RESCUE Stroke Caregiver Website to Enhance Discharge Planning



Status:Recruiting
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:June 22, 2015
End Date:April 30, 2020
Contact:Constance R Uphold, PhD MS BS
Email:Connie.Uphold@va.gov
Phone:(352) 376-1611

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Utilizing the RESCUE Stroke Caregiver Website to Enhance Discharge Planning

Aims and Intervention:

The long-term goal is to implement stroke caregiver programs that involve low-cost
interventions that are sustainable in routine clinical practice. The immediate objective is
to test, using a randomized controlled trial, a problem-solving intervention for stroke
caregivers that can be delivered during the transitional care period (e.g., time which
Veteran is discharged to home) followed by online, in-home sessions. The investigators will
modify the traditional, problem-solving intervention by adding web-based training using
interactive modules, factsheets, and tools on previously developed and nationally available
RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). The investigators will also
provide on-line, skills training and application of the problem-solving approach via the
RESCUE messaging center. The immediate, primary aim (#1) is to test the effect of the
intervention on stroke caregivers' depressive symptoms at 11 and 19 weeks after baseline data
collection. Aim #2 is to test the effect of the intervention on stroke caregivers' burden,
positive aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and
satisfaction with care at 11 and 19 weeks after baseline data collection. Aim #3 is to test
the effect of the intervention on Veterans' outcomes: functional abilities and healthcare
utilization (i.e., unintended hospital bed days of care, number of emergency room visits,
number of unscheduled clinic visits) at 11 and 19 weeks after baseline data collection. Aim
#4 is to determine the budgetary impact for implementing the intervention. Aim #5 is to
determine the facilitators, barriers and best practices for implementing the intervention.

Design and Methods:

The investigators will conduct a two-group randomized controlled trial. The investigators
will enroll 240 stroke caregivers at 8 study sites (North Florida/South Georgia Veterans
Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in Tampa,
Michael E. Debakey VAMC in Houston, Hunter Holmes McGuire VAMC in Richmond, Central Arkansas
Veterans Healthcare System, VA Tennessee Valley Healthcare System, and the VA Boston
Healthcare System). Eligible caregivers will be interviewed, complete baseline measures, and
then be randomized to two groups: 1) intervention group, or 2) standard care. A team member
will telephone caregivers at 11 weeks and 19 weeks after baseline data collection to answer
questions on instruments with established reliability and validity. Qualitative interviews
will be conducted with selected caregivers to obtain in-depth perceptions of the value,
facilitators, and barriers of the intervention.

Impact:

This is the first known study to test a transition-to-home intervention combined with
technology to improve the quality of caregiving and the recovery of Veterans.

Background:

Caregiver depression is common following a family member's stroke and is a major contributor
of survivor's hospital readmission and institutionalization. Researchers have consistently
found that interventions to help caregivers resolve problems are effective in reducing
depressive symptoms. However, these problem-solving interventions have been underused in
practice because they involve multiple, in-person or telephone sessions and require large
amounts of staff time to implement. To overcome these barriers, the long-term goal is to
implement stroke caregiver programs that involve low-cost interventions that are sustainable
in routine clinical practice. The immediate objective is to test, using a randomized
controlled trial, a problem-solving intervention for stroke caregivers that can be delivered
shortly after the Veterans' in-patient stays followed by online, in-home sessions. The
investigators will modify the traditional, problem-solving intervention by adding web-based
training using interactive modules, factsheets, and tools on previously developed and
nationally available RESCUE Caregiver website (www.cidrr8.research.va.gov/rescue). The
investigators will also provide on-line, skills training and application of the
problem-solving approach via the RESCUE messaging center, a secure site behind the VA
firewall. This work builds on the team's extensive experience in stroke caregiver education.

