Utilizing the RESCUE Stroke Caregiver Website to Enhance Discharge Planning
Phase: NA
Conditions: Depression, Quality of Life, Self Efficacy, Recovery of Function, Stress, Positive Aspects of Caregiving
Sponsor: VA Office of Research and Development

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NCT01600131 
Protocol 
 
1. 
Project Title:  Utilizing the RESCUE Stroke Caregiver Website to Enhance Discharge Planning 
 
2. 
Investigators:  Constance Uphold, PhD, PI; Magaly Freytes, PhD; Karen Besterman-Dahan, PhD; 
Stuti Dang, MD, MS; Ronald Shorr, MD, MS; Rebecca Beyth, MD, MSHS; Bruce Vogel, PhD; Samuel 
Wu, PhD; Timothy Hogan, PhD; Charles Levy, MD; Xinping Wang, PhD; Sergio Romero, PhD; Tatiana 
Schember, PhD 
 
3. 
Abstract: Caregiver depression is common following a family member’s stroke and is a major 
contributor of survivors’ hospital readmission and institutionalization. Our long-term goal is to implement stroke 
caregiver programs that involve low-cost interventions that are sustainable in routine clinical practice. Our 
immediate objective is to test, using a randomized controlled trial, a problem-solving intervention for stroke 
caregivers that can be delivered over the phone followed by online, in-home sessions. We will modify the 
traditional problem-solving intervention by adding web-based training using interactive modules, factsheets, 
and tools on our previously developed and nationally available RESCUE Caregiver website 
(http://www.cidrr8.research.va.gov/rescue/). We will also provide online 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. 
Our immediate, primary aim (#1) is to test the effect of the intervention on stroke caregivers’ 
depressive symptoms at approximately 11 and 19 weeks after baseline data collection. Primary 
Hypothesis: Stroke caregivers who receive the intervention will have less depressive symptoms compared to 
stroke caregivers in usual care. We propose four secondary aims.  Aim #2 is to test the effect of the 
intervention on stroke caregivers’ knowledge, perceived stress, burden, perceptions of positive aspects of 
caregiving, self-efficacy, health-related quality of life (HRQOL), and satisfaction with care at approximately 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 approximately 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:  We will conduct a two-group randomized controlled trial with repeated measures and use mixed 
methods to determine caregivers’ perceptions of the intervention. We will enroll 240 stroke caregivers from 8 
VA 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) usual care group.  A study team member will 
telephone caregivers at approximately 11 and 19 weeks after baseline to answer questions on instruments with 
established reliability and validity. The staff member will review the Veterans’ VA Computerized Patient Record 
System health record to obtain information on the Veterans’ healthcare utilization.  We 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 (NDE) 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, we will collaborate with our VA partners (Office of 
Nursing Services, Office of Geriatrics and Extended Care). 
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. Other outcomes will be a state-of-the-art 
website and an evidence-based model (telephone, transition to home and online, training and caregiver-
provider messaging) that can be transportable to other disease models. 
 

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4. 
Background:  The overarching theoretical model guiding our study is the health communication 
process model. This model has the following stages: planning and strategy development; development and 
pretesting concepts, messages, and materials; implementation; assessment of effectiveness; and feedback to 
the first stage. Within each stage there is an ongoing, synergist feedback loop between planning, 
implementation, and improvement (see graphic). A key component of this model is improving the health of 
communities (e.g., caregivers & Veterans in the VA) with programs that are “consumer-driven” and that use 
traditional coalition building strategies and participatory action methods to collaboratively engage stakeholders 
and partners. 
     The relational/problem-solving model of stress guides the intervention and the outcome variables selected 
in our project. Stress is viewed as a function of the reciprocal relations among stressful life events, emotional 
stress responses, and problem-solving coping. Successful problem-solving coping entails developing a 
creative and optimistic attitude and using a structured approach to manage challenges. The model can be 
summarized by the acronym COPE (Creativity, Optimism, Planning, and Expert Information). Effective problem 
solving entails developing a Creative way of thinking and using one’s imagination to develop ideas for solving 
problems. In this model, caregivers are encouraged to have an Optimistic attitude. Optimism involves viewing 
problems as a normal part of life and recognizing that effective problem solving can be learned and 
successfully used. Effective Problem solving involves several steps: 1) identifying and defining the problem; 2) 
prioritizing problems; 3) selecting the highest priority problem; 4) gathering Expert information; 5) setting 
realistic goals; 6) listing all possible solutions; 7) choosing the best solution; and 8) evaluating the plan.           
Underlying this model is the premise that successful family caregiving involves open, collaborative 
relationships with healthcare professionals. Healthcare professionals are viewed as partners who are available 
to motivate, support and provide expert information (i.e., causes/consequences of problems, when and how 
caregivers should obtain help) when needed. Consistent with the problem-solving model, in our project, we will 
use the theme of RESCUE (Resources and Education for Stroke Caregivers’ Understanding and 
Empowerment) to illustrate how caregivers in collaboration with providers act as “lifeguards” and are 
responsible for the safety of the stroke survivors who are under their watchful care. Regardless of what goals 
are set, the expected outcome of problem-solving is to minimize negative effects of stress on caregivers 
(depressive symptoms, perceived stress, burden) and patients (functional disabilities, healthcare utilization and 
costs); and optimize caregivers’ knowledge, skills/behaviors (i.e., self-efficacy, perceptions of positive aspects 
of caregiving, satisfaction with care) and health-related quality of life. 
 
5. 
Specific Aims and Hypotheses: 
 Our immediate, primary aim (#1): to test the effect of the intervention on stroke caregivers’ depressive 
symptoms at approximately 11 and 19 weeks after baseline data collection. Hypothesis #1 (primary): 
Stroke caregivers who receive the intervention will have less depressive symptoms at approximately 11 and 19 
weeks after baseline data collection compared to stroke caregivers in the usual care group.  
We propose four secondary aims (#2-5): 
Aim #2: to test the effect of the intervention on stroke caregivers’ knowledge, perceived stress, burden, 
perceptions of positive aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and 
satisfaction with care at approximately 11 and 19 weeks after baseline data collection.   
Hypotheses #2: (2a) Stroke caregivers who receive the intervention will have superior outcomes (i.e., greater 
knowledge, less stress, less burden, perceive more positive aspects of caregiving, greater self-efficacy, better 
health-related quality of life (HRQOL), and greater satisfaction with care) at approximately 11 and 19 weeks  
after baseline data collection than caregivers in the usual care group.  
Aim #3: 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 approximately 11 and 19 weeks after baseline data collection.  
Hypotheses #3: Veterans whose caregivers receive the intervention will have better functional abilities at 
approximately 11 and 19 weeks after baseline data collection and less healthcare utilization at 11 and 19 
weeks after baseline data collection compared to Veterans whose caregivers are in the usual care group. 
Aim #4: to determine the budgetary impact for implementing the intervention.  
Research question: What are the costs associated with the intervention and how do they compare to usual 
care? 

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Aim #5: to determine the facilitators, barriers, and best practices for implementing the intervention. 
Research questions: What are the recommendations of VA leaders, policy makers, and clinicians for planning, 
developing, promoting, and evaluating and implementing the intervention in other sites? What are the 
caregivers’ perceptions of the value, strengths, and weaknesses of the intervention, and what 
facilitators/barriers did they identify with the intervention? 
Our rationale is that findings from the primary and secondary aims will provide information about the impact of 
the intervention and will inform dissemination and translation of the intervention into VA practice. 
 
6. 
Research Plan: The project will use mixed methods.  Aims 1, 2, and 3 will test the effect of the stroke 
caregiver intervention on improving outcomes using quantitative methods.  Aim 4 will determine the budgetary 
impact of the intervention using micro-costing techniques (viz., direct measurement and pseudo-billing) 
combined with average costing to determine the average staff time, wage, space, and equipment costs 
associated with the intervention.  Aim 5 will use qualitative methods to determine the facilitators, barriers and 
best practices for implementing the intervention. 
 
