Medical OveruseNCT04294901
Engaging Patients to Promote Deprescribing
A study testing Direct to patient medication brochure in people with Medical Overuse and Inappropriate Prescribing, run by VA Office of Research and Development at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Overuse, Inappropriate Prescribing, Deprescriptions
- What is being tested?
- Direct to patient medication brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,946 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Mar 2021to 7 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- PPI Cohort Exclusions:
- Diagnosis warranting PPI treatment
- Medication warranting PPI treatment
- Gaba Cohort Exclusions:
- Neuropathic pain
- Seizure disorder
- and/or Cancer-related pain
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
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.
Read the detailed description
Background - Despite multiple provider- and system-level interventions to reduce potentially inappropriate medications (PIMs), many Veterans are still prescribed drugs that provide little benefit, placing them at unnecessary risk of adverse drug events (ADEs). One mechanism to reduce PIMs is through deprescribing, a de-implementation-based approach to thoughtfully discontinue a medication a patient is currently prescribed.
Many Choosing Wisely recommendations address PIMs. Specifically, proton pump inhibitors (PPIs), a medicine used to reduce gastric acid, should be de-escalated to the lowest dose necessary to provide relief. Many older patients with diabetes are over-controlled, with blood sugar levels lower than recommended, yet remain on multiple diabetes medicines and may be able to use fewer medicines. These patients are also at higher risk of low blood sugar from insulin and sulfonylureas, and should have limited use of these agents.
Finally, gabapentin is often used off-label to treat pain, with greatly increased use over the past several years. There are many barriers to deprescribing PIMs. Many interventions solely target the prescribing provider. Although some believe providers have primary responsibility for deprescribing, patient initiation of discontinuation conversations can effectively facilitate deprescribing. In a single-site pilot study, the investigators successfully reduced PIMs by engaging VA Primary Care patients by providing them with Veteran-centric EMPOWER ("Eliminating Medications through Patient Ownership of End Results") brochures. However, it is not known if this approach will be as successful for Veterans with other chronic conditions or at non-pilot sites.
Aims - The investigators propose three aims. 1) Examine the impact of a patient-centered intervention to change provider prescribing (the primary outcome), as determined by the frequency with which medications are either deprescribed or de-escalated. 2) Examine the effect of a patient-centered intervention on engaging patients, via post-visit surveys of Veterans' interaction with the brochures and their influence on deprescribing discussions and deprescribing. 3) Using qualitative methods, identify key organizational contextual factors related to intervention fidelity, feasibility, acceptability, and appropriateness to support future implementation.
Methods and Innovation - The investigators propose a multisite quasi-experimental trial using a Hybrid Type I Effectiveness-Implementation design of providing EMPOWER brochures directly to Veterans who may be deprescribing candidates for three cohorts of PIMs (PPIs, diabetes medications, and gabapentin). The investigators will mail brochures in advance of scheduled primary care visits, unlike distribution methods used in other studies. The primary outcome will be the composite of deprescribing and de-escalation of target medications, identified in pharmacy dispensing records of the Corporate Data Warehouse (Aim 1). Mail-based surveys sent after the scheduled primary care visit will assess patient engagement with the brochure and its impact on patient-provider communication (Aim 2). Finally, qualitative data from clinicians and staff addressing Proctor's Implementation Outcomes will provide the foundation for future implementation strategies (Aim 3).
Significance and Next Steps - The study directly addresses multiple Veteran Care Priorities, including health care value, primary care practice, quality/safety, and Whole Health, and is aligned with current VA initiatives to prioritize patient preferences via individually-tailored, proactive care plans. The proposed work is strongly supported by Pharmacy Benefits Management and Office of Patient Centered Care and Cultural Transformation, which will facilitate the dissemination of findings to improve the quality and safety of medication use within VA. By study end, the investigators will have established the effectiveness of an innovative, low-tech, patient-focused intervention to promote deprescribing of commonly used medications for three populations, thereby directly improving quality, safety, and value of VA care while also setting the stage for wider implementation and generalization of this approach to other potentially inappropriate medications.
- Conditions
- Medical Overuse, Inappropriate Prescribing, Deprescriptions
- Being tested
- Direct to patient medication brochure
- Keywords
- Physician-Patient Relations, Implementation Science, Decision Making, Shared
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct to patient medication brochureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-index date
Secondary outcomes (1)
Deprescribing Conversations
Patient report of a conversation about deprescribing during the index primary care visit. Note that this Outcome Measure was only assessed in a subsample of the "Intervention Group" Arm/Group participants and not at all in the "Historical Control Group" Arm/Group subjects.
Measured: Index visit until survey completion (up to 8 weeks post-index visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start29 Mar 2021
- Primary completion7 Oct 2023
- Study completion7 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medical OveruseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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. 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.
- Masking
- None (open label)
- Enrolment
- 5,946 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy M Linsky, MD MSc, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294901
- Sponsor's protocol ID
- IIR 18-228
- Status last verified
- May 2025
- First submitted
- 24 Feb 2020
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33991423Niznik 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.
