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Using NIATx Strategies to Implement Integrated Services in Routine Care

Primary Purpose

Addiction, Mental Health Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coach Site Visit
Walk-through
Learning Sessions
Coaching
Business as Usual
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Addiction focused on measuring Implementation Strategies, Sustainability, Integrated Services

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Organizations who are licensed addiction treatment providers in the state of Washington were identified and provided the opportunity to participate in the study.

Eligibility criteria include:

  • outpatient and/or intensive outpatient services
  • tax-exempt, government status or at least 50% publicly funded (e.g., block grants, Medicare, Medicaid)
  • no prior participation in NIATx research studies (this last criterion excludes 39 agencies who were involved in the NIDA funded NIATx 200)

Exclusion Criteria:

  • Public mental health and private addiction treatment agencies are also excluded because only addiction treatment providers in Washington are required to use the state clinical information system, and therefore cannot provide the necessary standardized data

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    NIATx Strategy

    Wait List Control

    Arm Description

    The implementation "intervention", NIATx, will be deployed by the first cohort of programs in a 1-year active implementation phase. Each program is assigned an expert quality improvement coach. The coach will help the staff identify ways to improve and integrate services for individuals with co-occurring substance use and mental health disorders. Supports include an in-person coach site visit, coaching including monthly coaching calls and peer to peer coaching calls and learning sessions which promote peer-to-peer sharing about specific goals and objectives and to receive guidance on how to implement organizational level changes to improve integrated treatment services. A walk-through will allow the provider to understand the co-occurring treatment process from a customer perspective.

    The wait-list control group will receive the NIATx strategy at the end of the twelve month implementation period for the initial cohort. During the first year of the study, they will follow a business as usual approach to the integration of co-occurring substance use and mental health services.

    Outcomes

    Primary Outcome Measures

    Change in Dual Diagnosis Capability in Addiction Treatment (DDCAT index) scores
    DDCAT is a 35-item observational benchmark measure of program level dual diagnosis capability, evaluating policy, clinical practice and workforce dimensions of integrated services for persons with co-occurring disorders.
    Change in Penetration Rates: Gain Short Screen
    Examine changes in the proportion of program patients screened using the Gain Short Screener. Data for each time point will be collected 90 days before and 90 days after the DDCAT Assessment..
    Change in Penetration Rates: Patients receiving integrated medication and psychosocial services
    Assessing increased penetration of integrated services based on changes in the proportion of program patients screened, diagnosed and receiving integrated medication and psychosocial services. Data for each time point will be collected 90 days before and 90 days after the DDCAT Assessment.
    Change in the Addiction Severity Index (ASI)
    Changes in ASI scores for the Psychiatric, Drug and Alcohol composite scores assessed at admission and 30-days post follow-up. Data for each time point will be collected 90 days before and 90 days after the DDCAT Assessment.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2016
    Last Updated
    March 16, 2022
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    Washington State Department of Social and Health Services, National Institute on Drug Abuse (NIDA), Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03007940
    Brief Title
    Using NIATx Strategies to Implement Integrated Services in Routine Care
    Official Title
    Using NIATx Strategies to Implement Integrated Services in Routine Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 30, 2015 (Actual)
    Primary Completion Date
    May 30, 2020 (Actual)
    Study Completion Date
    May 30, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    Washington State Department of Social and Health Services, National Institute on Drug Abuse (NIDA), Stanford University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is an implementation research study designed to evaluate a defined strategy, NIATx, for its effectiveness in installing and sustaining evidence-based integrated services for persons with co-occurring substance use and mental health disorders. This study is a cluster randomized wait-list control group design, in which a cohort of 25 addiction treatment agencies receives the active NIATx approach during an index 12 month period. The second (wait-list) cohort of 25 addiction treatment agencies activates NIATx strategies during a second index 12 month period. The primary "subjects" of the research are the treatment agencies themselves. The study specific aims are: Relative to wait-list, to determine if NIATx strategies improve implementation outcomes (integrated service fidelity and receipt of more integrated services) Relative to wait-list, to determine if NIATx strategies improve patient care outcomes (psychiatric, alcohol and drug problem severity) Across entire sample, to evaluate variation in the extent of and fidelity to NIATx strategies NIATx implementation strategies consist of learning sessions, individualized coaching and peer to peer sharing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Addiction, Mental Health Disorder
    Keywords
    Implementation Strategies, Sustainability, Integrated Services