Research Design & Methods (Aim #1, 2, 3) 
Design: A two-group, randomized controlled trial with three assessment points (baseline, approximately 11 
weeks, and approximately 19 weeks) will be conducted. The randomization will be stratified across study sites.  
Study Locations: We will recruit participants from a total of eight sites. We will have staff at three study sites 
in VISN8: NF/SG VHS in Gainesville, FL; James A. Haley Veterans Hospital in Tampa, FL; Bruce W. Carter 
Medical Center, in Miami, FL.  Staff at these sites will also recruit from Michael E. Debakey VAMC in Houston, 
TX, Hunter Holmes McGuire VAMC in Richmond, VA,  Central Arkansas Veterans Healthcare System , VA 
Tennessee Valley Healthcare System, and VA Boston Healthcare System via telephone and mail. All of the 
sites have large, in-patient hospitals, community living centers, and in-patient rehabilitation units; however, the 
Tampa site has a standardized, discharge planning process that involves Veteran education while the other 
sites have no discharge planning process. Thus, the usual/standard discharge planning care that Veterans 
receive at Tampa may be different than the care received by Veterans at the other sites. The research nurses 
will document the discharge planning care that the caregivers receive at all sites. In addition, research staff will 
review the Veterans’ CPRS health records and describe the discharge planning care that is documented in the 
records. To address the issue of potential differences in usual care between study sites, and to aid in recruiting 
the necessary sample size, we will use a stratified, randomization procedure to achieve balanced group 
membership across the study sites. In our data analytic plan we will stratify by study sites in addition to 
controlling for baseline measurements.  
 
Sample: We will recruit a total of 240 caregivers who will be randomized to an intervention or a usual care 
group (see randomization & power analysis in the data analysis section). 
Eligibility Criteria: Inclusion criteria: All caregivers of Veterans with a primary diagnosis of stroke  are eligible 
for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care 
for a Veteran who has a primary diagnosis of stroke (ICD10 codes for stroke: 160.0-169.998) and who has at 
least one activity of daily living (ADL) deficit or a new or worsening cognitive or physical functioning problem, 2) 
have internet and email access and ability, 3) are reachable by cell or home phone, 4) read English at the sixth 
grade reading level or better, 5) score 1 or greater on the Perceived Stress Scale and 6) plan to be ultimately 
discharged to home or have been discharged home within the preceding 4 months 7) agree to random 
assignment to the intervention or usual care group.  
    The research staff will use a checklist for caregiver enrollment to determine the caregivers’ eligibility. The 
research staff will determine whether the Veteran has a primary diagnosis of stroke by reviewing the Veterans’ 
CPRS health record and by conferring with the clinical staff. Caregiver status and responsibilities will be 
determined by caregiver self-report. We will determine the Veterans’ ADL deficits by asking caregivers which 
ADL deficits their Veteran has on the Barthel Index. Reading level will be indicated by the Brief Health Literacy 
Level screening tool.  Internet and email access and ability will be determined by caregiver self-report. 
    Exclusion criteria:  We will exclude caregivers of Veterans who are terminally ill, who are prisoners, who fail 
to meet one or more of the inclusion criteria, and whose Veterans have a life expectancy of less than 6 
months. We will also exclude professional caregivers who had no preexisting relationship to the Veteran. 
Caregivers who are enrolled in or have completed similar caregiver support programs will be excluded at PI 
discretion. Service use will be determined by reviewing the CPRS records. We will confer with the in-patient 

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staff and with our clinical team members (MDs, RNs) to approximate life expectancy. The study personnel will 
terminate the caregiver participation if the Veteran dies during the study.  
 
Rationale for Study Sample Size: The sample will consist of 240 caregivers. Assuming a standard deviation 
of 8.2, 84 subjects per group would achieve 80% power to detect a mean intervention effect size of 3.5 on 
depression at a 5% significance level. The sample size of 120 per group (i.e., intervention group, usual care 
group) was selected to account for the occurrence of a (30%) dropout rate. The 30% drop-out rate is a 
conservative estimate of attrition and is based on previous caregiver problem-solving intervention studies in the 
literature and on the attrition rates found in the internet intervention studies of our consultants, Drs. Nahm and 
Rupper. The expected effect size and variability was deemed reasonable based on a number of sources. In a 
study of caregivers of Alzheimer’s patients, the investigative team described large changes pre- and post-
treatment in a clinical setting, with depression from time of admission to 4 weeks post decreasing 20 points for 
“recovered” patients and 12 points for “still ill” patients. In a study of a telephone intervention to family 
caregivers of stroke caregivers, found an estimated 1 month treatment effect of 3.1.  
 
Recruitment and enrollment:    
The study will be open to all eligible caregivers.  The caregivers will be recruited from 8 settings (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 VA Boston 
Healthcare System). We will also recruit from each facility’s associated community-based outpatient clinics. 
Although we will recruit from the Houston, Richmond, Central Arkansas, Tennessee Valley and Boston VA 
Systems, all study procedures will be performed by staff at the North Florida/South Georgia, Tampa and Miami 
locations (i.e., no personnel at the Houston, Richmond, Arkansas, Tennessee or Boston facilities will be 
engaged in research). Staff at the main study sites (North Florida/South Georgia, Miami and Tampa) will be 
responsible for maintaining study records for participants recruited from Houston, Richmond, Arkansas, 
Tennessee and Boston. 
 
 
 
Face-to-face recruitment (Gainesville, Miami, Tampa) 
We will perform face-to-face recruitment for in-patient Veterans and Veterans returning for outpatient 
appointments at the Gainesville, Miami and Tampa sites. To recruit in-patient Veterans and Veterans returning 
to VA clinics for outpatient appointments, we will meet with the clinical staff in the VA settings that care for 
Veterans with strokes and describe our study. We will also notify VA clinicians of the study via email. Clinicians 
in the VA will ask Veterans with stroke who are receiving care on their units or facilities and/or their caregivers 
if they are interested in talking to a research staff member about the study. The VA clinicians who care for 
Veterans with a stroke are busy and often rotate shifts, so study Nurses will additionally review the VA’s 
computerized record system (CPRS) to identify in-patient Veterans in order to assist the clinicians in locating 
potential participants. The study Nurses will review the minimum amount of information necessary to determine 
if the Veteran is admitted for new onset stroke. Once a Veteran is identified as having a new onset stroke, the 
study Nurse will notify a VA clinician involved in that Veteran’s care either in person, by phone, or through 
encrypted e-mail. The clinician will then ask the Veteran and/ or caregiver if they are interested in talking to a 
research staff member about the study. If either the Veteran or caregiver is interested in the study, the study 
staff members will contact the caregiver and/or Veteran (using contact information found in CPRS or provided 
by the clinician) to arrange times to meet or talk with the caregiver and Veteran.  
 Next, we will make two recruitment contacts (i.e. in person or by phone) with the Veterans and 
caregivers. First recruitment contact: the research staff will explain the study to the Veteran and caregiver and 
ask if they are interested. If the Veteran and caregiver are still interested, the research staff will screen the 
caregiver for study eligibility. The research staff will use a checklist for caregiver enrollment to determine the 
caregivers’ eligibility. (See inclusion/exclusion criteria section for procedures to determine caregivers’ study 
eligibility). If Veterans and caregivers are interested and eligible, we will provide them with a folder containing 
copies of the informed consent documents so that they can review it and/or discuss with their family and 
friends.  Study staff will give caregivers and Veterans a recruitment card with brief study information and staff 
contact information for reference. Second recruitment contact: for eligible caregivers and Veterans, the 
research staff will meet in person or call the caregiver and Veteran on the telephone to implement the standard 
consenting process that will be in compliance with VA Central IRB and Research & Development Committees 

