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Completed

NCT Number: 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Research Foundation

Minneapolis, Minnesota, 55440, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Intervention

Behavioral

Intervention consists of simulated case based learning for physicians.

Office System Redesign Intervention

Behavioral

Intervention consists of clinical decision support within the electronic medical record.

Primary outcomes

  1. Clinical inertia

    Time frame: 12 month post intervention

Secondary outcomes

  1. Direct Medical Costs

    Time frame: 12 month pre and 12 month post intervention

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jan 6, 2006
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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