CClinicalTrials.gg
CompletedNCT03007940Updated Mar 31, 2022

Using NIATx Strategies to Implement Integrated Services in Routine Care

An interventional study of Coach Site Visit and Walk-through in Addiction and Mental Health Disorder, sponsored by University of Wisconsin, Madison. Completed. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Sep 2015, registered Dec 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Sex
All
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Study 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:

  1. Relative to wait-list, to determine if NIATx strategies improve implementation outcomes (integrated service fidelity and receipt of more integrated services)
  2. Relative to wait-list, to determine if NIATx strategies improve patient care outcomes (psychiatric, alcohol and drug problem severity)
  3. 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.

02

Conditions studied

  • Addiction
  • Mental Health Disorder

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Keywords

  • Implementation Strategies
  • Sustainability
  • Integrated Services
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 49 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    NIATx Strategy

    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.

    Other: Coach Site Visit · Other: Walk-through · Other: Learning Sessions · Other: Coaching

  • Placebo comparator
    Wait List Control

    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.

    Other: Business as Usual

Interventions

  • OtherCoach Site Visit

    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.

  • OtherWalk-through

    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.

  • OtherLearning Sessions

    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.

  • OtherCoaching

    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.

  • OtherBusiness as Usual

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Collected at baseline, 12 months, 24 months and 36 months

  2. 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..

    Time frame: Collected at baseline, 12 months, 24 months and 36 months

  3. 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.

    Time frame: Collected at baseline, 12 months, 24 months and 36 months

  4. 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.

    Time frame: Collected at baseline, 12 months, 24 months and 36 months

Other outcomes

  1. Consolidated Framework for Implementation Research Index

    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

  2. NIATx Stages of Implementation Completion

    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

  3. NIATx Fidelity

    Assess fidelity to the NIATx implementation strategies

    Time frame: Collected during 12 month intervention period

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29884164 ↗
  • 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. PubMed 34346729 ↗
  • 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. PubMed 31651302 ↗
  • 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. PubMed 34988462 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03007940
Lead sponsor
University of Wisconsin, Madison
Collaborators
Washington State Department of Social and Health Services, National Institute on Drug Abuse (NIDA), Stanford University
Responsible party
Sponsor
First posted
Jan 2, 2017
Start date
Sep 30, 2015
Primary completion
May 30, 2020
Completion
May 30, 2021
Last update
Mar 31, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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