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Engaging Patients to Promote Deprescribing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04294901
Recruitment Status : Completed
First Posted : March 4, 2020
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Medical Overuse Inappropriate Prescribing Deprescriptions Behavioral: Direct to patient medication brochure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3368 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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. At each intervention site, individual PCPs will be randomized to the sequence of patient cohorts. 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. Then, each PCP will be randomized to the order of three 4-month periods during which their eligible patients receive medication-specific brochures, one medication cohort at a time. The primary comparisons are between "brochure-intervention" patients and "baseline" patients (matched in terms of eligibility) from the same provider.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Engaging Patients to Promote Deprescribing
Actual Study Start Date : March 29, 2021
Actual Primary Completion Date : October 31, 2022
Actual Study Completion Date : October 31, 2022

Arm Intervention/treatment
Experimental: Gabapentin (Gaba)
Patients prescribed gabapentin with a total daily dose >1800mg without exclusion criteria who have a primary care appointment with a provider in the Gaba cohort
Behavioral: Direct to patient medication brochure
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.

Experimental: Diabetes (DM)
Patients prescribed either insulin or a sulfonylurea meeting inclusion/exclusion criteria who have a primary care appointment with a provider in the DM cohort
Behavioral: Direct to patient medication brochure
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.

Experimental: Proton Pump Inhibitor (PPI)
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
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.




Primary Outcome Measures :
  1. Our Aim 1 primary quantitative outcome will be binary: deprescribing versus not [ Time Frame: 6 months post-index date ]
    Non-refill of the medication in the 6 months following the primary care appointment as our a priori definition of cessation, based upon dispensing dates. If the medication continues to be dispensed, the investigators will determine any reduction in the total daily dose, indicating de-escalation (one component of our deprescribing definition). An exception to the de-escalation rule will be for insulin, where only complete cessation will qualify since dose changes are less likely to be reflected in the order compared to oral medications.


Secondary Outcome Measures :
  1. Deprescribing conversations [ Time Frame: index visit until survey completion, expected to occur 1-8 weeks post-index visit . ]
    Patient report of a conversation about deprescribing during the index primary care visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • PPI Cohort Exclusions:

    • Diagnosis warranting PPI treatment
    • Medication warranting PPI treatment
  • Gaba Cohort Exclusions:

    • Neuropathic pain
    • Seizure disorder
    • and/or Cancer-related pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294901


Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, United States, 01053-9764
United States, New York
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Amy M Linsky, MD MSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04294901    
Other Study ID Numbers: IIR 18-228
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement.
Time Frame: Within 1 year of publication
Access Criteria: Those requesting data will be asked to sign a Letter of Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Physician-Patient Relations
Implementation Science
Decision Making, Shared