- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05996237
Older Adults' Readiness to Stop Prescribed Medications
Older Adults' Readiness to Stop Prescribed Medications with Guidance from Health Care Professionals
Study Overview
Status
Conditions
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:
- Determine readiness to deprescribe among a sample of patients with 5+ prescriptions using validated scales.
- Determine correlates of readiness to deprescribe. Patients differing in age, gender, race, education, and comorbidity may differ in willingness to stop prescribed medications.
- 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 65 years or older
- Medical visit within past 6 months
- Self-report of at least 5 regular medications for at least 4 weeks
Exclusion criteria:
- Diagnosis of dementia or score <=4 on Memory Impairment Screen
- Hospitalization in prior 30 days with change in medications
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Motivation to Deprescribe
Time Frame: 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)
|
Change over 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported stopping/changing prescription medication
Time Frame: 6 months
|
Self-report of stopping, tapering, or altering use of any prescription, with or without physician discussion
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY23060137
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polypharmacy, Decision-making
-
Université Catholique de LouvainActive, not recruitingMedication Review | Polypharmacy (People Under Treatment With 5 or More Drugs) | Polypharmacy, Decision-makingBelgium
-
University Medical Center GroningenCompletedPrimary Health Care | Polypharmacy | Deprescriptions | Community Pharmacy Services | Decision Making, SharedNetherlands
-
Massachusetts General HospitalUnknownDecision Making | Video Decision AidsUnited States
-
Boston CollegeCompleted
-
Instituto Tecnologico y de Estudios Superiores...Completed
-
Brigham and Women's HospitalCompleted
-
University of ZurichPfizerCompletedDecision MakingSwitzerland
-
University Hospital, Clermont-FerrandCompleted
-
Umraniye Education and Research HospitalCompleted
-
University of UtahNational Institutes of Health (NIH)Completed