Using Networks, Informatics, Technology, and Education in Care for People With Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00421850|
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : May 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Behavioral: UNITED Planned Care||Not Applicable|
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.
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||3491 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||UNITED Planned Care for People With Diabetes|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
- 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)
- Health Care Utlization and Costs
- Satisfaction (Provider and Health Team)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421850
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Steven A. Smith, M.D.||Mayo Clinic|