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AddictionPhase 3NIATx 200NCT00934141

Evaluating Improvement Strategies in Addiction Treatment

A Phase 3 study testing Learning Session, Interest Circle Calls and Coaching in people with Addiction, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Addiction treatment is often characterized by long delays between first contact and treatment as well as high no-show and drop out rates leading to unused capacity in apparently full agencies. Patients do not get needed care and agency financial stability is threatened. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Addiction
What is being tested?
Learning Session, Interest Circle Calls and Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
1 siteUnited States
Study dates
Oct 2006to Jan 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • at least 60 admissions/year
  • provide outpatient and intensive outpatient levels of care (as defined by ASAM)
  • provide or use detox services provided by others
  • have tax-exempt or government status or rely on public funding (e.g., block grants, Medicare, Medicaid, local government, private philanthropy) for at least 50% of their budget
  • have adopted no more than two of the planned interventions

Who cannot join

  • are current NIATx members

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisonsin-Madison

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: Randomized Control Trial (RCT) Evaluating Improvement Strategies in Addiction Treatment

Addiction treatment is often characterized by long delays between first contact and treatment as well as high no-show and drop out rates leading to unused capacity in apparently full agencies. Patients do not get needed care and agency financial stability is threatened. The Network for Improvement of Addiction Treatment (NIATx) began as a high-intensity improvement collaborative of 39 addiction treatment agencies distributed across 25 states. NIATx substantially improved time to treatment and continuation in treatment by making improvements to organizational processes (such as first contact, intake and assessment, engagement, level of care transitions, paperwork, social support, outreach, and scheduling) in preliminary studies. While the results are very encouraging, they have, by intent, been obtained from a select group of agencies using a high-cost combination of services. A more practical diffusion model is needed to spread process improvements across the spectrum of treatment agencies. This study is a cluster-randomized trial to test the effectiveness and cost of less expensive combinations of the services that make up the NIATx collaborative (interest circles, coach calls, coach visits and learning sessions).

Read the detailed description

This cluster-RCT randomly assign 201 treatment agencies in 5 states to four experimental arms. The agencies were randomized to an intervention for 18 months with a 9 month sustainability period. The study aimed to: 1) Determine whether a state-based strategy can (with NIATx support) can lead mainstream treatment agencies to implement and sustain process changes that improve the study's primary outcomes: time to treatment, annual clinic admissions, and continuation in treatment; and 2) Evaluate the effectiveness and cost of the services making up NIATx. This study aims to create a practical model for improving efficiency and effectiveness of addiction treatment.

Conditions
Addiction
Being tested
Learning Session, Interest Circle Calls, Coaching, Website
Keywords
Organizational change, process improvement, addiction treatment, cost effectiveness study
Medical subject headings
Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Learning SessionOther

    Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.

  • Interest Circle CallsOther

    Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach

  • CoachingOther

    Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.

  • WebsiteOther

    The NIATx Web site features resources central to improvement. The site includes: 1) a catalog of change ideas and case studies; 2) a toolbox providing just-in-time training on topics such as conducting a walk-through and key innovations; 3) on-line tools to assess organizational (or project) readiness for and ability to sustain change; 4) electronic communication services to ask questions of experts, and participate in peer discussion groups; 5) links to relevant process improvement Web sites; and 6) a secure portion for treatment agencies to report and track progress. Hence, our control group will have access to the entire website.

Study groups in NCT00934141
Study groupRoleWhat they receive
Interest Circle Call + WebsiteExperimentalInterest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
Receives: Other: Interest Circle Calls; Other: Website
Coaching + WebsiteExperimentalCoaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
Receives: Other: Coaching; Other: Website
Full: LS, Coaching, ICC, WebsiteExperimentalLearning Session, Coaching, Interest Circle Calls, Website, see descriptions above
Receives: Other: Learning Session; Other: Interest Circle Calls; Other: Coaching; Other: Website
Learning Session + WebsiteExperimentalLearning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives-to help agencies learn and gather support from each other and from outside experts.
Receives: Other: Learning Session; Other: Website

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Average Waiting Time From First Contact to Treatment

    The average length of time in days it takes from when a patient first calls for help to the time a patient was able to meet a clinician. In this quality improvement study, changes in this measure over time are reported. Estimates of improvement show the average days of improvement per month based on a best linear unbiased predictor estimate for each site.

    Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered "analyzed" in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.

    Measured: Baseline and 15 months

  2. Change in Annual Number of Patient Admissions

    We aimed to increase clinics' treatment capacity in this quality improvement study. Capacity was measured by counting clinics' annual number of patient admissions. We monitored changes in admission counts, per clinic, in a pre-post analysis. Changes in the natural logarithm of annual admissions are presented, which approximates the average percentage change (year-to-year) in the number of new patient admissions per clinic.

    Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered "analyzed" in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.

    Measured: 48 months (2 year baseline period and 2 year post-intervention period)

  3. Change in Average Continuation Rate Through the Fourth Treatment Session

    This outcome represents change in the rate at which a clinic's patients continue in treatment. Continuation rate is defined as the percentage of patients that make at least 4 visits to the clinic, on different days, before being discharged. Estimates of improvement show the average percentage points of improvement per month based on a best linear unbiased predictor estimate for each site.

    Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered "analyzed" in the flow diagram, a clinic must have been included in at least one primary outcomes analysis.

    Measured: Baseline and 21 months

Secondary outcomes (1)

  1. Cost of Group

    The goal of the economic analysis was to estimate costs of each group for governmental authorities who might organize improvement collaboratives. We collected the cost of personnel (state employees, NIATx employees, coaches and consultants), data management, buildings and facilities, lodging, travel, telephone calls and miscellaneous costs. Costs were categorized as group specific (such as hotel costs for the learning sessions group) or non-group-specific, which included state-incurred costs for outreach, data management and infrastructure, encouraging participation and administration. Cost data were collected three times during the study period and aggregated to create a total cost estimate. Figures reported below represent costs at the arm/group level (costs were not assessed at the organizational level). Measure type is "Number."

