PTSDNCT04356274
Local Participatory Systems Dynamics to Increase Reach of Evidence Based Addiction and Mental Health Care
A study testing Participatory System Dynamics (PSD) and Audit and Feedback (AF) in people with PTSD and Depression, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The most common reasons Veterans seek VA addiction and mental health care is for help with opioid and alcohol misuse, depression and PTSD. Research evidence has established highly effective treatments that prevent relapse, overdose and suicide, but even with policy mandates, performance metrics, and electronic health… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD, Depression, Alcohol Use Disorder
- What is being tested?
- Participatory System Dynamics (PSD) and Audit and Feedback (AF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 29 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
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
The most common reasons Veterans seek VA addiction and mental health care is for help with opioid and alcohol misuse, depression and PTSD. Research evidence has established highly effective treatments that prevent relapse, overdose and suicide, but even with policy mandates, performance metrics, and electronic health records to fix the problem, these treatments may only reach 3-28% of patients. This study tests participatory business engineering methods (Participatory System Dynamics) that engage patients, providers and policy makers against the status quo approaches, such as data review, and will determine if participatory system dynamics works, why it works, and whether it can be applied in many health care settings to guarantee patient access to the highest quality care and better meet the addiction and mental health needs of Veterans and the U.S. population.
Read the detailed description
The broad aim is to empower all healthcare stakeholders to provide the highest quality care to all patients. The specific aims address the complexities and tradeoffs associated with implementing evidence-based practices (EBPs) in outpatient addiction and mental health systems. There is scientific consensus about the best evidence-based psychotherapies and pharmacotherapies (EBPs) to meet the needs of patients with opioid and alcohol use disorder, PTSD and depression. However, EBP coordination over time, within and across multidisciplinary teams of providers, is complex and constantly changing. Veterans Health Administration (VA) policy mandates, national training programs, and incentivized quality measures, have been insufficient for reaching more than 3 to 28% of patients with the highest quality treatments. In fact, limited EBP reach is common in health systems and the field of implementation science seeks to address it. One routine strategy is data auditing with provider feedback (audit-and-feedback; AF), however, the impact is highly variable. As an alternative, participatory system dynamics (PSD) has been used to explain causes of complex problems in business management for 60 years. Partnering with frontline staff using PSD to determine how EBP reach emerges from local resources and constraints, and is determined by system dynamics, such as delays and feedback. The dynamics of EBP reach were formally specified in differential equation models, and tested against VA data drawn from a national VA SQL database. Using existing enterprise data to tailor model parameters to each care team. PSD models were made accessible via a 'Modeling to Learn' interface and training, during which teams safely evaluated local change scenarios via simulation to find the highest yield options for meeting Veterans' needs. PSD learning simulations produce immediate, real-time feedback to the teams who coordinate care, improving day-to-day decisions and long-term improvement plans. The study design is a two-arm, 24-site (12 sites/arm) cluster randomized trial to test the effectiveness of PSD simulation as compared to more standard team AF data review. The hypothesis is that PSD will be superior to AF for improving EBP initiation and dose (Aim 1). The investigators will test the PSD theory of change that the effect of PSD on improved EBP reach is explained by improvement in team systems thinking (Aim 2). To confirm the potential for widespread usefulness of PSD, by also testing the generalizability of PSD causal dynamics across PSD and AF arms (Aim 3). This study has the potential to inform a new paradigm, by determining what works to improve health system quality defined as EBP reach, why it works, and under what conditions. If PSD is effective, study activities will address a national priority to improve Veterans' addiction and mental health care to prevent chronic symptoms, relapse, suicide and overdose. Findings from the proposed tests of effectiveness, causality, and generality, could also catalyze future applications to make a significant public health impact across the continuum of healthcare.
