跳至主要内容
临床试验/NCT04350866
NCT04350866已完成不适用

Enhancing Access to Insomnia (EASI) Care: Implementing Brief Behavioral Treatment for Insomnia in Primary Care Mental Health Integration Clinics

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 277,920 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
277,920
试验地点
1
主要终点
Veteran Participants Who Engaged in BBTI

研究概览

简要总结

This multi-site project (four VA Medical Centers) will test two approaches to improving the delivery of a behavioral insomnia treatment in the Primary Care setting to Veterans. The first approach is training providers to deliver Brief Behavioral Treatment for Insomnia (BBTI). The second approach is to give providers trained in BBTI additional support and resources to enhance their ability to deliver BBTI, what we call implementation. This project will measure delivery of BBTI over four phases: (1) pre-training; (2) pre-implementation; (3) implementation; and (4) post-implementation.

The main questions to answer:

Does delivery of BBTI improve with training alone and does it improve further with the addition of implementation support?

Does delivery of BBTI remain at similar levels after implementation support is removed?

Do Veterans who engage in BBTI reduce their insomnia symptoms?

详细描述

Chronic insomnia, one of the most common health problems among Veterans, significantly impacts health, function, and quality of life. Cognitive Behavioral Therapy for Insomnia (CBTI) is the first line treatment; however, despite efforts to train VA clinicians to deliver CBTI, there are still significant barriers to providing adequate access to insomnia care. Up to 44% of Veterans seen in Primary Care report insomnia, making it an optimal clinical setting for improving access to insomnia care. Furthermore, Brief Behavioral Treatment for Insomnia (BBTI), adapted from CBTI as a briefer, more flexible treatment, is easily delivered by Primary Care Mental Health Integration (PCMHI) clinicians and can greatly improve access to care for Veterans with insomnia. Yet, simply training PCMHI clinicians to deliver BBTI is not enough. Implementation strategies are needed for successful uptake, adoption, and sustainable delivery of care.

This stepped-wedge, hybrid III implementation-effectiveness trial involves four VA Medical Centers: Baltimore, Durham, Minneapolis, and Philadelphia. The hybrid design allows for testing of implementation and treatment effectiveness. The stepped-wedge design allows for fewer sites to achieve adequate power as all sites are exposed to BBTI training (BBTI) and BBTI + Implementation Strategies (BBTI+IS). The target sample are PCMHI clinicians and the impact of a bundle of strategies on the success of sustainable delivery of BBTI in Primary Care. Retrospective data collected from VA electronic health records will be used to obtain variables of interest related to Veteran treatment outcomes and data related to PCMHI clinician delivery of BBTI.

We will compare the impact PCMHI clinicians trained to deliver BBTI vs. the impact of BBTI training plus 12-months of access to an implementation strategy bundle (BBTI+IS). BBTI+IS vs. BBTI training alone is expected to result in more Veterans with access to insomnia care in PCMHI. We will also compare delivery of BBTI across all four phases, from pre-training to post-implementation. We will also measure Veteran-level outcomes for insomnia severity and PCMHI clinician fidelity on delivery of BBTI.

Outcome measures have been updated to reflect study protocol and analyses more accurately. Some of the prespecified Primary and Secondary Outcome Measures have been combined with one removed due to no data collection. The results reported reflect data that has been collected and analyzed.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Veterans in Primary Care and Primary Care Mental Health Integration (PCMHI) at the participating sites.

排除标准

  • Not meeting above criteria

研究组 & 干预措施

Baltimore VAMC

BBTI; ERIC strategies

干预措施: Expert Recommendations for Implementing Change bundle of strategies (Behavioral)

Baltimore VAMC

BBTI; ERIC strategies

干预措施: Brief Behavioral Treatment for Insomnia (Behavioral)

Minneapolis VAMC

BBTI; ERIC strategies

干预措施: Expert Recommendations for Implementing Change bundle of strategies (Behavioral)

Minneapolis VAMC

BBTI; ERIC strategies

干预措施: Brief Behavioral Treatment for Insomnia (Behavioral)

Philadelphia VAMC

BBTI; ERIC strategies

干预措施: Expert Recommendations for Implementing Change bundle of strategies (Behavioral)

Philadelphia VAMC

BBTI; ERIC strategies

干预措施: Brief Behavioral Treatment for Insomnia (Behavioral)

Durham VAMC

BBTI; ERIC strategies

干预措施: Expert Recommendations for Implementing Change bundle of strategies (Behavioral)

Durham VAMC

BBTI; ERIC strategies

干预措施: Brief Behavioral Treatment for Insomnia (Behavioral)

结局指标

主要结局

Veteran Participants Who Engaged in BBTI

时间窗: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)

The number of Veterans in PCMHI who engaged in BBTI as indicated in the medical records

次要结局

  • Veterans in PCMHI Identified With Insomnia(54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation))
  • Veterans in Primary Care Identified With Insomnia(54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation))
  • PCMHI Providers (Staff) Who Delivered (Adopted) BBTI(42 months; during the pre-implementation, implementation, and post-implementation phases.)
  • Implementation/Treatment Fidelity (Staff)(42 months; the BBTI-CRS was administered during pre-implementation (up to 3 times), implementation (1 time, at the end), and post-implementation (1 time, at the end))
  • BBTI Effectiveness (Intent to Treat)(42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 1-13 weeks.)
  • BBTI Effectiveness (Per Protocol)(42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 2-13 weeks.)
  • Barriers & Facilitators (CFIR Determinants)(42 months; qualitative interviews took place at the end of the pre-implementation, implementation, and post-implementation phases.)
  • Implementation Strategy Utilization Survey(12 months: 4 times - every 3-months during the Implementation phase.)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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