Clinical trial NCT04294901: Engaging Patients to Promote Deprescribing
Official title: Engaging Patients to Promote Deprescribing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Overuse
Inappropriate Prescribing
Deprescriptions
Keywords: Physician-Patient Relations
Implementation Science
Decision Making, Shared
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-03-04
Enrollment: 5946
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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. 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Deprescribing
timeFrame: 6 months post-index date
Secondary outcomes:
measure: Deprescribing Conversations
timeFrame: Index visit until survey completion (up to 8 weeks post-index visit)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System, Leeds, MA
state: Massachusetts
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Amy M Linsky, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.