- Conditions
- PTSD, Depression, Alcohol Use Disorder, Opioid Use Disorder
- Being tested
- Participatory System Dynamics (PSD), Audit and Feedback (AF)
- Keywords
- implementation science, quality improvement, participatory system dynamics, audit and feedback, evidence-based psychotherapy, evidence-based pharmacotherapy, addiction, mental health/behavioral health
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Alcoholism, Opioid-Related Disorders, Behavior, Addictive, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory System Dynamics (PSD)Other
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 (AF)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Participatory System Dynamics (PSD) | Experimental | 12 clinics assigned to PSD Receives: Other: Participatory System Dynamics (PSD) |
| Audit and Feedback (AF) | Experimental | 12 clinics assigned to AF Receives: Other: Audit and Feedback (AF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
Proportion of completed evidence-based practice templates during sessions with a relevant CPT code
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).
Measured: Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
Proportion of combination of prescriptions placed with the VA pharmacy and sessions with a relevant CPT code
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).
Measured: Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
Secondary outcomes (10)
Degree of acceptability of intervention assessed by the Acceptability of Intervention Measure (AIM) [followed by its scale information in the Description]
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)
Measured: At 6 months
Degree of appropriateness of intervention assessed by the Intervention Appropriateness Measure (IAM) [followed by its scale information in the Description]
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)
Measured: At 6 months
Degree of feasibility of intervention assessed by the Feasibility of Intervention Measure (FIM) [followed by its scale information in the Description]
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)
Measured: At 6 months
Patient Aligned Care team Burnout Measure (PACT) [followed by its scale information in the Description]
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)
Measured: At baseline and 6 months
Learning Organization Survey (LOS-27) [followed by its scale information in the Description]
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)
Measured: At baseline and 6 months
Team Decision Making Questionnaire (TDMQ) [followed by its scale information in the Description]
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)
Measured: At 6 months
Systems Thinking Scale (STS) [followed by its scale information in the Description]
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)
Measured: At baseline and 6 months
Systems Thinking Codebook and Session Observations [followed by its scale information in the Description]
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)
Measured: Over 6 months
Facilitator Fidelity to Intervention Guides and Theory of Change
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.
Measured: Over 6 months
Demographic Measures
4 item measure assessing ethnic (Hispanic, Latino, Latina, or Latinx), racial (American Indian/Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, White, More than One Race) and gender (Man, Woman, Non-binary) identity of respondent.
All items include a "Prefer not to say" option. Categories for demographic measures determined based on NIH reporting standards.
Measured: At baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Feb 2019
- Primary completion31 Jul 2026 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (188)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsey Zimmerman, Palo Alto Veterans Institute for Research
- Investigators
- Lindsey E Zimmerman, PhD, Principal investigator, National Center for PTSD, Dissemination & Training Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356274
- Sponsor's protocol ID
- ZIM_0002
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2019
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elbogen EB, Wagner HR, Johnson SC, Kinneer P, Kang H, Vasterling JJ, Timko C, Beckham JC. Are Iraq and Afghanistan veterans using mental health services? New data from a national random-sample survey. Psychiatr Serv. 2013 Feb 1;64(2):134-41. doi: 10.1176/appi.ps.004792011.
PubMed 23475498Hermes ED, Hoff R, Rosenheck RA. Sources of the increasing number of Vietnam era veterans with a diagnosis of PTSD using VHA services. Psychiatr Serv. 2014 Jun 1;65(6):830-2. doi: 10.1176/appi.ps.201300232.
PubMed 24733559Mott JM, Grubbs KM, Sansgiry S, Fortney JC, Cully JA. Psychotherapy Utilization Among Rural and Urban Veterans From 2007 to 2010. J Rural Health. 2015 Summer;31(3):235-43. doi: 10.1111/jrh.12099. Epub 2014 Dec 3.
PubMed 25471067Hankin CS, Spiro A 3rd, Miller DR, Kazis L. Mental disorders and mental health treatment among U.S. Department of Veterans Affairs outpatients: the Veterans Health Study. Am J Psychiatry. 1999 Dec;156(12):1924-30. doi: 10.1176/ajp.156.12.1924.
PubMed 10588406Hoggatt KJ, Williams EC, Der-Martirosian C, Yano EM, Washington DL. National prevalence and correlates of alcohol misuse in women veterans. J Subst Abuse Treat. 2015 May;52:10-6. doi: 10.1016/j.jsat.2014.12.003. Epub 2014 Dec 19.