    Measured: Baseline and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2009 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2009
  4. Study completionJan 2011

Resources

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 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00934141
Sponsor's protocol ID
DA020832
Other IDs
5R01DA020832-05
Acronym
NIATx 200
Status last verified
Jul 2013
First submitted
6 Jul 2009
Last updated
12 Aug 2013
Data monitoring committee
Yes

Publications

  • Gustafson DH, Quanbeck AR, Robinson JM, Ford JH 2nd, Pulvermacher A, French MT, McConnell KJ, Batalden PB, Hoffman KA, McCarty D. Which elements of improvement collaboratives are most effective? A cluster-randomized trial. Addiction. 2013 Jun;108(6):1145-57. doi: 10.1111/add.12117. Epub 2013 Mar 1.

    PubMed 23316787

  • Choi D, Hoffman KA, Kim MO, McCarty D. A high-resolution analysis of process improvement: use of quantile regression for wait time. Health Serv Res. 2013 Feb;48(1):333-47. doi: 10.1111/j.1475-6773.2012.01436.x. Epub 2012 Jun 20.

    PubMed 22716460

  • Quanbeck A, Wheelock A, Ford JH 2nd, Pulvermacher A, Capoccia V, Gustafson D. Examining access to addiction treatment: scheduling processes and barriers. J Subst Abuse Treat. 2013 Mar;44(3):343-8. doi: 10.1016/j.jsat.2012.08.017. Epub 2012 Sep 27.

    PubMed 23021494

  • Hoffman KA, Quanbeck A, Ford JH 2nd, Wrede F, Wright D, Lambert-Wacey D, Chvojka P, Hanchett A, McCarty D. Improving substance abuse data systems to measure 'waiting time to treatment': lessons learned from a quality improvement initiative. Health Informatics J. 2011 Dec;17(4):256-65. doi: 10.1177/1460458211420090.

    PubMed 22193826

  • Quanbeck AR, Gustafson DH, Ford JH 2nd, Pulvermacher A, French MT, McConnell KJ, McCarty D. Disseminating quality improvement: study protocol for a large cluster-randomized trial. Implement Sci. 2011 Apr 27;6:44. doi: 10.1186/1748-5908-6-44.

    PubMed 21524303

  • Quanbeck AR, Madden L, Edmundson E, Ford JH 2nd, McConnell KJ, McCarty D, Gustafson DH. A business case for quality improvement in addiction treatment: evidence from the NIATx collaborative. J Behav Health Serv Res. 2012 Jan;39(1):91-100. doi: 10.1007/s11414-011-9259-6.

    PubMed 21918924

  • Roosa M, Scripa JS, Zastowny TR, Ford JH 2nd. Using a NIATx based local learning collaborative for performance improvement. Eval Program Plann. 2011 Nov;34(4):390-8. doi: 10.1016/j.evalprogplan.2011.02.006. Epub 2011 Mar 2.

    PubMed 21371751

  • Quanbeck A, Lang K, Enami K, Brown RL. A cost-benefit analysis of Wisconsin's screening, brief intervention, and referral to treatment program: adding the employer's perspective. WMJ. 2010 Feb;109(1):9-14.

    PubMed 20942294

  • McCarty D, Chandler RK. Understanding the importance of organizational and system variables on addiction treatment services within criminal justice settings. Drug Alcohol Depend. 2009 Aug 1;103 Suppl 1:S91-3. doi: 10.1016/j.drugalcdep.2009.03.001. Epub 2009 Apr 8.

    PubMed 19356862

  • McCarty D, Gustafson D, Capoccia VA, Cotter F. Improving care for the treatment of alcohol and drug disorders. J Behav Health Serv Res. 2009 Jan;36(1):52-60. doi: 10.1007/s11414-008-9108-4. Epub 2008 Feb 8.

    PubMed 18259871

  • McCarty D, Roman PM, Sorensen J, Weisner C. Health Services Research for Drug and Alcohol Treatment and Prevention. J Drug Issues. 2009 Jan;39(1):197-208. doi: 10.1177/002204260903900115.

    PubMed 23378669

  • McConnell KJ, Hoffman KA, Quanbeck A, McCarty D. Management practices in substance abuse treatment programs. J Subst Abuse Treat. 2009 Jul;37(1):79-89. doi: 10.1016/j.jsat.2008.11.002. Epub 2009 Feb 4.

    PubMed 19195813

  • Gustafson DH. Essential Ingredients for Successful Redesign of Addiction Treatment. Bridge (Kans City). 2012;2(2):v2i2_article01.

    PubMed 25243237

  • Ford JH 2nd, Gilson A. Influence of participation in a quality improvement collaborative on staff perceptions of organizational sustainability. BMC Health Serv Res. 2021 Jan 7;21(1):34. doi: 10.1186/s12913-020-06026-3.

    PubMed 33413357

  • Ford JH 2nd, Stumbo SP, Robinson JM. Assessing long-term sustainment of clinic participation in NIATx200: Results and a new methodological approach. J Subst Abuse Treat. 2018 Sep;92:51-63. doi: 10.1016/j.jsat.2018.06.012. Epub 2018 Jun 27.

    PubMed 30032945

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Learning Session, Interest Circle Calls and Coaching in people with Addiction, run by University of Wisconsin, Madison at 1 site in United States.

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 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Average Waiting Time From First Contact to Treatment (time frame: Baseline and 15 months). The study lists 3 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 NCT00934141, which also lists 16 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 12 Aug 2013.

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