Older Adults' Readiness to Stop Prescribed Medications

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05996237
Collaborator
(none)
135
1
16
8.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    135 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Older Adults' Readiness to Stop Prescribed Medications With Guidance From Health Care Professionals
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Aug 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Registry participants

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Patient Motivation to Deprescribe [Change over 6 months]

      Self-report measure (Linsky 2020): range 1-5; high scores = greater readiness to deprescribe; mean (SD) in VA sample 2.99 (0.80)

    Secondary Outcome Measures

    1. Self-reported stopping/changing prescription medication [6 months]

      Self-report of stopping, tapering, or altering use of any prescription, with or without physician discussion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. 65 years or older

    2. Medical visit within past 6 months

    3. Self-report of at least 5 regular medications for at least 4 weeks

    Exclusion criteria:
    1. Diagnosis of dementia or score <=4 on Memory Impairment Screen

    2. Hospitalization in prior 30 days with change in medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Pittsburgh Pennsylvania United States 15261

    Sponsors and Collaborators

    • University of Pittsburgh

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steven M. Albert, Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT05996237
    Other Study ID Numbers:
    • STUDY23060137
    First Posted:
    Aug 18, 2023
    Last Update Posted:
    Aug 18, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 18, 2023