- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00272402
Reducing Clinical Inertia in Diabetes Care
In this randomized trial we evaluate two conceptually distinct but potentially synergistic interventions designed to reduce clinical inertia in the outpatient care of adults with type 2 diabetes. The project addresses the following specific aims;
Specific Aim 1. Implement and assess two conceptually distinct but potentially synergistic interventions to reduce clinical inertia related to control of A1c, SBP, and LDL in adults with diabetes.
- Hypothesis 1. Patients of physicians who receive the Cognitive Behavioral Intervention (CBI) (Group 1) will subsequently have less Clinical Inertia than those who receive no intervention (Group 4).
- Hypothesis 2. Patients of physicians who receive the Office Systems Redesign intervention (CBI) (Group 2) will subsequently have less Clinical Inertia than those who receive no intervention (Group 4).
- Hypothesis 3. Patients of physicians who receive the combined CBI plus OSR intervention (Group 3) will subsequently have less Clinical Inertia than those who receive CBI alone (Group 1) or OSR alone (Group 2).
Specific Aim 2. Assess the impact of interventions to reduce clinical inertia on health care charges.
• Hypothesis 4. After adjustment for baseline measures of health care charges, those who receive no intervention (Group 4), will have higher total health care charges over a 24-month follow-up, relative to the patients of physicians in intervention Group 1, Group 2, or Group 3.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this project is to improve the care of adults with diabetes (DM) by implementing effective interventions to reduce Clinical Inertia related to control of glycated hemoglobin (A1c), systolic blood pressure (SBP) and LDL-Cholesterol (LDL) in primary care office settings. Clinical inertia is defined as lack of treatment intensification in a patient not at evidence-based goals for A1c, SBP, or LDL. Clinical Inertia (CI) has been implicated as a major factor that contributes to inadequate A1c, SBP, and LDL control, and has been documented in over 80% of primary care office visits in various settings,despite the fact that only 3% to 23% of adults with diabetes have simultaneously achieved A1c < 7%, SBP < 130 mm Hg, and LDL < 100 mg/dl.
In this project we test two interventions designed to reduce clinical inertia. The Cognitive Behavioral Intervention (CBI) is directed at individual primary care physicians and has three components: (a) analyze each physician's clinical moves with diabetes patients to identify patterns that indicate clinical inertia, (b) engage each physician in a series of simulated clinical cases to assess the underlying causes of clinical inertia, and (c) provide each physician with a series of tailored simulated clinical scenarios that are designed to correct the failures of thinking and decision making that result in that physician's observed patterns of clinical inertia. The CBI intervention is based on recent work in cognitive science and learning theory and has been successfully applied in other research and educational settings.
The Office Systems Redesign (OSR) Intervention is also directed to primary care physicians and has three major components: (a) identify specific patients in need of intensified diabetes care and schedule four consecutive monthly office visits with their primary care physician, (b) provide the physician with tailored and specific clinical decision support at the time of each visit based on evidence-based treatment algorithms, (c) implement physician visit resolution and accountability reporting immediately after each visit, using tools adapted from clinical trial protocols.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55440
- HealthPartners Research Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Physicians must practice at one of the 18 HPMG clinics and meet all these additional eligibility criteria: (a) be a general internist or family physician, (b) provide ongoing clinical care for 20 or more adults with diabetes mellitus in 2003, and (c) provide written informed consent to participate in the study.
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 3
Control group
|
|
Other: 1
Simulated case-based learning
|
Intervention consists of simulated case based learning for physicians.
|
Other: 2
EMR clinical decision support tool.
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Intervention consists of clinical decision support within the electronic medical record.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical inertia
Time Frame: 12 month post intervention
|
12 month post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Direct Medical Costs
Time Frame: 12 month pre and 12 month post intervention
|
12 month pre and 12 month post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick J O'Connor, MD MPH, HealthPartners Institute
Publications and helpful links
General Publications
- O'Connor PJ. Commentary--improving diabetes care by combating clinical inertia. Health Serv Res. 2005 Dec;40(6 Pt 1):1854-61. doi: 10.1111/j.1475-6773.2005.00437.x. No abstract available.
- O'Connor PJ, Desai J, Solberg LI, Reger LA, Crain AL, Asche SE, Pearson TL, Clark CK, Rush WA, Cherney LM, Sperl-Hillen JM, Bishop DB. Randomized trial of quality improvement intervention to improve diabetes care in primary care settings. Diabetes Care. 2005 Aug;28(8):1890-7. doi: 10.2337/diacare.28.8.1890.
- Sperl-Hillen JM, O'Connor PJ, Rush WA, Johnson PE, Gilmer T, Biltz G, Asche SE, Ekstrom HL. Simulated physician learning program improves glucose control in adults with diabetes. Diabetes Care. 2010 Aug;33(8):1727-33. doi: 10.2337/dc10-0439.
- Gilmer TP, O'Connor PJ, Sperl-Hillen JM, Rush WA, Johnson PE, Amundson GH, Asche SE, Ekstrom HL. Cost-effectiveness of an electronic medical record based clinical decision support system. Health Serv Res. 2012 Dec;47(6):2137-58. doi: 10.1111/j.1475-6773.2012.01427.x. Epub 2012 May 11.
- O'Connor PJ, Sperl-Hillen JM, Rush WA, Johnson PE, Amundson GH, Asche SE, Ekstrom HL, Gilmer TP. Impact of electronic health record clinical decision support on diabetes care: a randomized trial. Ann Fam Med. 2011 Jan-Feb;9(1):12-21. doi: 10.1370/afm.1196.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0308300
- R01DK068314 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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