Older Adults' Readiness to Stop Prescribed Medications | NCT05996237

Studies
Older Adults' Readiness to Stop Prescribed Medications

NCT05996237

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jan 9, 2025Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Polypharmacy, Decision-making

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2023Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Aug 9, 2023

First Submission Date that Met QC Criteria

Aug 9, 2023

First Posted Date

Aug 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2025

Last Update Posted Date

Jan 9, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Steven M. Albert, Professor, University of PittsburghPrincipal Investigator

Lead Sponsor

University of PittsburghOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Self-reported stopping/changing prescription medication	Self-report of stopping, tapering, or altering use of any prescription, with or without physician discussion	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15261	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

Time Frame

After 6/1/25, available for 2 years

Access Criteria

Written request to investigator

URL

Not provided