Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04208217
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-02
First Post:
2019-12-18
Brief Title:
Participatory System Dynamics vs Usual Quality Improvement Staff Use of Simulation as an Effective Scalable and Affordable Way to Improve Timely Mental Health Care
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Participatory System Dynamics vs Usual Quality Improvement Is Staff Use of Simulation an Effective Scalable and Affordable Way to Improve Timely Veteran Access to High-quality Mental Health Care
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
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
Detailed 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 dont receive EBPs Systems theory explains limited EBP reach as a system behavior emerging dynamically from local components eg patient demandhealth 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
SignificanceImpact This study is proposed in the high priority area of VA addiction and mental health care to improve Veteran access to VAs 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 disciplinestreatments
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 StepsImplementation 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
SignificanceImpact This study is proposed in the high priority area of VA addiction and mental health care to improve Veteran access to VAs 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 disciplinestreatments
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 StepsImplementation 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 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12760065 | OTHER_GRANT | VA Office of Research Development | None |