SimCare: Physician Intervention to Improve Diabetes Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT00262704
First received: December 6, 2005
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes.


Condition Intervention
Diabetes Mellitus
Behavioral: Simulated case-based customized learning
Behavioral: Simulated case based customized learning + leader feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: SimCare: Physician Intervention to Improve Diabetes Care

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • glycemic control [ Time Frame: All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin (A1c) values and A1c test rates were used to assess glycemic control.

  • lipid control [ Time Frame: All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians ] [ Designated as safety issue: No ]
    LDL-cholesterol levels and test rates were used to assess lipid control.


Enrollment: 2020
Study Start Date: December 2001
Study Completion Date: September 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group A
Control group
Active Comparator: Group B
Simulated case-based customized learning
Behavioral: Simulated case-based customized learning
Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback
Active Comparator: Group C
Simulated case based customized learning + leader feedback
Behavioral: Simulated case based customized learning + leader feedback
Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback + Physician Opinion Leader Feedback Tailored to Provider's Specific Practice Style

Detailed Description:

This randomized trial will test the hypothesis that (a) an influential physician feedback intervention, (b) a "narrative process trace" feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with diabetes mellitus.

The unit of randomization and the unit of analysis will be primary care physicians who have more than 10 adult patients with diabetes mellitus. The 162 physicians eligible for this study provide care to about 6,804 adults with diagnosed diabetes at 24 primary care clinics. The narrative process trace intervention uses automated medical record (AMR)-mounted clinical cases to assess physicians' diabetes care decisions, with results provided as feedback to physicians. The influential physician feedback intervention emphasizes individualized education of physicians, which will be guided by the narrative process trace in the combined intervention group. Usual care includes the use of a diabetes clinical guideline, use of a diabetes patient registry that provides key clinical data for each adult patient with diabetes, and access to clinic-based diabetes education nurses. We have shown in previous controlled studies that the guideline, diabetes registry, and clinic-based diabetes education nurses have failed to significantly improve diabetes care on a population basis, thus justifying the additional, stronger interventions that now will be tested.

Dependent variables include glycemic control and cardiovascular risk reduction of all 3,360 patients cared for by the 80 study physicians. Secondary analysis will assess rates of screening for microvascular complications. Physicians will be randomized in blocks based on specialty, number of diabetes patients, and years of practice experience. Hierarchical data analysis will be used to accommodate the nested data and propensity scores will be used to correct for selection effects and missing data. Results of this experiment will advance our theoretical understanding of physician behavior change and quantify cost and impact of three specific intervention strategies to improve chronic disease care in the primary care setting. The study will have substantial impact on clinical practice and policy whether the results are positive or negative. If successful, the interventions will be easily disseminated to other primary care practice settings.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients- Diabetes patients associated with the n=57 physicians were selected according to the following criteria: (1) enrolled in HealthPartners on January 1, 1998, (2) be at least 19 years of age on January 1, 1998, (3) have an established diagnosis of diabetes mellitus in 1998 based on meeting at least one of the following two criteria: (a) have one or more inpatient, or two or more outpatient International Classification of Diseases-9 (ICD-9) diagnostic codes 250.xx for diabetes, or (b) have a filled prescription for a diabetes-specific drug including insulins, sulphonylureas, biguanides, alpha-glucosidase inhibitors, thiazolidinediones, or meglitinides.
  • Physicians-All primary care adult care physicians (family physicians or primary care internists) employed full-time at HealthPartners medical groups as of 2000 were eligible for this study.

Exclusion Criteria:

  • None
  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: NCT00262704

Locations
United States, Minnesota
HealthPartners Research Foundation
Minneapolis, Minnesota, United States, 55440
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Patrick J O'Connor, MD MPH HealthPartners Institute for Education and Research
  More Information

Publications:
Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT00262704     History of Changes
Other Study ID Numbers: 0001600, R01HS010639
Study First Received: December 6, 2005
Last Updated: August 20, 2014
Health Authority: United States: Federal Government

Keywords provided by HealthPartners Institute for Education and Research:
physician intervention
diabetes mellitus
primary care
quality improvement
disease management

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

ClinicalTrials.gov processed this record on August 20, 2014