The REACH Caregiver

Intervention Program: From

Clinical Trial to Community

Implementation

Lou Burgio, Ph.D.Lou Burgio, Ph.D.

HRJ Endowed Chair

University of Michigan

Background dementia (Facts and Figures, Alzheimers Association, 2012)

Dementia describes a syndrome of neurodegenerative disorders affecting memory/recall, executive function, and daily activity performance. Most common form of activity performance. Most common form of dementia is Alzheimers Disease (AD)

Approximately 5.2 million individuals in the U.S. are affected by AD

One in eight people age 65 and older (13 percent) has Alzheimers disease.

Nearly half of people age 85 and older (45 percent) have Alzheimers disease

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Background - caregiving

Two thirds of all persons with dementia reside in the community receiving care from over 15 million receiving care from over 15 million caregivers, 75% of whom are informal caregivers, generally family members. 75% of these family caregivers are women.

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Background - caregiving

In 2011, these caregivers provided an estimated 17.4 billion hours of unpaid care, a contribution to the nation valued at over $210 billion. at over $210 billion.

The physical and emotional impact of dementia caregiving is estimated to result in $8.7 billion in increased health care costs in the United States.

Dementia is a Public Health Epidemic,

both in the U.S. and Globally

AD is a disease and NOT a natural outcome of aging

It is the sixth leading cause of death in U.S.U.S.

While deaths from other major causes

continue to experience significant

declines, those from Alzheimers

disease have continued to rise.

Caregiver Support Programs:

Good News and Bad News (Translating Innovation to Impact. A White Paper. Agency on Aging, 2012)

Caregiver Support Programs

The Good News

There is a considerable amount of published research on dementia caregiver interventionscaregiver interventions

White paper(2012) lists research (RCTs) on 44 different caregiver support programs

Caregiver Support Programs

The Not So Good News

Most of the translational research (i.e., adapting RCT protocols for feasible use in the community) has concentrated on in the community) has concentrated on only 9 programs, including:

Savvy Caregiver, NYUCI, Environmental Skills Building (Skills2Care), STAR-C, REACH II

Caregiver Support Programs:

the Bad News As of mid-2012 only 11 papers had been

published on results of translational studies. (Note that all used quasi-experimental designs):experimental designs):

Savvy Caregiver

Skills2Care

STAR-C

REACH II

REACH VA

REACH OUT

NIH-funded multi-site, NIH-funded multi-site,

randomized clinical trial (RCT)

testing a dementia caregiver

intervention program

Overall Goal of REACH Intervention:Overall Goal of REACH Intervention:Reduce stress and burden of dementia caregivers caring for loved ones in the home

REACH II Intervention

The REACH II intervention was designed to

address six areas focused on reducing caregiver

stress:

Safety Safety

Social Support

CR Problem Behaviors (behavior management)

Emotional well-being (relaxation techniques)

Caregiver Self-care and Health Behaviors

System that allowed caregivers to be involved in

Support Group through the phone

Procedures

Maximum of 12 home visits over 6 months

4-6 therapeutic phone calls

REACH-OUT Translational Trial

Lou Burgio (PI)

Goal: Translate RCT-version of REACH II intervention for feasible use in the community, specifically, Area Agencies community, specifically, Area Agencies on Aging (AAAs)

Analysis sample = 256

How was REACH II Clinical Trial

Translated to Community?

Two Phases

Phase I: Using Community Participatory Research (CPR) methods, Al. Dept. of Senior Services and University of Senior Services and University of Alabama partnered to adapt the REACH II intervention protocol for AAAs

Phase II: Use traditional clinical research methods to test the effectiveness of the adapted intervention.

REACH OUT Phase I: CPR

Advisory Committee formed: AAA directors and case managers, LB and Project Coordinator, and the State Commissioner of Senior Services

Over a 4 month period, the Advisory Committee had a Over a 4 month period, the Advisory Committee had a series of face-to-face meetings and phone conferences to decide how to adapt all aspects of the program to make it more feasible

Over an additional 5 month period, with consultation from Advisory Committee, we (UA) adapted procedural and trainer manuals from REACH II to reflect the adaptations made by the Advisory Committee

How Did the Translated

Intervention Look?Very Similar to the REACH RCT

We used the same:

Mode of delivery (in-home sessions)

Therapeutic technique (Formal Problem Therapeutic technique (Formal Problem Solving; action-oriented sessions

Taught the CGs most (not all) of the same skills as REACH II

Tailored the intervention to the dyads needs (Risk Assessment)

How Did the Translated

Intervention Look?

SPECIFICSInitially a risk assessment is conducted to produce

tailored interventions.

Interventions include:

Education about AD, Caregiving and Stress1. Education about AD, Caregiving and Stress

2. Caregiver Health (Health Passport)

3. Home Safety (Check-list)

4. Behavioral Management (Behavioral Prescriptions)

5. CG Stress Management (Signal Breath Relaxation)excluded social support and use of technology

How was REACH OUT I

Different from REACH RCT? 4 (vs. 12), hour-long home visits to families

over 3-4 months (not 6) to introduce treatment components

1st home visit: Initial visit includes Risk AssessmentAssessment

2nd home visit: ~ 3 weeks later

3rd home visit: ~ 4 weeks later

4th home visit: ~ 4 weeks later (final home visit)

3 therapeutic phone calls (not 6) between home visits

REACH OUT Phase II: Use of

Traditional Clinical Research

Methods to Test Effectiveness

Translated REACH OUT program stayed constant from this point on

Pre- Post-assessment (quasi- Pre- Post-assessment (quasi-experimental design)

General Linear Modeling (GLM) used to analyze the data

REACH OUT I Outcomes?

Very Similar to REACH Clinical Trial

REACH OUT I: Caregiver

Outcomes Caregiver improvement in their overall

health and depression

Reduction in feelings of burden from

caregivingcaregiving

CG reported fewer feelings of anger towards

the CR

REACH OUT I: Care-recipient

Outcomes Care recipients were less likely to be left

unsupervised

Less wandering

CR less likely to have access to dangerous CR less likely to have access to dangerous

objects

Improvement in care recipients problem

behaviors

Lessons Learned During

Implementation Need formal certification in REACH OUT

Formal screen for burden (4-item Zarit) as entry criterion

Re-training (recalibration) of Re-training (recalibration) of interventionists and assessors at 6-months

Now recommending six, in place of four in-home sessions

Need maintenance sessions for long-term effect

Lessons Learned During

Implementation Very helpful--perhaps necessary--to

have a community Champion (State Commissioner on Aging fully supportive)

Conducting formal caregiver support Conducting formal caregiver support programs conflicts with long-standing case manager role

Expectations for evaluation well beyond current standards

Barriers and

Recommendations

Policy In the U.S. we have, at best, only a

patchwork of State and Federal Policies to assist dementia caregivers

We need: We need:

Coherent and consistent Federal policy for caregiver support

Mandated dementia training and education initiatives

Reimbursements for informal caregivers

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Barriers and

Recommendations

ResearchWe need: More funding for translational

research

Caregiver support systems offered Caregiver support systems offered through primary care medicine

Better linkage between caregiver intervention researchers and funders to relatively new area of research called Translation Science (AHRQ, PCORI) 27