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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00421850
First received: January 11, 2007
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: UNITED Planned Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: UNITED Planned Care for People With Diabetes

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • Health Care Utlization and Costs
  • Satisfaction (Provider and Health Team)

Estimated Enrollment: 3491
Study Start Date: July 2001
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients in primary care referred to Diabetes Educator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421850

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Novo Nordisk A/S
Investigators
Principal Investigator: Steven A. Smith, M.D. Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00421850     History of Changes
Other Study ID Numbers: 1938-00
Study First Received: January 11, 2007
Last Updated: May 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014