Reducing Risk of Dementia Through Deprescribing (R2D2)

Indiana University

Status: Active, not recruiting

Conditions: Alzheimer Disease, Late Onset; Dementia

Treatments: Other: Deprescribing of target anticholinergics; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04270474

1706800075

R01AG061452 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 344 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Participants:

• 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 for Participants:

• 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").

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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344 participants in 2 patient groups

Active Intervention (ACT)

Experimental group

Description:

Pharmacist-based Deprescribing

Treatment:

Other: Deprescribing of target anticholinergics

Usual Care (UC)

Sham Comparator group

Description:

Usual Care

Treatment:

Other: Usual Care