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: 8867710
• 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/8867710
• 关键词: 18 year old; 18 year old; Accounting; Address; Address; Adult; Adult; Adult Children; Adult Children; Age; Age; Aging; Aging; Ambulatory Care Facilities; Ambulatory Care Facilities; Area; Area; Budgets; Budgets; Caregiver Burden; Caregiver Burden; Caregiver support; Caregivers; Caregivers; Caring; Caring; Case Manager; Case Manager; Characteristics; Characteristics; Child; Child; Chronic Disease; Chronic Disease; Clinic; Clinic; Clinical; Clinical; Clinical Data; Clinical Data; Coin; Collaborations; Collaborations; Communities; Communities; Community Services; Community Services; Complex; Complex; Computerized Patient Records; Computerized Patient Records; Consent; Consent; Control Groups; Control Groups; Critiques; Critiques; Data; Data; Data Collection; Data Collection; Day Care; Day Care; Dementia; Dementia; Dementia caregivers; Diagnosis; Diagnosis; Dimensions; Dimensions; Distress; Distress; Dropout; Drops; Education; Education; Educational Models; Effectiveness; Effectiveness; Elderly; Elderly; Enrollment; Enrollment; Equation; Equation; Family; Family; Family Caregiver; Family Caregiver; Feedback; Feedback; Future; Future; Guidelines; Guidelines; Health Services Accessibility; Health Services Accessibility; Healthcare; Healthcare; Healthcare Systems; Healthcare Systems; Home environment; Home environment; Hour; Hour; Human Subject Research; Human Subject Research; Improve Access; Improve Access; Individual; Individual; Information Dissemination; Institutionalization; Institutionalization; Intervention; Intervention; Intervention Trial; Interview; Interview; Lead; Lead; Leadership; Leadership; Length; Length; Life; Long-Term Care; Long-Term Care; Longitudinal Studies; Longitudinal Studies; Measurable; Measurable; Measures; Measures; Medical; Medical Care Costs; Medical Records; Medical Records; Medical center; Medical center; Mental Health; Mental Health; Methods; Methods; Minority; Minority; Modality; Modality; Modeling; Modeling; Monitor; Monitor; New York; New York; Nurses; Nurses; Occupations; Occupations; Outcome; Outcome; Participant; Participant; Patient-Focused Outcomes; Patients; Patients; Pharmacological Treatment; Pharmacology; Philadelphia; Philadelphia; Pilot Projects; Pilot Projects; Population; Population; Postdoctoral Fellow; Postdoctoral Fellow; Primary Health Care; Primary Health Care; Protocols documentation; Protocols documentation; Provider; Provider; Psychosocial Assessment and Care; Psychosocial Assessment and Care; Quality of life; Quality of life; Randomized; Randomized; Recording of previous events; Recording of previous events; Recruitment Activity; Relative (related person); Reporting; Reporting; Research; Research; Research Personnel; Research