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Reducing Clinical Inertia in Diabetes Care

Primary Purpose

Diabetes Mellitus, Hypertension, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Intervention
Office System Redesign Intervention
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus focused on measuring physician decision support, diabetes mellitus, electronic medical records, office systems redesign

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • HealthPartners Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

No Intervention

Arm Label

1

2

3

Arm Description

Simulated case-based learning

EMR clinical decision support tool.

Control group

Outcomes

Primary Outcome Measures

Clinical inertia

Secondary Outcome Measures

Direct Medical Costs

Full Information

First Posted
January 3, 2006
Last Updated
September 4, 2012
Sponsor
HealthPartners Institute
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00272402
Brief Title
Reducing Clinical Inertia in Diabetes Care
Official Title
Reducing Clinical Inertia in Diabetes Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypertension, Hyperlipidemia
Keywords
physician decision support, diabetes mellitus, electronic medical records, office systems redesign

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Simulated case-based learning
Arm Title
2
Arm Type
Other
Arm Description
EMR clinical decision support tool.
Arm Title
3
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Intervention
Intervention Description
Intervention consists of simulated case based learning for physicians.
Intervention Type
Behavioral
Intervention Name(s)
Office System Redesign Intervention
Intervention Description
Intervention consists of clinical decision support within the electronic medical record.
Primary Outcome Measure Information:
Title
Clinical inertia
Time Frame
12 month post intervention
Secondary Outcome Measure Information:
Title
Direct Medical Costs
Time Frame
12 month pre and 12 month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J O'Connor, MD MPH
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Research Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55440
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16336552
Citation
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.
Results Reference
background
PubMed Identifier
16043728
Citation
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.
Results Reference
background
PubMed Identifier
20668151
Citation
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.
Results Reference
result
PubMed Identifier
22578085
Citation
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.
Results Reference
result
PubMed Identifier
21242556
Citation
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.
Results Reference
result

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Reducing Clinical Inertia in Diabetes Care

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