PubMed 25661517Fulton JJ, Calhoun PS, Wagner HR, Schry AR, Hair LP, Feeling N, Elbogen E, Beckham JC. The prevalence of posttraumatic stress disorder in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans: a meta-analysis. J Anxiety Disord. 2015 Apr;31:98-107. doi: 10.1016/j.janxdis.2015.02.003. Epub 2015 Feb 19.
PubMed 25768399Karlin BE, Cross G. From the laboratory to the therapy room: National dissemination and implementation of evidence-based psychotherapies in the U.S. Department of Veterans Affairs Health Care System. Am Psychol. 2014 Jan;69(1):19-33. doi: 10.1037/a0033888. Epub 2013 Sep 2.
PubMed 24001035Karlin BE, Brown GK, Trockel M, Cunning D, Zeiss AM, Taylor CB. National dissemination of cognitive behavioral therapy for depression in the Department of Veterans Affairs health care system: therapist and patient-level outcomes. J Consult Clin Psychol. 2012 Oct;80(5):707-18. doi: 10.1037/a0029328. Epub 2012 Jul 23.
PubMed 22823859Ruzek JI, Karlin BE, & Zeiss AM. Implementation of Evidence-Based Psychological Treatments in the Veterans Health Administration. In: McHugh RK, Barlow DH, eds. Dissemination of evidence-based psychological treatments. New York, NY: Oxford University Press. , 2012.
Eftekhari A, Ruzek JI, Crowley JJ, Rosen CS, Greenbaum MA, Karlin BE. Effectiveness of national implementation of prolonged exposure therapy in Veterans Affairs care. JAMA Psychiatry. 2013 Sep;70(9):949-55. doi: 10.1001/jamapsychiatry.2013.36.
PubMed 23863892Watts BV, Shiner B, Zubkoff L, Carpenter-Song E, Ronconi JM, Coldwell CM. Implementation of evidence-based psychotherapies for posttraumatic stress disorder in VA specialty clinics. Psychiatr Serv. 2014 May 1;65(5):648-53. doi: 10.1176/appi.ps.201300176.
PubMed 24430622Department of Defense, & Department of Veterans Affairs. The management of MDD Working Group. VA/DOD clinical practice guideline for management of major depressive disorder (MDD). , 2009.
Department of Veterans Affairs, & Department of Defense. VA/DoD Clinical practice guideline for the management of post-traumatic stress. , 2010.
Department of Veterans Affairs, & Department of Defense. VA/DoD Clinical practice guideline for the management of substance use disorders. , 2009.
Lemke S, Boden MT, Kearney LK, Krahn DD, Neuman MJ, Schmidt EM, Trafton JA. Measurement-based management of mental health quality and access in VHA: SAIL mental health domain. Psychol Serv. 2017 Feb;14(1):1-12. doi: 10.1037/ser0000097.
PubMed 28134552
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04356274
- Acronym / sponsor ID
- ZIM_0002
- Conditions
- PTSD, Depression, Alcohol Use Disorder, Opioid Use Disorder
- Keywords
- implementation science, quality improvement, participatory system dynamics, audit and feedback, evidence-based psychotherapy, evidence-based pharmacotherapy, addiction, mental health/behavioral health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The most common reasons Veterans seek VA addiction and mental health care is for help with opioid and alcohol misuse, depression and PTSD. Research evidence has established highly effective treatments that prevent relapse, overdose and suicide, but even with policy mandates, performance metrics, and electronic health records to fix the problem, these treatments may only reach 3-28% of patients. This study tests participatory business engineering methods (Participatory System Dynamics) that engage patients, providers and policy makers against the status quo approaches, such as data review, and will determine if participatory system dynamics works, why it works, and whether it can be applied in many health care settings to guarantee patient access to the highest quality care and better meet the addiction and mental health needs of Veterans and the U.S. population.
