Youth Risk Behavior Surveillance System |
YRBSS |
Clinical Trial: Reducing Clinical Inertia in Diabetes Care
This study is not yet open for patient recruitment.
Verified by HealthPartners Research Foundation January 2006
Purpose
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.
| Condition | Intervention |
|---|---|
| Diabetes Mellitus Hypertension Hyperlipidemia | Behavior: Cognitive Behavioral Intervention Behavior: Office System Redesign Intervention |
MedlinePlus related topics: Diabetes; High Blood Pressure; Metabolic Disorders
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Secondary Outcomes: Age; Gender; Charlson comorbidity; Direct Medical Costs
Expected Total Enrollment: 110
Study start: February 2006; Expected completion: June 2008
Last follow-up: May 2008; Data entry closure: June 2008
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.
Eligibility
Accepts Healthy Volunteers
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
Location and Contact Information
Molly A. Hollister 952-967-5080 Molly.A.Hollister@healthpartners.com
Minnesota
HealthPartners Research Foundation, Minneapolis, Minnesota, 55440, United States
Patrick J O''''Connor, MD MPH, Principal Investigator, HealthPartners Research Foundation
More Information
Publications
O''''connor PJ. Improving diabetes care by combating clinical inertia. Health Serv Res. 2005 Dec;40(6 Pt 1):1854-61. 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.
Last Updated: January 5, 2006
Record first received: January 3, 2006
ClinicalTrials.gov Identifier: NCT00272402
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10

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