Background Existing interventions for informal caregivers (CGs) of care recipients (CRs) with dementia vary on multiple dimensions (e.g., content, administration time, mode of delivery), and findings indicate that these programs are effective in improving CG and CR outcomes. Our team has developed and evaluated two CG programs that are unique in that they are relatively brief (i.e., 3 months) and rely solely on telephone administration. The original program, the Telehealth Education Program (TEP), provides CG support, psychoeducation, and skills training in a group format. The second program adapted the original TEP to be delivered to individual CGs and includes collaborative care management services. Key components of this CR/CG-centered program include direct collaboration among teams of care managers, primary care providers (PCPs), and CGs. The decision to develop an individually-tailored, collaborative care program was partly in response to the success of collaborative care models with other patient populations and the fact that the majority of individuals with dementia receive their healthcare from their PCPs. Nonetheless, an individually-delivered program lacks the benefits derived from the mutual peer support and feedback provided by group-based interventions. What remains to be determined, therefore, is whether modifying the individually-delivered care management program to deliver TEP in a group format is more effective than the individually-delivered program alone. Objectives The objectives of the project include: a) testing the comparative effectiveness of 2 delivery models (individual TEP + individual care management vs. group TEP + individual care management) of a telephone-based, collaborative dementia care intervention for CGs, and b) exploring whether the individual or individual + group intervention is more effective/acceptable among spousal vs. adult children CGs. Methods To meet these objectives, we will use a prospective, randomized control group, repeated measures (i.e., baseline, 3, 6, and 12 month follow-up) design. Participants will include 405 CGs (spouses and children 18 years of age and older) of Veterans diagnosed with dementia and receiving routine clinical care at two VA sites. CGs will be recruited for participation if they live with and/or provide 4+ hours f care/day. CGs will be randomly assigned to usual care, the individual intervention, or the individual + group intervention. The main objectives of both interventions are to facilitate resource connection and provide education, psychosocial support, and care management for individuals caring for Veterans with dementia, thereby improving access to and use of non-institutional services, rates of guideline adherent care, and CG/CR outcomes. In both interventions, CGs will receive education, continuous support, skills training, and monitoring of Veterans' medication adherence, symptoms, and service needs. CGs will be asked to complete an assessment battery of standardized measures of CR- and CG-characteristics. Veterans' clinical medical records (including cost data) also will be evaluated for screening and clinical data collection purposes. Generalized estimating equations (GEE) will be the primary method used to analyze the nested, longitudinal data. Anticipated Impact on Veteran's Healthcare Approximately 1/2 million Veterans have dementia and approximately 80% of these individuals receive care at home from informal CGs. Patient/CG-centered, integrated care management programs that also include CG education, psychosocial support, and skills training have the capacity to significantly facilitate use of services and to improve outcomes, including quality of life, for Veterans with dementia and their families. CRITIQUE 1 1. Significance. This proposal addresses dementia caregiver support, a high priority in VA care particularly given the aging veteran population. The sub-hypotheses are interesting as they compare individual to group administration that will inform both understanding the mechanism of action and the optimal mode of delivery. This can inform future implementation studies. 2. Approach (including Feasibility). The investigators addressed most if not all of reviewers' initial concerns. They have focused on the first two specific aims and have removed the third exploratory aim. The investigators' discussion of expected effect size remains separate from the effect size derived from the pilot data and does not take into account the possible diminution of effect by including collaborative care in both treatment arms -which they have retained in this resubmission. The proposal adequately outlines the feasibility of caseload and the number of required FTE care managers. The investigators report success in administering assessments with administration time of 60 to 90 minutes in caregiver samples. 90 minutes still seems overly burdensome for this sample. The low drop-out rates in the pilot study are reassuring. 3. Impact and Innovation. More evidence-based caregiver interventions are needed for both dementia and other chronic disease groups. The results of this study will be informative for both groups. The intervention is moderately innovative, but the analysis and planned comparisons are more innovative. Conducting the intervention in primary care and the use of collaborative care are strong aspects of the intervention that bode well for both its effectiveness and its eventual uptake by the VA. 4. Investigator Qualifications, and Facilities and Resources. Both sites are well suited to conduct the study with a long history of geriatric research and specialty clinics. The investigators have strong ties to primary care and have demonstrated buy-in from both local and national-level operational partners. Any concerns about staffing was addressed in this revised protocol. 5. Multiple PI Leadership Plan. (if applicable) No concerns. 6. Adequacy of Response to Previous Feedback Provided by HSR&D Regarding the Proposed Study. The investigators responded well to concerns about the original proposal. They have simplified the hypotheses and aims. They retained some aspects of the study such as extensive assessment, which remains a concern. They continue to base power calculations on standard effect sizes rather than what they observed in the pilot study. Otherwise, investigators adequately addressed all prior reviewer concerns. 7. Responsiveness to Research Priorities or Special Solicitations. 8. Protection of Human Subjects from Research Risk. The investigators are now proposing to assess capacity to consent to in care receivers and then obtaining consent when appropriate. The investigators have added more detail about managing any potential for risk or psychological distress should this become evident during the course of the intervention. Both sites have expertise in managing mental health issues and risk in late-life. 9. Inclusion of Women and Minorities in Research. Inclusion of women and minorities is adequately addressed. 