AddictionNCT03007940
Using NIATx Strategies to Implement Integrated Services in Routine Care
A study testing Coach Site Visit, Walk-through and Learning Sessions in people with Addiction and Mental Health Disorder, run by University of Wisconsin, Madison.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Addiction, Mental Health Disorder
- What is being tested?
- Coach Site Visit, Walk-through and Learning Sessions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2015to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
- Conditions
- Addiction, Mental Health Disorder
- Being tested
- Coach Site Visit, Walk-through, Learning Sessions, Coaching, Business as Usual
- Keywords
- Implementation Strategies, Sustainability, Integrated Services
- Medical subject headings
- Behavior, Addictive, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coach Site VisitOther
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-throughOther
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 SessionsOther
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.
CoachingOther
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 UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NIATx Strategy | Experimental | 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. Receives: Other: Coach Site Visit; Other: Walk-through; Other: Learning Sessions; Other: Coaching |
| Wait List Control | Placebo comparator | 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. Receives: Other: Business as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Collected at baseline, 12 months, 24 months and 36 months
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..
Measured: Collected at baseline, 12 months, 24 months and 36 months
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.
Measured: Collected at baseline, 12 months, 24 months and 36 months
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.
Measured: Collected at baseline, 12 months, 24 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start30 Sep 2015
- Primary completion30 May 2020
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State Department of Social and Health Services, National Institute on Drug Abuse (NIDA), Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007940
- Sponsor's protocol ID
- 2016-0438
- Other IDs
- R01DA037222, 2016-0438, STUDY00029387
- Status last verified
- Mar 2022
- First submitted
- 19 Dec 2016
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 29884164Chokron 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 34346729Assefa 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 31651302Ford 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 34988462Ford JH 2nd, Zehner ME, Schaper H, Saldana L. Adapting the stages of implementation completion to an evidence-based implementation strategy: The development of the NIATx stages of implementation completion. Implement Res Pract. 2023 Sep 19;4:26334895231200379. doi: 10.1177/26334895231200379. eCollection 2023 Jan-Dec.
PubMed 37790170
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using NIATx Strategies to Implement Integrated Services in Routine Care
- ClinicalTrials.gov ID
- NCT03007940
- Acronym / sponsor ID
- 2016-0438
- Conditions
- Addiction, Mental Health Disorder
- Keywords
- Implementation Strategies, Sustainability, Integrated Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Washington State Department of Social and Health Services, National Institute on Drug Abuse (NIDA), Stanford University
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIATx Strategy | Experimental | Other: Coach Site Visit, Other: Walk-through, Other: Learning Sessions, Other: CoachingThe 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. |
| Wait List Control | Placebo comparator | Other: Business as UsualThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Organizations who are licensed addiction treatment providers in the state of Washington were identified and provided the opportunity to participate in the study.
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coach Site VisitThe 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. | Other | NIATx Strategy |
| Walk-throughWalk-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. | Other | NIATx Strategy |
| Learning SessionsThe 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. | Other | NIATx Strategy |
| CoachingA 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. | Other | NIATx Strategy |
| Business as UsualPrograms 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. | Other | Wait List Control |
Primary outcome
Change in Dual Diagnosis Capability in Addiction Treatment (DDCAT index) scores
Time frame: Collected at baseline, 12 months, 24 months and 36 months
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
Time frame: Collected at baseline, 12 months, 24 months and 36 months
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
Time frame: Collected at baseline, 12 months, 24 months and 36 months
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)
Time frame: Collected at baseline, 12 months, 24 months and 36 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 29884164Ford 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 publication: PubMed 34346729Chokron 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 publication: PubMed 31651302Assefa 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 publication: PubMed 34988462Ford 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.
- Derived from this study: PubMed 37790170Ford JH 2nd, Zehner ME, Schaper H, Saldana L. Adapting the stages of implementation completion to an evidence-based implementation strategy: The development of the NIATx stages of implementation completion. Implement Res Pract. 2023 Sep 19;4:26334895231200379. doi: 10.1177/26334895231200379. eCollection 2023 Jan-Dec.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Coach Site Visit, Walk-through and Learning Sessions in people with Addiction and Mental Health Disorder, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dual Diagnosis Capability in Addiction Treatment (DDCAT index) scores (time frame: Collected at baseline, 12 months, 24 months and 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007940, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.