Reducing Risk of Dementia Through Deprescribing (R2D2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 4
- 主要终点
- Change in Health Utilities Index (HUI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •ICD-9/10 codes, or
- •Current use of a medication for Alzheimer's Disease or a Related Dementia, or
- •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").
研究组 & 干预措施
Usual Care (UC)
Usual Care
干预措施: Usual Care (Other)
Active Intervention (ACT)
Pharmacist-based Deprescribing
干预措施: Deprescribing of target anticholinergics (Other)
结局指标
主要结局
Change in Health Utilities Index (HUI)
时间窗: Baseline, 6, 12, 18, and 24 months
Participant self-reported measure of health-related quality of life, evaluating domains including vision, hearing, speech, ambulation, dexterity, emotion, cognitive function and pain. These attributes produce a single score on a standardized utility measure with individual health domain scores ranging from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI) scores ranging from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health. HUI scores will be collected at each outcome assessment and change in HUI scores over time will be compared between the intervention and usual care groups.
Change in Patient Reported Outcome Measurement Information System (PROMIS)
时间窗: Baseline, 6, 12, 18, and 24 months
Participant self-reported, 4-item scales evaluating depression, anxiety, pain, and insomnia will be collected for each participant at each time point. Each PROMIS measure raw score can be converted to a T-score where 50 represents the general population norm for that symptom and each 10-point deviation represents one standard deviation (SD) from the population norm. Changes in the T-scores over time will be compared between the intervention and usual care groups.
Change in Cognitive Composite Score
时间窗: Baseline, 6, 12, 18, and 24 months
Cognitive composite scores will be collected from participants at baseline, 6, 12, 18 and 24 months and changes in the composite scores over time will be compared between the intervention and usual care groups. An overall cognitive composite score including measures of information processing speed, memory, and executive function will be conducted at each time point from the average of each measure's z-score, constructed by subtracting the mean baseline scores and dividing by the baseline standard deviation. The z-score transformation of the cognitive composite score will have a mean of 0 and standard deviation of 1 at baseline, with higher scores representing improvement in cognition.
次要结局
未报告次要终点
研究者
Noll Campbell
Adjunct Associate Professor
Indiana University