10. Budget. The investigators have included more extensive discussion justifying staffing and effort needed for recruitment. This reviewer has no remaining concerns about the budget. 11. Overall Impression. 12. Key Strengths. 1. Interesting sub-hypotheses examining optimal strategy for administration 2. Caregiver support interventions delivered within primary care are needed 3. Investigative team with sophisticated research experience 13. Key Weaknesses. 1. Concerns about adequate power given pilot data remain. 2. Caregiver interviews that can last up to 90 minutes may be overly burdensome, though the proposal does counter the concern that there will be attrition because of this. CRITIQUE 2 1. Significance. Development of interventions to support dementia caregivers is a high priority for VA as the population of Veterans served continues to age. This proposal is responsive to national VA priority areas (Long-term Care and Caregiving; Access/Rural Health) and will obviously be of benefit to VA transformations now and in the future. The interventions to be tested in this study are short in duration compared to other caregiver interventions and are delivered by telephone. Veterans and their caregivers are likely to benefit from this unique intervention in measurable as well as immeasurable ways. 2. Approach. The investigators are proposing a longitudinal RCT to evaluate the comparative efficacy of individual TEP+individual care management to group TEP+individual care management. Both will be compared to usual care. The investigators hypothesize that the group TEP will confer even greater benefit for caregivers than individual TEP, but that these effects may be moderated by caregiver type. As such, sampling and randomization will be stratified so that any moderating effects of caregiver type (adult child vs. spouse/partner) can be evaluated. Assessments will occur at baseline, 3, 6, and 12 months. There is some residual concern that assessments that are 60-90 minutes in length will be burdensome to otherwise very busy individuals (caregivers). However, the investigators seem assured that this is reasonable and, like in their past studies, retention of participants will be high. Otherwise, the approach is reasonable and well justified based on past work. 3. Impact and Innovation. The proposed work could have relatively quick impact on VA support for dementia caregivers. The project has high likelihood of ultimately helping improve VA's support of caregivers, which is a quickly growing need in many domains. 4. Investigator Qualifications, and Facilities and Resources. This is a strong research team situated in maximally supportive environments, with an HSR&D COIN, MIRECC, and Center for Integrated Healthcare. Both PIs have ample experience with the research, including RCTs, that lead up to the proposed work. Their respective sites are also familiar with the intervention and associated research. 5. Multiple PI Leadership Plan. The multiple PI plan seems reasonable given the contributions of each PI to the project, its history, and its implementation. 6. Adequacy of Response to Previous Feedback Provided by HSR&D Regarding the Proposed Study. The investigators were very thoughtful in their responses to reviewers' critiques. They removed the exploratory aim of the study, thereby tightening up the focus on the evaluative Aims 1 and 2. Power considerations were clarified and justified based on prior work. The potential for dissemination of the resulting product/service was clarified, as was the role of the Case Managers and their ability to provide services to the large number of participants. Human subjects risks and protections were more carefully considered. While the investigators clarified the suspected length of time for assessments and assured reviewers that this amount of time would be ok, they might have instead looked more critically at their measures and cut out any that weren't entirely necessary to the aims or exchange them for shorter measures. 7. Responsiveness to Research Priorities or Special Solicitations. 8. Protection of Human Subjects from Research Risk. The researchers and their respective sites are well prepared to conduct this research while maximally protecting the human subject participants. The investigators added details about responses and actions should care recipients or caregivers are found to be at risk. 9. Inclusion of Women and Minorities in Research. The study participants will directly reflect the demographics of caregivers and care recipients in the regions in which the study will take place. As such, the vast majority of caregivers are likely to be women. There are no concerns about inclusion of women or minorities in this research. 10. Budget. Budget seems adequate for the proposed activities - no concerns. 11. Overall Impression. This proposal is well written and the investigators did an outstanding job of addressing most of the reviewers' previous concerns. The topic is of critical importance to VA and the potential impact of this research is great. It has a strong theoretical basis bolstered by preliminary data and established methods for recruitment/enrollment. The research approach is strong and very likely to meet the proposed aims. 12. Key Strengths. 1. This project will disentangle differential needs of spouse/partners vs. adult children caregivers, directly informing educational methods and delivery in VA according to specific caregiver needs. 2. Strong significance and likely impact 3. Strong investigative team, at low cost to R&D, and with proven track record of research and established connections with stakeholders. 13. Key Weaknesses. 1. Some residual concern about the length of the assessments (60-90 minutes) for aging (spouses/partners) and otherwise busy (adult children) caregivers. 2. No additional weaknesses identified.
The proposed study seeks to compare usual care and two different interventions for caregivers (CGs) of Veterans with dementia that are brief and administered by telephone. In the first intervention, care management (i.e., assistance from a nurse or social worker who works with the CG and Veteran's primary care providers), support, psychoeducation, and skills training are tailored to each individual CG and delivered on an individual basis. In the second intervention, care management is tailored and delivered to each individual CG, but support, psychoeducation, and skills training are delivered (also by phone) in a group format. This study will allow us to examine the added benefit of participating in a CG group that provides mutual peer support and feedback. We also will evaluate the extent to which spousal vs. adult child CGs respond differently to the two interventions. Findings will help refine patient/CG-centered care management and support programs designed to facilitate access to services and improve the quality of life of Veterans with dementia and their families.
