Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale
研究概览
简要总结
The purpose of this study is to compare patient priorities care (PPC) and usual care (UC) patients to identify differences in post-encounter medication changes, treatment burden (TBQ), and shared decision making in Older Patient Assessment of Chronic Illness Care (OPACIC), to understand PPC participant's sense-making and communication approaches related to deprescribing decisions in relation to the identified health priorities and to identify and categorize adverse drug withdrawal events (ADWEs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dementia listed as an active problem in the medical record, including Alzheimer's disease, vascular dementia, frontotemporal dementia, Parkinson's dementia, Lewy body disease.
- •The functional assessment staging tool (FAST) score of 5 or lower (This will be established by the patient's clinician).
- •2 or more additional chronic conditions
- •Takes 5 or more regular medications and
- •A caregiver present during visits. Caregivers may include family members or unrelated caregivers and will be identified through chart review and confirmed by clinician, patient, and surrogate decision maker if necessary. Identified caregivers must be involved in decisions and care of People living with dementia (PLWD) and routinely attend clinic visits with patient
排除标准
- •FAST score of 6 or more (This will be established by the patient's clinician).
- •Significant hearing, vision, or advanced cognitive impairment that limits ability to participate in PPC encounters,
- •Caregiver is unwilling or able to participate in visits, or
- •Deemed ineligible by their Primary care physician (PCP)
研究组 & 干预措施
Usual Care
干预措施: Usual care (Behavioral)
PPC
干预措施: PPC (Behavioral)
结局指标
主要结局
Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale
时间窗: 3 months
Naranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.
Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)
时间窗: Baseline, 3 month
This is a 15 item questionnaire and each is scored from 0(not a problem) to 10(big problem) for a maximum score of 150, higher number indicating more burden
Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale
时间窗: 3 months
Naranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.
Number of medication changes
时间窗: Baseline, 3 month
Type of medication changes
时间窗: Baseline, 3 month
次要结局
- Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score(Baseline, 3 months)
研究者
Aanand Dinkar Naik
Professor
The University of Texas Health Science Center, Houston