30.9, G31.01, G31.09,&#xD;
          G31.1, G31.2, F41.81, G31.84 and F03.91.&#xD;
  &#xD;
          Care Partner Inclusion Criteria&#xD;
  &#xD;
          Care partners must meet all of the following criteria to participate in the study:&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  English-speaking at both Indiana sites or English and/or Spanish speaking at the&#xD;
               University of Texas site&#xD;
  &#xD;
          A note about inclusion of care partners: Clinician determination of a patient's capacity to&#xD;
          participate in a visit independently is part of a pragmatic approach. This means that&#xD;
          clinic staff will determine when a care partner is needed. Generally, we act under the&#xD;
          assumption that patients who require a care partner will have already included them in&#xD;
          previous visits and/or provider communications (and we anticipate that this will be&#xD;
          documented in the EHR), whereas patients who attend clinic visits independently and have no&#xD;
          documentation indicating the involvement of a care partner in their medical decisions, or a&#xD;
          need for one, will be determined to have the capacity to also participate in a PPC visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Participants who meet any of the following criteria will be excluded from the study:&#xD;
  &#xD;
            -  Is not community-dwelling- e.g. lives in a nursing home&#xD;
  &#xD;
            -  Is enrolled in hospice&#xD;
  &#xD;
            -  Individuals who decline to receive the PPC intervention (i.e. decline to have the PPC&#xD;
               conversation) will be excluded from the study.&#xD;
  &#xD;
                 -  Note that declining to receive the PPC intervention will in no way impact the&#xD;
                    care that patients receive now or in the future.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jennifer L Carnahan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Regenstrief Institute, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emily Burke, BA</last_name>
      <phone>3172749047</phone>
      <email>esburke@regenstrief.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jennifer L Carnahan, MD</last_name>
      <email>jenncarn@iupui.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Regenstrief Institute, Inc.</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jennifer L Carnahan, MD</last_name>
      </contact>
      <investigator>
        <last_name>Jennifer L Carnahan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rafael Samper-Ternent, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://patientprioritiescare.org</url>
      <description>Patient Priorities Care homepage</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Regenstrief Institute, Inc.</investigator_affiliation>
      <investigator_full_name>Jennifer L Carnahan</investigator_full_name>
      <investigator_title>Research Scientist</investigator_title>
    </responsible_party>
    <keyword>dementia</keyword>
    <keyword>mild cognitive impairment</keyword>
    <keyword>patient priorities care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Since this study is a pragmatic trial in a clinical environment, the majority of our outcomes will be determined via data that is already held in the EHR. Therefore a plan for sharing IPD seems unnecessary.</ipd_description>
    </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/NCT06001775
  org study id: FY22_Pilot1_Carnahan
  secondary id: 15345
  secondary id: Pro00063400
  secondary id: U54AG063546
  nct id: NCT06001775
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pragmatic, embedded clinical trial is to analyze the implementation of
        Patient Priorities Care in primary care and geriatrics clinics with patients living with
        dementia or mild cognitive impairment. This study aims are:
  
          -  demonstrate the feasibility of using the electronic health record to identify a diverse
             cohort of eligible patient and patient-care partner dyads who will engage in a Patient
             Priorities Care conversation with a trained facilitator.
  
          -  demonstrate feasibility of pragmatically assessing clinical outcomes using the
             electronic health record, including a) number of days at home, b) total medications, and
             c) new referrals to specialist physicians.
  
          -  examine key feasibility measures across racial, ethnic, and socioeconomic subgroups.
  
        Participants will receive a packet of information about Patient Priorities Care from their
        primary care clinic, in advance of their next upcoming clinic appointment. Individuals who
        receive a packet will have the opportunity to engage in a conversation about what matters
        most to them and what their priorities are, with trained facilitators at the clinic.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Number of patients with documentation of Patient Priorities Care discussion in the electronic health record
  time frame: Baseline
  description: We will use a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded
  measure: Identification of a care partner
  time frame: 2 months pre and 2 months post baseline
  description: Identification of a care partner for 50% of eligible persons living with dementia and mild cognitive impairment. Care partners will be identified based on information provided by the patient, the electronic health record, and the clinical team.
  measure: Acceptability
  time frame: Baseline and up to 2 months post baseline
  description: We will utilize Sekhon et al's Theoretical Framework of Acceptability (TFA) to qualitatively assess acceptability, which includes meeting definitions outlined within the framework, represented by seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.
  measure: Appropriateness
  time frame: Baseline and up to 2 months post baseline
  description: We will assess appropriateness via qualitative exit interviews with patients, care partners, and clinicians.
  measure: Feasibility of the intervention using Proctor et al as a guide
  time frame: Baseline and up to 2 months post baseline
  description: Feasibility will be assessed qualitatively using the description provided by Proctor et al as a guide.
  measure: Fidelity to the intervention
  time frame: Baseline and up to 2 months post baseline
  description: Fidelity will be assessed when select charts are reviewed for adherence to the protocol.
  measure: Potential for future adoption of Patient Priorities Care intervention
  time frame: Baseline and up to 2 months post baseline
  description: We will assess potential for future adoption of the intervention via qualitative exit interviews with patients, care partners, and clinicians.
  measure: Number of patient days at home
  time frame: 2 months pre and 2 months post baseline
  description: We will use the electronic health record to assess for hospital visits, emergency room visits, or nursing home admissions.
  measure: Number of total medications
  time frame: 2 months pre and 2 months post baseline
  description: We will use the electronic health record to assess the medication list total at 2 months pre and post baseline.
  measure: Number of new referrals to specialist physicians
  time frame: 2 months pre and 2 months post baseline
  description: We will use the electronic health record to assess referrals to specialists at 2 months pre and post baseline
  arm group label: Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment
  arm group type: Experimental
  description: Patients (and their care partners when available) will receive a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) will initiate a Patient Priorities Care conversation with the patient or patient care partner dyad. This conversation will be documented in the Electronic Health Record.
  intervention type: Behavioral
  intervention name: Patient Priorities Care
  description: According to patientprioritiescare.org a Patient Priorities Care conversation helps to align healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare.
  arm group label: Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jennifer L Carnahan, MD
  role: Principal Investigator
  affiliation: Regenstrief Institute, Inc.
  last name: Emily Burke, BA
  phone: 3172749047
  email: esburke@regenstrief.org
  last name: Jennifer L Carnahan, MD
  email: jenncarn@iupui.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: United States
  url: http://patientprioritiescare.org
  description: Patient Priorities Care homepage
  responsible party type: Principal Investigator
  investigator affiliation: Regenstrief Institute, Inc.
  investigator full name: Jennifer L Carnahan
  investigator title: Research Scientist
  mesh term: Dementia
  mesh term: Cognitive Dysfunction
  sharing ipd: No
  ipd description: Since this study is a pragmatic trial in a clinical environment, the majority of our outcomes will be determined via data that is already held in the EHR. Therefore a plan for sharing IPD seems unnecessary.