Comparative Effectiveness of Delivery Methods for Caregiver Support and Education

护理人员支持和教育的实施方法的比较有效性

• 批准号: 10173874
• 负责人: Shahrzad Mavandadi
• 金额: --
• 依托单位: PHILADELPHIA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-10-01 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10173874
• 关键词: 18 year old; Address; Adult; Adult Children; Age; Aging; Ambulatory Care Facilities; Area; Budgets; Caregiver Burden; Caregiver support; Caregivers; Caring; Case Manager; Characteristics; Child; Chronic Disease; Clinic; Clinical; Clinical Data; Coin; Collaborations; Communities; Community Services; Complex; Computerized Patient Records; Consent; Control Groups; Critiques; Data; Data Collection; Day Care; Dementia; Dementia caregivers; Diagnosis; Dimensions; Distress; Dropout; Education; Educational Models; Effectiveness; Elderly; Enrollment; Equation; Family; Family Caregiver; Feedback; Future; Guidelines; Health Services Accessibility; Healthcare; Healthcare Systems; Home environment; Hour; Human Subject Research; Improve Access; Individual; Information Dissemination; Institutionalization; Intervention; Intervention Trial; Interview; Lead; Leadership; Length; Long-Term Care; Longitudinal Studies; Measurable; Measures; Medical Care Costs; Medical Records; Medical center; Mental Health; Methods; Minority; Modality; Modeling; Monitor; New York; Nurses; Occupations; Outcome; Participant; Patient-Focused Outcomes; Patients; Pharmacology; Philadelphia; Pilot Projects; Population; Postdoctoral Fellow; Primary Health Care; Protocols documentation; Provider; Psychosocial Assessment and Care; Quality of life; Randomized; Recording of previous events; Reporting; Research; Research Personnel; Research Priority; Residual state; Resources; Risk; Role; Rural Health; Sampling; Services; Site; Social Network; Social Workers; Social support; Spouses; Symptoms; Telephone; Testing; Time; Veterans; Woman; Work; base; care providers; care recipients; caregiver education; caregiver interventions; caregiving; clinical care; clinical implementation; collaborative care; comparative effectiveness; comparative efficacy; cost; dementia care; demographics; design; evidence base; experience; follow-up; group intervention; human subject; human subject protection; impression; improved; improved outcome; informal caregiver; innovation; intervention participants; medical specialties; medication compliance; participant retention; patient population; peer; peer support; primary outcome; programs; prospective; psychoeducation; psychological distress; recruit; reduce symptoms; research and development; response; screening; service utilization; skills training; sociodemographics; standardize measure; success; supportive environment; telehealth; therapy development; treatment arm; treatment as usual; uptake

 DESCRIPTION (provided by applicant): 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.

