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: 10172948
• 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/10172948
• 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）： 背景是对非正式护理人员（CGS）的现有干预措施（CGS），痴呆症的护理接受者（CRS）在多个维度上（例如内容，管理时间，交付方式）各不相同，并且发现这些程序有效地改善了CG和CR结果。我们的团队已经制定并评估了两个独特的CG计划，因为它们相对简短（即3个月），并且仅依靠电话管理。原始计划“远程医疗教育计划”（TEP）提供了CG的支持，心理教育和技能培训。第二个程序将原始TEP调整为交付给单个CGS，并包括协作护理管理服务。以CR/CG为中心的计划的关键组成部分包括护理经理团队，初级保健提供者（PCP）和CGS之间的直接协作。制定一个单独的，合作的护理计划的决定部分是对与其他患者人群的协作模型成功的成功，以及大多数患有痴呆症患者从PCP中获得医疗保健的事实。尽管如此，一个单独交付的计划缺乏来自基于小组干预措施提供的相互同伴支持和反馈所带来的好处。因此，要确定的要确定的是，是否要修改单独交付的护理管理计划以小组格式交付TEP是否比单独交付的计划更有效。目的该项目的对象包括：a）测试基于电话的，针对CGS的电话，协作性痴呆症护理干预措施的2种交付模型（单个TEP +个人护理管理与组TEP +个人护理管理）的比较有效性，以及b）探索个人或单个单个 +组干预是否更有效/可以在配偶与成人儿童中更有效/接受。实现这些目标的方法，我们将使用一个前瞻性，随机对照组，重复措施（即基线，3、6和12个月的随访）。参与者将包括诊断为痴呆症的退伍军人的405个CG（配偶和18岁以上的儿童），并在两个VA部位接受常规临床护理。如果CG与他们一起生活和/或提供4个以上的f护理/天，将招募参加他们的参与。 CGS将随机分配给通常的护理，个人干预或单个 +组干预。两种干预措施的主要目标是支持资源联系，为照顾患有痴呆症的退伍军人的个人提供教育，社会心理支持和护理管理，从而改善了对非机构服务的访问和使用，指导率的遵守护理率以及CG/CR的结果。在这两种干预措施中，CGS都将获得教育，持续支持，技能培训以及对退伍军人药物依从性，症状和服务需求的监测。将要求CGS完成一系列CR和CG-特征量标准化度量的评估电池。还将评估退伍军人的临床医疗记录（包括成本数据），以进行筛查和临床数据收集目的。广义估计方程（GEE）将是用于分析嵌套的纵向数据的主要方法。对退伍军人医疗保健的预期影响约有1/20万退伍军人患有痴呆症，其中约80％的人会在家里接受非正式CGS的护理。以CG教育，社会心理支持和技能培训在内的患者/CG中心，以综合护理管理计划为中心，有能力为有痴呆症及其家人的退伍军人提供大量支持服务的使用，并改善包括生活质量的成果，包括生活质量。批评1 1。意义。 该提案解决了痴呆症护理人员的支持，这是VA护理的高度优先事项，尤其是考虑到老年退伍军人人口。子弹药很有趣，因为它们将个体与小组管理进行比较，这将既可以理解行动机理和最佳交付方式。这可以为未来的实施研究提供信息。 2。方法（包括可行性）。 调查人员讨论了大多数审稿人的最初问题。他们专注于前两个特定目标，并删除了第三个探索目标。调查人员对预期效果大小的讨论与试点数据的效果大小保持分离，并且没有通过在两个治疗臂中包括协作护理来考虑可能的效果维度，这是他们在此重新提交中保留的。 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。 调查人员报告说，在护理人员样本中，使用60至90分钟的管理时间进行评估的成功。对于这个样本，90分钟似乎仍然太繁重了。试点研究中的低脱液率令人放心。 3。影响力和创新。 痴呆症和其他慢性病组都需要更多基于证据的护理人员干预措施。这项研究的结果对于两组都将是有益的。干预 具有适度的创新性，但是分析和计划的比较更具创新性。进行初级保健干预和使用协作护理是干预措施的强大方面，它对弗吉尼亚州的有效性和最终吸收都很好。 4。调查员资格，设施和资源。 这两个地点都非常适合进行研究，并具有长期的老年研究和专业诊所的历史。调查人员与初级保健有着密切的联系，并证明了本地和国家水平的运营伙伴的买入。在此修订的协议中解决了对人员的任何担忧。 5。多重PI领导计划。 （如果适用） 无需担心。 6。关于拟议研究的HSR＆D提供了对先前反馈的反应的充分性。 调查人员对原始提案的担忧做出了很好的反应。他们简化了假设和目标。