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: 10452325
• 负责人: JERRY H GURWITZ
• 金额: $ 105.23万
• 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/10452325
• 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.

项目总结/摘要 潜在的不适当处方包括使用可能不再需要的药物， 可能会增加伤害的风险。不适当的处方是一个“发病率倍增器”，增加整体症状 负担，并对健康相关的生活质量和功能产生不利影响。不适当的处方某些 药物类别，如镇静/催眠药、抗精神病药、高度抗胆碱能药和某些口服 降血糖药物对老年人构成特别的风险，并且可能在那些患有糖尿病的人中更普遍。 由于阿尔茨海默病和阿尔茨海默病相关痴呆（AD/ADRD）的患病率较高， 多药治疗和相关的多种药物治疗。制定一个程序来教育和提高护理人员的敏感性 减少老年痴呆症患者不适当处方负担的研究（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，它使用食品和药物管理局（FDA）哨兵倡议基础设施。总体 我们提案的目标是开发、实施和评估以患者/患者为中心的， 对AD/ADRD患者不适当处方的多方面教育干预。我们的研究 假设是，在患者/护理人员及其提供者中进行关于不适当处方的教育， 降低AD/ADRD患者的药物相关发病率，并改善药物治疗 保护这些弱势群体的安全。我们的研究人群将包括社区居住的患者， AD/ADRD，基于AD/ADRD诊断或使用阿尔茨海默病药物确定， 有不恰当处方的证据我们将评估教育干预的效果， 刺激患者/供应商之间关于药物安全性（与常规护理相比）的沟通， 处方不当的患者比例，本研究的主要结局。审判将是健康的 以计划为基础，在两个大型国家卫生计划中进行。研究设计将是前瞻性、群集性 三组随机、比较有效性干预试验：（1）患者/护理人员联合， 提供者教育干预;（2）仅提供者教育干预;（3）常规护理。一年 R61规划阶段将先于为期四年的R33实施阶段。在R33阶段， 顺序实施两个独立的务实试验，每个试验招募超过11，000名患者， 根据第一次试验的结果和经验进行试验。R33的目标是：（1）评估 对AD/ADRD患者不适当处方的患者/护理人员教育干预，采用 前瞻性，三组随机分组试验设计;（2）制定研究传播计划 将调查结果提供给可能实施干预措施或决定其未来用途的利益攸关方。的 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 我们有一个强大的、多学科的研究团队。