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at the study sites. We will also implement the following consenting process with the caregivers’ Veterans. We 
will explain that the Veterans will not be involved in the study intervention, but that the research team needs to 
review the Veterans’ medical record to obtain information on the Veterans’ demographic characteristics, clinical 
characteristics, and healthcare utilization. We will determine the Veterans’ decision-making capacity by asking 
the Veteran three questions to determine their orientation (what is the month?, what is the year?, what state 
are we in?). If the Veteran is unable to answer these questions correctly, they will be considered to have 
potential diminished decision-making capacity. We will also assess their comprehension. After the research 
team member has discussed the study with the Veteran, the research team member will ask the Veteran to 
reiterate back their understanding of study, the potential risks/benefits of the study, that his/her participation is 
voluntary, and that he/she can terminate participation, and so on. Veterans who are unable to reiterate their 
understanding will be considered to have potential diminished decision making capacity.  Since stroke can 
affect different parts of the brain, the Veteran may have full decision making capability, but be aphasic or 
unable to speak clearly and unable to answer the questions related to orientation or be able to describe the 
study.  In these cases, we will confer with the clinical staff regarding the Veteran’s aphasia and decision 
making capacity. We were advised by a neuropsychologist regarding how to assess stoke patients’ decision-
making capacity.  We will obtain assent of the Veterans and we will respect any dissent of the Veterans. The 
legally authorized representation (LAR) will be asked to give consent for Veterans with diminished decision 
making capacity.  The research team member will inform the LAR of the roles and responsibilities of the LAR 
and will provide the LAR with all the information that would have been provided to the participant.  If the 
Veterans have physical disabilities and unable to sign the informed consent forms and HIPAA authorization 
forms, the Veterans will be asked to make marks on the forms with witnesses present.  
 
 
Outpatient Recruitment via Telephone (All Sites) 
We will recruit Veterans that have been discharged home within the previous 4 months from all five 
settings. To recruit Veterans that have been discharged home within the last 4 months, we will develop a list of 
potential participants (including SSN and date of birth) by reviewing the VA Patient Care Encounter Package 
Dataset and the VA's Computerized Records System (CPRS) to identify Veterans at the 8 recruitment 
locations with a diagnosis of stroke based on ICD10 codes. We will mail letters of invitation and self-
addressed, stamped, recruitment postcards with an opt-in/opt-out option to the Veteran or their next of kin.  
A research staff member will then telephone the Veteran or their next of kin (i.e., those who returned 
the postcards with positive responses, those who did not return the postcards). The staff member will identify 
the Veteran’s caregiver or confirm the next of kin is the Veteran’s caregiver, explain the study and ask if there 
are questions. If the Veteran and caregiver are willing to participate, the staff member will confirm that the 
individuals meet all the other study eligibility criteria. The research staff will use a checklist for caregiver 
enrollment to determine the caregivers’ eligibility (see inclusion/exclusion criteria section for procedures to 
determine caregivers’ study eligibility). Once eligibility is confirmed, study personnel will mail Informed Consent 
Forms and HIPAA Authorization Forms, with a self-addressed stamped envelope so that the caregiver can mail 
it back to us. After caregivers and Veterans have had a chance to review the consent and HIPAA forms, the 
research staff will call the caregiver on the telephone to implement the standard consenting process that will be 
in compliance with VA Central IRB and Research & Development Committees at the study sites. We will also 
implement the consenting process, as described above, with the caregivers’ Veterans. Once study personnel 
receive the signed forms, the original consents will be retained by PI in participant’s subject file and a copy will 
be mailed to participants. Study documents for subjects from the Houston, Richmond, Central Arkansas, 
Tennessee Valley and Boston locations will be maintained by staff at the main study sites (Gainesville, Miami 
and Tampa).  
A brief description of the study and staff contact information will also be posted on the RESCUE 
website (http://www.cidrr8.research.va.gov/rescue). Caregivers or Veterans who contact study staff will be 
screened and consented following the same procedures described previously. 
 
 
Recruitment at Affiliate Facilities:   
 
Recruitment may also occur at affiliate facilities (hospitals or rehabilitation facilities). Clinicians at these 
facilities will hand recruitment cards to inpatient Veterans with stroke on their units and the Veterans’ 
caregivers. The cards will contain information about the study and a contact number. We will also post 
recruitment flyers with the research nurse’s contact information at these facilities. If interested, the caregiver or 
Veteran will contact study staff who will arrange a time to explain the study, screen for eligibility and consent 

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either in-person at the facility or over the phone. All other recruitment and enrollment procedures will be 
followed as outlined above. Affiliate facility staff members will not be directly engaged in research and no 
patient information will be shared from the affiliate facility.  
 
Recruitment tracking: We will track the number of caregivers who decline to participate and the reasons for 
their non-participation. 
 
Randomization:  
The proposed study will use a two-group randomized design with 3 assessment points (baseline, 
approximately 11 weeks, and approximately 19 weeks). Following baseline assessments, the participant will be 
randomly assigned to one of the two study groups (Intervention or Usual Care). The Pocock-Simon covariate 
adaptive randomization procedure will be used so that there will be approximately equal number of subjects 
assigned to the two groups within each covariate level (depressed or not and high or low ADL) and within each 
study site. The statistician will develop the randomization scheme and share it with the project coordinator and 
a research staff member at each site. When a caregiver is enrolled in the study, this staff member at site will 
obtain the group assignment for that caregiver from the randomization system. 
 
Data Collection:  
Research personnel will follow a step-by-step study procedure manual to collect the data. Research staff will 
meet or telephone caregivers who are interested in learning more about the study. We will arrange times to 
meet or talk with the caregivers that are convenient with the caregivers. The research staff will discuss the 
study and provide the caregivers a copy of the informed consent document, so that they can review it and/or 
discuss with their family and friends.  For caregivers who are willing to participate, the research staff will 
arrange an in-person or telephone meeting to determine the caregivers’ study eligibility (also see 
inclusion/exclusion criteria & recruitment and enrollment sections). For eligible caregivers, the research staff 
will meet in person with the caregivers and Veterans or call them to implement the standard consenting 
process that will be in compliance with VA Central IRB and Research & Development Committees at the 3 
study sites. If a discharge date is not known at this time, study staff will call the caregiver on a weekly basis to 
check on the status of the veteran’s discharge.  
    Once the Veteran and caregiver are enrolled in the study, baseline data will be collected over the phone. If 
the Veteran is an inpatient at the time of enrollment, baseline data will be collected after the Veteran is 
discharged. The research staff will ask the caregivers questions on the demographic data forms and survey 
questionnaires (stroke caregivers’ depression, knowledge, perceived stress, burden, perception of positive 
aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and satisfaction with care).  
    The research staff member will also review the caregivers' Veterans CPRS record to document the 
Veterans' age, gender, race/ethnicity, category of facility (hospital, community living center, rehabilitation 
facility) from which the Veteran was discharged to home, length of hospital and/or post-stroke rehabilitation 
stay, date/location/type of the stroke, number of previous strokes, and healthcare use. The research staff 
member will document any information in the record related to the Veterans' discharge plans (i.e., treatments, 
medicines, patient and family education, case management, services).  
    The post-test assessments (stroke caregivers’ depression, perceived stress, knowledge, burden, perception 
of positive aspects of caregiving, self-efficacy, health-related quality of life (HRQOL), and satisfaction with 
care) will be collected at approximately 11 weeks and approximately 19 weeks after the Veterans’ discharge.  
A study team member at the main study site (Gainesville), who will be blinded to the group assignment of the 
caregivers, will telephone the caregivers to obtain the post-test assessments. The research staff will also 
review the Veterans' CPRS record and document the Veterans' healthcare utilization since their discharge to 
home. To minimize loss to follow-up, we will contact participants 24 hours before each post-test assessment to 
remind them of their scheduled appointment time. We will also mail postcards to enrolled caregivers who we 
cannot contact after 3 attempts to reduce attrition. 
     In the event that the RN conducting the intervention or the research personnel conducting the pre-and post-
test assessments uncovers that the caregivers are experiencing unmanageable stress, but not severe stress, 
the research personnel will advise the caregivers to call their assigned VA primary care social workers and 
primary care clinicians (MD, ARNP, PA) of their Veterans’ care team.  The research personnel will also give 
the caregivers the phone number of the VA Caregiver Support Line and other referral sources as needed.  If 
the research personnel assesses that the caregivers are in severe stress or crisis or if the research personnel 

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uncovers that the Veteran has serious changes in his/her health, the research personnel will call the primary 
care provider/social worker of the Veteran’s care team  or the local emergency response system (9-1-1).  In the 
event that any abuse or neglect is suspected, study personnel will follow established procedures by oversight 
agencies, including VHA as directed in the VA Handbook 1050.01, to contact the Office of Inspector General, 
Office of Investigation, as well as the IRB and the state of Florida Abuse Hotline.   
 
