Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care

VA Office of Research and Development

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Internet-based Self-help Insomnia Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03151083

CDX 16-001

Details and patient eligibility

About

Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or physical health problem. Through previous and on-going projects at VACT, the investigators are developing a general strategy for implementing Internet-based Self-help programs in VA primary care, specifically among Patient Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An implementation strategy is defined as a systematic intervention to integrate evidence-based health innovations into usual care. The strategy the investigators propose to test consists of four core components: (1) a clinical intermediary for patient support, (2) provider/staff facilitation and education, (3) patient education, and (4) stepped-care for those requiring additional treatment. In the proposed study, the investigators will compare this strategy to a low intensity (control) strategy with respect to the implementation related outcomes of patent engagement, provider adoption through referral to the program, and patient completion, over a six-month active implementation period. The investigators will target the very common clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic insomnia. The program has been shown to improve insomnia severity and other sleep related outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month active implementation periods. The purpose this study is to evaluate the preliminary (1) effectiveness of an implementation strategy for Internet-based Self-help Interventions and (2) clinical outcomes of a specific Internet-based self-help program for insomnia, SHUTiTM, in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental implementation strategy the investigators are developing, relative to a control strategy, will result in higher rates of program engagement by patients, greater provider adoption through referral to the program, greater program completion, and improved patient insomnia outcomes.

Full description

Objective: The purpose this study is to evaluate the preliminary (1) effectiveness of an implementation strategy for Internet-based Self-help Interventions and (2) clinical outcomes of a specific Internet-based self-help program for insomnia, SHUTiTM, in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental implementation strategy the investigators are developing, relative to a control strategy, will result in higher rates of program engagement by patients, greater provider adoption through referral to the program, greater program completion, and improved patient insomnia outcomes.

Research Design: The investigators will employ a hybrid implementation-effectiveness study design through which the investigators will primarily test the effectiveness of the implementation strategy, while secondarily evaluating the clinical effectiveness of the SHUTiTM program. The investigators will use a quasi-experimental pre-/post-cohort design whereby SHUTiTM will initially be implemented using a low-intensity (control) strategy, followed by implementation using the experimental strategy. The SHUTiTM program's association with clinical response will be evaluated in an uncontrolled pre-/post-format.

Methodology: Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or physical health problem. Through previous and on-going projects at VACT, the investigators are developing a general strategy for implementing Internet-based Self-help programs in VA primary care, specifically among Patient Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An implementation strategy is defined as a systematic intervention to integrate evidence-based health innovations into usual care. The strategy the investigators propose to test consists of four core components: (1) a clinical intermediary for patient support, (2) provider/staff facilitation and education, (3) patient education, and (4) stepped-care for those requiring additional treatment. The investigators' currently approved protocol (#0002) involves interviewing VA providers, administrators, and staff in order to expand and modify the components of this strategy. In the proposed study, the investigators will compare this strategy to a low intensity (control) strategy with respect to the implementation related outcomes of patent engagement, provider adoption through referral to the program, and patient completion, over a six-month active implementation period. Use of the program will continue and implementation outcomes will be gathered over an additional one-year sustainment phase. The investigators will target the very common clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic insomnia. The program has been shown to improve insomnia severity and other sleep related outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month active implementation periods.

Impact/Significance: The development and testing of evidence-based implementation strategies for Internet-based self-help programs in VA outpatient care is essential given that (1) there is an increasing number of Internet-based self-help programs providing evidence-based treatment for a variety of mental and behavioral health disorders, (2) VA has committed to improving access to care, especially evidence-based and self-care resources, and (3) there is a Congressional mandate that VA implement Internet-based care. This will be first controlled trial of an implementation strategy for Internet-based self-help programs in a VA primary care (PACT/PCMHI) context.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients Receiving care from a VA Connecticut West Haven PACT/PCMHI Provider
• Diagnosed with insomnia lasting 3 months by the PACT provider, as evidenced by referral by the provider for access to the SHUTiTM program
• Able to provide valid informed consent, as evidenced by answering questions indicating their understanding of the content of the Informed Consent Document
• Willing to participate in an internet-based self-help program for insomnia after the access to and requirements of the program are explained to them
• English-speaking (The SHUTiTM program is only available in English)

Exclusion criteria

• Evidence of acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month, including suicidality, homicidally, mania, or psychotic decompensation.
• Evidence of a conservator of person either verbally reported by the patient or upon inspection of the medical record.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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77 participants in 3 patient groups

Phase 1: Implementation As Usual (Implementation Through Rese

Active Comparator group

Description:

SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).

Treatment:

Behavioral: Internet-based Self-help Insomnia Intervention

Phase 2: Primary Care Coached Digital CBTi Implementation (Im

Experimental group

Description:

SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.

Treatment:

Behavioral: Internet-based Self-help Insomnia Intervention

Phase 3: Primary Care Mental Health Collaborative Care Implem

Experimental group

Description:

SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.

Treatment:

Behavioral: Internet-based Self-help Insomnia Intervention