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：退伍军人的自杀风险在服兵役后的第一年最高。这 自杀风险的加剧与将平民生活重新融入的困难有关。角色缺陷 功能（知道自己是谁，生活中的去向）是最常见的报道之一 重新整合期间的挑战。角色功能对于成人生活角色的最佳功能至关重要（例如， 就业）及其可预测自杀构想和尝试。但是，没有证据 解决角色功能以减少自杀风险并改善成人生活角色功能的干预措施。 意义：接触退伍军人在传统诊所之外的服务分离的重要性 设置很明显；退伍军人自杀的风险在服务分离的第一年内最高，退伍军人是 在此期间，与VA护理或其他服务没有很好的联系。健康教练是一种非临床健康 行为改变方式旨在改善角色功能并可以实际交付（通过 尽管退伍军人健康管理局（VHA）接受了健康教练，但 没有严格的，全功能的试验检查了健康教练的有效性。几乎保养的健康 教练可能是一种易于扩展的低成本方法，可以在诊所外接触重新融合的退伍军人 降低自杀风险并改善成人生活角色功能的设置。 创新：尚无研究检查在重新融入退伍军人之外的健康教练的使用 诊所环境。这项研究的战略利用实际上是基于VHA在此的投资的基础 非临床模式有可能在高风险过渡期内降低自杀风险。 具体目的：该试点研究将1）研究研究程序的可行性和可接受性 重新整合退伍军人的健康教练干预； 2）评估调解人和结果的度量 在未来的确认效率试验中适合适用性； 3）确定实施的障碍和促进者 重新融入退伍军人的健康指导。 方法论：我们将在兵役三个月内注册94名退伍军人的国家样本 分离并关注他们9个月，捕获他们的第一年分离。参与者会 随机分配到健康教练 +增强的常规护理（EUC）或EUC。干预小组将收到 通过电话或视频（通过参与偏好），最多12次健康教练会议。所有参与者都会 收到有关功能领域组织的有关VA福利和服务的小册子，以增强 “通常的护理。”参与者将在干预中期（第2个月）的基线上完成自我报告评估， 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 他们在健康教练和干预教练方面的经历的访谈将完成有关 他们提供教练的经验。 VHA管理数据将用于确定VHA护理利用率。 我们将使用研究日志数据，满意度措施和定性访谈来检查研究的可行性 干预的方法和可接受性，包括潜在危害。评估包容性的措施 未来的效率试验将涉及表征典型变化，人身内部变化的描述性分析 跨时间，并调整了95％置信区间的治疗效果大小的估计值。告知障碍 并促进者以实施虚拟交付的健康教练，我们将分析资深定性 采访和教练退出访谈使用主要的描述性主题分析方法。 下一步：本研究中收集的数据将为设计提供了随后的有效试验的实际试验 在退伍军人和未来的实施策略之间进行健康指导。这一研究将 告知实际使用实际交付的健康教练作为基于人群的康复方法的战略使用 降低自杀风险并改善重新整合退伍军人的生活角色的功能。