Efforts to improve retention of participants: To improve the chances that participants will complete the 
project, we will conduct the 11-week and 19-week post-test assessments at times that are convenient to the 
caregivers.  
Overview of the Intervention 
We will use a nurse-guided, multi-component transition-to-home planning intervention. The intervention is 
designed to enhance, rather than substitute for the usual post-discharge efforts that are already in place at VA 
medical facilities. The transition-to-home component of the intervention (i.e., caregiver training using the 
RESCUE website) will be conducted in one or two sessions with stroke caregivers over the phone after 
baseline data collection. The in-home component will include 8 sessions of skills training on the RESCUE 
website followed by application of the problem-solving approach via the RESCUE messaging center. The 
intervention is designed to enhance stroke caregiver problem-solving skills and improve both caregiver and 
Veteran outcomes. The intervention is based on the relational/problem-solving model of stress. The 
intervention is tailored to address the self-identified needs of the caregivers.     
    The uniqueness of this proposed intervention is that it adds technology-based components (Internet training 
and messaging) to the traditional, in-person, problem-solving intervention. We designed our intervention to be 
minimally disruptive to caregivers’ schedules. This entailed developing an intervention that could be delivered 
in a one-time session over the phone followed by online training and messaging that caregivers could do at 
convenient times. Below, we separately discuss each component of the intervention: a) RESCUE website, b) 
transition-to-home telephone session, and c) In-home, online training and problem-solving sessions. 
a) The RESCUE Stroke Caregiver Website serves as the foundation for the entire intervention (transition-to-
home session and the in-home sessions). The goal of the website, which is named Resources and Education 
for Stroke Caregivers’ Understanding and Empowerment (RESCUE), is to help family members become skilled 
caregivers by providing comprehensive information to manage their own problems and those of their survivors. 
The website is evidence-based and consumer driven and houses information/tools, a problem-solving module, 
and a problem-solving diary form that are integral components of the intervention (see following sections and 
appendix for examples; visit the website at http://www.cidrr8.research.va.gov/rescue/).     
      The website includes the following sections: 1) an extensive list of resources; 2) a library of the 
monthly/bimonthly patient education newsletters; 3) self-help tools; 4) a glossary of medical terms with 
phonetic pronunciations; 5) testimonials or stories from stroke caregivers; 6) links to other stroke and caregiver 
websites; 7) a factsheet library; 8) a problem-solving training module, and 9) a problem-solving diary form. A 
major component of our proposed intervention is the comprehensive library of factsheets for stroke caregivers 
(see following table for categories and topics).  
 
b) Intervention Component (#1): Transition-to-Home Telephone Session: (includes the RESCUE 
problem-solving module and diary accessible on http://www.cidrr8.research.va.gov/rescue/ and in 
appendix). The research nurses at each site will conduct telephone sessions with the caregivers shortly after 
baseline data is collected. The nurses will follow a structured protocol (see following table) and script. The 
problem-solving module on the RESCUE website serves as the primary teaching tool for this session. Similar 
to how teachers use power-point presentations for classroom instruction, the nurses will use the module to 
teach the problem solving method. 
   
Protocol: Telephone, Transition-to-Home Session(s) using the Problem-Solving Module and RESCUE website 
#1 Objective:  
Rapport building 
and caregiver 
assessment   
The nurses will begin with an “icebreaker” to build rapport by asking the caregivers to talk about their 
families. Next, the nurses will ask the caregivers to talk about their stroke survivors before and after 
the stroke. Last, the nurses will ask the caregivers to talk about themselves and what they know or 
have learned while in the hospital about taking care of someone who has suffered a stroke. 

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#2 Objective:  
Tour of the 
RESCUE 
caregiver website 
The nurses will mail the caregivers the RESCUE workbook that prominently displays the RESCUE 
website access procedures on the cover.  The nurses will then give the caregivers a guided tour of 
the RESCUE website over the phone.  The nurses will navigate through the website with the 
caregiver and show the caregivers the various website features.  
 #3 Objective:  
 
Review of the 
Problem-Solving 
Module on the 
RESCUE website 
 
a) The nurses will ask the caregivers to click and open the problem-solving module. The module 
discusses the basic concepts of the problem-solving approach. Problems are viewed as challenges 
and successfully handled by developing a Creative way of thinking. Problems are resolved by 
developing an Optimistic attitude. Using a Planning-solving approach involves 8 steps: 1) 
identifying  and defining problems; 2) prioritizing problems; 3) selecting the highest priority problem; 
4) gathering Expert information; 5) setting realistic goals; 6) listing all possible solutions; 7) choosing 
the best solution; and 8) evaluating the plan. b) Prior to moving to the next part of the module, the 
research nurses will ask scripted questions to determine the caregivers’ understanding and will 
clarify information as needed.   
#4 Objective:  
 
Application of the 
problem-solving 
approach and the 
RESCUE website 
to address a 
common 
caregiver problem 
– STRESS & 
DEPRESSION 
a) The nurses and caregivers will next read the illustrative example or scenario in the problem-
solving module that discusses a fictional caregiver named Alice who has depression and stress. The 
nurses will show the caregiver how to apply the problem-solving approach using the information and 
tools on the RESCUE website to help resolve Alice’s stress and depression. b) The research nurses 
will then illustrate how to apply the problem-solving approach. c) Throughout the instruction, the 
nurses will emphasize the importance of having a positive attitude, remembering that most 
caregivers experience depressive symptoms (i.e., normalizing their experiences) and reinforcing that 
there are strategies to alleviate stress. 
#5 Objective 
 
Development of a 
personalized 
problem-solving 
plan 
a) The caregivers will identify all potential problems.  
b) Caregivers will use a printed copy of the “problem-solving diary” that is on the RESCUE website. 
This diary will be mailed to the caregivers. The caregivers will use the diary to write down their 
problems, prioritize their problems, and identify the most troublesome problem.  The caregivers will 
read and discuss the factsheet(s) on the RESCUE caregiver website related to their most 
troublesome problem.  The caregivers will list realistic goal(s), possible solutions, and evaluation 
plans.  
#6 Objective 
Summary of the 
problem-solving 
approach, in-
home sessions, 
and RESCUE 
workbook 
a) The nurses will summarize the session and answer questions.  
b) The nurses will review the purpose and procedures of the follow-up sessions that the caregivers 
will participate in at home on their computers (referred to as "in-home sessions"). The nurses will 
review the RESCUE website and verify that the caregivers know how to use the RESCUE 
messaging center (see in-home section). 
  
