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Using Networks, Informatics, Technology, and Education in Care for People With Diabetes

20 mei 2011 bijgewerkt door: Mayo Clinic

UNITED Planned Care for People With Diabetes

The costs of diabetes care (in health care dollars & human suffering) in the United States are second only to mental illness. Randomized control trials & observational studies have shown that glycemic control is predictive of the onset & severity of complications from diabetes and costs of care. In addition, a significant percentage of costs associated with diabetes can be reduced or delayed by appropriate diagnosis, preventive strategies, & management. The Planned Care Model (advocated by the Institute for Healthcare Improvement) has shown success in demonstrating improved practice performance and patient outcomes during a limited pilot in our clinical practice. We are proposing to generalize the Planned Care Model, to assess the value of planned care for all people with diabetes. The Planned Care Model will be implemented at each practice site and will consist of a structured communication schema between the patient and the primary health care team, to improve care for people with diabetes. Traditional care will be defined as the traditional system of care for patients prior to their participation in the Planned Care Model. It is hypothesized that this Planned Care Model will improve compliance with appropriate care guidelines and improve short and long term health outcomes (metabolic, satisfaction, morbidity, mortality and healthcare utilization). In conjunction with this study, providers at each of the practice sites will be randomly assigned to a structured communication with specialty care, referred to as UNITED Planned Care (Use of Networks, Informatics, Telemedicine, and Education in Disease Management). This communication schema will only be possible once the assigned provider?s patient is participating in the Planned Care Model. The UNITED Planned Care model will include point-of-care evidence based messages and specialty advice determined by performance gaps and outcomes for the patient. UNITED Planned Care is hypothesized to have the greatest impact on short & long term health outcomes.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The problem: The quality of diabetes care is highly variable, with some patients receiving sub-optimal care. Best practice is ideally described by research findings. Most providers are not aware of research findings. Traditional continuing medical education (CME) and dissemination of practice guidelines have failed to reduce variation around best practice.

A proposed solution: We hypothesize that practitioners that receive evidence-based information addressing a specific deficiency in their practice, in a timely fashion and at the point-of-care, are more likely to improve the quality of their diabetes care. To test this hypothesis we suggest the following randomized controlled trial.

Randomized trial

Participants: Primary care teams

Intervention: (UNITED PLANNED CARE MODEL)In the setting of the Planned Care Model, for providers and their teams assigned to this intervention, a Diabetes Electronic Management System will produce individualized performance reports on all health care teams. Specific performance gaps will be identified and will trigger two actions: 1) Specific messages will be forwarded to the team addressing a performance gap. 2) A diabetologist will provide counsel and support specific to these deficiencies. (e.g. based on performance reports generated by DEMS, an individual provider who has a patient with a performance gap of an LDL cholesterol> 150 not on medications, would get specific evidence based message about goal LDL cholesterol in patients with diabetes, & support/suggestions from the specialist)

Control (USUAL PLANNED CARE) In the setting of the Planned Care Model, providers and their team wills receive periodic information about cardiovascular risk reduction in diabetes but not specific to a patient?s performance gap. These teams will have access to the specialists using usual referral channels. None of these sources will be responding to these practitioners? performance gaps. There will be no proactive support or suggestions from the specialist.

Outcomes: 1) Processes (.e.g., frequency of lipid profile measurement); 2) Patient metabolic outcomes (.e.g., % of patients in the practice with LDL concentrations < 100 mg/dL); 3) Patient-centered outcomes (e.g., % of patients who suffered an atherosclerotic event); 4) CQI process and cost-effectiveness.

Significance:

A. Implement a Planned Care model in at least 3 primary care sites in Rochester-Kasson B. Pilot and Implement a structured specialty communication links and point of care evidence based messages in support of CME by telecommunication links to include DEMS.

C. Measure patient satisfaction with care delivery D. Measure provider and health care team satisfaction with care delivery E. Measure metabolic outcomes of patients participating in the project F. Measure demographics and other co-morbidities for patients participating in the project G. Audit for performance metrics, patients outcomes yearly after intervention and complete statistical assessment in keeping with primary hypotheses of the project H. Provision of anonymized patient data in support of the assessment of the outcomes of the study

Studietype

Ingrijpend

Inschrijving

3491

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • All patients in primary care referred to Diabetes Educator

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Processes of clinical care for diabetes
Cardiovascular risk as determined by UKPDS Risk
Metabolic outcomes (HgbA1c)
Metabolic outcomes (LDL Cholesterol)
Metabolic Outcomes (Systolic Blood Pressure)

Secundaire uitkomstmaten

Uitkomstmaat
Health Care Utlization and Costs
Satisfaction (Provider and Health Team)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medewerkers

Onderzoekers

  • Hoofdonderzoeker: Steven A. Smith, M.D., Mayo Clinic

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2001

Primaire voltooiing (Werkelijk)

1 januari 2005

Studie voltooiing (Werkelijk)

1 januari 2005

Studieregistratiedata

Eerst ingediend

11 januari 2007

Eerst ingediend dat voldeed aan de QC-criteria

11 januari 2007

Eerst geplaatst (Schatting)

12 januari 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

23 mei 2011

Laatste update ingediend die voldeed aan QC-criteria

20 mei 2011

Laatst geverifieerd

1 mei 2011

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 1938-00

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