Local Participatory Systems Dynamics to Increase Reach of Evidence Based Addiction and Mental Health Care
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ClinicalTrials.gov Identifier: NCT04356274 |
Recruitment Status :
Enrolling by invitation
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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PTSD Depression Alcohol Use Disorder Opioid Use Disorder | Other: Participatory System Dynamics (PSD) Other: Audit and Feedback (AF) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 720 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participatory System Dynamics: Participatory system dynamics 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. Audit and Feedback: Audit and feedback 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. 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 Audit and Feedback: A Cluster Randomized Trial of Mechanisms of Implementation Change to Expand Reach of Evidence-based Addiction and Mental Health Care |
Actual Study Start Date : | February 1, 2019 |
Estimated Primary Completion Date : | August 31, 2024 |
Estimated Study Completion Date : | August 31, 2024 |

Arm | Intervention/treatment |
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Experimental: Participatory System Dynamics (PSD)
12 clinics assigned to PSD
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Other: Participatory System Dynamics (PSD)
Participatory system dynamics 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: Audit and Feedback (AF)
12 clinics assigned to AF
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Other: Audit and Feedback (AF)
Audit and feedback is a health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff reviewing clinical care team data to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy. |
- Proportion of patients diagnosed with alcohol use disorder, depression, opioid use disorder, or PTSD who meet evidence-based psychotherapy and pharmacotherapy initiation and course measures divided by total number of patients with these diagnoses [ Time Frame: Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation) ]Initiation of an evidence-based practice is indicated by an evidence-based psychotherapy template or evidence-based pharmacotherapy prescription after intake. Adequate course is based on receiving an adequate number of evidence-based psychotherapy sessions to be a "completer" (typically 8 sessions) or enough refills for a guideline-recommended adequate trial of each medication (varies by medication). Data is gathered based on electronic health record data from the VA Corporate Data Warehouse (CDW).
- Proportion of completed evidence-based practice templates during sessions with a relevant CPT code [ Time Frame: Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation) ]We will study 5 evidence-based psychotherapies: 3 for depression (Cognitive Behavior Therapy (CBT-D), Acceptance and Commitment Therapy (ACT), and Interpersonal Psychotherapy (IPT)) and 2 for PTSD (Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT)). Data is gathered based on electronic health record data from the Corporate Data Warehouse (CDW).
- Proportion 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 evidence-based practice reach (24 months total observation) ]We will study 8 evidence-based pharmacotherapies: 2 for depression (84 and 180 days therapeutic continuity at new antidepressant start), 2 for Opioid Use Disorder (OUD) (methadone and buprenorphine), and 4 for Alcohol Use Disorder (AUD) (Acamprosate, Disulfiram, Naltrexone, and Topiramate). Data is gathered based on electronic health record data from the Corporate Data Warehouse (CDW).
- Degree of acceptability of intervention assessed by the Acceptability of Intervention Measure (AIM) [followed by its scale information in the Description] [ Time Frame: At 6 months ]
Assesses degree of differences in team perceptions of PSD and AF on a survey with 4 items.
Scale: 1-5, in 1 point increments (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = completely agree)
- Degree of appropriateness of intervention assessed by the Intervention Appropriateness Measure (IAM) [followed by its scale information in the Description] [ Time Frame: At 6 months ]
Assesses degree of for differences in team perceptions of PSD and AF on a survey with 4 items.
Scale: 1-5, in 1 point increments (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = completely agree)
- Degree of feasibility of intervention assessed by the Feasibility of Intervention Measure (FIM) [followed by its scale information in the Description] [ Time Frame: At 6 months ]
Assesses degree of differences in team perceptions of PSD and AF on a survey with 4 items.
Scale: 1-5, in 1 point increments (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = completely agree)
- Patient Aligned Care team Burnout Measure (PACT) [followed by its scale information in the Description] [ Time Frame: At baseline and 6 months ]
Quality of work satisfaction and burnout in a 4-item descriptive survey with measures 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%)
(Question 1) Answered in # of years (Question 2-3) Yes or No (Question 4-5) Scale: 1-5, in 1 point increments (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Very Often, 5 = Always)
- Learning Organization Survey (LOS-27) [followed by its scale information in the Description] [ Time Frame: At baseline and 6 months ]
Psychological safety in the workplace using a 27-item survey developed out of the learning organization tradition and demonstrated to have good psychometric properties during VA validation which assesses 7 clinic context factors: a) supportive learning environment (including psychological safety), b) leadership that reinforces learning, c) experimentation, d) training, e) knowledge acquisition, f) time for reflection, and g) performance monitoring
(Questions 1-23) Scale: 0-4, in 1 point increments (0 = Never, 4 = Always) (Questions 24-27) Scale: 0 to 7, in 1 point increments (0 = Highly Inaccurate, 7 = Highly Accurate)
- Team Decision Making Questionnaire (TDMQ) [followed by its scale information in the Description] [ Time Frame: At 6 months ]
Team dynamics in the workplace using a four factor scale survey validated to assess the impact of a team intervention on team decision-making, support learning and development of quality services
Scale: 1-7, in 1 point increments incl N/A (N/A = Not Applicable, 1 = Not at all, 2 = To a very small extent, 3 = To a small extent, 4 = To a moderate extent, 5 = To a great extent, 6 = To a very great extent, 7 = To a vast extent)
- Systems Thinking Scale (STS) [followed by its scale information in the Description] [ Time Frame: At baseline and 6 months ]
Use of systems thinking in the work place and the ability to recognize, understand, and synthesize interactions and interdependencies, including how actions and components can reinforce or counteract each other.
Scale: 1-5, in 1 point increments (1 = Never, 2 = Seldom, 3 = Some of the time, 4 = Often, 5 = Most of the time)
- Systems Thinking Codebook and Session Observations [followed by its scale information in the Description] [ Time Frame: Over 6 months ]
Observation of systems thinking in language/explanations, and performance demonstrating system thinking skills (competence) measured on four constructs: Complex, Feedback, Behavior, Time
Scale: Level 1-4 in 1 point increments (1 = Construct is demonstrated at most simple level, 4 = Construct is fully demonstrated at most complex level)
- Facilitator Fidelity to Intervention Guides and Theory of Change [ Time Frame: Over 6 months ]Review fidelity with qualitative checks against AF/PSD facilitator scripts for session learning objectives, 'key idea' and 'definitions,' including tracking the proportion of AF/PSD session activities (in minutes) on these components.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria Clinics:
- 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 Clinics:
- clinics with less than 12 months of data in 2018
- clinics already 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)

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): NCT04356274
United States, California | |
VA Palo Alto Health Care System | |
Palo Alto, California, United States, 94304 |
Principal Investigator: | Lindsey E Zimmerman, PhD | National Center for PTSD, Dissemination & Training Division |
Documents provided by Lindsey Zimmerman, Palo Alto Veterans Institute for Research:
Responsible Party: | Lindsey Zimmerman, Principal Investigator, Palo Alto Veterans Institute for Research |
ClinicalTrials.gov Identifier: | NCT04356274 |
Other Study ID Numbers: |
ZIM_0002 |
First Posted: | April 22, 2020 Key Record Dates |
Last Update Posted: | April 22, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
implementation science quality improvement participatory system dynamics audit and feedback |
evidence-based psychotherapy evidence-based pharmacotherapy addiction mental health/behavioral health |
Disease Alcoholism Behavior, Addictive Pathologic Processes Compulsive Behavior |
Impulsive Behavior Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |