Engaging Patients to Promote Deprescribing

NCT04294901 | Completed Results

• 1 other identifier: IIR 18-228
• Study Type: interventional
• Target: 5,946
• Locations: 1 country
• Sites: 4

Brief Summary

One mechanism to reduce potentially inappropriate medications is through deprescribing, a deimplementation-based approach to thoughtfully discontinue a medication a patient is currently prescribed. Many interventions to overcome deprescribing barriers target the provider, who is already overburdened. Although some believe providers have primary responsibility for deprescribing, patient-initiated discontinuation discussions can effectively facilitate deprescribing. In a single-site pilot study, the investigators successfully engaged VA Primary Care patients to facilitate deprescribing of select potentially inappropriate medications. The investigators now propose a multisite randomized controlled trial of engaging Veterans who may be deprescribing candidates. By study end, the investigators will have established the effectiveness of an innovative, low-tech, patient-focused intervention to promote deprescribing, thereby directly improving quality, safety, and value of VA care while also setting the stage for generalization of this approach to other potentially inappropriate medications.

Conditions

Medical Overuse; Inappropriate Prescribing; Deprescriptions

Keywords

Physician-Patient Relations; Implementation Science; Decision Making, Shared

Outcome Measures

Primary Outcomes (1)

• Deprescribing

  Non-refill of the medication in the 6 months following the primary care appointment (i.e., cessation) or any reduction in the total daily dose (i.e., de-escalation). There is an exception to the de-escalation rule for insulin, where only complete cessation will qualify since dose changes are less likely to be reflected in the order compared to oral medications.

  6 months post-index date

Secondary Outcomes (1)

• Deprescribing Conversations

  Index visit until survey completion (up to 8 weeks post-index visit)

Study Arms (2)

Intervention

EXPERIMENTAL

Patients prescribed gabapentin with a total daily dose \>1800mg meeting inclusion/exclusion criteria who have a primary care appointment with a provider in the Gaba cohort; Patients prescribed either insulin or a sulfonylurea meeting inclusion/exclusion criteria who have a primary care appointment with a provider in the DM cohort; Patients prescribed a PPI meeting inclusion/exclusion criteria who have a primary care appointment with a provider in the PPI cohort

Behavioral: Direct to patient medication brochure

Control

NO INTERVENTION

Historical control patients seen by intervention PCPs in the 18-12 months prior to the intervention window.

Interventions

Direct to patient medication brochure BEHAVIORAL

An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran with a Primary Care appointment at one of three Veteran Affairs Medical Centers (including Community Based Outpatient Clinics)
• PPI Cohort:
• \>90 consecutive days of PPI at any dose
• Diabetes Cohorts:
• HbA1c \<7%
• At least one of Age \>65 years
• Renal impairment
• Cognitive impairment
• either \>90 consecutive days insulin or sulfonylurea or \>90 consecutive days of \>2 DM medications (neither of which is insulin or sulfonylurea)
• Gaba Cohort:
• \>90 consecutive days with total daily dose \>1800mg

You may not qualify if:

• Diagnosis warranting PPI treatment
• Medication warranting PPI treatment
• Neuropathic pain
• Seizure disorder
• and/or Cancer-related pain

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Publications (3)

• Zimmerman KM, Linsky AM. A narrative review of updates in deprescribing research. J Am Geriatr Soc. 2021 Sep;69(9):2619-2624. doi: 10.1111/jgs.17273. Epub 2021 May 15.

  PMID: 33991423 BACKGROUND

• Niznik JD, Zhao X, Slieanu F, Mor MK, Aspinall SL, Gellad WF, Ersek M, Hickson RP, Springer SP, Schleiden LJ, Hanlon JT, Thorpe JM, Thorpe CT. Effect of Deintensifying Diabetes Medications on Negative Events in Older Veteran Nursing Home Residents. Diabetes Care. 2022 Jul 7;45(7):1558-1567. doi: 10.2337/dc21-2116.

  PMID: 35621712 BACKGROUND

• Jones KF, Stolzmann K, Wormwood J, Pendergast J, Miller CJ, Still M, Bokhour BG, Hanlon J, Simon SR, Rosen AK, Linsky AM. Effectiveness of Patient-Directed Education to Sustain Deprescribing: A Pragmatic Trial. Drugs Aging. 2025 Nov;42(11):1073-1083. doi: 10.1007/s40266-025-01251-z. Epub 2025 Oct 18.

  PMID: 41108442 DERIVED

Limitations and Caveats

Total numbers for Baseline Characteristics are less than the number of subjects due to missing data

Results Point of Contact

• Title: Amy Linsky, MD, MSc
• Organization: VA Boston Healthcare System

amy.linsky@va.gov

857-364-2760

Study Officials

• Amy M Linsky, MD MSc

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will target Veterans at three primary care sites who meet eligibility criteria for one of the PIM cohorts and are prescribed the target medication at the time of their scheduled primary care visit. Each PCP was assigned to receive three medication groups (i.e., PPIs, diabetes medications, and gabapentin) in a randomized order, and during each period of time for each medication/medication group assignment, prescriptions for that specific medication/medication group were assessed. Patients that received the specific medication or medication group from the PCP during the time of assignment were enrolled in the study. The study will begin with a 13-month retrospective baseline period, with one month for baseline subject identification and 12 months for observation of baseline subjects' deprescribing outcomes. The primary comparisons are between "brochure-intervention" patients and "baseline" patients (matched in terms of eligibility) from the same provider.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 4, 2020
• Study Start: March 29, 2021
• Primary Completion: October 7, 2023
• Study Completion: October 7, 2023
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 1 year of publication
• Access Criteria: Those requesting data will be asked to sign a Letter of Agreement.

Locations

US (4)