 
RESCUE Problem-Solving Diary Form: The caregivers will write their personalized problem-solving plans on a 
diary form. A blank diary form can be printed from the RESCUE website. The form provides spaces to list and 
prioritize problems, goals, solutions, and evaluation plans. During the telephone session, the caregivers will 
use a printed diary form to develop their personalized plan that they will update as needed (e.g., in-home 
sessions and after the study is completed). Caregivers will be reminded that they can go to the RESCUE 
website and print the blank diary forms as needed. 
RESCUE Information:  Caregivers will be given the URL of the VA-secured RESCUE Messaging Center and 
information (telephone number) about how to call the VA National Caregiver Support Line.   
 
c) Intervention Component (#2): In-Home Skills Training and Problem-Solving Sessions. The sessions 
will reinforce, sustain, and add to what was learned during the transition-to-home telephone session. The goals 
of the in-home component are to refresh the caregiver's knowledge of the problem-solving method, motivate 
and empower the caregivers’ abilities to access information on the RESCUE website to resolve their personal 
problems, and provide additional skills training to facilitate caregivers’ successful adjustment after Veterans’ 
return to home. We will begin the in-home sessions within the first four months after the Veterans’ discharge 
because this is the time caregivers recognize that the changes in their loved one may be permanent and 

9 
Updated 06/19/2017 
 
become most stressed. This is also the time that caregivers are most in need of information and support as 
they adjust to new roles.  We will conduct 8 sessions. 
    The in-home sessions involve two parts:  1) skills training on the RESCUE website, and 2) problem-solving 
planning via the RESCUE messaging center. For part one, caregivers will learn a new caregiving skill each 
session by reading a different factsheet on the RESCUE website.  
    In the second part of each in-home session, the caregivers will apply their skills training to develop 
personalized problem-solving plans using the RESCUE messaging center. The messaging center is a secure 
site that is located behind the VA firewall. The messaging center uses a free-text format that will enable the 
caregivers at home and the research nurses to asynchronously communicate and collaborate online over an 
encrypted channel. Participants will receive reminder emails 48 hours before each messaging center session. 
The messaging center is designed to assist participants in improving their abilities to problem-solve and 
thereby decrease their depressive symptoms. The caregiver-nurse interaction on the messaging center will 
reinforce information that the caregiver received during the transition-to-home session and the skills training on 
the RESCUE website. The role of the research nurses is to empower participants via the messaging center to 
act on their own behalf by providing acceptance and integration of new knowledge and suggesting alternatives.  
    The RESCUE messaging center is an adaptation of the currently available Low-ADL Monitoring Program 
(LAMP) platform that has been successfully used at our facility (North Florida/South Georgia VHS) by 1774 
Veterans since 2003. With the guidance of our Co-I, Dr. Levy, and consultant, Steven Moore, we modified the 
existing code base on the LAMP platform and began the initial steps to create the RESCUE messaging center. 
We also pretested the current message center.   
    During the transition-to-home session, the research nurses will discuss the procedures of the in-home 
sessions and explain how to access and use the RESCUE messaging center. In the transition-to-home 
session, the nurses will stress that the messaging center should not be relied on by the caregivers to have 
their problems solved by the research nurses.  Rather, the caregivers will be told that the messaging center is 
to help them learn how to solve their own problems. The nurses will emphasize that the caregiver should NOT 
use the messaging center as a substitute for their primary care provider or to address problems that are urgent 
and require immediate support and help. In the in-home sessions, if the caregivers have any problems with the 
RESCUE messaging center, they can call the project coordinator. 
    We will maintain records of “exact correspondence” of the caregiver and nurse communications on the 
messaging center. We will also collect data on the time spent or minutes that the caregivers and study nurse 
interact via the messaging center. This data will allow us to monitor participant adherence. To minimize loss to 
follow-up, if necessary, we will contact participants 24 hours before scheduled data collections/sessions to 
remind them of their session. We will also mail reminder postcards to enrolled caregivers that we are unable to 
contact after 3 attempts to reduce attrition. 
 
If after starting, a caregiver is unable or unwilling to continue with the intervention they will be offered 
the opportunity to discontinue the intervention but remain in the study for data collection phone calls. These 
phone calls will occur approximately 11 and 19 weeks after baseline data collection. To be eligible to complete 
these optional data collection phone calls, the caregiver must have completed at least one phone or 
messaging center intervention session. 
    
Usual Care Group: The caregivers’ Veterans will receive usual or standard care.  The caregivers will receive 
the standard information and discharge planning that is provided to all stroke caregivers.  There will be no 
changes in the care the Veterans normally receive or in the information and discharge planning that the 
caregivers normally receive.  
 
Fidelity Considerations:   We will develop standardized manuals and protocols. This manual will provide 
step-by-step guidelines on recruiting/enrolling participants, implementing the informed consent process, in 
conducting the transition-to-home and in-home sessions and implementing the data collection procedures. We 
will provide extensive training to all of our team members. The PI and one staff member will periodically visit 
(minimally once a year) the Tampa and Miami study sites and observe the research nurses conducting the 
transition-to-home session. Feedback will be provided as needed. 
    Similar to our previous projects, we will have regular conference calls with our team members at the three 
study sites (Gainesville, Miami and Tampa).  In these meetings, team members will describe how they are 

10 
Updated 06/19/2017 
 
implementing the intervention and discuss protocol issues. To monitor the delivery of the intervention, we will 
listen to each research nurse’s first one or two transition-to-home sessions to identify any fidelity issues at the 
beginning of the project. Following this initial monitoring, we will periodically listen to the remaining sessions, 
making sure that we have fidelity checks during the beginning, middle, and end of the first component of the 
intervention. We will also ask the research nurses to track the number of minutes they spend with each 
participant and to keep detailed notes of any deviations from our study protocol that occur during the transition-
to-home sessions. The PI and project coordinator will discuss the deliveries of the intervention and evaluate 
adherence to study protocols, noting all deviations on a form. Feedback will be provided to the research 
nurses.  
    In a similar fashion, we will monitor the in-home sessions (in the intervention) that are conducted via the 
RESCUE messaging center. We will review the first two “exact correspondences” of the caregiver and nurse to 
identify initial, fidelity issues. After this assessment, we will periodically review the exact correspondences 
between the caregiver and nursing on the messaging center to ensure that we have fidelity checks throughout 
the project.  The research nurses conducting the in-home sessions will also keep detailed notes of any 
deviations in protocol that occur during the in-home sessions.  The PI and project coordinator will review the 
fidelity check data and provide feedback, as needed, to the main study, research nurse.  
     
    We will evaluate “enactment” using the Treatment Fidelity Tool.  After completion of the study, we will ask 
caregivers (in intervention group) to rate the amount of information and contact they received during the 
transition-to-home and in-home sessions (too little, just right, too much), how much they used the skill-building 
strategies (not used, used a little, used often, used all the time) and the RESCUE website (never, infrequently, 
monthly, every 2-3 weeks, every week, every day,) how helpful the intervention was (not helpful, little, 
moderate, extremely,) and whether their problems were resolved (not resolved, making progress, fully 
resolved, resolved now). We will ask caregivers in the standard care group how much they used the RESCUE 
website (never, infrequently, monthly, every 2-3 weeks, every week, every day) and whether their problems 
were resolved (not resolved, making progress, fully resolved, resolved now). 
 
Training of investigative team members: Prior to interacting with participants, team members at all study 
sites will have a training meeting in Gainesville. This meeting will include the PI, project coordinator (PC), site 
PIs, and all research nurses. Other research team members will participate at designated times. We will 
carefully review the study manual and protocols and the project timeline. Although all of the research nurses 
will be experienced clinicians with expertise in motivational interviewing, we will review the principles and 
techniques of this approach. We will give feedback to research staff members after they have completed 
“mock” sessions performing the screening, the informed consent, and baseline assessment procedures. We 
will also give feedback to the nurses after they have completed “mock sessions” for the transition-to-home 
intervention. These staff members will be required to "pass” a role-playing session in front of the PI, site PIs, 
and PC.   
    We will extensively train the study staff who will conduct the post-test assessments, including the qualitative 
interviews. We have hired study staff that have experience in motivational and qualitative interviewing. 
Nonetheless, we will extensively train the study staff on these techniques. The study staff will practice 
interviewing techniques with feedback from the PI and project coordinator. The study staff will be required to 
“pass” a role-playing session.  
    Similarly, we will train the research nurses who will communicate with the caregivers via the RESCUE 
messaging center in the intervention group (second intervention component). We will conduct “mock sessions” 
in which the PI and project coordinator will monitor the nurse as she/he conducts these sessions. The nurse 
will be required to successfully “pass” two messaging sessions with a “proxy” caregiver in front of the PI and 
PC who will provide feedback for improving the nurse’s online messaging skills. 
 
