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临床试验/NCT06040502
NCT06040502已完成不适用

Reducing Inappropriate Medication Use for BPSD and Improving Health Outcomes for PLWD

University of California, Davis2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2023年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
2
主要终点
Acceptability

研究概览

简要总结

Investigators previously developed a low-cost, practical, patient- and care partner-centric, evidence-informed systematic approach (the "DICE Approach" or DICE), to assess and manage behavioral and psychological symptoms of dementia (BPSD).

The goals of this proposal are to refine and test the application of DICE in primary care clinics by: (a) using existing clinic staff to deliver DICE; and (b) using the electronic medical record to identify and recruit PLWD (persons living with dementia) and their care partners (n=100) based on criteria that are clinically meaningful and inclusive of the maximum number of participants in the most equitable way.

Clinic-based social workers in four primary care practices at University of California Davis (UCD) will coordinate behavioral management using DICE with care partners, PLWD and other clinic providers. Outcomes will include: 1) feasibility/ability to carry out the approach; 2) acceptability to PLWD and their care partners; and 3) the ability to measure psychiatric medication use and health care use in the electronic medical record. Findings from this study will guide the design of a much larger future study using the DICE Approach to improve outcomes for PLWD and their care partners.

详细描述

PRÉCIS

Intervention Structure, Implementation Protocol, Fidelity/Adherence Monitoring Plan:

In this study, Investigators will refine and pilot the application of The DICE Approach (DICE) in 4 primary care clinics by: (a) leveraging existing clinic staff to deliver DICE to care partner-PLWD dyads; (b) using electronic resources to identify and recruit PLWD-care partner dyads based on clinically relevant and minimum inclusion/exclusion criteria; and c) evaluating clinically relevant outcomes using the electronic medical record (EMR). DICE will be implemented in four large primary care clinics within the UCD Health System over a 6-month period (n=100 PLWD-care partner dyads; 25 dyads per site, allowing comparison of implementation and outcomes by site characteristics). Key "study champions" at each of the four primary care clinics will be the licensed practical nurse assigned to each clinic who will serve as the Onsite DICE Coordinator (ODC).

As a minimal risk study embedded in primary care practices, Investigators plan to obtain a waiver of informed consent for PLWD, care partners and clinic staff in order to reduce introduction of artificial care resources or biases wherever possible. Additionally, a Health Insurance Portability Act (HIPAA) waiver will be obtained for subject identification (see a. below) and outcome ascertainment from the EMR. There will be minimal personal health information (PHI) data collected. At the time the agreement is finalized, the Internal Review Board (IRB) of Record to make the HIPAA determinations, or if necessary UC Davis IRB will make the HIPAA determinations before releasing the acknowledgment of a reliance on an external IRB.

Investigators have arranged with University of California Davis LVN supervisors (Ms. Elder and Ms. Skillsky) to do a 6-hour training for all of the LVNs on a single day. This will be a hybrid of in person (kick off session and ending brainstorming session) and watching the online modules together in a campus auditorium. Clinicians will then use the approach in a "test" case in study months 2-3 during which they will engage in as needed coaching with a DICE trainer (a geriatric psychiatrist and education specialist) to ensure they are using the approach with fidelity. The DICE trainer will also be available as needed for coaching during the remainder of the study for approach related questions. Manualization and training with follow-up coaching have been shown to be effective implementation strategies that can enhance fidelity of implementation of an evidence-based program. Other clinic personnel (social workers and PCPs {primary care providers}) will also receive the manual, an email overview of the study, and be invited to train using the website or at the on-site training. Following training and case consultation, the ODCs will then use the DICE Approach for any PLWD they encounter during the 6-month study period (months 4-9). Primary outcome metrics will be collected using the electronic medical record and by estimating time spent in the approach and strategies extracted from clinic notes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Person living with dementia (as defined by chart diagnosis) and their care partner
  • Care partner age >18 as defined in the EMR
  • Care partner English speaking
  • Historical controls
  • Person living with dementia (as defined by chart diagnosis)

排除标准

  • Age of care partner <18 (this age group is rarely the responsible or legal party for PLWD)
  • Non-English speaking

结局指标

主要结局

Acceptability

时间窗: 6 months

Acceptability will be measured by the implementation rates of the ODC's recommendations of strategies for BPSD (generated by use of DICE) among dyads, as well as by other providers within the primary care practice. This information will be obtained through chart abstractions within the EMR. Exit interviews of participants (ODCs, other providers and care partners) will be conducted to further deepen the knowledge of intervention acceptability and implementation challenges

Ease of Use -- Feasibility of using the DICE Approach #2

时间窗: 6 months

Number of contacts between Onsite DICE Champions (ODCs) and dyads

Time required to implement -- Feasibility of using the DICE Approach #3

时间窗: 6 months

Time requirements for ODCs implementing DICE (as estimated by the ODCs and corroborated by clinic notes).This information will be obtained through chart abstractions within the EMR.

Operationalization -- Feasibility of using the DICE Approach #1

时间窗: 6 months

Rate of enrollment of PLWD-care partner dyads

次要结局

  • Measurement of Psychotropic Medication use(6 months)
  • Measurement of Health care use(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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