Reducing Risk of Dementia Through Deprescribing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2026-07-30

Brief Summary

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A cluster-randomized controlled trial (RCT) called "Reducing Risk of Dementia through Deprescribing" (R2D2) to evaluate the impact of a deprescribing intervention on important cognitive and safety outcomes.

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Detailed Description

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The R2D2 study will test whether the adverse cognitive effects of anticholinergic medications are reversible by implementing a pharmacist-based deprescribing intervention for older adults within primary care practices. Two groups will be recruited: providers (physicians and advanced practice providers including nurse practitioners), and patients. Primary care providers of those prescribed eligible anticholinergic medications will be recruited for participation in the study, and their patients who also meet eligible criteria will be subsequently approached and recruited. Participants will be randomized to one of two groups: the deprescribing intervention group or usual care; the intervention group will receive a pharmacist-based deprescribing intervention, while the usual care group will receive care as usually provided by their primary and/or specialty care providers. The intervention and follow-up data collection will occur over 24 months in order to test the long-term impact of the intervention on the planned clinical outcomes. Study outcomes include cognition (primary) and safety (secondary) through validated self-reported scales.

Conditions

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Dementia Alzheimer Disease, Late Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This cluster-randomized trial will randomize at the level of physicians. Physicians agreeing to participate in the trial will be randomized to intervention or usual care in blocks of two or four. Physician randomization status will determine participants' study group. Physicians randomized to usual care will not have access to the intervention. Study outcomes will be collected directly from participants; no outcomes will be collected from physicians.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The principle investigator and all outcome assessor will be blinded to the arm assignment of the subjects. No access to unblinded data will be provided to blinded staff.

Study Groups

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Active Intervention (ACT)

Pharmacist-based Deprescribing

Group Type EXPERIMENTAL

Deprescribing of target anticholinergics

Intervention Type OTHER

The active intervention group (ACT) will receive a pharmacist-based deprescribing intervention focused only on targeted anticholinergic medications. The intervention pharmacist will serve as the central source of communication between participants, providers, and (as needed) dispensing pharmacy to coordinate the deprescribing process. The study pharmacists will navigate a shared-decision model between the physicians and participant in order to personalize the selection of appropriate alternatives and switch/titration schedules. Importantly, the pharmacist will supervise the titration and deprescribing plan and communicate with both participants and physicians throughout the study.

Usual Care (UC)

Usual Care

Group Type SHAM_COMPARATOR

Usual Care

Intervention Type OTHER

Those in the usual care group will not have access to the study intervention, but will receive a one-time information packet through the mail reviewing risks of polypharmacy, but no information specific to anticholinergic medications. They will receive clinical care as usually provided by their primary care or specialty care physicians.

Interventions

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Deprescribing of target anticholinergics

The active intervention group (ACT) will receive a pharmacist-based deprescribing intervention focused only on targeted anticholinergic medications. The intervention pharmacist will serve as the central source of communication between participants, providers, and (as needed) dispensing pharmacy to coordinate the deprescribing process. The study pharmacists will navigate a shared-decision model between the physicians and participant in order to personalize the selection of appropriate alternatives and switch/titration schedules. Importantly, the pharmacist will supervise the titration and deprescribing plan and communicate with both participants and physicians throughout the study.

Intervention Type OTHER

Usual Care

Those in the usual care group will not have access to the study intervention, but will receive a one-time information packet through the mail reviewing risks of polypharmacy, but no information specific to anticholinergic medications. They will receive clinical care as usually provided by their primary care or specialty care physicians.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 65 and older;
* At least one office visit to their primary care physician within the previous 12 months;
* Use of a target anticholinergic medication within the last two weeks OR medical record evidence of exposure to target anticholinergic medications at or above a cognitive risk threshold in the prior 12 months
* Able to communicate in English;
* Access to a telephone

Exclusion Criteria

* Permanent resident of an extended care facility (nursing home)
* Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by International Classification of Diseases (ICD) version 9/10 codes
* Diagnosis of Alzheimer's Disease or Related Dementia as determined by (a), (b), or (c) below:

1. ICD-9/10 codes, or
2. Current use of a medication for Alzheimer's Disease or a Related Dementia, or
3. A pattern of responses to the Functional Activities Questionnaire (FAQ) that indicate dementia (i.e., ≥ 3 FAQ items are scored at "requires assistance," or if ≥ 1 FAQ item is scored at "dependent").

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No