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/NCT05996237</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY23060137</org_study_id>
      <nct_id>NCT05996237</nct_id>
    </id_info>
    <brief_title>Older Adults' Readiness to Stop Prescribed Medications</brief_title>
    <official_title>Older Adults' Readiness to Stop Prescribed Medications With Guidance From Health Care Professionals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pittsburgh</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>
        Polypharmacy, regular use of 5+ prescribed medications, is common among older adults and&#xD;
        potentially harmful. Patients differ in their concern about medications, comfort in raising&#xD;
        questions about them, and trust and confidence in physician judgment. This pilot&#xD;
        observational research will determine older adults' readiness to &quot;deprescribe,&quot; that is, stop&#xD;
        prescribed medications under physician guidance.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this research is to assess readiness to deprescribe, that is, to determine how&#xD;
        willing patients are to stop prescriptions that may no longer be necessary or may no longer&#xD;
        have a favorable benefit-risk ratio. This readiness depends on many factors, including a&#xD;
        patient's trust in a health care provider, how proactive patients are in seeking care, and&#xD;
        patients' comfort in changing longstanding medical regimens.&#xD;
  &#xD;
        The proposed two-wave survey research will use validated instruments and recruit from an&#xD;
        older adult research registry to determine (i) readiness to deprescribe at baseline, (ii)&#xD;
        correlates of such readiness, and (iii) effects of intercurrent illness and changing health&#xD;
        on readiness to deprescribe at 6 months.&#xD;
  &#xD;
        Specific aims:&#xD;
  &#xD;
          1. Determine readiness to deprescribe among a sample of patients with 5+ prescriptions&#xD;
             using validated scales.&#xD;
  &#xD;
          2. Determine correlates of readiness to deprescribe. Patients differing in age, gender,&#xD;
             race, education, and comorbidity may differ in willingness to stop prescribed&#xD;
             medications.&#xD;
  &#xD;
          3. Determine the effect of intercurrent illness on readiness to deprescribe. Over 6 months,&#xD;
             we anticipate some patients will have a new onset of illness or hospitalization, or&#xD;
             increasing levels of disability. We would like to determine if these changes in medical&#xD;
             status affect readiness to deprescribe.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Patient Motivation to Deprescribe</measure>
      <time_frame>Change over 6 months</time_frame>
      <description>Self-report measure (Linsky 2020): range 1-5; high scores = greater readiness to deprescribe; mean (SD) in VA sample 2.99 (0.80)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-reported stopping/changing prescription medication</measure>
      <time_frame>6 months</time_frame>
      <description>Self-report of stopping, tapering, or altering use of any prescription, with or without physician discussion</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">135</enrollment>
    <condition>Polypharmacy, Decision-making</condition>
    <arm_group>
      <arm_group_label>Registry participants</arm_group_label>
      <description>Participants in the University of Pittsburgh Claude D. Pepper Center community research registry. Potential participants will have stable regimens of 5+ prescribed medications and recent physician contact but no hospitalization in the prior 6 months.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Participants in the University of Pittsburgh Claude D. Pepper communty research registry.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 65 years or older&#xD;
  &#xD;
            2. Medical visit within past 6 months&#xD;
  &#xD;
            3. Self-report of at least 5 regular medications for at least 4 weeks&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Diagnosis of dementia or score &lt;=4 on Memory Impairment Screen&#xD;
  &#xD;
            2. Hospitalization in prior 30 days with change in medications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Steven M Albert, PhD</last_name>
      <phone>412-383-8693</phone>
      <email>smalbert@pitt.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Pittsburgh</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15261</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Steven M Albert, PhD</last_name>
        <phone>412-383-8693</phone>
        <email>smalbert@pitt.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
      <investigator_full_name>Steven M. Albert</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified individual-level data will be made available to investigators upon request following publication of key findings.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After 6/1/25, available for 2 years</ipd_time_frame>
      <ipd_access_criteria>Written request to investigator</ipd_access_criteria>
    </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/NCT05996237
  org study id: STUDY23060137
  nct id: NCT05996237
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Polypharmacy, regular use of 5+ prescribed medications, is common among older adults and
        potentially harmful. Patients differ in their concern about medications, comfort in raising
        questions about them, and trust and confidence in physician judgment. This pilot
        observational research will determine older adults' readiness to "deprescribe," that is, stop
        prescribed medications under physician guidance.
  The purpose of this research is to assess readiness to deprescribe, that is, to determine how
        willing patients are to stop prescriptions that may no longer be necessary or may no longer
        have a favorable benefit-risk ratio. This readiness depends on many factors, including a
        patient's trust in a health care provider, how proactive patients are in seeking care, and
        patients' comfort in changing longstanding medical regimens.
  
        The proposed two-wave survey research will use validated instruments and recruit from an
        older adult research registry to determine (i) readiness to deprescribe at baseline, (ii)
        correlates of such readiness, and (iii) effects of intercurrent illness and changing health
        on readiness to deprescribe at 6 months.
  
        Specific aims:
  
          1. Determine readiness to deprescribe among a sample of patients with 5+ prescriptions
             using validated scales.
  
          2. Determine correlates of readiness to deprescribe. Patients differing in age, gender,
             race, education, and comorbidity may differ in willingness to stop prescribed
             medications.
  
          3. Determine the effect of intercurrent illness on readiness to deprescribe. Over 6 months,
             we anticipate some patients will have a new onset of illness or hospitalization, or
             increasing levels of disability. We would like to determine if these changes in medical
             status affect readiness to deprescribe.
  observational model: Cohort
  time perspective: Prospective
  measure: Patient Motivation to Deprescribe
  time frame: Change over 6 months
  description: Self-report measure (Linsky 2020): range 1-5; high scores = greater readiness to deprescribe; mean (SD) in VA sample 2.99 (0.80)
  measure: Self-reported stopping/changing prescription medication
  time frame: 6 months
  description: Self-report of stopping, tapering, or altering use of any prescription, with or without physician discussion
  arm group label: Registry participants
  description: Participants in the University of Pittsburgh Claude D. Pepper Center community research registry. Potential participants will have stable regimens of 5+ prescribed medications and recent physician contact but no hospitalization in the prior 6 months.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  last name: Steven M Albert, PhD
  phone: 412-383-8693
  email: smalbert@pitt.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pittsburgh
  investigator full name: Steven M. Albert
  investigator title: Professor
  sharing ipd: Yes
  ipd description: De-identified individual-level data will be made available to investigators upon request following publication of key findings.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: After 6/1/25, available for 2 years
  ipd access criteria: Written request to investigator