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

Primary Purpose

Suicidal Self-directed Violence, Suicidal Preparatory Behavior

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Academic Detailing (AD)
LEAP
Usual care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicidal Self-directed Violence focused on measuring implementation science, implementation strategy, suicide prevention, academic detailing, quality improvement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Control

Arm Description

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

Control sites will be selected to match intervention sites on baseline referral rates.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Receipt of Cognitive Behavioral Therapy for Suicide Prevention at SP 2.0 clinic
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
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
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
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
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
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.

Full Information

First Posted
August 16, 2023
Last Updated
August 24, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT06011759
Brief Title
Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth
Acronym
MIDAS SPCT
Official Title
Maintaining Implementation Through Dynamic Adaptations (MIDAS) - Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) (QUE 20-025)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Self-directed Violence, Suicidal Preparatory Behavior
Keywords
implementation science, implementation strategy, suicide prevention, academic detailing, quality improvement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
A multi-faceted implementation intervention including qualitative interviews and feedback and optional delivery of Academic Detailing and/or LEAP.
Arm Title
Control
Arm Type
Experimental
Arm Description
Control sites will be selected to match intervention sites on baseline referral rates.
Intervention Type
Behavioral
Intervention Name(s)
Academic Detailing (AD)
Intervention Description
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]."
Intervention Type
Behavioral
Intervention Name(s)
LEAP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Experimental control sites receiving usual care
Primary Outcome Measure Information:
Title
Referral to SP 2.0 Clinic
Description
Change in percentage of referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative.
Time Frame
Baseline to 12-months post-baseline
Secondary Outcome Measure Information:
Title
Receipt of Cognitive Behavioral Therapy for Suicide Prevention at SP 2.0 clinic
Description
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.
Time Frame
Baseline to 12-months post-baseline
Title
Completion of Cognitive Behavioral Therapy for Suicide Prevention at SP 2.0 clinic
Description
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.
Time Frame
Baseline to 12-months post-baseline
Title
Receipt of Problem Solving Therapy for Suicide Prevention
Description
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.
Time Frame
Baseline to 12-months post-baseline
Title
Completion of Problem Solving Therapy for Suicide Prevention
Description
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.
Time Frame
Baseline to 12-months post-baseline
Title
Receipt of Dialectical Behavior Therapy
Description
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.
Time Frame
Baseline to 12-months post-baseline
Title
Completion of Dialectical Behavior Therapy
Description
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.
Time Frame
Baseline to 12-months post-baseline
Other Pre-specified Outcome Measures:
Title
Change in Employee Engagement in Quality Improvement
Description
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.
Time Frame
Baseline to 12-months post-baseline
Title
Change in Employee Burnout
Description
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).
Time Frame
Baseline to 12-months post-baseline
Title
Change in Workgroup Cohesion & Engagement
Description
7-item measure from the VA's newly developed Patient Safety Culture. Values 1 to 5 where higher values indicate more positive scores.
Time Frame
Baseline to 12-months post-baseline
Title
Change in quality improvement skills application
Description
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.
Time Frame
Baseline to 12-months post-baseline
Title
Change in provider satisfaction with academic detailing
Description
7-item measure of satisfaction with Academic Detailing. Values 1 to 5 where higher values indicate higher satisfaction.
Time Frame
Baseline to 12-months post-baseline
Title
Change in provider satisfaction with LEAP
Description
6-item measure of satisfaction with LEAP. Values 1 to 5 where higher values indicate higher satisfaction.
Time Frame
Baseline to 12-months post-baseline
Title
Change in Best Places to Work Score
Description
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."
Time Frame
Baseline to 12-months post-baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul N Pfeiffer, MD MS
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob E Kurlander, MD MS MS
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy B. Sussman, MD MS
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-2303
Country
United States

12. IPD Sharing Statement

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

Learn more about this trial

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

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