Clinical trial NCT04239924: Community Paramedic Coaching Program for Caregivers and People With Dementia
Official title: Community Paramedic Coaching Program for Caregivers and People With Dementia (CP3D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Community Care
Coaching
Paramedic
Caregivers
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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).

The study will employ a stepped design using a rapid-cycle evaluation approach. Three cohorts of 4-5 patient-caregiver dyads each will start the intervention at staggered intervals. Within each cohort, a new dyad will begin the program approximately every two weeks, with an approximate four week gap between each cohort for feedback collection and program iteration. Real-time feedback obtained from multiple intervention stakeholders (caregivers, persons with dementia, coaches, clinical staff/providers - up to 10 enrolled) will be used to iteratively improve intervention delivery and program implementation for the next, all while the first group continues the pilot. In this way, problems can be identified and solutions generated, with enough time to adapt the program and evaluate revisions. Staggering participant start dates allows for multiple rapid-cycle iterations within a single pilot study.

NOTE: While COVID-19 restrictions are in place, all feedback interviews will take place by telephone or WebEx videoconferencing, beginning 17 March 2020.

Eligibility criteria: 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

Patient Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Visits to the Emergency Department by the Person With Dementia
timeFrame: up to 24 months
measure: Number of Visits to the Emergency Department by the Caregiver of the Person With Dementia
timeFrame: up to 24 months
measure: Feasibility: Proportion of Coaching Phone Calls Completed
timeFrame: up to 12 months
measure: Feasibility: Proportion of Coaching Home Visits Completed
timeFrame: up to 12 months
Secondary outcomes:
measure: Change in Zarit Burden Interview (ZBI-12) Score
timeFrame: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
measure: Change in Generalized Anxiety Disorder (GAD-7) Score
timeFrame: Baseline, week 13, week 25, week 50
measure: Change in Center for Epidemiologic Studies Depression Scale (CESD-10)
timeFrame: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
measure: Change in Revised Caregiving Satisfaction Scale (RCSS)
timeFrame: Baseline, week 13, week 25, week 50
measure: Change in Revised Scale for Caregiving Self-Efficacy
timeFrame: First home visit (~ week 1) and last home visit (~up to week 50)
measure: Change in Work-Family Conflict Scale (WFC)
timeFrame: First home visit (~ week 1) and last home visit (~up to week 50)
measure: Change in Caregiver Quality of Life (C-DEMQOL) Score
timeFrame: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
measure: Change in Knowledge of Dementia (DKAS) Score
timeFrame: First home visit (~ week 1) and week 13
measure: Clinic Utilization by Persons With Dementia
timeFrame: up to 24 months
measure: Clinic Utilization by Caregivers of Persons With Dementia
timeFrame: up to 24 months
measure: Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure
timeFrame: First home visit (~ week 1) and week 13
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Manish N Shah, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: