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Evaluating Improvement Strategies in Addiction Treatment (NIATx 200)

29. Juli 2013 aktualisiert von: University of Wisconsin, Madison

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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

201

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53706
        • University of Wisonsin-Madison

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • are current NIATx members

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Interest Circle Call + Website
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.
Sonstiges: Interest Circle Calls
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
Sonstiges: Website
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.
Experimental: Coaching + Website
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.
Sonstiges: Website
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.
Sonstiges: Coaching
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.
Experimental: Full: LS, Coaching, ICC, Website
Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
Sonstiges: Interest Circle Calls
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
Sonstiges: Website
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.
Sonstiges: Coaching
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.
Sonstiges: Learning Session
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.
Experimental: Learning Session + Website
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.
Sonstiges: Website
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.
Sonstiges: Learning Session
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Average Waiting Time From First Contact to Treatment
Zeitfenster: Baseline and 15 months

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.
Baseline and 15 months
Change in Annual Number of Patient Admissions
Zeitfenster: 48 months (2 year baseline period and 2 year post-intervention period)

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.
48 months (2 year baseline period and 2 year post-intervention period)
Change in Average Continuation Rate Through the Fourth Treatment Session
Zeitfenster: Baseline and 21 months

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.
Baseline and 21 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cost of Group
Zeitfenster: Baseline and 18 months
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."
Baseline and 18 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Wisconsin, Madison

Mitarbeiter

National Institute on Drug Abuse (NIDA)
Oregon Health and Science University

Ermittler

  • Hauptermittler: David H Gustafson, PhD, University of Wisconsin, Madison

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2006

Primärer Abschluss (Tatsächlich)

1. Juli 2009

Studienabschluss (Tatsächlich)

1. Januar 2011

Studienanmeldedaten

Zuerst eingereicht

6. Juli 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2009

Zuerst gepostet (Schätzen)

8. Juli 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

12. August 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juli 2013

Zuletzt verifiziert

1. Juli 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DA020832
  • 5R01DA020832-05 (US NIH Stipendium/Vertrag)

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