- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06011759
Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth (MIDAS SPCT)
Maintaining Implementation Through Dynamic Adaptations (MIDAS) - Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) (QUE 20-025)
Study Overview
Status
Intervention / Treatment
Detailed Description
Sustained integration of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of EBPs. The current project focuses on increasing referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative.
The investigators have recruited 4 sites for this non-randomized intervention project. Sites have agreed to participate in pre-implementation interviews to gather information regarding barriers and facilitators to use of the SP 2.0 initiative. Sites will then be provided with tailored feedback regarding interview findings and potential use of Academic Detailing and LEAP to address these. Sites may then select to receive either Academic Detailing and/or LEAP which will be provided by MIDAS QUERI. Primary outcome will be rate of SP 2.0 referral adjusted for pre-intervention rate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48105-2303
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Note- the investigators are recruiting clinics/medical centers - not individual patients. Prior to implementation, the investigators will work with sites to ensure they have met the preconditions necessary to begin sustained optimization of the EBP:
- 1) a team leader or champion
- 2) an identified department with service leadership buy-in and control over the processes/practices impacted by the implementation
- 3) readily accessible data to measure process and impact of the implementation and use of the EBP
- 4) availability of required resources
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
A multi-faceted implementation intervention including qualitative interviews and feedback and optional delivery of Academic Detailing and/or LEAP.
|
Learn.
Engage.
Act.
Process (LEAP) program is a structured 6-month core curriculum plus 6 monthly collaborative sessions.
The LEAP quality improvement program engages frontline teams in sustained incremental improvements of EBPs over a six-month period, allowing space for busy clinicians to learn and immediately apply fundamental QI skills.
LEAP encompasses: 1) a structured, accessible curriculum based on the Institute for Healthcare Improvement's (IHI) Model for Improvement and Plan-Do-Study-Act cycles of change; 2) team-based, hands-on learning, and 3) coaching support and a QI network to enhance learning and accountability.
The National Resource Center for Academic Detailing (NaRCAD) describes AD as "an innovative, one-on-one outreach education technique that helps clinicians provide evidence-based care to their patients.
Using an accurate, up-to-date synthesis of the best clinical evidence in an engaging format, academic detailers ignite clinician behavior change, ultimately improving patient health.
A successful AD visit is highly interactive, always a dialogue, and assesses a clinician's individual needs, beliefs, attitudes, issues, and concerns in order to promote better [practice]."
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SP2Clin Metric
Time Frame: Baseline to 12-months post-baseline
|
The quarterly SP2Clin metric data is reported and available on a VA national dashboard.
The SP2Clin metric is calculated by the number of suicide prevention telehealth consults submitted among those with a suicide behavior event.
|
Baseline to 12-months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Number of Consults to SP 2.0 Clinic
Time Frame: Baseline to 12-months post-baseline
|
Change in number of telehealth consults to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative.
|
Baseline to 12-months post-baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality Improvement Skills Application
Time Frame: Baseline to 12-months post-baseline
|
16-item measure of change in quality improvement skills application.
Values 1 to 4 where higher values indicate more frequent use of quality improvement skills.
|
Baseline to 12-months post-baseline
|
|
Provider Satisfaction With Academic Detailing
Time Frame: Post-first Academic Detailing session
|
7-items measuring satisfaction with Academic Detailing.
Each response option uses a Likert-type scale with values 1 to 5 where higher values indicate higher satisfaction.
|
Post-first Academic Detailing session
|
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Change in Provider Satisfaction With LEAP
Time Frame: Baseline to 12-months post-baseline
|
6-item measure of satisfaction with LEAP.
Values 1 to 5 where higher values indicate higher satisfaction.
|
Baseline to 12-months post-baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paul N Pfeiffer, MD MS, VA Ann Arbor Healthcare System, Ann Arbor, MI
- Principal Investigator: Jeremy B. Sussman, MD MS, VA Ann Arbor Healthcare System, Ann Arbor, MI
- Principal Investigator: Jacob E Kurlander, MD MS MS, VA Ann Arbor Healthcare System, Ann Arbor, MI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUX 23-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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