- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00414986
Using Learning Teams for Reflective Adaptation for Diabetes and Depression (ULTRA-DM/MDD)
21. november 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1565
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80045
- University of Colorado Health Sciences Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Under primary care for type 2 diabetes
Exclusion Criteria:
- Are not minimally literate in either English or Spanish
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Surveillance of Hemoglobin A1c, blood pressure, lipids, depression process of care
Tidsramme: Baseline, 9, and 18 month
|
Baseline, 9, and 18 month
|
|
HEDIS-like measures of acute phase management of depression
Tidsramme: Baseline, 9, and 18 months
|
Baseline, 9, and 18 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patient report (by survey) of their primary care experience
Tidsramme: baseline, 9-months, 18-months
|
baseline, 9-months, 18-months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David West, PhD, Department of Family Medicine, University of Colorado Health Sciences Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2005
Primær færdiggørelse (Faktiske)
1. februar 2012
Studieafslutning (Faktiske)
1. februar 2012
Datoer for studieregistrering
Først indsendt
21. december 2006
Først indsendt, der opfyldte QC-kriterier
21. december 2006
Først opslået (Skøn)
22. december 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 05-0457
- R18DK067083 (U.S. NIH-bevilling/kontrakt)
- MH069806
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .