Ignite Creation Date:
2024-05-06 @ 10:04 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03151083
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2017-04-19
Brief Title:
Implementing and Evaluating Computer-Based Interventions for Mental Health Testing an Implementation Strategy for VA Outpatient Care
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Implementing and Evaluating Computer-Based Interventions for Mental Health CDA 14-420
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 providerstaff 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
Detailed 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 programs 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 providerstaff 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
ImpactSignificance 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 PACTPCMHI context
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 programs 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 providerstaff 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
ImpactSignificance 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 PACTPCMHI context
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None