Local Participatory Systems Dynamics to Increase Reach of Evidence Based Addiction and Mental Health Care

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 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)]
• 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)]
• 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)]

Secondary outcome measures (10)

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• VA Palo Alto Health Care System — Palo Alto

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. PMID 23475498
• Hermes 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. PMID 24733559
• Mott 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. PMID 25471067
• Hankin 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. PMID 10588406
• Hoggatt 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. PMID 25661517
• Fulton 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. PMID 25768399
• Karlin 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. PMID 24001035
• Karlin 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. PMID 22823859

Identifiers

NCT: NCT04356274 · ZIM_0002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