NCT00272402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

January 3, 2006

Last Update Submit

September 4, 2012

Conditions

Keywords

physician decision supportdiabetes mellituselectronic medical recordsoffice systems redesign

Outcome Measures

Primary Outcomes (1)

  • Clinical inertia

    12 month post intervention

Secondary Outcomes (1)

  • Direct Medical Costs

    12 month pre and 12 month post intervention

Study Arms (3)

1

OTHER

Simulated case-based learning

Behavioral: Cognitive Behavioral Intervention

2

OTHER

EMR clinical decision support tool.

Behavioral: Office System Redesign Intervention

3

NO INTERVENTION

Control group

Interventions

Intervention consists of simulated case based learning for physicians.

1

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

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Research Foundation

Minneapolis, Minnesota, 55440, United States

Location

Related Publications (5)

  • 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.

    PMID: 16336552BACKGROUND
  • 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.

    PMID: 16043728BACKGROUND
  • 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.

MeSH Terms

Conditions

Diabetes MellitusHypertensionHyperlipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Patrick J O'Connor, MD MPH

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 6, 2006

Study Start

February 1, 2006

Primary Completion

June 1, 2008

Study Completion

December 1, 2009

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations