跳至主要内容
临床试验/NCT04239924
NCT04239924已完成不适用

Community Paramedic Coaching Program for Caregivers and People With Dementia (CP3D)

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Number of Visits to the Emergency Department by the Person With Dementia

研究概览

简要总结

This pilot study is designed to evaluate the potential effectiveness of the implementation strategy and intervention delivery model of a community paramedic coaching program for caregivers of persons with dementia, in direct coordination with the participant and caregiver's primary health care team. Specifically, the acceptability, appropriateness, and feasibility of the program will be assessed, collecting data from all implementation stakeholders at baseline, 13 weeks, 25 weeks, and post-intervention (~50 weeks) using quantitative survey instruments and qualitative interviews.

详细描述

The intervention is an adaptation of the evidence-based REACH program (Resources Enhancing Alzheimer's Caregiver Health), designed for and validated in multiple settings to give education, tools, and support to informal caregivers of people with dementia, delivered through a series of at-home visits (minimum of 9 in-person and 3 phone sessions) conducted by trained and certified coaches over 6-12 months. The content of the coaching visits will follow the REACH program protocol, with materials customized with information about local community resources (e.g., Dane County).

Coach/administrator training for delivery of the REACH intervention will be conducted by master trainers from the Rosalynn Carter Institute (RCI) for Caregiving, a department of Georgia Southwestern State University, who administers, certifies, and provides oversight for REACH sites nationally (https://www.rosalynncarter.org/programs/rci-reach/). For the purposes of this pilot study, the investigators have coordinated with RCI to extend delivery of REACH content over a 12-month period, with home visits occurring more frequently at the beginning and spreading further apart towards the end, and additional phone "REVIEW" sessions between home-visits.

Each home visit covers specific coaching content, building on strategies and behaviors covered in prior sessions. The program includes flexibility to allow coaches to adapt the timing/delivery of content to attend to the needs of the caregiver (e.g., answering questions about previously-covered topics, covering topics from a future visit to help coach a caregiver through an emergent dementia-related issue). Sessions typically last 1-2 hours. Following each visit, the coach completes a fidelity checklist and writes client progress notes as per the REACH protocol.

This pilot adapts prior REACH implementations in two main ways: (1) intervention coaches will be community paramedics with advanced medical training, rather than social workers (or other non-medical social service personnel), and (2) the program will be formally coordinated with the participant and caregiver's primary care practice, allowing for care coordination and information sharing between participants, coaches, and clinic staff/providers. Participants will also have the ability to share information about their use of community dementia care resources (e.g., social services, transportation, senior center case management, dementia caregiver support groups, dementia-related educational programming, respite) with coaches so they can communicate necessary information to the clinic for possible inclusion in the participant's Electronic Health Record (EHR) (as per the clinic's determination), facilitate care coordination, and help keep the participant's care plan up to date. Paramedic coaches will be utilizing their medical knowledge, but not providing any direct medical care.

This pilot study also differs from prior REACH trials in that outcome measures include health care and emergency services utilization, particularly related to the occurrence of acute medical and behavioral problems, as well as perceptions of health care quality, in addition to caregiver psycho-socio-emotional measures (already included in the standard REACH assessment package).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Patient Inclusion Criteria:
  • •Diagnosis or indication in medical record of mild to moderate dementia (any subtype)
  • •English speaking
  • •Community-dwelling (independent and assisted living acceptable)
  • •Living with their primary informal caregiver
  • •Patient of a UW Health primary care provider affiliated with and participating in the study

排除标准

  • •Receiving intensive care management services
  • •Receiving aggressive care for another condition (e.g., chemotherapy for cancer, surgery planned for problem)
  • •In isolation due to contagious illness
  • •Enrolled in home hospice
  • •Currently incarcerated, in police custody, or ward of the state
  • •Legally blind or deaf (unable to hear or see even with assistive devices)
  • •Lacks decisional capacity and no available legally authorized representative (LAR) to provide consent
  • •Patient refuses enrollment
  • •Caregiver Inclusion Criteria:
  • •Adult informal caregiver (≥18 years old) of a person eligible for this study (determination based upon caregiver self-identification).
  • •Lives in the same household (primary residence) as the patient with dementia.
  • •Has a working telephone
  • •English speaking
  • •UW Health primary care provider
  • •Caregiver Exclusion Criteria:
  • •Unable to participate in the program as defined
  • •Employed by a professional/private agency to provide care to the care recipient (i.e., professional caregiver, not an informal caregiver)
  • •Has a diagnosis of dementia or cognitive impairment causing functional impairment
  • •In isolation due to contagious illness
  • •Legally blind or deaf (unable to hear or see even with assistive devices)
  • •Refuses enrollment
  • •Stakeholder Inclusion Criteria:
  • •Involved in the implementation study activities in related to the intervention, either as a clinician, member of the UW Health staff, paramedic coach, or social service provider.

研究组 & 干预措施

Paramedic Coaching

Experimental

The intervention is an adaptation of the evidence-based REACH program

干预措施: Paramedic Coaching (Behavioral)

结局指标

主要结局

Number of Visits to the Emergency Department by the Person With Dementia

时间窗: up to 24 months

As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for persons with dementia.

Number of Visits to the Emergency Department by the Caregiver of the Person With Dementia

时间窗: up to 24 months

As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for average older adults.

Feasibility: Proportion of Coaching Phone Calls Completed

时间窗: up to 12 months

The intervention will be deemed feasible if at least 75% of the intended coaching phone calls are completed. The minimum number of coaching calls is 3, additional calls will be scheduled opposite weeks of home visits as needed.

Feasibility: Proportion of Coaching Home Visits Completed

时间窗: up to 12 months

The intervention will be deemed feasible if at least 75% of the intended home visits are completed. The minimum number of intended home visits is 9.

次要结局

  • Change in Revised Caregiving Satisfaction Scale (RCSS)(Baseline, week 13, week 25, week 50)
  • Change in Center for Epidemiologic Studies Depression Scale (CESD-10)(First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50))
  • Change in Revised Scale for Caregiving Self-Efficacy(First home visit (~ week 1) and last home visit (~up to week 50))
  • Change in Knowledge of Dementia (DKAS) Score(First home visit (~ week 1) and week 13)
  • Change in Generalized Anxiety Disorder (GAD-7) Score(Baseline, week 13, week 25, week 50)
  • Change in Zarit Burden Interview (ZBI-12) Score(First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50))
  • Change in Work-Family Conflict Scale (WFC)(First home visit (~ week 1) and last home visit (~up to week 50))
  • Change in Caregiver Quality of Life (C-DEMQOL) Score(First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50))
  • Clinic Utilization by Persons With Dementia(up to 24 months)
  • Clinic Utilization by Caregivers of Persons With Dementia(up to 24 months)
  • Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure(First home visit (~ week 1) and week 13)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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