Clinical trial NCT04270474: Reducing Risk of Dementia Through Deprescribing
Official title: Reducing Risk of Dementia Through Deprescribing (R2D2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease, Late Onset
Keywords: deprescribing
anticholinergics
dementia
cognition
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-02-17
Enrollment: 344
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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").

Primary outcomes:
measure: Change in Cognitive Composite Score
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in Patient Reported Outcome Measurement Information System (PROMIS)
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in Health Utilities Index (HUI)
timeFrame: Baseline, 6, 12, 18, and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network Foundation, Inc.
state: Indiana
Study officials:
affiliation: Indiana University/Purdue University
name: Noll L Campbell, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
References: