Community Paramedic Coaching Program for Caregivers and People With Dementia

Dementia Clinical Trial

— CP3D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239924
• Other study ID #: 2019-1218
• Secondary ID: A534100SMPH/EMER
• Status: Completed
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Paramedic Coaching
The intervention is an adaptation of the evidence-based REACH program, specific coaching content is delivered by paramedics in 1-2 hour in-home sessions and over the phone throughout a 12-month period.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Visits to the Emergency Department by the Person With Dementia	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.	up to 24 months
Primary	Number of Visits to the Emergency Department by the Caregiver of the Person With Dementia	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.	up to 24 months
Primary	Feasibility: Proportion of Coaching Phone Calls Completed	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.	up to 12 months
Primary	Feasibility: Proportion of Coaching Home Visits Completed	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.	up to 12 months
Secondary	Change in Zarit Burden Interview (ZBI-12) Score	The Zarit Burden Interview measures caregiver burden. This is a 12-item survey with a total possible range of scores from 0-48, where higher scores indicate increased burden. The investigators hypothesize the score will decrease as a result of the intervention.	First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
Secondary	Change in Generalized Anxiety Disorder (GAD-7) Score	The GAD-7 is a 7-item survey that measures anxiety symptom severity. The total possible range of scores is 0-21, where higher scores indicate increased symptom severity. The investigators hypothesize the score will decrease as a result of the intervention.	Baseline, week 13, week 25, week 50
Secondary	Change in Center for Epidemiologic Studies Depression Scale (CESD-10)	The CESD-10 is a general measure of depression frequently used in caregiver studies. It is a 10-item survey with a total possible range of scores of 0-30 where higher scores indicate increased depression. The investigators hypothesize the score will decrease as a result of the intervention.	First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
Secondary	Change in Revised Caregiving Satisfaction Scale (RCSS)	The RCSS is a 6-item survey used to measure the positive aspects of caring. The range of total possible scores is 6-30 where higher scores indicate increased caregiver satisfaction. The investigators hypothesize the score will increase as a result of the intervention.	Baseline, week 13, week 25, week 50
Secondary	Change in Revised Scale for Caregiving Self-Efficacy	The revised scale for caregiving self-efficacy measures three domains: obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts. It is a 15-item scale with a total possible range of scores between 0-100, where higher scores are better. The investigators hypothesize the score will increase as a result of the intervention.	First home visit (~ week 1) and last home visit (~up to week 50)
Secondary	Change in Work-Family Conflict Scale (WFC)	WFC is measured for the caregiver. It is a 6-item survey with a total possible range of scores between 6-30 with higher scores indicating lesser work-family conflict. The investigators hypothesize the score will increase as a result of the intervention.	First home visit (~ week 1) and last home visit (~up to week 50)
Secondary	Change in Caregiver Quality of Life (C-DEMQOL) Score	C-DEMQOL is measured for the caregiver. The investigators will be asking 18 of the questions from the scale to understand the quality of life the caregivers experience. Scores can range from 18-90, with a higher score reflecting a higher quality of life.	First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)
Secondary	Change in Knowledge of Dementia (DKAS) Score	DKAS is measured for the caregiver. It is a 25 item true-false survey of facts about dementia. Scoring is by measuring the proportion of questions answered correctly. The range for score values is 0 to 50, the higher the score the better the outcome (a.k.a. the more knowledgeable about dementia).	First home visit (~ week 1) and week 13
Secondary	Clinic Utilization by Persons With Dementia	As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for persons with dementia.	up to 24 months
Secondary	Clinic Utilization by Caregivers of Persons With Dementia	As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for caregivers of persons with dementia.	up to 24 months
Secondary	Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure	Assesses caregivers perception of communication with health care team and extent to which the team considers their capacity and preferences in decision making. This measure consists of 12 questions, with scores ranging from 12-60, where higher scores indicate increased communication with the health care team.	First home visit (~ week 1) and week 13

External Links

•   Rosalynn Carter Institute of Caregiving