Personnel; Research Priority; Research Priority; Residual state; Residual state; Resources; Resources; Risk; Risk; Role; Role; Rural Health; Rural Health; Sampling; Sampling; Services; Services; Site; Site; Social Network; Social Network; Social Workers; Social Workers; Social support; Social support; Spouse Caregiver; Spouses; Spouses; Symptoms; Symptoms; Telephone; Telephone; Testing; Testing; Time; Time; Veterans; Veterans; Woman; Woman; Work; Work; Writing; arm; base; base; care providers; care recipients; caregiver education; caregiver education; caregiver interventions; caregiving; caregiving; clinical care; clinical care; clinical implementation; collaborative care; collaborative care; collaborative environment; comparative effectiveness; comparative effectiveness; comparative efficacy; comparative efficacy; cost; cost; dementia care; demographics; demographics; design; design; evidence base; evidence base; experience; experience; follow-up; follow-up; group intervention; group intervention; human subject; human subject; human subject protection; impression; impression; improved; improved; improved outcome; informal caregiver; innovation; innovation; interest; intervention participants; medical specialties; medical specialties; medication compliance; medication compliance; meetings; participant retention; patient population; patient population; peer; peer; peer support; primary outcome; primary outcome; programs; programs; prospective; prospective; psychoeducation; psychoeducation; psychological distress; psychological distress; recruit; reduce symptoms; research and development; research and development; response; response; screening; screening; service utilization; service utilization; skills training; skills training; sociodemographics; standardize measure; standardize measure; success; success; supportive environment; telehealth; telehealth; therapy development; therapy development; treatment arm; treatment as usual; treatment as usual; uptake; 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 针对痴呆症护理接受者 (CR) 的非正式护理人员 (CG) 的现有干预措施在多个方面（例如内容、给药时间、交付方式）各不相同，研究结果表明这些计划可有效改善 CG 和 CR 的结果。团队开发并评估了两个 CG 计划，其独特之处在于它们相对较短（即 3 个月）并且完全依赖电话管理。原始计划远程医疗教育计划 (TEP) 提供 CG 支持，第二个项目采用了小组形式的心理教育和技能培训，将原来的 TEP 交付给个人 CG，并包括协作护理管理服务，该项目的关键组成部分包括护理经理团队、初级护理人员之间的直接协作。制定个性化协作护理计划的决定部分是为了响应与其他患者群体的协作护理模式的成功以及大多数痴呆症患者接受医疗保健的事实。他们的 PCP。然而，单独提供的计划缺乏基于团体的干预措施提供的同伴相互支持和反馈所带来的好处，因此仍有待确定的是是否修改单独提供的护理管理计划以以团体形式提供 TEP。比单独提供的计划更有效 目标 该项目的目标包括： a) 测试基于电话的 2 种提供模式（个人 TEP + 个人护理管理与团体 TEP + 个人护理管理）的比较有效性。 , 协作性痴呆b) 探讨在配偶 CG 中个人或个人+团体干预是否更有效/更可接受 方法 为了实现这些目标，我们将使用前瞻性、随机对照组、重复措施（即）。 、基线、3、6 和 12 个月随访）设计参与者将包括 405 名被诊断患有痴呆症并接受常规临床护理的退伍军人 CG（配偶和 18 岁及以上儿童）。在两个 VA 站点，如果每天提供 4 小时以上的护理，则将招募 CG 参与。 CG 将被随机分配到常规护理、个人干预或个人 + 团体干预。这两项干预措施的目的是促进资源连接，并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，从而改善非机构服务的获取和使用、指南依从护理率和 CG/CR 结果。