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: 10093357
• 负责人: JERRY H GURWITZ
• 金额: $ 81.38万
• 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 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10093357
• 关键词: Adverse drug event; Advisory Committees; Affect; Alzheimer' s Disease; Alzheimer' s disease diagnosis; 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; Emergency Situation; Emergency department visit; Enrollment; Evaluation; Future; Goals; Health Personnel; Health system; Healthcare Systems; High Prevalence; Hospitalization; Hypoglycemia; Impaired cognition; Individual; Infrastructure; Interdisciplinary Study; Intervention; Intervention Trial; Lead; 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; Records; Research; Research Design; Risk; Sentinel; Skilled Nursing Facilities; Symptoms; Testing; United States Food and Drug Administration; United States National Institutes of Health; Visit; Vulnerable Populations; arm; base; 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; 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.

项目摘要/摘要 可能不适当的处方包括使用可能不再需要的药物或 可能会增加伤害的风险。不适当的处方是“发病率乘数”，增加了总体症状 负担，对与健康相关的生活质量和功能产生不利影响。不适当的处方 镇静/催眠药，抗精神病药，高抗胆碱能剂和某些口服等药物类别 降血糖药物对老年人有特殊风险，并且在患有的患者中可能更普遍 由于较高的患病率 多种疾病和相关的多药。制定的计划来教育和敏感护理人员 通过阿尔茨海默氏病研究减轻老年人的不适当处方负担 AD）将测试基于健康计划的干预措施，利用NIH合作者的分布研究 网络，使用食品药品监督管理局（FDA）哨兵计划基础设施。总体 我们建议的目标是开发，实施和评估以患者/护理人员为中心的效果，以此为中心 广告/ADRD患者的多方面教育干预。我们的研究 假设是，关于患者/看护者及其提供者之间不适当处方的教育可以 降低AD/ADRD患者的药物相关发病率，并改善药物治疗 这个脆弱人群的安全。我们的研究人群将包括社区居民患者 AD/ADRD，根据AD/ADRD的诊断或对阿尔茨海默氏病的药物的使用而确定的 有不当处方的证据。我们将评估旨在的教育干预措施的影响 刺激有关药物安全的患者/护理人员的交流（与通常的护理） 本研究的主要结果是不适当的处方患者的比例。试验将是健康 基于计划的国家，以两个大型国家卫生计划进行。研究设计将是一个预期的集群 随机，比较有效性干预试验，三个臂：（1）一名患者/护理人员和 提供者教育干预； （2）仅提供者的教育干预； （3）通常的护理。一年 R61计划阶段将在四年制R33实施阶段之前。在R33阶段，我们将 依次实施两个单独的务实试验，每个试验都有超过11,000名患者，适应第二个患者 基于第一个的发现和经验的试验。 R33的目的是：（1）评估 患者/护理人员教育干预对AD/ADRD患者的不适当处方 前瞻性，簇的随机试验设计，带有三个臂； （2）制定一个分发研究的计划 向可能实施干预或对其未来使用决定的利益相关者的调查结果。这 拟议的研究是可行的，因为我们的合作伙伴包括两个大型国家健康计划，我们将利用 现有的FDA前哨基础设施，我们拥有一个强大的多学科研究团队。