Inappropriate Prescribing Clinical Trial
Official title:
Engaging Patients to Promote Deprescribing
Verified date | October 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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
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 . |
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