Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth (MIDAS SPCT)

• ClinicalTrials.gov Identifier: NCT06011759
• Recruitment Status: Active, not recruiting
• First Posted: August 25, 2023
• Last Update Posted: August 25, 2023
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: August 16, 2023
• First Posted Date: August 25, 2023
• Last Update Posted Date: August 25, 2023
• Actual Study Start Date: November 1, 2022
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 24, 2023)

Referral to SP 2.0 Clinic [ Time Frame: Baseline to 12-months post-baseline ]

Change in percentage of referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 24, 2023)

• Receipt of Cognitive Behavioral Therapy for Suicide Prevention at SP 2.0 clinic [ Time Frame: Baseline to 12-months post-baseline ]
  The change in prevalence of any receipt of Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP). Receipt of any CBT-SP will be measured by extracting from the medical record note templates completed by CBT-SP therapists.
• Completion of Cognitive Behavioral Therapy for Suicide Prevention at SP 2.0 clinic [ Time Frame: Baseline to 12-months post-baseline ]
  The change in prevalence of completion of Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP). Completion of any CBT-SP will be measured by extracting from the medical record note templates completed by CBT-SP therapists.
• Receipt of Problem Solving Therapy for Suicide Prevention [ Time Frame: Baseline to 12-months post-baseline ]
  The change in prevalence of any receipt of Problem Solving Therapy for Suicide Prevention (PST-SP). Receipt of any PST-SP will be measured by extracting from the medical record note templates completed by PST-SP therapists.
• Completion of Problem Solving Therapy for Suicide Prevention [ Time Frame: Baseline to 12-months post-baseline ]
  The change in prevalence of completion of Problem Solving Therapy for Suicide Prevention (PST-SP). Completion of any PST-SP will be measured by extracting from the medical record note templates completed by PST-SP therapists.
• Receipt of Dialectical Behavior Therapy [ Time Frame: Baseline to 12-months post-baseline ]
  The change in prevalence of any receipt of Dialectical Behavior Therapy for Suicide Prevention (DBT-SP). Receipt of any DBT-SP will be measured by extracting from the medical record note templates completed by DBT-SP therapists.
• Completion of Dialectical Behavior Therapy [ Time Frame: Baseline to 12-months post-baseline ]
  The change in prevalence of completion of Dialectical Behavior Therapy for Suicide Prevention (DBT-SP). Completion of any DBT-SP will be measured by extracting from the medical record note templates completed by DBT-SP therapists.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 24, 2023)

• Change in Employee Engagement in Quality Improvement [ Time Frame: Baseline to 12-months post-baseline ]
  3-item pilot measure of the extent to which employees engage in quality improvement activities. Scores are 1-5 with higher ratings indicating more engagement in QI.
• Change in Employee Burnout [ Time Frame: Baseline to 12-months post-baseline ]
  3-item measure comprising I feel burned out from my work (Exhaustion), I worry that this job is hardening me emotionally (Depersonalization), and I have accomplished many worthwhile things in this job (Reduced Achievement; reverse score). "High Burnout" measures the percent of staff who are feeling burned out on all three burnout symptoms at a frequency of "once a week" to "every day." Scored: 0-100%, where LOWER score is more favorable. Exhaustion (physical burnout) Depersonalization (emotional burnout), Reduced Achievement (cognitive burnout).
• Change in Workgroup Cohesion & Engagement [ Time Frame: Baseline to 12-months post-baseline ]
  7-item measure from the VA's newly developed Patient Safety Culture. Values 1 to 5 where higher values indicate more positive scores.
• 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.
• Change in provider satisfaction with academic detailing [ Time Frame: Baseline to 12-months post-baseline ]
  7-item measure of satisfaction with Academic Detailing. Values 1 to 5 where higher values indicate higher satisfaction.
• 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.
• Change in Best Places to Work Score [ Time Frame: Baseline to 12-months post-baseline ]
  3-item scale. "Best Places to Work" is a summary measure of the group's satisfaction with the job, organization, and likelihood to recommend VA as a good place to work. This is a measure normally administered within the All-employee Survey (AES). This score is functionally similar to those reported for Federal agencies by the Partnership for Public Service (http://bestplacestowork.org). Overall Satisfaction (% Positive), Organization Satisfaction (% Positive), and Recommend My Organization (% Positive). Score as Percent positive = "Very Satisfied/Satisfied" or "Strongly Agree/Agree."

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth
• Official Title: Maintaining Implementation Through Dynamic Adaptations (MIDAS) - Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) (QUE 20-025)
• Brief Summary: Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice. The MIDAS QUERI program helps providers improve the way they treat VA patients. This project will focus on increasing referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative through the delivery of Academic Detailing and LEAP (a team-based quality improvement program). SP 2.0 provides accessible, evidence-based suicide prevention treatment to all Veterans with a history of suicidal self-directed violence or preparatory behaviors in the past 12 months.

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. Sites will be compared to control sites which will be matched based on similar baseline referral rates. Primary outcome will be rate of SP 2.0 referral adjusted for pre-intervention rate.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

A multi-faceted implementation intervention including qualitative interviews and feedback and optional delivery of Academic Detailing and/or LEAP.

Masking: None (Open Label)
Primary Purpose: Health Services Research

Condition

• Suicidal Self-directed Violence
• Suicidal Preparatory Behavior

Intervention

• Behavioral: Academic Detailing (AD)
  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]."
• Behavioral: 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.
• Behavioral: Usual care
  Experimental control sites receiving usual care

Study Arms

• Experimental: Intervention
  A multi-faceted implementation intervention including qualitative interviews and feedback and optional delivery of Academic Detailing and/or LEAP.
  Interventions:

  • Behavioral: Academic Detailing (AD)
  • Behavioral: LEAP
• Experimental: Control
  Control sites will be selected to match intervention sites on baseline referral rates.
  Intervention: Behavioral: Usual care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 24, 2023): 4
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2025
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06011759
• Other Study ID Numbers: QUX 23-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Site-level data that underlie results reported, after de-identification will be available.
• Supporting Materials: Study Protocol
• Supporting Materials: Analytic Code
• Time Frame: For 36 months after article is published.
• Access Criteria: Upon request by researchers who provide a methodologically sound proposal. Further details will be available.

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Same as current
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul N Pfeiffer, 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
• Principal Investigator: Jeremy B. Sussman, MD MS; VA Ann Arbor Healthcare System, Ann Arbor, MI

• PRS Account: VA Office of Research and Development
• Verification Date: August 2023