PubMed 35621712Jones 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.
PubMed 41108442
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Patients to Promote Deprescribing
- ClinicalTrials.gov ID
- NCT04294901
- Acronym / sponsor ID
- IIR 18-228
- Conditions
- Medical Overuse, Inappropriate Prescribing, Deprescriptions
- Keywords
- Physician-Patient Relations, Implementation Science, Decision Making, Shared
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,946 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 7 Oct 2023 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background - Despite multiple provider- and system-level interventions to reduce potentially inappropriate medications (PIMs), many Veterans are still prescribed drugs that provide little benefit, placing them at unnecessary risk of adverse drug events (ADEs). One mechanism to reduce PIMs is through deprescribing, a de-implementation-based approach to thoughtfully discontinue a medication a patient is currently prescribed.
Many Choosing Wisely recommendations address PIMs. Specifically, proton pump inhibitors (PPIs), a medicine used to reduce gastric acid, should be de-escalated to the lowest dose necessary to provide relief. Many older patients with diabetes are over-controlled, with blood sugar levels lower than recommended, yet remain on multiple diabetes medicines and may be able to use fewer medicines. These patients are also at higher risk of low blood sugar from insulin and sulfonylureas, and should have limited use of these agents.
Finally, gabapentin is often used off-label to treat pain, with greatly increased use over the past several years. There are many barriers to deprescribing PIMs. Many interventions solely target the prescribing provider. Although some believe providers have primary responsibility for deprescribing, patient initiation of discontinuation conversations can effectively facilitate deprescribing. In a single-site pilot study, the investigators successfully reduced PIMs by engaging VA Primary Care patients by providing them with Veteran-centric EMPOWER ("Eliminating Medications through Patient Ownership of End Results") brochures. However, it is not known if this approach will be as successful for Veterans with other chronic conditions or at non-pilot sites.
Aims - The investigators propose three aims. 1) Examine the impact of a patient-centered intervention to change provider prescribing (the primary outcome), as determined by the frequency with which medications are either deprescribed or de-escalated. 2) Examine the effect of a patient-centered intervention on engaging patients, via post-visit surveys of Veterans' interaction with the brochures and their influence on deprescribing discussions and deprescribing. 3) Using qualitative methods, identify key organizational contextual factors related to intervention fidelity, feasibility, acceptability, and appropriateness to support future implementation.
Methods and Innovation - The investigators propose a multisite quasi-experimental trial using a Hybrid Type I Effectiveness-Implementation design of providing EMPOWER brochures directly to Veterans who may be deprescribing candidates for three cohorts of PIMs (PPIs, diabetes medications, and gabapentin). The investigators will mail brochures in advance of scheduled primary care visits, unlike distribution methods used in other studies. The primary outcome will be the composite of deprescribing and de-escalation of target medications, identified in pharmacy dispensing records of the Corporate Data Warehouse (Aim 1). Mail-based surveys sent after the scheduled primary care visit will assess patient engagement with the brochure and its impact on patient-provider communication (Aim 2). Finally, qualitative data from clinicians and staff addressing Proctor's Implementation Outcomes will provide the foundation for future implementation strategies (Aim 3).
Significance and Next Steps - The study directly addresses multiple Veteran Care Priorities, including health care value, primary care practice, quality/safety, and Whole Health, and is aligned with current VA initiatives to prioritize patient preferences via individually-tailored, proactive care plans. The proposed work is strongly supported by Pharmacy Benefits Management and Office of Patient Centered Care and Cultural Transformation, which will facilitate the dissemination of findings to improve the quality and safety of medication use within VA. By study end, the investigators will have established the effectiveness of an innovative, low-tech, patient-focused intervention to promote deprescribing of commonly used medications for three populations, thereby directly improving quality, safety, and value of VA care while also setting the stage for wider implementation and generalization of this approach to other potentially inappropriate medications.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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. 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Direct to patient medication brochurePatients 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 |
| Control | No intervention | –Historical control patients seen by intervention PCPs in the 18-12 months prior to the intervention window. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Veteran with a Primary Care appointment at one of three Veteran Affairs Medical Centers (including Community Based Outpatient Clinics)
Key exclusion criteria (7 listed)
- PPI Cohort Exclusions:
- Gaba Cohort Exclusions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct to patient medication brochureAn 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. | Behavioural | Intervention |
Primary outcome
Deprescribing
Time frame: 6 months post-index date
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.
1 secondary outcome
Deprescribing Conversations
Time frame: Index visit until survey completion (up to 8 weeks post-index visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33991423Zimmerman 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.
- Background: PubMed 35621712Niznik 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.
- Derived from this study: PubMed 41108442Jones 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy M Linsky, MD MSc principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct to patient medication brochure in people with Medical Overuse and Inappropriate Prescribing, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deprescribing (time frame: 6 months post-index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294901, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.