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

Primary Purpose

PTSD, Depression, Alcohol Use Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Participatory System Dynamics (PSD)
Audit and Feedback (AF)
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for PTSD focused on measuring implementation science, quality improvement, participatory system dynamics, audit and feedback, evidence-based psychotherapy, evidence-based pharmacotherapy, addiction, mental health/behavioral health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participatory System Dynamics (PSD)

Audit and Feedback (AF)

Arm Description

12 clinics assigned to PSD

12 clinics assigned to AF

Outcomes

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
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
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
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).

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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.
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.

Full Information

First Posted
March 8, 2019
Last Updated
August 3, 2021
Sponsor
Palo Alto Veterans Institute for Research
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1. Study Identification

Unique Protocol Identification Number
NCT04356274
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participatory System Dynamics (PSD)
Arm Type
Experimental
Arm Description
12 clinics assigned to PSD
Arm Title
Audit and Feedback (AF)
Arm Type
Experimental
Arm Description
12 clinics assigned to AF
Intervention Type
Other
Intervention Name(s)
Participatory System Dynamics (PSD)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Audit and Feedback (AF)
Intervention Description
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 Measure Information:
Title
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
Description
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).
Time Frame
Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
Title
Proportion of completed evidence-based practice templates during sessions with a relevant CPT code
Description
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).
Time Frame
Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
Title
Proportion of combination of prescriptions placed with the VA pharmacy and sessions with a relevant CPT code
Description
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).
Time Frame
Pre-/Post- 12-month period average of evidence-based practice reach (24 months total observation)
Secondary Outcome Measure Information:
Title
Degree of acceptability of intervention assessed by the Acceptability of Intervention Measure (AIM) [followed by its scale information in the Description]
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)
Time Frame
At 6 months
Title
Degree of appropriateness of intervention assessed by the Intervention Appropriateness Measure (IAM) [followed by its scale information in the Description]
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)
Time Frame
At 6 months
Title
Degree of feasibility of intervention assessed by the Feasibility of Intervention Measure (FIM) [followed by its scale information in the Description]
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)
Time Frame
At 6 months
Title
Patient Aligned Care team Burnout Measure (PACT) [followed by its scale information in the Description]
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)
Time Frame
At baseline and 6 months
Title
Learning Organization Survey (LOS-27) [followed by its scale information in the Description]
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)
Time Frame
At baseline and 6 months
Title
Team Decision Making Questionnaire (TDMQ) [followed by its scale information in the Description]
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)
Time Frame
At 6 months
Title
Systems Thinking Scale (STS) [followed by its scale information in the Description]
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)
Time Frame
At baseline and 6 months
Title
Systems Thinking Codebook and Session Observations [followed by its scale information in the Description]
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)
Time Frame
Over 6 months
Title
Facilitator Fidelity to Intervention Guides and Theory of Change
Description
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.
Time Frame
Over 6 months
Title
Demographic Measures
Description
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.
Time Frame
At baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey E Zimmerman, PhD
Organizational Affiliation
National Center for PTSD, Dissemination & Training Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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