Measures: We carefully chose measures that had good psychometric properties, were easy to administer, and 
were relatively short in length to reduce participant burden. An important consideration in our selection was 
including measures that had been used in our previous studies and in other caregiver studies so that we could 
compare our results with others. In addition, to address the “common caregiver dataset requirement” in this 
targeted solicitation we selected caregiver measures that have been evaluated historically in the literature. 
Most of the measures selected were tools that our team members had used previously in other studies. In the 

11 
Updated 06/19/2017 
 
table below, we describe the measures we will use for screening caregivers to determine their study eligibility 
as well as the measures related to testing hypotheses 1-3. Our other measures are described in later sections. 
 
Instruments/Measures 
Concept – 
Instrument/Measure 
Description of Instrument/Measure 
Mean  
Time  
Screening Instruments 
Caregiver Literacy Level – 
BRIEF health literacy 
screening tool  
Haun, et al., 2009 
This is a four-item health literacy screening tool that has been shown to accurately identify 
individuals with inadequate health literacy or persons who have below 7th grade reading level. 
The tool has adequate sensitivity and specificity.  
<2 
minutes 
Veterans’ Activity of Daily 
Living - Barthel Index  
Mahoney FI & Barthel D, 
1965 
This tool consists of 10 items that measure patients’ abilities to perform self-care tasks (e.g., 
feeding, bathing, personal toileting, dressing, chair/bed transfers, ambulation). The tool has 
been used extensively in studies of outcomes of care in rehabilitation settings. We will screen 
caregivers by asking them if their stroke survivor needs assistance performing the tasks.  
<2 
minutes 
Perceived Stress Scale-
Screening  
Cohen S & Williamson G, 
1988 
The PSS-4 was designed for use with community samples with at least a junior high school 
education, the items are easy to understand and the response alternatives are simple to grasp.  
Moreover, the questions are quite general in nature and hence relatively free of content specific 
to any sub population group.  Caregivers should score a 1 or greater on this tool to be eligible 
for enrollment. 
 
<2 
minutes 
Caregiver Measures (Pre- and Post-Test Assessments) 
Demographic and Health 
Characteristics 
Age, sex, marital status, educational level, race/ethnicity, relationship to stroke survivor will be 
collected by self-report. 
<5 
minutes 
Stroke Knowledge  
National Institutes of Health 
Stroke Knowledge is an instrument developed by the National Institutes of Health to measure 
individuals’ knowledge of stroke.  
<5 
minutes 
Perceived Stress Scale  
Cohen S & Williamson G, 
1988 
The PSS-4 was designed for use with community samples with at least a junior high school 
education, the items are easy to understand and the response alternatives are simple to grasp.  
Moreover, the questions are quite general in nature and hence relatively free of content specific 
to any sub population group.   
<2 
minutes 
Depressive Symptoms - 
Center for Epidemiologic 
Studies Depression (CES-D 
20)  
Eaton W, et al., 1994 
CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). It 
assesses depressive symptoms and is not a clinical measure of depression.  Scores range 
from 0-60 with higher scores indicating greater depressive symptoms. It has been used in 
numerous studies with caregivers, and has good reliability and validity.  
<8 
minutes 
Positive Aspects of 
Caregiving Scale—11-Item 
Boerner, et al., 2004 
The Positive Aspects of Caregiving Scale is an 11-item 5-point Likert scale ranging from 
disagree a lot (1) to agree a lot (5). Higher scores indicate greater benefits from caregiving. 
<5 
minutes 
 
Revised Scale for 
Caregiver Self-Efficacy 
Steffen et al. 2002 
This is a 15-item measure of caregivers’ judgments regarding their ability to perform effectively 
in specific, caregiving settings. We will administer two sub-scales of the instrument: Caregiver 
Self-Efficacy for Obtaining Respite and Caregiver Self Efficacy for Controlling Upsetting 
Thoughts about Caregiving. Respondents rate their level of confidence for each item on a scale 
from 0 to 100. The tool has established reliability and validity. We selected this self-efficacy tool 
because it was developed specifically for caregivers 
<5 
minutes 

12 
Updated 06/19/2017 
 
Caregiver Burden – Short 
Version of the Zarit 
Burden Interview (S-ZBI)  
Zarit, 1980 
This is a 12-item instrument that has been reduced from the original, full 29-item instrument.125 
The short version was correlated with the full version with correlation coefficients ranging from 
0.92 to 0.97. The S-ZBI measures the degree of burden felt by caregivers. Items fall into five 
categories (health, well-being, finances, social life, relationship with impaired person). The 
instrument was originally developed to measure burden of caregivers of patients with dementia. 
However, the S-ZBI has been used in stroke caregiver studies. We selected this tool above 
other burden instruments because it is brief, easy-to-answer, measures both subjective and 
objective burden, and is widely-used.  
<5 
minutes 
RAND 12-Item  Health 
Survey (VR-12)  
Kazis et al., 1998 
The VR-12 consists of 12 items that measure health-related quality of life. As recommended by 
Ware,126 we will transform raw data scores so that comparisons can be made with norms. 
Thus, scores will range from 0-100, with higher scores indicating better general health 
perceptions. The tool has been widely used in stroke caregiver studies and has established 
psychometric properties. We have used this tool in prior studies. 
<2 
minutes 
Patient Satisfaction – 
General Satisfaction 
Subscale of the Long-
Form Patient Satisfaction 
Question. (PSQ-III)  
Ware JE, et al., 1976 
The General Satisfaction Subscale consists of 6 items. Responses to items range from 
1=strongly agree to 5=strongly disagree. Lower scores indicate greater satisfaction. The 
subscale has adequate internal consistency and test-retest reliabilities. Validity of the tool has 
been supported in numerous studies. We selected this tool because it is brief, has good 
psychometric properties131 and is easy-to-read as we found in our previous studies.  
<5 
minutes 
Oberst Caregiving 
Burden Scale  
Oberst et al, 1991 
This instrument uses a 5-point response scale to measure the perceived amount of time spent 
and perceived level of difficulty for 15 caregiving tasks. Higher scores indicate more perceived 
time spent or difficulty with caregiving tasks. 
<8 
minutes 
Problem Checklist 
This instrument was created for the study. The instrument asks caregivers to indicate what 
problems they or their Veterans are dealing with. 
<5 
minutes 
Veteran Measures 
Demographic and 
Health-related variables 
Age, gender, race/ethnicity, facility from which Veteran was discharge to home (i.e., hospital, 
community living center, rehabilitation), length of post-stroke rehabilitation, location/type of the 
stroke, and number of previous strokes will be obtained from CPRS review. 
N/A 
Functional Abilities – 
Barthel Index 
(Caregivers answer this 
form) 
Mahoney FI & Barthel D, 
1965 
The Barthel Index is a frequently used tool to measure functional ability in both clinical and 
research settings. It has established validity, reliability, and sensitivity. We decided not to use 
the Functional Independence Measure (FIM), because FIM scores in the Veterans’ CPRS 
records will not coincide when the study assessments will be conducted.  Because the FIM 
items are based on the Barthel Index, we believe this index is a good proxy for the FIM.   
<2 
minutes 
Healthcare Utilization – 
Unintended hospital bed 
days of care, number of 
emergency room visits, 
number of unscheduled 
clinic visits 
Data on healthcare utilization will be obtained from the CPRS records.  
N/A 
Cost Data – See Aim #3 
We will obtain the standard cost data from the VA Managerial Cost Accounting System (MCAS) 
(formerly DSS) National Data Extracts (NDE) (total, nursing, pharmacy, laboratory, etc.) by fixed 
and variable categories and the Non-VA Medical Care files. 
N/A 
 
Measures to check fidelity (see section on Fidelity) 
 
Enactment  
We will use the Treatment Fidelity Tool and ask caregivers in the intervention to rate the amount 
and value of the information they received (see section on fidelity).  
<5 
minutes 
 
 
 

13 
Updated 06/19/2017 
 
RESCUE messaging 
center 
We will monitor the content of the Messaging Center sessions via “exact correspondence” 
between caregivers and the nurse. 
N/A 
 
Data Analysis: 
Hypothesis #1 (primary): Stroke caregivers who receive the intervention will have less depressive 
symptoms at approximately 11 and 19 weeks compared to stroke caregivers in the usual care group.  
Our primary endpoint is the caregiver depressive score. The focus of the primary analysis will be to examine 
the effect of the intervention based on “intention to treat.” Data from all the participants will be part of the 
primary analyses regardless of actual number of completed in-home sessions. Thus, we are examining the 
effectiveness of the intervention taking into account real world compliance factors. As an exploratory study 
element, we will assess compliance and attempt to determine its effect on study results. 
     For the primary analysis, the general linear mixed model for repeated measures will be used to model the 
follow-up depression times (approximately 11 and 19 weeks after baseline data collection), adjusted for site 
and baseline scores as fixed effects. Since the Tampa site has a standardized, discharge planning process 
that involves Veteran education while the other sites have no discharge planning process, there may be 
different responses due to usual care between the Tampa versus other sites. Thus, we will first explore 
whether or not there is a differential treatment effect at the Tampa site by fitting a full model that allows for 
Tampa to have a differential time and group effect for each time point. Let yij be the depression score for 
person i at time j, then Full fixed effects model will be:  
E(yij) = β0 + β1Baselinei + β2Tampai + Σsβ3s I(Site i =s)+ β4Timeij+ β5Groupi + β6Groupi*Timeij + β7Tampai*Timeij 
+ β8Tampai*Groupi + β9 Tampai*Groupi*Timeij 
with covariates for baseline depression and time since discharge (Baseline), site (e.g., Tampa=1 if Tampa, 0 
otherwise; and β3s represent effects of sites compared to reference site Gainesville), time (Time=0 for 11 
weeks, 1 for 19 weeks), and group (0 if active control, 1 if intervention). Of primary interest is the estimated 
within-site intervention effect at approximately 11 weeks after baseline data collection, controlling for baseline 
and stratifying by site. The initial test will be the test of β8+ β9=0, which tests whether the Tampa site has a 
differential group effect compared to the other sites at approximately 11 weeks after baseline data collection.  If 
a site difference in treatment effect is found, then results will be conditional on Tampa or Miami/Gainesville.  In 
this case, the primary tests of interest will be the estimated within-site intervention effect at approximately 11 
weeks after baseline data collection, controlling for baseline and stratifying by site.  In the model above, this 
corresponds to the test of β5 =0 for other sites and β5 +β8=0 for Tampa. If no difference is found in our initial 
interaction test, we will assume that the Tampa site does not have a differential treatment effect and the 
interaction will be removed from the model.  The new fixed effect portion of the model will simplify to the 
Reduced model:  
E(yij) = β0 + β1Baselinei + β2Tampai + Σsβ3s I(Site i =s)+ β4Timeij+ β5Groupi + β6Groupi*Timeij  
 
Of primary interest is the estimated within-site intervention effect at approximately 11 weeks after baseline data 
collection, controlling for baseline covariates and stratifying by site. In the model above, this is the test of β5 =0.  
In order to control for possible chance sample imbalances resulting from randomization, the model will include 
covariates for baseline prognostic factors (e.g., discharge from hospital, community living center, or 
rehabilitation facility; caregivers’ relationship to Veteran; number of previous strokes among Veterans, etc.), 
deemed to have significant relationships with response and groupwise imbalances. Thus, analyses will be able 
to compare the groups on the measure of interest while controlling for these factors. As a supplemental 
analysis we will assess long term intervention effects at the approximately 19 week after baseline data 
collection time point.  In the Full model above, this is the test of β6 =0 for other sites, and β6+ β9=0 for Tampa. 
In the reduced model, this is simply the test of β6 =0. All tests will be performed at the α=0.05 significance 
level.  The correlation among observations from the same person will be accounted for through the inclusion of 
a random person effect into the mixed model analysis. 
  
Hypotheses #2 (secondary): (2a) Stroke caregivers who receive the intervention will have superior 
outcomes (i.e., less burden, less stress, greater self-efficacy, perceive greater positive aspects of 

14 
Updated 06/19/2017 
 
caregiving, better HRQOL, and greater satisfaction with care) at approximately 11 and 19 weeks after 
baseline data collection than caregivers in the usual care group. 
The analysis plan for Hypothesis 2 will closely follow the plan outlined above for Hypothesis 1 for each 
secondary outcome of interest. 
 
Hypotheses #3 (secondary): Veterans whose caregivers receive the intervention will have better 
functional abilities at approximately 11 and 19 weeks after baseline data collection and less healthcare 
utilization at approximately 11 and 19 weeks after baseline data collection compared to Veterans 
whose caregivers are in the usual care group. 
Since the Barthel Index score can be treated as continuous, the analysis plan follows exactly as above in 
Hypothesis 1. Since the Veteran healthcare utilization measures are count data, the models will be somewhat 
different. There will be no baseline covariates added to the model, as they are not applicable to the count 
measures. Analyses will be conducted for the period following baseline data collection to approximately 11 
weeks and 19 weeks after baseline data collection. Generalized linear models for count data (such as Poisson 
or negative binomial regression models, depending on the presence or absence of over-dispersion) will be 
employed to determine the group effects on healthcare utilization. As before, the site type will be included in 
the full model and possible site differences will be accounted for. Log link functions will be employed on the 
count data to create the correct distributional data forms. As before, in order to control for possible sample 
imbalances resulting from randomization, all models will include covariates for prognostic factors deemed to 
have significant relationships with response and significant groupwise imbalances. Thus, analyses will be able 
to compare the groups on the measures of interest while controlling for these factors. 
Handling of Missing Data: We should not have a problem with missing data as our data will be collected in-
person or over the telephone. Our data collectors will receive extensive training on interviewing and how to 
politely encourage participants to answer all questions on research instruments. In the event of drop-outs, the 
missingness mechanism will be explored. If the assumption of Missing Completely at Random (MCAR) or the 
common assumption of Missing at Random (MAR) are plausible, then little change to the analysis plan is 
necessary. The mixed models analysis using direct-likelihood approaches will be unbiased and appropriate. 
Study efficiency (power) will of course be affected by the smaller amount of available information, thus we have 
inflated the planned recruitment sample size. If the missingness assumptions are not plausible, then Missing 
Not at Random (MNAR) techniques will be employed and analysis results will be interpreted with caution. 
 
Research Design and Methods (Aim #4)  
Research Question: What are the budgetary impacts associated with the intervention and how do these 
costs compare to usual care? 
Data collection & measures: We will obtain cost data in the VA Managerial Cost Accounting System (MCAS) 
(formerly DSS) National Data Extracts (NDE) (total, nursing, pharmacy, laboratory, etc.) by fixed and variable 
categories and the Non-VA Medical Care files, supplemented by the direct measures (i.e., microcosting) of the 
intervention as necessary.  
Research Question: What are the budgetary impacts associated with the intervention and how do these 
costs compare to the costs of usual care? 
 The budgetary impact of this intervention will consist of two parts:  (1) the incremental cost of the intervention 
itself over and above usual care, and (2) the impact of the intervention on healthcare utilization. To determine 
the incremental costs of the intervention, we will use micro-costing techniques (viz., direct measurement and 
pseudo-billing) combined with average costing to determine the average staff time, wage, space, and 
equipment costs associated with the intervention. The micro-cost estimate for the transition-to-home and in-
home sessions will use the average elapsed time of such sessions along with an estimate of the average 
national wage of the type of nurse most likely to deliver the intervention in the field.   
    To determine the intervention’s impact on the costs of healthcare utilization, we will rely on ISPOR’s 2014 
budgetary impact analysis guidelines. Data on VA-funded utilization costs will be obtained from MCAS) 138 and 
the Non-VA Medical Care files. We will tabulate all costs from these sources for study enrollees over the period 
of the study, calculate the difference between intervention and usual care average costs and test for the 
statistical significance of this difference using the Z-score method proposed by Zhou. 
    The final step in determining the budgetary impact of the intervention will combine parts 1 and 2 to 
determine the complete impact of the intervention on the VA budget.  While the incremental cost of the 

15 
Updated 06/19/2017 
 
intervention (part 1) will be positive, the impact of the intervention on the costs of VA utilization will likely vary 
directly with the impact of the intervention on VA utilization.  
 
Research Design and Methods (Aim #5)  
Research question #1: What are the recommendations of non-VA and VA leaders, policy makers, and 
clinicians for implementing the intervention in other sites?  
An important component of our project is assuring that our research is “consumer-driven” and uses the 
feedbacks from multiple individuals, including caregivers, Veterans, and stakeholders/partners within the non-
VA and VA agencies and programs. To accomplish this we will use traditional strategies and participatory 
action methods. Participatory action research involves engaging parties in a collaborative effort to examine 
current practices, problem solve, plan, and monitor processes to affect change. Throughout the project, we will 
communicate face-to-face with our local stakeholders (staff members at the sites) and via regular telephone 
conference calls with members in our partner VA Offices and Programs (VA Offices of Nursing Service, VA 
Office of Geriatrics and Extended Care, VA My HealtheVet).  These stakeholders and partners will function as 
advisors and will not be members of the team.  We will discuss problems and successes that we are 
encountering with our stakeholders and partners. We will not share any identifiable information. We will 
maintain and periodically review notes of our communications and meetings, which will provide valuable 
feedback concerning refinement, development, and evaluation of our methods for future initiatives. 
Research Question #2: What are the caregivers’ perceptions of the value, strengths/weaknesses of the 
intervention and what facilitators/barriers did they identify with the intervention? 
To obtain feedback from caregivers and to answer this research question, we will conduct in-depth, qualitative 
interviews with 15 stroke caregivers (5 from each study site).  
 
Sample (size, recruitment, enrollment):  We will select a purposive subsample of 15 caregivers who 
participated in the intervention arm of the study.  Sample size considerations in qualitative studies include the 
purpose/goal of the study and the depth of data needed to reach theoretical saturation and adequately answer 
the study question. Typically, 8-12 participants are needed to reach theoretical sample. We will select 
caregivers from each recruitment site following their completion of the intervention. We will telephone the 
selected caregivers and ask if they are willing to participate in the qualitative interviews. If the caregivers are 
willing, we will arrange a telephone meeting in which the research assistant will conduct the interviews.  We will 
enroll caregivers from each site until we have the desired sample size.  
 
Data collection: A trained study team member will conduct the in-depth, qualitative interviews over the 
telephone. The study team member will use an interview guide and will ask caregivers their perceptions of the 
value, strengths/weaknesses of the intervention, and about the barriers and facilitators in participating in the 
intervention. The interviews will be digitally recorded, transcribed verbatim by a research team member, and 
validated by another member of the research team. We will follow traditional qualitative research methods, 
which recommend that interviews are recorded, transcribed, and then analyzed, rather than using note taking.  
The recordings will allow the team to conduct more accurate data analysis. 
 
Data analysis: We will use the constant comparative method to analyze the qualitative interviews.  Two team 
members, who are experienced qualitative researchers, will begin by reading the first two caregiver transcripts 
to identify initial concepts and codes. Then, they will enter data labels and codes into NVivo, a software 
program that our team has purchased and used in previous projects. NVivo compiles data related to a code, 
groups related data, and provides a print out of all data for each code to assist further analysis. The two 
qualitative researchers will regularly interact with the PI to discuss and ultimately arrive at consensus about 
coding schemes. A final coding framework and codebook will be created.  As the interviews are completed, the 
two qualitative team members will continue their coding and use an iterative, inductive process to generate 
categories and themes based on identified regularities and repetitive patterns in the data. The qualitative team 
members will interact regularly with the PI and the entire team to discuss the findings and to search for 
alternative explanations in the data. Throughout the analysis, the two qualitative team members will write 
memos in NVivo about data analysis decisions. Common themes with selected, supportive quotations will be 
presented.  
 

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Updated 06/19/2017 
 
Data Security.  To ensure privacy, efforts will be taken to protect the identity of participants and ensure that 
data are kept confidential.  Following data collections procedures, we will de-identify data. Participants will be 
identified by unique, identifying codes rather than direct identifiers on all written and electronic documents and 
computer files. While the data may contain some protected health information only a study team member 
possessing the code can link the data to a particular participant.   In the event that the study team needs to 
contact the participants, they will look up their coded information in his/her local files to track participants' real 
name and contact information.  Electronic files will be stored in folders with restricted access on a protected 
computer shared drive behind the VA firewall in a secured server.  Any hard copies of data forms and coded 
data will be double-locked in a VHS restricted access location.  The data will be only accessible to personnel 
involved in the study. All staff will be trained to avoid breach of confidentiality issues. We will obtain a data 
transfer agreement to transport paper data collection the other study sites to the NF/SG VHS via UPS or by 
having members of the research team personally transport the data using a government-issued or personal 
vehicle.  Data will be secured by using sealed envelopes in a locked container.  
 
In the intervention arm, qualitative interviews between the study team members and the caregivers will be 
audio-recorded.  These interviews will be audio-recorded using PHILLIPSLFH 9600 digital pocket memo 
w/speech pro recorder. These recorders are VA encrypted (encryption is FIPS 140-2 validated) voice recorders 
and were recently purchased by the PI for another study. The audio sessions will be downloaded and stored 
on a protected, secure VA research server, and then deleted from the portable device. Digital recordings will 
use first names only and any identifying information will be removed once transcribed. All electronic records 
will be stored on a secure VA server that has limited access to only study personnel and is accessible via 
desktop workstations that are password protected. 
 
In the intervention arm, the caregivers will participate in the in-home component of the intervention (online 
skills training and application of problem-solving skills via the RESCUE messaging center). The RESCUE 
messaging center is an adaptation of the low-ADL Monitoring Program (LAMP) platform that has been used at 
the North/Florida South Georgia Veterans Healthcare System since 2003. The messaging center is a secure 
site that is located behind the VA firewall. 
 
7. 
Possible Discomforts and Risks:  Participants may feel tired and uncomfortable or become stressed 
while discussing stroke-related issues and problems.  Caregivers may become tired or have stress during the 
baseline and post-test data collection sessions. There also is a slight risk that there could be a privacy breach 
and information about the caregivers in both arms of the study could be revealed inappropriately or 
accidentally. 
 
8. 
Possible Benefits: There are no direct benefits from this study.  Participants may benefit from learning 
problem-solving techniques that may help them transition into their role as caregivers more efficiently.  Also, 
participants may benefit from obtaining information and resources on the RESCUE website.  Possible future 
benefits are identification of best practices for improving discharge planning and transitional care for caregivers 
of Veterans with stroke. 
 
9.  
Conflict of Interest:  There is no conflict of interest for the investigators and/or the participants.