在这两次干预中， CG 将接受教育、持续支持、技能培训，并监测退伍军人的用药依从性、症状和服务需求，并要求 CG 完成一系列针对退伍军人临床病历的标准化测量。 （包括成本数据）也将用于筛选和临床数据收集目的进行评估，广义估计方程（GEE）将是用于分析对退伍军人医疗保健的预期影响的主要方法。 1/2 百万退伍军人患有痴呆症，其中约 80% 的人在家中接受以患者/CG 为中心的非正式 CG 的综合护理管理计划，其中还包括 CG 教育、心理社会支持和技能培训，这些计划能够显着促进治疗效果。意见 1 1. 意义。 该提案涉及痴呆症护理人员的支持，这是退伍军人管理局护理中的一个高度优先事项，特别是考虑到老龄化退伍军人群体。这些子假设很有趣，因为它们将个人与团体管理进行比较，这将有助于了解作用机制和最佳交付模式。为未来的实施研究提供信息。 2. 方法（包括可行性）。 研究人员解决了大部分（如果不是全部）审稿人最初的担忧，他们专注于前两个具体目标，并删除了第三个探索性目标。研究人员对预期效果大小的讨论仍然与从试点数据中得出的效果大小分开。没有考虑到在两个治疗组中加入协作护理可能会降低效果——他们在这次重新提交中保留了协作护理。 该提案充分概述了案件量的可行性以及所需 FTE 护理经理的数量。 研究人员报告说，在护理人员样本中进行 60 至 90 分钟的评估仍然显得过于繁重，试点研究中的低退出率令人放心。 痴呆症和其他慢性疾病群体都需要更多基于证据的护理人员干预措施，这项研究的结果将为这两个群体提供信息。 具有一定的创新性，但分析和计划比较更具创新性，在初级保健中进行干预和使用协作护理是干预措施的重要方面，这预示着其有效性和 VA 的最终采用。 4. 研究者资格、设施和资源。 这两个地点都非常适合开展这项研究，具有悠久的老年学研究和专科诊所的历史，研究人员与初级保健有着密切的联系，并且得到了当地和国家级运营合作伙伴的支持。本修订后的议定书。 5. 多个 PI 领导计划（如果适用）。 不用担心。 6. 对 HSR&D 先前提供的有关拟议研究的反馈的回应是否充分。 研究人员对最初提议的担忧做出了很好的回应，他们简化了研究的一些方面，例如广泛的评估，这仍然是一个令人担忧的问题，他们继续根据标准效应大小而不是实际效果进行计算。除此之外，研究人员充分解决了审稿人之前的所有担忧。 7. 对研究重点或特别征集的响应。 8. 保护人类受试者免受研究风险。研究人员现在建议评估被护理者的同意能力，然后在适当的时候获得同意。 如果在干预过程中出现明显的风险或心理困扰，研究人员会提供更多详细信息。这两个中心都拥有管理心理健康问题和晚年风险的专业知识。 9. 让妇女和少数群体参与研究。 妇女和少数群体的包容性得到了充分解决。 10.预算。 调查人员进行了更广泛的讨论，证明招聘所需的人员配置和努力是合理的。该审查员对预算没有任何担忧。 11. 总体印象 12. 主要优势。 1. 有趣的子假设检验最佳管理策略 2. 需要在初级保健中提供护理人员支持干预措施 3、研究经验丰富的研究团队 13. 主要弱点。 1. 对于给定试点数据的足够功率的担忧仍然存在。 2. 长达 90 分钟的看护者面谈可能过于繁重，尽管该提案确实消除了因此而出现人员流失的担忧。 批评 2 1. 意义。 随着服务的退伍军人人口持续老龄化，制定支持痴呆症护理人员的干预措施是退伍军人事务部的高度优先事项，该提案响应国家退伍军人事务部的优先领域（长期护理和护理；获取/农村卫生），并且显然将具有重要意义。与其他护理人员干预措施相比，本研究中测试的干预措施持续时间较短，并且通过电话提供，退伍军人及其护理人员可能会从这种可衡量的独特干预措施中受益。不可估量的2.方法。 研究人员提出一项纵向随机对照试验，以评估个体 TEP+个人护理管理与团体 TEP+个人护理管理的比较效果。研究人员认为，团体 TEP 将为护理人员带来更大的益处。个人 TEP，但这些影响可能会受到看护者类型的调节，因此，抽样和随机化将进行分层，以便可以评估看护者类型（成年子女与配偶/伴侣）的任何调节影响。基线、3、6 和 12 个月仍然存在一些担忧，即 60-90 分钟的评估会对其他非常忙碌的个人（护理人员）造成负担，但研究人员似乎确信这是合理的，例如。在他们过去的研究中，参与者的保留率会很高。否则，根据过去的工作，该方法是合理且合理的。 拟议的工作可能会对 VA 对痴呆症护理人员的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 对护理人员的支持，这是许多领域快速增长的需求。 4. 研究者资格、设施和资源。 这是一个强大的研究团队，拥有最大程度的支持性环境，拥有 HSR&D COIN、MIRECC 和综合医疗中心，两位 PI 都拥有丰富的研究经验，包括 RCT，这些经验也为他们各自的工作场所提供了支持。熟悉干预和相关研究。 5. 多重PI领导力计划。 考虑到每个 PI 对项目的贡献、项目的历史和实施，多个 PI 计划似乎是合理的。 6. 对 HSR&D 先前提供的有关拟议研究的反馈的回应是否充分。 调查人员对审稿人的批评的回应非常周到，他们取消了研究的探索性目标，从而加强了对评估目标 1 和 2 的关注。根据先前的工作，对权力考虑进行了澄清和论证。由此产生的产品/服务得到了澄清，案例管理者的角色及其为大量参与者提供服务的能力也得到了更仔细的考虑。 虽然调查人员澄清了评估的可疑时间长度，并向审查人员保证这个时间是可以的，但他们可能会更加批判性地审视他们的措施，并删除任何对目标来说并非完全必要的措施，或者将其换成其他措施。 7. 对研究重点或特别征集的响应。 8. 保护人类受试者免受研究风险。 研究人员及其各自的研究中心已做好充分准备来开展这项研究，同时最大限度地保护人类受试者参与者。 9. 将妇女和少数族裔纳入研究。 。 研究参与者将直接反映研究进行地区的护理人员和护理接受者的人口统计数据，因此，绝大多数护理人员很可能是这样的。 10. 预算。 预算似乎足以满足拟议的活动 - 无需担心 11. 总体印象。 该提案写得很好，研究人员在解决大多数审稿人之前的担忧方面做得非常出色。该主题对于 VA 至关重要，并且这项研究的潜在影响很大，它具有由初步数据支持的强大理论基础。和既定的招募/注册方法。研究方法很有效，很可能实现拟议的目标。 12. 主要优势。 1. 该项目将理清配偶/伴侣与成年子女照顾者的不同需求，根据特定照顾者的需求直接告知退伍军人事务部的教育方法和交付。 2. 重大意义和可能影响 3. 强大的研究团队，研发成本低，具有良好的研究记录并与利益相关者建立了联系。 13. 主要弱点。 1. 对于年老（配偶/伴侣）和其他忙碌的（成年子女）照顾者的评估长度（60-90 分钟）仍然存在一些担忧。 2. 没有发现其他弱点。