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NIATx Strategy
    Arm Type
    Experimental
    Arm Description
    The implementation "intervention", NIATx, will be deployed by the first cohort of programs in a 1-year active implementation phase. Each program is assigned an expert quality improvement coach. The coach will help the staff identify ways to improve and integrate services for individuals with co-occurring substance use and mental health disorders. Supports include an in-person coach site visit, coaching including monthly coaching calls and peer to peer coaching calls and learning sessions which promote peer-to-peer sharing about specific goals and objectives and to receive guidance on how to implement organizational level changes to improve integrated treatment services. A walk-through will allow the provider to understand the co-occurring treatment process from a customer perspective.
    Arm Title
    Wait List Control
    Arm Type
    Placebo Comparator
    Arm Description
    The wait-list control group will receive the NIATx strategy at the end of the twelve month implementation period for the initial cohort. During the first year of the study, they will follow a business as usual approach to the integration of co-occurring substance use and mental health services.
    Intervention Type
    Other
    Intervention Name(s)
    Coach Site Visit
    Intervention Description
    The coach will conduct a one-day on site visit and will review the walk-through and DDCAT assessment results, and help the change team design an initial change project with Plan-Do-Study-Act (PDSA) cycles. The site visit will use a standardized agenda to ensure NIATx fidelity.
    Intervention Type
    Other
    Intervention Name(s)
    Walk-through
    Intervention Description
    Walk-Through: Provider change teams will participate in a coach-led webinar that introduces how to conduct a NIATx walk-through from the co-occurring patient perspective and how to write up results using a standard report format. The walk-through will be conducted within two months of the initial coach site visit.
    Intervention Type
    Other
    Intervention Name(s)
    Learning Sessions
    Intervention Description
    The study includes two one-day coach-led learning sessions. The learning sessions promote peer-to-peer sharing about specific goals and objectives. The agenda is tailored to specific treatment service integration issues. The first coach-led learning session teaches providers how to use NIATx process improvement strategies. Providers share walk-through results and initial change projects. Skill development activities include how to: identify change opportunities, use specific tools (e.g., flowcharting), develop PDSA cycles, effectively use data and learning successful change strategies. At the final session, providers present results, sustainment plans, and identify ways for the group to continue to interact.
    Intervention Type
    Other
    Intervention Name(s)
    Coaching
    Intervention Description
    A NIATx coach leads the active 12 month implementation phase. The coach works with executive directors, change leaders and teams. After the site visit, a coach will hold individual monthly coaching calls (10 hours in total), and participate in group coaching calls (2 hours in total). In the individual calls, the coach and change team review change projects; discuss successes; and identify ideas for future change projects. Group coaching calls involve change leaders from multiple providers. On these calls, change leaders will discuss common change-related issues, progress, and exchange innovative implementation strategies with their peers. These calls provide opportunities for the coach to share new strategies and discuss implementation issues such as the development of a sustain plan.
    Intervention Type
    Other
    Intervention Name(s)
    Business as Usual
    Intervention Description
    Programs in this intervention will continue with their own plans without coaching support to integrate services for individuals with co-occurring substance abuse and mental health disorders. Once the programs in the wait-list control group receive the NIATx Strategy, they will participate in all of the interventions listed above.
    Primary Outcome Measure Information:
    Title
    Change in Dual Diagnosis Capability in Addiction Treatment (DDCAT index) scores
    Description
    DDCAT is a 35-item observational benchmark measure of program level dual diagnosis capability, evaluating policy, clinical practice and workforce dimensions of integrated services for persons with co-occurring disorders.
    Time Frame
    Collected at baseline, 12 months, 24 months and 36 months
    Title
    Change in Penetration Rates: Gain Short Screen
    Description
    Examine changes in the proportion of program patients screened using the Gain Short Screener. Data for each time point will be collected 90 days before and 90 days after the DDCAT Assessment..
    Time Frame
    Collected at baseline, 12 months, 24 months and 36 months
    Title
    Change in Penetration Rates: Patients receiving integrated medication and psychosocial services
    Description
    Assessing increased penetration of integrated services based on changes in the proportion of program patients screened, diagnosed and receiving integrated medication and psychosocial services. Data for each time point will be collected 90 days before and 90 days after the DDCAT Assessment.
    Time Frame
    Collected at baseline, 12 months, 24 months and 36 months
    Title
    Change in the Addiction Severity Index (ASI)
    Description
    Changes in ASI scores for the Psychiatric, Drug and Alcohol composite scores assessed at admission and 30-days post follow-up. Data for each time point will be collected 90 days before and 90 days after the DDCAT Assessment.
    Time Frame
    Collected at baseline, 12 months, 24 months and 36 months
    Other Pre-specified Outcome Measures:
    Title
    Consolidated Framework for Implementation Research Index
    Description
    Assess change in Outer Setting, Inner Setting, Characteristics of the Intervention and the Individual Scores as rated by DDCAT Assessor
    Time Frame
    Collected at baseline, 12 months, 24 months and 36 months
    Title
    NIATx Stages of Implementation Completion
    Description
    Assess provider stages of completion related to NIATx intervention based on proportion of activities completed and duration of activities.
    Time Frame
    Collected during 12 month intervention period
    Title
    NIATx Fidelity
    Description
    Assess fidelity to the NIATx implementation strategies
    Time Frame
    Collected during 12 month intervention period