The immediate, primary aim (#1) is to test the effect of the intervention on stroke
caregivers' depressive symptoms at 11 and 19 weeks after baseline data collection. Primary
Hypothesis: Stroke caregivers who receive the intervention will have less depressive symptoms
at 11 and 19 weeks after baseline data collection compared to stroke caregivers who receive
standard care. The investigators propose four secondary aims. Aim #2 is to test the effect of
the intervention on stroke caregivers' burden, positive aspects of caregiving, self-efficacy,
health-related quality of life (HRQOL), and satisfaction with care at 11 and 19 weeks after
baseline data collection. Aim #3 is to test the effect of the intervention on Veterans'
outcomes: functional abilities and healthcare utilization (i.e., unintended hospital bed days
of care, number of emergency room visits, number of unscheduled clinic visits) at 11 and 19
weeks after baseline data collection. Aim #4 is to determine the budgetary impact for
implementing the intervention. Aim #5 is to determine the facilitators, barriers and best
practices for implementing the intervention.

Methods:

The investigators will conduct a two-group randomized controlled trial with repeated measures
and use mixed methods to determine caregivers' perceptions of the intervention. The
investigators will enroll 240 stroke caregivers at 8 study sites (North Florida/South Georgia
Veterans Healthcare System, Miami VA Healthcare System, James A. Haley Veterans Hospital in
Tampa, Michael E. Debakey VAMC in Houston, Hunter Holmes McGuire VAMC in Richmond, Central
Arkansas Veterans Healthcare System, VA Tennessee Valley Healthcare System, and the VA Boston
Healthcare System). Eligible caregivers will be interviewed, complete baseline measures, and
then be randomized to two groups: 1) intervention group, or 2) standard care. A study team
member will telephone caregivers at 11 weeks and 19 weeks after baseline data collection to
answer questions on instruments with established reliability and validity. The team member
will review the Veterans' VA Computerized Patient Record System health record to obtain
information on the Veterans' healthcare utilization. The investigators will determine the
budgetary impact of the intervention by examining the cost data in the VA Managerial Cost
Accounting System (MCAS) (formerly DSS) National Data Extracts and Non-VA Medical Care files.
Qualitative interviews will be conducted with selected caregivers to obtain in-depth
perceptions of the value, facilitators, and barriers of the intervention. Throughout all
phases of the project, the investigators will collaborate with VA (Offices of Nursing Service
and Office of Geriatrics and Extended Care.

Impact:

This is the first known study to test transition-to-home intervention combined with
technology to improve the quality of caregiving and the recovery of Veterans. Other outcomes
will be a state-of-the-art website and an evidence-based model (in-patient, discharge
planning and online, training and caregiver-provider messaging) that can be transportable to
other disease models

Inclusion Criteria:

All caregivers of Veterans with a primary diagnosis of stroke are eligible for
participation if they meet the following criteria:

- are the primary caregiver and provide the majority of care for a Veteran who has a
primary diagnosis of stroke (ICD9 codes for stroke: 430-438) and who has at least one
activity of daily living (ADL) deficits or a new or worsening cognitive or physical
functioning problem,

- have Internet and email access and ability,

- are reachable by cell or home phone,

- read English at the sixth grade reading level or better,

- score 1 or greater on the Perceived Stress Scale

- Veteran has been discharged to home within the preceding four months or plans to be
ultimately discharged to home

- are agreeable to be randomized to the intervention or standard care group

Exclusion Criteria:

Caregivers who fail to meet one or more of the inclusion criteria and whose Veterans

- are terminally ill

- have a life expectancy of less than 6 months

- are a prisoner, or

- are professional caregivers who had no preexisting relationship to the Veteran

- are enrolled or have completed similar caregiving interventions (at PI discretion)

Life expectancy and service use will be determined by reviewing the CPRS records and
conferring with the in-patient staff and with the investigators' clinical team members
(MDs, RNs).
We found this trial at
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Tampa, Florida 33612
Phone: 813-558-3952
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Gainesville, Florida 32608
Phone: (352) 376-1611
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Miami, Florida 33125
Phone: 305-575-3388
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