Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease Study (D-PRESCRIBE-AD)

制定一项计划，对护理人员进行教育和宣传，以减少患有阿尔茨海默病的老年人的不适当处方负担研究 (D-PRESCRIBE-AD)

• 批准号: 10693845
• 负责人: JERRY H GURWITZ
• 金额: $ 107.78万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10693845
• 关键词: Adverse drug event; Advisory Committees; Affect; Alzheimer' s Disease; Alzheimer' s disease diagnosis; Alzheimer' s disease patient; Alzheimer' s disease related dementia; Anti-Cholinergics; Antipsychotic Agents; Caregivers; Categories; Cluster randomized trial; Communication; Communities; Data; Decision Making; Drops; Education; Educational Intervention; Educational Materials; Effectiveness; Elderly; Electronic Health Record; Emergency Situation; Emergency department visit; Enrollment; Evaluation; Future; Goals; Health Personnel; Health system; Healthcare Systems; High Prevalence; Hospitalization; Hypoglycemia; Impaired cognition; Individual; Infrastructure; Institution; Interdisciplinary Study; Intervention; Intervention Trial; Morbidity - disease rate; Oral; Outcome; Outcome Study; Outpatients; Participant; Patient Care; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Polypharmacy; Population; Pragmatic clinical trial; Prevalence; Procedures; Provider; Randomized; Research; Research Design; Risk; Sentinel; Skilled Nursing Facilities; Specific qualifier value; Symptoms; Testing; United States Food and Drug Administration; United States National Institutes of Health; Visit; Vulnerable Populations; arm; care providers; caregiver education; collaboratory; comorbidity; comparative effectiveness; design; expectation; experience; falls; health care service utilization; health plan; health related quality of life; high risk; hospitalization rates; hypnotic; implementation science; improved; medication safety; mortality; multiple chronic conditions; pragmatic trial; primary outcome; programs; prospective; provider communication; scale up; secondary outcome; sedative; study population; therapy design; treatment as usual; trial design

PROJECT SUMMARY/ABSTRACT Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing is a “morbidity multiplier,” increasing overall symptom burden, and adversely affecting health-related quality of life and function. Inappropriate prescribing of certain drug categories such as sedative/hypnotics, antipsychotics, highly anticholinergic agents, and certain oral hypoglycemic medications poses particular risks for older adults, and may be more prevalent among those with Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and associated polypharmacy. The Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer’s Disease Study (D-PRESCRIBE- AD) will test a health plan-based intervention leveraging the NIH Collaboratory's Distributed Research Network, which uses the Food and Drug Administration (FDA) Sentinel Initiative infrastructure. The overarching goal of our proposal is to develop, implement, and evaluate the effect of a patient/caregiver-centered, multifaceted educational intervention on inappropriate prescribing in patients with AD/ADRD. Our research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and lead to an improvement in medication safety for this vulnerable population. Our study population will include community-dwelling patients with AD/ADRD, identified based on a diagnosis of AD/ADRD or use of a medication for Alzheimer’s Disease, who have evidence of inappropriate prescribing. We will evaluate the effect of educational interventions designed to stimulate patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be health plan-based, conducted in two large, national health plans. The study design will be a prospective, cluster randomized, comparative effectiveness intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention; (2) a provider only educational intervention; and (3) usual care. A one-year R61 planning phase will precede a four-year R33 implementation phase. During the R33 phase we will sequentially implement two separate pragmatic trials, each enrolling over 11,000 patients, adapting the second trial based on the findings and experience gained in the first. The R33 aims are: (1) to assess the impact of the patient/caregiver educational intervention on inappropriate prescribing to AD/ADRD patients, employing a prospective, cluster randomized trial design with three arms; and (2) to create a plan for disseminating study findings to stakeholders who might implement the intervention or make decisions about its future use. The proposed study is feasible because our partners include two large, national health plans, we will leverage an existing FDA Sentinel infrastructure, and we have a strong, multidisciplinary research team.

项目概要/摘要 潜在的不当处方包括使用可能不再需要的药物或 不适当的处方可能会增加伤害的风险，从而增加整体症状。 负担，并对与健康相关的生活质量和功能产生不利影响。 药物类别，如镇静/催眠药、抗精神病药、强抗胆碱能药物和某些口服药物 降血糖药物对老年人构成特别的风险，并且在患有糖尿病的人中可能更为普遍 阿尔茨海默病和阿尔茨海默病相关痴呆（AD/ADRD）由于患病率较高 制定一项教育和提高护理人员敏感性的计划。 减少患有阿尔茨海默病的老年人的不适当处方负担研究（D-PRESCRIBE- AD）将利用 NIH 合作实验室的分布式研究来测试基于健康计划的干预措施 网络，使用食品和药物管理局 (FDA) 哨兵计划基础设施。 我们提案的目标是开发、实施和评估以患者/护理人员为中心的效果， 我们的研究对 AD/ADRD 患者的不当处方进行多方面的教育干预。 假设是，对患者/护理人员及其提供者进行不当处方教育可以 减少 AD/ADRD 患者与药物相关的发病率并改善药物治疗 我们的研究人群将包括社区居住的患者。 AD/ADRD，根据 AD/ADRD 的诊断或使用治疗阿尔茨海默病的药物而确定， 有证据表明处方不当。我们将评估旨在预防的教育干预措施的效果。 促进患者/护理人员与提供者就药物安全（与常规护理相比）进行沟通 处方不当的患者比例，该研究的主要结果将是健康的。 基于计划，在两个大型国家卫生计划中进行 该研究设计将是一个前瞻性的集群。 随机、比较有效性干预试验，分为三组：(1) 患者/护理人员联合进行 提供者教育干预；(2) 仅提供者教育干预；以及 (3) 常规护理。 R61 规划阶段将先于为期四年的 R33 实施阶段。 随后实施两项独立的实用性试验，每项试验均招募超过 11,000 名患者，并采用第二项试验 基于第一次试验的结果和经验，R33 的目的是： (1) 评估影响。 针对 AD/ADRD 患者的不当处方，对患者/护理人员进行教育干预，采用 三组前瞻性整群随机试验设计；以及 (2) 制定传播研究计划 将调查结果提供给可能实施干预措施或对其未来使用做出决定的利益相关者。 拟议的研究是可行的，因为我们的合作伙伴包括两个大型的国家卫生计划，我们将利用 现有的 FDA Sentinel 基础设施，我们拥有强大的多学科研究团队。

项目成果

Motivating deprescribing conversations for patients with Alzheimer's disease and related dementias: a descriptive study.

激发阿尔茨海默病和相关痴呆症患者的去处方对话：一项描述性研究。

• 发表时间: 2022
• 作者: Antonelli, Mary T;Cox, John S;Saphirak, Cassandra;Gurwitz, Jerry H;Singh, Sonal;Mazor, Kathleen M
• 通讯作者: Mazor, Kathleen M