NCT05996237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

August 9, 2023

Last Update Submit

January 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Motivation to Deprescribe

    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 Outcomes (1)

  • Self-reported stopping/changing prescription medication

    6 months

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants in the University of Pittsburgh Claude D. Pepper communty research registry.

You may qualify if:

  • years or older
  • Medical visit within past 6 months
  • Self-report of at least 5 regular medications for at least 4 weeks

You may not qualify if:

  • Diagnosis of dementia or score \<=4 on Memory Impairment Screen
  • Hospitalization in prior 30 days with change in medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 18, 2023

Study Start

September 21, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

De-identified individual-level data will be made available to investigators upon request following publication of key findings.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After 6/1/25, available for 2 years
Access Criteria
Written request to investigator

Locations