Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
61 participants
INTERVENTIONAL
2006-02-28
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Simulated case-based learning
Cognitive Behavioral Intervention
Intervention consists of simulated case based learning for physicians.
2
EMR clinical decision support tool.
Office System Redesign Intervention
Intervention consists of clinical decision support within the electronic medical record.
3
Control group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive Behavioral Intervention
Intervention consists of simulated case based learning for physicians.
Office System Redesign Intervention
Intervention consists of clinical decision support within the electronic medical record.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
HealthPartners Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick J O'Connor, MD MPH
Role: PRINCIPAL_INVESTIGATOR
HealthPartners Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HealthPartners Research Foundation
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0308300
Identifier Type: -
Identifier Source: org_study_id