Detailed description
The broad aim is to empower all healthcare stakeholders to provide the highest quality care to all patients. The specific aims address the complexities and tradeoffs associated with implementing evidence-based practices (EBPs) in outpatient addiction and mental health systems. There is scientific consensus about the best evidence-based psychotherapies and pharmacotherapies (EBPs) to meet the needs of patients with opioid and alcohol use disorder, PTSD and depression. However, EBP coordination over time, within and across multidisciplinary teams of providers, is complex and constantly changing. Veterans Health Administration (VA) policy mandates, national training programs, and incentivized quality measures, have been insufficient for reaching more than 3 to 28% of patients with the highest quality treatments. In fact, limited EBP reach is common in health systems and the field of implementation science seeks to address it. One routine strategy is data auditing with provider feedback (audit-and-feedback; AF), however, the impact is highly variable. As an alternative, participatory system dynamics (PSD) has been used to explain causes of complex problems in business management for 60 years. Partnering with frontline staff using PSD to determine how EBP reach emerges from local resources and constraints, and is determined by system dynamics, such as delays and feedback. The dynamics of EBP reach were formally specified in differential equation models, and tested against VA data drawn from a national VA SQL database. Using existing enterprise data to tailor model parameters to each care team. PSD models were made accessible via a 'Modeling to Learn' interface and training, during which teams safely evaluated local change scenarios via simulation to find the highest yield options for meeting Veterans' needs. PSD learning simulations produce immediate, real-time feedback to the teams who coordinate care, improving day-to-day decisions and long-term improvement plans. The study design is a two-arm, 24-site (12 sites/arm) cluster randomized trial to test the effectiveness of PSD simulation as compared to more standard team AF data review. The hypothesis is that PSD will be superior to AF for improving EBP initiation and dose (Aim 1). The investigators will test the PSD theory of change that the effect of PSD on improved EBP reach is explained by improvement in team systems thinking (Aim 2). To confirm the potential for widespread usefulness of PSD, by also testing the generalizability of PSD causal dynamics across PSD and AF arms (Aim 3). This study has the potential to inform a new paradigm, by determining what works to improve health system quality defined as EBP reach, why it works, and under what conditions. If PSD is effective, study activities will address a national priority to improve Veterans' addiction and mental health care to prevent chronic symptoms, relapse, suicide and overdose. Findings from the proposed tests of effectiveness, causality, and generality, could also catalyze future applications to make a significant public health impact across the continuum of healthcare.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participatory System Dynamics (PSD) | Experimental | Other: Participatory System Dynamics (PSD)12 clinics assigned to PSD |
| Audit and Feedback (AF) | Experimental | Other: Audit and Feedback (AF)12 clinics assigned to AF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Participatory System Dynamics (PSD) |
| 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. | Other | Audit and Feedback (AF) |
Primary outcome
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).
10 secondary outcomes
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
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
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
Patient Aligned Care team Burnout Measure (PACT) [followed by its scale information in the Description]
Time frame: At baseline and 6 months
Learning Organization Survey (LOS-27) [followed by its scale information in the Description]
Time frame: At baseline and 6 months
Team Decision Making Questionnaire (TDMQ) [followed by its scale information in the Description]
Time frame: At 6 months
Systems Thinking Scale (STS) [followed by its scale information in the Description]
Time frame: At baseline and 6 months
Systems Thinking Codebook and Session Observations [followed by its scale information in the Description]
Time frame: Over 6 months
Facilitator Fidelity to Intervention Guides and Theory of Change
Time frame: Over 6 months
Demographic Measures
Time frame: At baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 23475498Elbogen EB, Wagner HR, Johnson SC, Kinneer P, Kang H, Vasterling JJ, Timko C, Beckham JC. Are Iraq and Afghanistan veterans using mental health services? New data from a national random-sample survey. Psychiatr Serv. 2013 Feb 1;64(2):134-41. doi: 10.1176/appi.ps.004792011.
- Background: PubMed 24733559Hermes ED, Hoff R, Rosenheck RA. Sources of the increasing number of Vietnam era veterans with a diagnosis of PTSD using VHA services. Psychiatr Serv. 2014 Jun 1;65(6):830-2. doi: 10.1176/appi.ps.201300232.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsey E Zimmerman, PhD principal investigator
National Center for PTSD, Dissemination & Training Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory System Dynamics (PSD) and Audit and Feedback (AF) in people with PTSD and Depression, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04356274, which also lists 188 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.