Engaging Patients to Promote Deprescribing

Inappropriate Prescribing Clinical Trial

Official title:

Engaging Patients to Promote Deprescribing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294901
• Other study ID #: IIR 18-228
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: October 7, 2023

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3368
• Est. completion date: October 7, 2023
• Est. primary completion date: October 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Deprescriptions
• Inappropriate Prescribing
• Medical Overuse

Intervention

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.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York
United States	VA Central Western Massachusetts Healthcare System, Leeds, MA	Leeds	Massachusetts
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Diabet — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our Aim 1 primary quantitative outcome will be binary: deprescribing versus not	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.	6 months post-index date
Secondary	Deprescribing conversations	Patient report of a conversation about deprescribing during the index primary care visit	index visit until survey completion, expected to occur 1-8 weeks post-index visit .