NCT00262704

Brief Summary

This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,020

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2001

Shorter than P25 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

Study Start

First participant enrolled

December 1, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

8 months

First QC Date

December 6, 2005

Last Update Submit

August 20, 2014

Conditions

Diabetes Mellitus

Keywords

physician interventiondiabetes mellitusprimary carequality improvementdisease management

Outcome Measures

Primary Outcomes (2)

  • glycemic control

    Glycosylated hemoglobin (A1c) values and A1c test rates were used to assess glycemic control.

    All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians

  • lipid control

    LDL-cholesterol levels and test rates were used to assess lipid control.

    All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians

Study Arms (3)

Group A

NO INTERVENTION

Control group

Group B

ACTIVE COMPARATOR

Simulated case-based customized learning

Behavioral: Simulated case-based customized learning

Group C

ACTIVE COMPARATOR

Simulated case based customized learning + leader feedback

Behavioral: Simulated case based customized learning + leader feedback

Interventions

Simulated case-based customized learningBEHAVIORAL

Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback

Group B
Simulated case based customized learning + leader feedbackBEHAVIORAL

Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback + Physician Opinion Leader Feedback Tailored to Provider's Specific Practice Style

Group C

Eligibility Criteria

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

You may qualify if:

  • Patients- Diabetes patients associated with the n=57 physicians were selected according to the following criteria: (1) enrolled in HealthPartners on January 1, 1998, (2) be at least 19 years of age on January 1, 1998, (3) have an established diagnosis of diabetes mellitus in 1998 based on meeting at least one of the following two criteria: (a) have one or more inpatient, or two or more outpatient International Classification of Diseases-9 (ICD-9) diagnostic codes 250.xx for diabetes, or (b) have a filled prescription for a diabetes-specific drug including insulins, sulphonylureas, biguanides, alpha-glucosidase inhibitors, thiazolidinediones, or meglitinides.
  • Physicians-All primary care adult care physicians (family physicians or primary care internists) employed full-time at HealthPartners medical groups as of 2000 were eligible for this 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 (8)

  • O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Biltz G. Clinical Inertia and Outpatient Medical Errors. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20513/

    PMID: 21249838BACKGROUND

  • Dutta P, Biltz GR, Johnson PE, Sperl-Hillen JM, Rush WA, Duncan JE, O'Connor PJ. SimCare: A Simulation Model to Investigate Physician Decision-Making in the Care of Patients with Type 2 Diabetes. In K. Henriksen, J. Battles, D. Lewin, and E. Marks. Advances in Patient Safety: From Research to Implementation. Rockville, MD. Agency for Healthcare Research and Quality (AHRQ). 2005; Vol.4: Programs, Tools, and Products; 179-192. <http://www.ahrq.gov/qual/advances/>

    BACKGROUND

  • O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA. Identification, Classification, and Frequency of Medical Errors in Outpatient Diabetes Care. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 1: Research Findings). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20464/

    PMID: 21249801BACKGROUND

  • O'Connor PJ. Overcome clinical inertia to control systolic blood pressure. Arch Intern Med. 2003 Dec 8-22;163(22):2677-8. doi: 10.1001/archinte.163.22.2677. No abstract available.

    PMID: 14662620BACKGROUND

  • O'Connor PJ. Setting evidence-based priorities for diabetes care improvement. Int J Qual Health Care. 2003 Aug;15(4):283-5. doi: 10.1093/intqhc/mzg062. No abstract available.

    PMID: 12930043BACKGROUND

  • Johnson PE, Veazie PJ, Kochevar L, O'Connor PJ, Potthoff SJ, Verma D, Dutta P. Understanding variation in chronic disease outcomes. Health Care Manag Sci. 2002 Aug;5(3):175-89. doi: 10.1023/a:1019740401536.

    PMID: 12363045BACKGROUND

  • O'Connor PJ. Patient archetypes, physician archetypes, and tailored diabetes care. J Am Board Fam Pract. 2002 Jul-Aug;15(4):334-7. No abstract available.

    PMID: 12150470BACKGROUND

  • O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Asche SE, Dutta P, Biltz GR. Simulated physician learning intervention to improve safety and quality of diabetes care: a randomized trial. Diabetes Care. 2009 Apr;32(4):585-90. doi: 10.2337/dc08-0944. Epub 2009 Jan 26.

    PMID: 19171723RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

December 6, 2005

First Posted

December 7, 2005

Study Start

December 1, 2001

Primary Completion

August 1, 2002

Study Completion

September 1, 2002

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

US(1)