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Participatory System Dynamics vs Usual Quality Improvement: Staff Use of Simulation as an Effective, Scalable and Affordable Way to Improve Timely Mental Health Care?

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ClinicalTrials.gov Identifier: NCT04208217
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
PTSD Depression Opioid Use Disorder Behavioral: Modeling to Learn (MTL) Behavioral: Usual quality improvement (QI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Modeling to Learn: Modeling to Learn is a facilitated health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff running simulations of clinic improvement strategies to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy.

Usual Quality Improvement: Usual quality improvement is a health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff reviewing team data to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy.

Anticipate that 720 frontline providers will participate across both arms of this trial. There will be no interaction with current patients for the purposes of research. No new data will be collected beyond data generated during routine care.

Masking: None (Open Label)
Primary Purpose: Health Services Research
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?
Estimated Study Start Date : September 14, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modeling to Learn (MTL)
12 clinics randomly assigned to MTL
Behavioral: Modeling to Learn (MTL)
Modeling to Learn is a facilitated health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff running simulations of clinic improvement strategies to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy.

Experimental: Usual quality improvement (QI)
12 clinics randomly assigned to usual QI
Behavioral: Usual quality improvement (QI)
Usual quality improvement is a health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff reviewing data to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy.




Primary Outcome Measures :
  1. Proportion of patients initiating and completing a course of evidence-based psychotherapy (EBPsy) or evidence-based pharmacotherapy (EBPharm) [ Time Frame: Pre-/Post- 12-month period average of EBP reach (24 months total observation)] ]
    Proportion evidence-based practice (EBP) reach is defined as the proportion of VA outpatient addiction and mental health patients who receive evidence-based psychotherapy and/or evidence-based pharmacotherapy for opioid use disorder, depression, or PTSD in routine outpatient VA care.

  2. Number of completed EBPsy templates during sessions with a relevant CPT code [ Time Frame: Pre-/Post- 12-month period average of EBP reach (24 months total observation)] ]
    Proportion of 3 EBPsy treatments for depression - Cognitive Behavior Therapy (CBT-D), Acceptance and Commitment Therapy (ACT), Interpersonal Psychotherapy (IPT) 2 EBPsy for PTSD - Prolonged Exposure (PE), and Cognitive Processing Therapy (CPT)

  3. Number of combination of prescriptions placed with the VA pharmacy and sessions with a relevant CPT code [ Time Frame: Pre-/Post- 12-month period average of EBP reach (24 months total observation)] ]
    Proportion of 2 EBPharm treatments for depression - 84 and 180 days therapeutic continuity at new antidepressant start and 2 EBPharm for Opioid Use Disorder (OUD) - methadone and buprenorphine


Secondary Outcome Measures :
  1. Differences in team perceptions of MTL and QI assessed by the Acceptability of Intervention Measure (AIM) [ Time Frame: at 6 months ]

    Assesses differences in team perceptions of MTL and QI using the 4 item survey 'Acceptability of Intervention Measure (AIM)'.

    Scale: 1-5, in 1 point increments (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = completely agree)


  2. Differences in team perceptions of MTL and QI assessed by the Intervention Appropriateness Measure (IAM) [ Time Frame: at 6 months ]

    Assesses differences in team perceptions of MTL and QI using the 4 item survey 'Intervention Appropriateness Measure (IAM)'.

    Scale: 1-5, in 1 point increments (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = completely agree)


  3. Differences in team perceptions of MTL and QI assessed by the Feasibility of Intervention Measure (FIM) [ Time Frame: at 6 months ]

    Assesses differences in team perceptions of MTL and QI using the 4 item survey 'Feasibility of Intervention Measure (FIM)'.

    Scale: 1-5, in 1 point increments (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = completely agree)


  4. Patient Aligned Care Team Burnout Measure (PACT) [ Time Frame: At baseline and 6 months ]

    Quality of work satisfaction and burnout in a 4-item descriptive measure from VA team-based primary care that tracks 1) years of experience with the team, 2) working on more than one team, 3) turnover/change in team staff, 4) team overwork, and the single-item 5) self-reported burnout (sensitivity 83.2% and specificity 87.4%).

    Higher turnover numbers and high reported levels of burn out are considered negative.


  5. Participatory Measure: Context [ Time Frame: At baseline and 6 months ]
    Assesses differences in MTL and QI decision context Scale: 1-5 (1 = VA Central Office, 2 = VA Facility Leadership, 3 = Clinic Managers, 4 = Our team, 5 = Individual providers on our team)

  6. Participatory Measure: Partnership Structural Values [ Time Frame: At 6 months ]

    Assess differences in MTL and QI partnership structural values in a 22-item measure with subscales a) partner focus, b) core values, c) participation, d) cooperation, e) respect, and f) trust

    Subscale a) partner focus Scale: 1-5, in 1 point increments (1 = not at all , 5 = to a great extent) Alpha = 0.82

    Subscale b-f) core values, participation, cooperation, respect, trust) Scale: 1-5, in 1 point increments (1 = strongly disagree, 5 = strongly agree) Subscale b) Alpha = 0.89 Subscale c) Alpha = 0.78 Subscale d) Alpha = 0.83 Subscale e) Alpha = 0.83 Subscale f) Alpha = 0.86


  7. Participatory Measure: Relationships [ Time Frame: At 6 months ]

    Assess differences in MTL and QI relationships in a 15-item measure with subscales a) participatory decision-making, b) leadership, and c) use of resources

    Subscale a) participatory decision-making Scale: 1-5, in 1 point increments (1 = never, 5 = always) Alpha = 0.83

    Subscale b) leadership Scale: 1-5, in 1 point increments (1 = very ineffective, 5 = very effective) Alpha = 0.94

    Subscale c) use of resources Scale: 1-5, in 1 point increments (1 = makes poor use, 5 = makes excellent use) Alpha = n/a


  8. Participatory Measure: Synergy [ Time Frame: At 6 months ]

    Assess differences in MTL and QI synergy in a 5-item measure.

    Scale: 1-5, in 1 point increments (1 = not at all, 5 = to a great extent) Alpha = 0.90


  9. Participatory Measure: Capacity-Building Index [ Time Frame: At 6 months ]

    Assess differences in MTL and QI capacity-building index in a 5-item measure

    Scale: 1-5, in 1 point increments (1 = Not at all, 2 = Very Little, 3 = Somewhat, 4 = To a Large Extent, 5 = To a Very Great Extent) Alpha = 0.90


  10. Facilitator Quality: Engagement Principles [ Time Frame: At 6 months ]

    10-item engagement principles measure that assesses investigator readiness to conduct participatory implementation science research. Assesses team and co-facilitator self-ratings of co-facilitators' use of engagement principles, such as building trusting relationships, knowledge of local conditions, and support for existing local capacities

    Scale: 1-5, in 1 point increments (1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree)

    Response options range from 1 (strongly disagree) to 5 (strongly agree). Items will be summed for analyses, and the investigators will evaluate for convergence/divergence across facilitator and team ratings


  11. MTL Fidelity Checklist for 12-Session Plan [ Time Frame: Throughout 6 months ]
    Track MTL arm fidelity to 12-Session plan resources, sessions, online outputs, and standardized weekly emails

  12. QI Fidelity Checklist for 12-Session Plan [ Time Frame: Throughout 6 months ]
    Track QI arm fidelity to 12-Session plan resources, sessions, online outputs, and standardized weekly emails

  13. Quality Improvement Activity Tracking [ Time Frame: Throughout 6 months ]
    Tracking form adapted from a current VA operations-focused, implementation facilitation trial by the VA Team-Based Behavioral Health QUERI Program with four strengths specific to our study of: 1) assessment of activity costs readily comparable to other another VA multisite trial, 2) measure from Behavioral Health Interdisciplinary Program (BHIP) Enhancement Project, team-focused MH care, like PSD, 3) emphasis on quantifying a) staff and b) facilitator time, rather than categorizing content, 4) prior use in VA.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

24 health care systems currently functioning below the median VA mental health recommendations for Strategic Analytics for Improvement & Learning (SAIL) and below the median for 3 of 8 SAIL evidence-based treatment approaches.

  • VA divisions and community-based outpatient clinics (CBOCs) or 'clinics' from regional VA health systems
  • Must be below the overall VA quality median (as assessed by the Strategic Analytics for Improvement and Learning or SAIL), which includes 3 of 8 SAIL measures associated with four evidence-based psychotherapies and three evidence-based pharmacotherapies for depression, PTSD, and opioid use disorder.

Exclusion Criteria:

Health care systems functioning above median VA mental health recommendations for Strategic Analytics for Improvement & Learning (SAIL) and below the median for 3 of 8 SAIL evidence-based treatment approaches. Only one health care system can be included per arm - MTL vs QI.

  • clinics with less than 12 months of data in 2018
  • clinics involved in Office of Veterans Access to Care (OVACS) quality improvement program at baseline
  • clinics where the VA Cerner electronic health record (EHR) implementation rollout will occur during the project period (Veterans Integrated Services Networks (VISNs) 20, 21 ,22, and 7)
  • clinics who serve less than 122 unique patients each month on average
  • clinics without an onsite multidisciplinary team of mental health or addiction service providers (minimum required: 1 psychiatrist, 1 psychologist, 1 social worker onsite)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208217


Contacts
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Contact: Lindsey E Zimmerman, PhD (650) 493-5000 ext 27010 lindsey.zimmerman@va.gov
Contact: Stacey D Park, BA (650) 614-9997 ext 27379 stacey.park2@va.gov

Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Contact: Lindsey E Zimmerman, PhD    650-493-5000 ext 27010    lindsey.zimmerman@va.gov   
Contact: Stacey D Park, BA    (650) 614-9997 ext 27379    stacey.park2@va.gov   
Sub-Investigator: Craig S. Rosen, PhD         
Principal Investigator: Lindsey E. Zimmerman, PhD         
Sub-Investigator: Rachel Kimerling, PhD BA         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Lindsey E. Zimmerman, PhD VA Palo Alto Health Care System, Palo Alto, CA
Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04208217    
Other Study ID Numbers: IIR 17-294
12760065 ( Other Grant/Funding Number: VA Office of Research & Development )
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
implementation science
quality improvement
modeling to learn
usual quality improvement
evidence-based psychotherapy
evidence-based pharmacotherapy
addiction
mental health/behavioral health
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms