Reducing Clinical Inertia in Diabetes Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT00272402
First received: January 3, 2006
Last updated: September 4, 2012
Last verified: September 2012
  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
Behavioral: Cognitive Behavioral Intervention
Behavioral: Office System Redesign Intervention

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: Reducing Clinical Inertia in Diabetes Care

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinical inertia [ Time Frame: 12 month post intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Direct Medical Costs [ Time Frame: 12 month pre and 12 month post intervention ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: February 2006
Study Completion Date: December 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Simulated case-based learning
Behavioral: Cognitive Behavioral Intervention
Intervention consists of simulated case based learning for physicians.
2
EMR clinical decision support tool.
Behavioral: Office System Redesign Intervention
Intervention consists of clinical decision support within the electronic medical record.
No Intervention: 3
Control group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  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: NCT00272402

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: NCT00272402     History of Changes
Other Study ID Numbers: 0308300, R01DK068314
Study First Received: January 3, 2006
Last Updated: September 4, 2012
Health Authority: United States: Federal Government

Keywords provided by HealthPartners Institute for Education and Research:
physician decision support
diabetes mellitus
electronic medical records
office systems redesign

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperlipidemias
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014