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Organizations who are licensed addiction treatment providers in the state of Washington were identified and provided the opportunity to participate in the study. Eligibility criteria include: outpatient and/or intensive outpatient services tax-exempt, government status or at least 50% publicly funded (e.g., block grants, Medicare, Medicaid) no prior participation in NIATx research studies (this last criterion excludes 39 agencies who were involved in the NIDA funded NIATx 200) Exclusion Criteria: Public mental health and private addiction treatment agencies are also excluded because only addiction treatment providers in Washington are required to use the state clinical information system, and therefore cannot provide the necessary standardized data

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29884164
    Citation
    Ford JH 2nd, Osborne EL, Assefa MT, McIlvaine AM, King AM, Campbell K, McGovern MP. Using NIATx strategies to implement integrated services in routine care: a study protocol. BMC Health Serv Res. 2018 Jun 8;18(1):431. doi: 10.1186/s12913-018-3241-4.
    Results Reference
    background
    PubMed Identifier
    34346729
    Citation
    Chokron Garneau H, Assefa MT, Jo B, Ford JH 2nd, Saldana L, McGovern MP. Sustainment of Integrated Care in Addiction Treatment Settings: Primary Outcomes From a Cluster-Randomized Controlled Trial. Psychiatr Serv. 2022 Mar 1;73(3):280-286. doi: 10.1176/appi.ps.202000293. Epub 2021 Aug 4.
    Results Reference
    result
    PubMed Identifier
    31651302
    Citation
    Assefa MT, Ford JH 2nd, Osborne E, McIlvaine A, King A, Campbell K, Jo B, McGovern MP. Implementing integrated services in routine behavioral health care: primary outcomes from a cluster randomized controlled trial. BMC Health Serv Res. 2019 Oct 24;19(1):749. doi: 10.1186/s12913-019-4624-x.
    Results Reference
    result
    PubMed Identifier
    34988462
    Citation
    Ford JH 2nd, Kaur A, Rao D, Gilson A, Bolt DM, Garneau HC, Saldana L, McGovern MP. Improving Medication Access within Integrated Treatment for Individuals with Co-Occurring Disorders in Substance Use Treatment Agencies. Implement Res Pract. 2021 Jan 1;2:26334895211033659. doi: 10.1177/26334895211033659. Epub 2021 Sep 17.
    Results Reference
    result

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