Initial Testing of Whole Health STEPS (Structured Tiered Engagement with Peer Support)

Whole Health STEPS 的初步测试（具有同伴支持的结构化分层参与）

• 批准号: 10493154
• 负责人: EMILY JOHNSON
• 金额: --
• 依托单位: SYRACUSE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-10-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10493154
• 关键词: Belief; Caring; Categories; Characteristics; Clinical; Clinical Trials Design; Confidence Intervals; Data; Data Analyses; Data Collection; Development; Diagnostic; Doctor of Philosophy; Drops; Elements; Enrollment; Equipment and supply inventories; Evidence based practice; Feedback; Goals; Health; Health Services; Healthcare; Hour; Individual; Intervention; Interview; Manuals; Mental Health; Mental Health Services; Mental disorders; Methods; Military Personnel; Mission; Modeling; Occupational; Outcome; Outcome Measure; Participant; Patient-Focused Outcomes; Population; Primary Health Care; Process; Process Assessment; Provider; Psychologist; Psychotherapy; Qualitative Evaluations; Qualitative Methods; Randomized; Randomized Clinical Trials; Recording of previous events; Recovery; Research; Research Training; Role; Self Assessment; Self Management; Self-Direction; Services; Side; Specialist; Structure; Symptoms; Techniques; Telephone; Testing; Time; Training; Training Support; United States Department of Veterans Affairs; Veterans; Vision; Waiting Lists; Well in self; acceptability and feasibility; associated symptom; barrier to care; base; career; design; feasibility research; feasibility testing; flexibility; functional disability; functional outcomes; future implementation; health care service; health goals; health plan; implementation evaluation; improved; improved functioning; novel strategies; patient engagement; patient oriented; peer; peer support; primary care setting; primary outcome; psychosocial; retention rate; satisfaction; skills; social; statistics; telephone coaching; tool; uptake; willingness

This RR&D CDA2 will support training for Emily M. Johnson, PhD, as a RR&D research psychologist and develop and evaluate a new package of services, Whole Health STEPS (Structured Tiered Engagement with Peer Support). The training goals for this project are to develop skills in (1) designing and evaluating adaptive stepped care interventions, (2) frameworks for enhancing and evaluating implementation in patient-centered interventions, (3) qualitative methods for enhancing stakeholder engagement and evaluating Veteran engagement in healthcare, and (4) clinical trials design for brief psychosocial interventions. These trainings will support my career focused on patient centered intervention and increasing Veteran engagement in healthcare using methods prioritizing stakeholder engagement.] Whole Health STEPS is an 8-week stepped-care package of four levels of Whole Health services facilitated by a peer support specialist. The four levels include supported self-management (an individual Whole Health STEPS orientation session and use of a self-directed Whole Health tool), brief telephone coaching (weekly 15-minute telephone-based coaching using focused prompts), Whole Health Coaching (weekly hour-long sessions incorporating the full coaching framework), and referral to a higher level of care. Across all levels, Veterans will have brief weekly telephone assessments using the Whole Health Goal Attainment Scale to evaluate progress and inform step-up decisions. Veterans who are not making progress at any of the given levels will be stepped-up to a higher level of care. [The research will involve qualitative stakeholder engagement interviews with primary care peer support staff (n=12), an open trial of Whole Health STEPS (n=10), and a pilot randomized clinical trial (n=44)] with a waitlist control to evaluate the preliminary impact of Whole Health STEPS on reducing functional impairment. [The design also supports further revision of the Whole Health STEPS manual] and evaluates research and intervention feasibility. Specifically, this trial will evaluate feasibility of several aspects of Whole Health STEPS including Veteran satisfaction, peer relationship, intervention retention, fidelity, and appropriateness of the new elements (i.e., the step-up decision points). Further, the design will evaluate research feasibility for a subsequent larger trial including assessment retention and participant willingness to be randomized. The primary patient outcome will be functional impairment evaluated by the Inventory of Psychosocial Functioning. [Stakeholders participating in the interviews will be asked to complete one research interview. Veterans in the open trial will be asked to complete assessments at baseline, after each session, and at the end of Whole Health STEPS.] All Veterans in the pilot RCT will be asked to complete research assessments at baseline, 2 months, and 4 months. Veterans randomized to receive Whole Health STEPS immediately will complete Whole Health STEPS in the first two months. Veterans randomized to the waitlist control will receive Whole Health STEPS between 2 and 4 months. Veterans will be randomized using a stratified permuted block design based on baseline functional impairment. The primary outcome will be evaluated by calculating Cohen’s d effect size at the 2-month assessment point and comparing with a pre-established one-sided confidence interval using a non-central t distribution method. Other quantitative outcome measures will be evaluated with descriptive statistics including means, standard deviations, and confidence intervals. Retention rates will be evaluated using percent of Veterans who withdraw or drop out over time. Qualitative feedback will be evaluated using the Rapid Assessment Process, a qualitative approach designed to provide a rapid but comprehensive qualitative evaluation to interpret and implement changes in a short time frame using triangulation, iterative data analysis, and additional data collection.

该RR&D CDA2将支持艾米丽M的培训。约翰逊，博士，作为一个RR&D研究心理学家， 开发和评估一个新的服务包，即整体健康步骤（结构化分层参与， 同伴支持）。本项目的培训目标是培养以下技能：（1）设计和评估自适应 阶梯式护理干预，（2）加强和评估以患者为中心的 干预措施，（3）提高利益相关者参与和评估退伍军人的定性方法 参与医疗保健，以及（4）为简短的心理社会干预设计临床试验。这些培训将 支持我的职业生涯，专注于以患者为中心的干预，并增加退伍军人在医疗保健方面的参与 使用优先考虑利益攸关方参与的方法。Whole Health STEPS是一个为期8周的分步护理包 四个层次的整体健康服务由同行支持专家促进。这四个层次包括 支持的自我管理（个人的整体健康步骤定向会议和使用自我指导的 整体健康工具）、简短的电话辅导（每周15分钟的电话辅导， 整体健康教练（每周一次，每次一小时，包含完整的教练框架），以及 转介到更高级别的护理。在所有级别，退伍军人将有简短的每周电话评估 使用整体健康目标达成量表来评估进展并为升级决策提供信息。退伍军人 那些在任何给定水平上都没有取得进展的人将被提升到更高的护理水平。[在 研究将涉及与初级保健同行支持人员的定性利益相关者参与访谈 （n=12）、Whole Health STEPS的开放试验（n=10）和一项有等待名单的初步随机临床试验（n=44）] 控制，以评估整体健康步骤对减少功能障碍的初步影响。（The 设计还支持进一步修订全健康步骤手册]，并评估研究和 干预可行性。具体而言，本试验将评估整体健康步骤的几个方面的可行性 包括退伍军人满意度，同伴关系，干预保留，忠诚度和新的适当性 元件（即，升级决策点）。此外，设计将评估研究的可行性， 后续更大规模的试验，包括评估保留和参与者随机化意愿。的 主要患者结局将是通过心理社会功能量表评估的功能损害。 [参与访谈的利益攸关方将被要求完成一次研究访谈。退伍军人 将要求开放试验在基线、每次治疗后和整个试验结束时完成评估 健康步骤。]将要求试点RCT中的所有退伍军人在基线时完成研究评估， 一个月，四个月。随机分配接受Whole Health STEPS的退伍军人将立即完成 在头两个月里，整个健康步骤。随机分配到候补名单对照组的退伍军人将获得 2至4个月的健康步骤。退伍军人将使用分层排列区组设计进行随机分配 基于基线功能障碍主要结果将通过计算科恩的d 2个月评估点的效应量，并与预先确定的单侧置信度进行比较 使用非中心t分布方法。其他定量结局指标将进行评价， 描述性统计，包括平均值、标准差和置信区间。保留率将是 评估使用退伍军人谁退出或退出随着时间的推移百分比。质量反馈将是 使用快速评估程序进行评估，这是一种定性方法，旨在提供快速但 全面的定性评价，以在短时间内解释和实施变化， 三角测量、迭代数据分析和附加数据收集。