 描述（由申请人提供）： 背景是非正式护理人员（CGS）的痴呆症的干预措施在多个角色方面有所不同（例如，内容dministration时间，交付方式），调查结果表明这些程序正在改善CG CG和CR ITCOM。在相对简介中（即3个月）中的独特之处，并依靠原始计划，远程医疗教育计划（TEP）提供了CG支持，心理教育和技能培训。交付给单个CG和包容性护理管理CES。部分回应与其他人群的合作模型和痴呆症的大多数人的成功因此，确定以组格式的方式修改授权的护理管理计划是否更有效地单独交付了该项目的目标。管理与小组的TEP +个人护理管理）基于电话的协作痴呆症护理CGS，b）探索个人或个人 +组干预是否更属于配偶与成人子女CG（即基线，基线，，，，，，，，，，，基础）。 3、6和12个月的随访）将包括405个CG，如果他们与4个以上的f the Fortipation”这两种干预措施的主要目标是促进资源联系，为关心痴呆症的个人提供教育，心理社会支持和护理管理，并在两者中使用指导率的依从性护理和CG/CR ITCOM国际，接受教育，技能培训以及对退伍军人的监测，症状和服务的症状。数据收集的目的是分析嵌套的纵向数据，对退伍军人的医疗保健的影响大约有80％的人在家中从非正式的CG中照顾。对患有痴呆症的退伍军人及其家人的退伍军人促进了包括生活质量的服务。 该提案解决了痴呆症护理人员的支持，这是针对小组管理的涉及，这将非常了解LI的机制。 2。方法（包括盛宴）。 调查人员解决了大多数IITIEAL的关注点，他们重点是前两个特定的目标，并删除了探索目的的探索目的。包括在两个治疗臂中的协作护理 - 他们在提交中保留了。 该提案充分概述了案件的可行性和所需的FTE护理经理的数量。 调查人员报告的是，在样本中，在护理人员样本中的60至90分钟。 更多的痴呆症国际痴呆症和其他慢性疾病组 是适度的创新，但是分析和计划的比较更具创新性。 4。调查员资格，设施和资源。 这两个站点将长期进行研究。 5。多重PI领导计划（如果适用） 无需担心。 6。关于支撑研究的HSR＆D提供了对先前反馈的反应的充分性。 他们简化了假设和目标，例如广泛的评估，这是一个关注的问题。 7.研究优先级或特殊解决方案的反应。 8。对人类的保护风险的保护。 调查人员哈贝增加了更多的替代，任何风险或心理困扰的可能性在国际E期间都显而易见。 9。将妇女和少数民族纳入研究。 充分补充了妇女和少数民族的包含。 10。预算。 调查人员HABE提供了有关预算的更多讨论。 11。整体印象。 1。有趣的子弹药检查了管理的最佳策略 2.护理人员支持干预措施需要在需要的初级护理中 3。具有复杂研究经验的调查团队 13。关键弱点。 1。仍然关注鉴于飞行员数据的足够功能。 2。最多可以持续90分钟的护理人员采访可能会繁重的使用。 批评2 1。意义。 痴呆症护理人员的发展是对Terrans Topals的负担。与其他护理人员相比，在研究中要测试的干预措施是在持续时间的，并且通过电话进行了交付。 研究人员提出了一个纵向RCT，以评估单个TEP +个体护理管理与小组TEP TEP TEP TEP TEP TEP TEP TEP TEP TEP TEP TEP TEP TOP +个体护理管理的比较。可以通过护理人员的类型进行调节，因此可以评估任何适度几个月。但是，一些长度为60-90分钟的ressss会很繁重过去的工作。 支撑的工作可以快速影响VA对痴呆症护理人员的支持。 这支天气研究团队位于最大的支持环境中，拥有HSR＆D Coin，Mirecc和Integrated中心。 。 鉴于每个PI对项目的贡献是历史和iStory插入，多重PI计划似乎是合理的。 6。关于支撑研究的HSR＆D提供了对先前反馈的反应的充分性。 调查人员对审稿人的批评是对评估目标1和2的重点。案件经理和大量TS的案例风险和保护。 虽然调查人员澄清了可疑的时间，并且及时算出了这一数量的tild，但他们更加批判地看着thir措施，并削减了任何目的或交换目标所必需的任何措施为了换取较短的措施。 8。保护人类受试者免受研究风险。 研究人员已经准备好了关于反应的最大最大最大最大nvestigators。 研究参与者将在将发生的地区的护理人员和护理人员的受众人口。 成为妇女。 预算似乎足以适应拟议的活动 - 没有任何关注。 这项提议是著名的，对审阅者以前的关注的工作对VA的重要性，这项研究的潜在影响很棒。目标12。 1.此项目将根据特定的照顾者需求，将配偶/伴侣与弗吉尼亚州的律师照顾者进行分解。 2。强大的意义和可能的影响 3。强大的调查团队，以低成本的研发成本，并有了可靠的研究跟踪，并与利益相关者建立了联系。 13。关键弱点。 1。S。 2。未发现其他弱点。