NCT00262197

Brief Summary

This project evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. This project will implement and evaluate the impact of this intervention on diabetes medical error rates and resource use.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2001

Longer than P75 for not_applicable diabetes-mellitus

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
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

First QC Date

December 5, 2005

Last Update Submit

September 4, 2012

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitusMedical error ratesPharmacotherapy

Outcome Measures

Primary Outcomes (3)

  • The following dependant variables were measured in this study;

  • Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and

  • LDL-cholesterol levels and test rates in the 12 months post-intervention.

Secondary Outcomes (3)

  • Age

  • Gender

  • Charlson comorbidity score

Interventions

Customized Physician InterventionBEHAVIORAL
Customized Patient InterventionBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In addition, participating patients met all of the following criteria: (a) age less than 75 years, (b) Charlson comorbidity score of 3 or less, (c) linked to the a primary care physician who was participating in the study in two consecutive calendar years, (d) had pharmacy coverage at the time of the intervention and for the previous 12-month period, and (e) had either HBA1c \> 7% or LDL \> 130 mg/dl (or LDL \> 100 mg/dl if the patient also had CHD).

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Sperl-Hillen JM, O'Connor PJ. Factors driving diabetes care improvement in a large medical group: ten years of progress. Am J Manag Care. 2005 Aug;11(5 Suppl):S177-85.

    PMID: 16111440BACKGROUND

  • O'Connor PJ, Gray RJ, Maciosek MV, Fillbrandt KM, DeFor TA, Alexander CM, Weiss TW, Teutsch SM. Cholesterol levels and statin use in patients with coronary heart disease treated in primary care settings. Prev Chronic Dis. 2005 Jul;2(3):A05. Epub 2005 Jun 15.

    PMID: 15963307BACKGROUND

  • Gilmer TP, O'Connor PJ, Rush WA, Crain AL, Whitebird RR, Hanson AM, Solberg LI. Predictors of health care costs in adults with diabetes. Diabetes Care. 2005 Jan;28(1):59-64. doi: 10.2337/diacare.28.1.59.

    PMID: 15616234BACKGROUND

  • 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

  • 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, Sperl-Hillen J, Johnson PE, Rush WA, Crain AL. Customized feedback to patients and providers failed to improve safety or quality of diabetes care: a randomized trial. Diabetes Care. 2009 Jul;32(7):1158-63. doi: 10.2337/dc08-2247. Epub 2009 Apr 14.

    PMID: 19366977DERIVED

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 5, 2005

First Posted

December 6, 2005

Study Start

December 1, 2001

Study Completion

August 1, 2005

Last Updated

September 5, 2012

Record last verified: 2012-09