Using NIATx Strategies to Implement Integrated Services in Routine Care

Addiction Clinical Trial

Official title:

Using NIATx Strategies to Implement Integrated Services in Routine Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007940
• Other study ID #: 2016-0438
• Secondary ID: R01DA0372222016-
• Status: Completed
• Phase: N/A
• Start date: September 30, 2015
• Est. completion date: May 30, 2021

Study information

• Verified date: March 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Mental Disorders
• Mental Health Disorder

Intervention

Other:
• Coach 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.
• Walk-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.
• Learning 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.
• Coaching
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.
• Business 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Drug Abuse (NIDA), Stanford University, Washington State Department of Social and Health Services

References & Publications (4)

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): — View 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/ap — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Collected at baseline, 12 months, 24 months and 36 months
Other	NIATx Stages of Implementation Completion	Assess provider stages of completion related to NIATx intervention based on proportion of activities completed and duration of activities.	Collected during 12 month intervention period
Other	NIATx Fidelity	Assess fidelity to the NIATx implementation strategies	Collected during 12 month intervention period
Primary	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.	Collected at baseline, 12 months, 24 months and 36 months
Primary	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..	Collected at baseline, 12 months, 24 months and 36 months
Primary	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.	Collected at baseline, 12 months, 24 months and 36 months
Primary	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.	Collected at baseline, 12 months, 24 months and 36 months