他们保留了研究的某些方面，例如广泛的评估，这仍然是一个问题。他们继续基于标准效应大小的功率计算，而不是在试点研究中观察到的功率。否则，调查人员适当地解决了所有先前的审阅者关注点。 7。对研究优先级或特殊征集的响应能力。 8。保护人类受试者免受研究风险。现在，调查人员提议评估在护理接收者中同意的能力，然后在适当时获得同意。 研究人员在干预过程中成为证据，添加了有关管理任何风险或心理困扰潜力的详细信息。这两个站点都有专家在管理晚年的心理健康问题和风险方面。 9。将妇女和少数民族纳入研究。 适当地解决了妇女和少数民族的包容。 10。预算。 调查人员包括更广泛的讨论，证明了招聘所需的人员的合理性人员和努力。该审阅者对预算没有剩余的担忧。 11。总体印象。 12。关键优势。 1。有趣的子弹药检查了管理的最佳策略 2。需要在初级保健中提供的护理人员支持干预措施 3。具有复杂研究经验的调查团队 13。关键弱点。 1。鉴于飞行员数据仍然存在对足够功能的担忧。 2.护理人员的访谈可以持续长达90分钟，这可能过于繁重，尽管该提议确实对此表示关注，认为因此会有属性。 批评2 1。意义。 发展痴呆症护理人员的干预措施的发展是VA的重点，因为退伍军人的人口持续不断衰老。该提案对国家VA优先领域（长期护理和护理；访问/农村健康）的反应迅速，显然将对VA转型有益。与其他护理人员干预措施相比，本研究中要测试的干预措施的持续时间很短，并且通过电话提供。退伍军人及其护理人员很可能会从这种独特的干预措施中受益。 2。方法。 研究人员正在提出纵向RCT，以评估单个TEP+个体护理管理对TEP+个人护理管理的比较有效性。两者都将与通常的护理进行比较。调查人员假设该小组TEP比单个TEP赋予了护理人员更大的好处，但是这些影响可能会受到照料者类型的调节。因此，将对采样和随机化进行分层，以便可以评估护理人员类型的任何调节作用（成人子女与配偶/伴侣）。评估将在基线，3、6和12个月进行。有一些剩余的担忧，即60-90分钟的评估将使非常忙碌的个人（看护人）燃烧。但是，调查人员似乎认为这是合理的，就像他们过去的研究一样，保留参与者将很高。否则，根据过去的工作，该方法是合理的，并且是合理的。 3。影响力和创新。 拟议的工作可能会对痴呆症护理人员的VA支持产生相对较快的影响。该项目很有可能最终帮助改善VA对看护人的支持，这在许多领域中都是快速增长的需求。 4。调查员资格，设施和资源。 这是一个强大的研究团队，位于最大支持的环境中，拥有HSR＆D Coin，MireCC和Integrated Healthcare中心。这两个PI在包括RCT在内的研究中都有丰富的经验，这些研究导致了拟议的工作。他们的相对站点也熟悉干预和相关研究。 5。多重PI领导计划。 鉴于每个PI对项目，其历史和实施的贡献，多重PI计划似乎合理地。 6。关于拟议研究的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判性的回应非常周到。他们删除了研究的探索目的，从而收紧了对评估目的1和2的关注。根据先前的工作，澄清并证明了权力考虑因素。阐明了案件经理的角色及其为大量参与者提供服务的能力，阐明了生成产品/服务的潜力。人类受试者的风险和保护措施更加仔细地考虑。 虽然调查人员阐明了可疑的评估时间，并假设审稿人认为这段时间还可以，但他们可能会更批判地研究其测量结果，并削减了任何目的不是完全必要的或将其交换为较短的测量值所必需的。 7。对研究优先级或特殊征集的响应能力。 8。保护人类受试者免受研究风险。 研究人员及其各自的地点已准备好进行这项研究，同时最大程度地保护人类受试者。调查人员增加了有关反应和行动的详细信息，应发现护理人员或护理人员处于危险之中。 9。将妇女和少数民族纳入研究。 研究参与者将直接反映研究要进行的地区的护理人员和护理人员的人口统计。因此，绝大多数护理人员可能是 成为女性。不担心将妇女或少数群体纳入这项研究。 10。预算。 预算似乎足以适应拟议的活动 - 无需担心。 11。总体印象。 该提议的写作很好，调查人员在解决大多数审阅者以前的问题方面做得非常出色。该主题对VA至关重要，这项研究的潜在影响很棒。它具有强大的理论基础，并由初步数据和招募/入学方法建立的方法加强。研究方法很强，很可能达到拟议的目标。 12。关键优势。 1。该项目将消除配偶/伴侣与成人儿童护理人员的差异需求，直接根据特定的护理人员需求直接向VA的教育方法和交付。 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，并具有可靠的研究记录并与利益相关者建立了联系。 13。关键弱点。 1。对衰老（配偶/伴侣）和其他繁忙（成年子女）的评估时间（60-90分钟）的长度（60-90分钟）。 2。未发现其他弱点。