- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00108927
Improving Diabetes in Primary Care (IMPACT)
Improving Diabetes Through Primary Care Translation (IMPACT)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The focus of the study is on the primary care environment, where the majority of patients with diabetes seek on-going health care. The proposed group-randomized and controlled clinical trial-targeted at 24 primary care clinics-evaluates the effectiveness of the TRANSLATE intervention, a multifaceted diabetes intervention program promoting better comprehensive diabetes management. The intervention begins by evaluating the organizational structures of primary care offices and identifying existing barriers in these small complex systems. A set of nine well-developed intervention components-selected from among some of the most successful strategies in the literature for altering clinical outcomes-are then introduced to correct existing deficiencies at each clinic. The TRANSLATE components function as an interdependent system, providing substantial support to both the provider and patient. Key features include the targeting of high-risk patients, a patient reminder system for routine visits, both passive and patient-specific physician reminders, a disease-specific networked reporting system, and physician education. Implementation is facilitated by a local diabetes intervention team assisted by a site coordinator and a local physician champion. Notably, the model does not centralize care, but rather promotes dissemination of care delivery improvements by promoting infrastructure changes at the primary care clinic where most care is delivered. Quality improvement methods are employed to optimize implementation in each unique clinic setting. Upper level administrative personnel are integrated into the regular review of implementation measures and resource use.
The study hypothesis is that implementation of the TRANSLATE intervention will result in meaningful improvement in physiologic outcome measures and important disease process measures-at a reasonable cost-within primary care settings.
The specific aims of the project are to rigorously evaluate the effectiveness of the TRANSLATE program by comparing intervention and control clinics on the following three clinical and economic outcomes:
- the change in A1c and systolic blood pressure values among all patients with diagnosed diabetes mellitus in participating primary care clinics over 12 months;
- the quality of diabetes care delivery as measured by the distribution and prevalence of appropriate A1c, microalbumin, low density lipoprotein measurements, and foot exams over 12 months;
- the economic impact on the health care delivery system as measured by the short- and long-term cost from the perspective of the health care system.
Tipo di studio
Iscrizione
Contatti e Sedi
Luoghi di studio
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55414
- Dept of Family Medicine and Community Health, University of Minnesota Medical School
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
(The unit of randomization is the medical clinic)
- Clinics were excluded if they participated in an effective quality improvement program within the last two years.
- Clinics must have 3-22 full time equivalent providers
- Clinics must be located in Minnesota or Western Wisconsin
- Clinics must be willing to implement a diabetes registry
- Must be a single specialty, general internal medicine or family practice clinic
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Prospettive temporali: Prospettiva
Collaboratori e investigatori
Investigatori
- Investigatore principale: Kevin A Peterson, MD MPH, University of Minnesota
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1 R18 DK061709 (completed)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .