A pilot trial of health coaching to improve functioning and reduce suicide risk among reintegrating Veterans

健康辅导试点试验，以改善重返社会退伍军人的功能并降低自杀风险

• 批准号: 10610376
• 负责人: Lauren M Denneson
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10610376
• 关键词: Address; Adult; Adverse event; Articulation; Calibration; Caring; Client; Client satisfaction; Clinic; Clinical; Confidence Intervals; Data; Employment; Enrollment; Evaluation; Evidence based intervention; Face; Feasibility Studies; Feedback; Feeling suicidal; Future; Goals; Health; Health behavior change; Intervention; Interview; Investments; Joints; Knowledge; Life; Measures; Mediator; Methodology; Methods; Mission; Modality; Outcome; Pamphlets; Participant; Patient Self-Report; Persons; Pilot Projects; Population; Procedures; Process; Questionnaires; Randomized; Rehabilitation therapy; Reporting; Research; Research Design; Resources; Role; Sample Size; Sampling; Self Direction; Self Perception; Services; Suicide attempt; Suicide prevention; Telephone; Time; Variant; Veterans; Veterans Health Administration; Violence; acceptability and feasibility; care providers; confirmatory trial; cost; design; effectiveness evaluation; efficacy evaluation; efficacy trial; experience; follow up assessment; follow-up; functional improvement; functional status; future implementation; group intervention; high risk; implementation facilitators; implementation strategy; improved; innovation; intervention participants; military service; outreach; participant interview; pilot test; pilot trial; population based; post intervention; preference; reducing suicide; rehabilitation research; research and development; response; satisfaction; suicidal risk; suicide rate; surveillance data; treatment as usual; treatment effect; usual care arm; virtual delivery

Background: Veterans’ suicide risk is highest during the first year after military service separation. This heightened suicide risk has been associated with difficulties reintegrating into civilian life. Deficiencies in role functioning (knowing who you are and where you are heading in life) is one of the most commonly reported challenges during reintegration. Role functioning is critical for optimal functioning in adult life roles (e.g., employment) and it is predictive of suicidal ideation and attempts. However, there are no evidence-based interventions that address role functioning to reduce suicide risk and improve functioning in adult life roles. Significance: The importance of reaching Veterans proximal to service separation outside of traditional clinic settings is clear; Veterans’ risk for suicide is highest within the first year of service separation and Veterans are not well-connected to VA care or other services during this time period. Health coaching is a non-clinical health behavior change modality that is designed to improve role functioning and can be delivered virtually (via telephone/video). Although health coaching has been embraced by the Veterans Health Administration (VHA), no rigorous, fully powered trials have examined the effectiveness of health coaching. Virtually-delivered health coaching may be an easily scalable, low-cost approach to reach reintegrating Veterans outside of clinic settings to reduce suicide risk and improve functioning in adult life roles. Innovation: No studies have examined the use of health coaching among reintegrating Veterans outside of the clinic setting. This study’s strategic use of virtually-delivered health coaching builds on VHA’s investment in this non-clinical modality that has the potential to reduce suicide risk during a high-risk transition period. Specific Aims: This pilot study will 1) Examine the feasibility of study procedures and acceptability of the health coaching intervention among reintegrating Veterans; 2) Evaluate measures of mediators and outcomes for suitability in a future confirmatory efficacy trial; and 3) Determine barriers and facilitators of implementation of health coaching among reintegrating Veterans. Methodology: We will enroll a national sample of 94 Veterans within three months of military service separation and follow them for 9 months, capturing their first year of separation. Participants will be randomized to health coaching + enhanced usual care (EUC) or EUC only. The intervention group will receive up to 12 health coaching sessions over the phone or via video (per participant preference). All participants will receive a booklet about VA benefits and services, organized by functional domains, as an enhancement to “usual care.” Participants will complete self-report assessments at baseline, mid-intervention (month 2), post- intervention (month 4), and follow-up (month 9). Approximately 30 participants will complete qualitative interviews on their experiences with health coaching and intervention coaches will complete exit interviews on their experiences delivering coaching. VHA administrative data will be used to ascertain VHA care utilization. We will use study log data, a satisfaction measure, and qualitative interviews to examine feasibility of the study methods and acceptability of the intervention, including potential harms. Evaluation of measures for inclusion in a future efficacy trial will involve characterizing typical variation, descriptive analyses of within-person change across time, and adjusted estimates of treatment effect sizes with 95% confidence intervals. To inform barriers and facilitators to implementing virtually-delivered health coaching we will analyze Veteran qualitative interviews and coach exit interviews using a primarily descriptive thematic analysis approach. Next steps: Data gathered in this study will inform design of a subsequent efficacy trial of virtually-delivered health coaching among reintegrating Veterans and future implementation strategies. This line of research will inform the strategic use of virtually-delivered health coaching as a population-based rehabilitation approach to reduce suicide risk and improve functioning in life roles among reintegrating Veterans.

背景：退伍军人在退伍后的第一年自杀风险最高。 血腥自杀风险与重新融入平民生活的困难有关。 功能（知道你是谁以及你的人生方向）是最常报道的问题之一 重新融入社会过程中的挑战对于成人生活角色的最佳发挥至关重要（例如， 就业），它可以预测自杀意念和企图，但是，没有证据支持。 针对角色功能的干预措施，以降低自杀风险并改善成人生活角色的功能。 意义：接触传统诊所之外接近服务隔离的退伍军人的重要性 环境很明确；退伍军人在退役的第一年内自杀的风险最高，而且退伍军人 在此期间与 VA 护理或其他服务没有良好联系的健康指导属于非临床健康。 旨在改善角色功能并可以虚拟方式交付的行为改变方式（通过 尽管退伍军人健康管理局 (VHA) 已接受健康指导， 目前还没有严格、全面的试验来检验健康指导的有效性。 辅导可能是一种易于扩展、低成本的方法，可以帮助退伍军人在诊所外重新融入社会 降低自杀风险并改善成人生活角色功能的环境。 创新：没有研究考察健康辅导在非正规军重新融入社会的退伍军人中的使用情况。 这项研究对虚拟健康辅导的战略使用建立在 VHA 对此的投资之上。 有可能降低高风险过渡期自杀风险的非临床方式。 具体目标：本试点研究将 1) 审查研究程序的可行性以及研究的可接受性 2) 评估中介因素和结果的衡量标准 未来验证性疗效试验的适用性；以及 3) 确定实施的障碍和促进因素 重返社会的退伍军人的健康指导。 方法：我们将在服兵役三个月内招募 94 名退伍军人作为全国样本 跟踪他们 9 个月，记录他们分离的第一年。 随机分为健康指导 + 强化常规护理 (EUC) 或仅 EUC 干预组。 通过电话或视频进行最多 12 次健康辅导课程（根据参与者的偏好）。 收到一本关于 VA 福利和服务的小册子，按功能领域组织，作为对 “常规护理。”参与者将在基线、干预中期（第 2 个月）、术后完成自我报告评估。 干预（第 4 个月）和随访（第 9 个月）大约 30 名参与者将完成定性工作。 关于他们接受健康辅导和干预教练的经历的访谈将在以下日期完成退出访谈 他们提供指导的经验将用于确定 VHA 护理利用率。 我们将使用研究日志数据、满意度衡量和定性访谈来检验研究的可行性 干预措施的方法和可接受性，包括对纳入措施的评估。 未来的功效试验将涉及典型变异的特征、人体内变化的描述性分析 跨时间，并以 95% 置信区间调整治疗效果大小的估计值，以告知障碍。 和实施虚拟健康辅导的促进者，我们将分析退伍军人的定性 使用主要描述性主题分析方法进行访谈和教练离职访谈。 后续步骤：本研究中收集的数据将为虚拟交付的后续疗效试验的设计提供信息 重返社会的退伍军人的健康指导和未来的实施策略将是这一领域的研究。 告知战略性使用虚拟健康辅导作为基于人群的康复方法 降低自杀风险并改善重返社会退伍军人的生活角色功能。