Clinical Trials Logo

Clinical Trial Summary

Evidence-based VA care is best for meeting Veterans' mental health needs, such as depression, PTSD and opioid use disorder, to prevent suicide or overdose. But some key evidence-based practices only reach 3-28% of patients. Participatory system dynamics (PSD) helps improve quality with existing resources, critical in mental health and all VA health care. PSD uses learning simulations to improve staff decisions, showing how goals for quality can best be achieved given local resources and constraints. This study aims to significantly increase the proportion of patients who start and complete evidence-based care, and determine the costs of using PSD for improvement. Empowering frontline staff with PSD simulation encourages safe 'virtual' prototyping of complex changes to scheduling, referrals and staffing, before translating changes to the 'real world.' This study determines if PSD increases Veteran access to the highest quality care, and if PSD better maximizes VA resources when compared against usual trial-and-error approaches to improving quality.


Clinical Trial Description

Background: Evidence-based practices (EBPs) are the most high value treatments to meet Veterans' addiction and mental health needs, reduce chronic impairment, and prevent suicide or overdose. Over 10 years, VA invested in dissemination of evidence-based psychotherapies and pharmacotherapies based on substantial evidence of effectiveness as compared to usual care. Quality metrics also track progress. Despite these investments, patients with prevalent needs, such as depression, PTSD and opioid use disorder often don't receive EBPs. Systems theory explains limited EBP reach as a system behavior emerging dynamically from local components (e.g., patient demand/health service supply). Participatory research and engagement principles guide participatory system dynamics (PSD), a mixed-methods approach used in business and engineering, shown to be effective for improving quality with existing resources. Significance/Impact: This study is proposed in the high priority area of VA addiction and mental health care to improve Veteran access to VA's highest quality care. The PSD program, Modeling to Learn (MTL), improves frontline management of dynamic complexity through simulations of staffing, scheduling and service referrals common in healthcare, across generalist and specialty programs, patient populations, and provider disciplines/treatments. Innovation: Recent synthesis of VA data in the enterprise-wide SQL Corporate Data Warehouse (CDW) makes it feasible to scale participatory simulation learning activities with VA frontline addiction and mental health staff. MTL is an advanced quality improvement (QI) infrastructure that helps VA take a major step toward becoming a learning health care system, by empowering local multidisciplinary staff to develop change strategies that fit to local capacities and constraints. Model parameters are from one VA source and generic across health services. If findings show that MTL is superior to usual VA quality improvement activities of data review with facilitators from VA program offices, this paradigm could prove useful across VA services. The PSD approach also advances implementation science. Systems theory explains how dynamic system behaviors (EBP reach) are defined by general scientific laws, yet arise from idiographic local conditions. Empowering staff with systems science simulation encourages the safe prototyping of ideas necessary for learning, increasing ongoing quality improvement capacities, and saving time and money as compared to trial-and-error approaches. Specific Aims: 1. Effectiveness: Test for superiority of MTL over usual QI for increasing the proportion of patients (1a) initiating, and (1b) completing a course of evidence-based psychotherapy (EBPsy) and evidence-based pharmacotherapy (EBPharm). 2. Scalable: (2a) Evaluate usual QI and MTL fidelity. (2b) Test MTL fidelity for convergent validity with participatory measures. (2c) Test the participatory theory of change: Evaluate whether 12 month period EBP reach is mediated by team scores on participatory measures. 3. Affordable: (3a) Determine the budget impact of MTL. (3b). Calculate the average marginal costs per 1% increase in EBP reach. Methodology: This study proposes a two-arm, 24-clinic (12 per arm) cluster randomized trial to test for superiority of MTL over usual QI for increasing EBP reach. Clinics will be from 24 regional health care systems (HCS) below the SAIL mental health median, and low on 3 of 8 SAIL measures associated with EBPs. Computer-assisted stratified block randomization will balance MTL and usual QI arms at baseline using Corporate Data Warehouse (CDW) data. Participants will be the multidisciplinary frontline teams of addiction and mental health providers. Next Steps/Implementation: MTL was developed in partnership with the VA Office of Mental Health and Suicide Prevention (OMHSP) and if shown to be effective, scalable, and affordable for improving timely Veteran access to EBPs, MTL will be scaled nationally to more clinics by expanding MTL online resources, and training more VA staff to facilitate MTL activities instead of usual QI. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04208217
Study type Interventional
Source VA Office of Research and Development
Contact
Status Enrolling by invitation
Phase N/A
Start date July 22, 2021
Completion date September 30, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A