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Using Learning Teams for Reflective Adaptation for Diabetes and Depression (ULTRA-DM/MDD)

21 november 2012 uppdaterad av: University of Colorado, Denver

Using Learning Teams for Reflective Adaptation

The study will randomize 54 primary care practices to two intervention and a comparison groups. Both interventions will involve an on-site Improvement Facilitator who will assist the practice in forming an Improvement Team, using rapid-cycle tests of change, and implementing chronic care office systems for type 2 diabetes and depression. One intervention is based on complexity science and the other is a traditional QI intervention.

Studieöversikt

Detaljerad beskrivning

Evidence-based guidelines for primary care of diabetes have been established and disseminated, yet adoption of guidelines in community-based primary care practice has been disappointing. This effectiveness study proposes a randomized trial involving 54 community-based primary care practices to test two innovative interventions to improve diabetes and depression care. One intervention, derived from theoretically based and efficacious programs tested in other settings, adopts a broad focus and seeks to improve diabetes and depression care by a) increasing the practice's organizational capacity to manage change, and b) implementing and sustaining chronic care office systems that support clinician efforts to improve care for diabetes. The intervention will combine two integrated components. The first component will utilize an Improvement Facilitator that will assess the practice's current use of chronic care office systems and their organizational capacity to manage change, provide feedback to key stakeholders in the practice, and work with the practice over six months to form an Improvement Team that will both address organizational capacity to create and sustain improvement and implement chronic care systems. In the second component of the intervention, the practice will participate in a local Improvement Collaborative that will afford opportunities to learn and share experiences during implementation and maintenance phases of the intervention with five similar practices in their geographic area. The second intervention is based on traditional QI methods and focuses on a chronic disease registry with regular reports to the physicians. It also uses PDSA cycles to assist in implementing change. This intervention will offer tools to improve diabetes and/or asthma care. Both interventions will be evaluated in two ways. First, a randomized trial using rigorous quantitative methods will measure 2 primary and 3 secondary endpoints at 9 and 18 months, including a) the ADA Physician Recognition Program performance measures by both patient-report and review of the medical record, and b) HEDIS measures of acute phase management of depression, c) assessment of the extent to which practices implement and physicians use elements of the chronic care model in their care of diabetes and depression. Change from baseline to 9 months will assess adoption of chronic care improvements, and change from 9 to 18 months will assess sustainability of improvements. Second, a multimethod assessment process will be used to analyze all qualitative and quantitative data separately to understand how and why the intervention led to the observed effects. The practice assessment will strive to understand which components of the interventions were most effective, their relative costs for implementation, and how they might be further improved. Successful components of the intervention will be refined and made available to our collaborators in the project; the Copic Insurance Company and the Colorado Clinical Guidelines Collaborative, for use in their statewide activities to improve diabetes care.

Studietyp

Interventionell

Inskrivning (Faktisk)

1565

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Colorado
      • Denver, Colorado, Förenta staterna, 80045
        • University of Colorado Health Sciences Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Under primary care for type 2 diabetes

Exclusion Criteria:

  • Are not minimally literate in either English or Spanish

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1
Practice in this arm will receive the Chronic Care Improvement intervention
An in-practice change facilitator will assist the Improvement Team in enhancing the relationship infrastructure of the practice and in implementing diabetes and depression office systems.
Experimentell: 2
Practices in this arm will receive the standard CQI intervention. An in-practice CQI coordinator will assist the practices in implement a chronic disease registry.
In-practice change facilitator assists the practice in implementing a chronic disease registry
Aktiv komparator: 3
Practice in this arm will have access to all chronic care tools, but will not have an in-practice change agent.
Practices will have access to all tools used in Arm 1 via a project website

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care
Tidsram: Baseline, 9, and 18 month
Baseline, 9, and 18 month
HEDIS-like measures of acute phase management of depression
Tidsram: Baseline, 9, and 18 months
Baseline, 9, and 18 months

Sekundära resultatmått

Resultatmått
Tidsram
Patient report (by survey) of their primary care experience
Tidsram: baseline, 9-months, 18-months
baseline, 9-months, 18-months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: David West, PhD, Department of Family Medicine, University of Colorado Health Sciences Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2005

Primärt slutförande (Faktisk)

1 februari 2012

Avslutad studie (Faktisk)

1 februari 2012

Studieregistreringsdatum

Först inskickad

21 december 2006

Först inskickad som uppfyllde QC-kriterierna

21 december 2006

Första postat (Uppskatta)

22 december 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

22 november 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 november 2012

Senast verifierad

1 november 2012

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 05-0457
  • R18DK067083 (U.S.S. NIH-anslag/kontrakt)
  • MH069806

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Depression

Kliniska prövningar på Chronic Care Improvement (CCI) Intervention

3
Prenumerera