NCT00258674

Brief Summary

The purpose of this study is to test the effectiveness of physician profiling and care coordination by a diabetes resource nurse in improving the quality of diabetes care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,891

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2000

Typical duration 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

January 1, 2000

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

October 23, 2012

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

November 23, 2005

Results QC Date

October 21, 2011

Last Update Submit

February 10, 2026

Conditions

Keywords

DiabetesCare coordinationCase managementPhysician profiling

Outcome Measures

Primary Outcomes (3)

  • Change Score for "HbA1c <9 Percent"

    Each patient was assigned a "change score" of -1, 0, or 1. A positive value indicated a patient non-adherent to the guideline recommendation for HbA1c \<9 percent at baseline had achieved such a level at follow up. Patient-level change scores were then summed and averaged over each study arm.

    This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)

  • Change Score for "LDL <100 mg/dL"

    Each patient was assigned a "change score" of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of LDL \<100 mg/dL at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.

    change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001)

  • Change Score for "Blood Pressure (b.p.) <130/80 mmHg"

    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of blood pressure \<130/80 mmHg at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.

    change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001)

Secondary Outcomes (14)

  • Change Score for "HbA1c Level"

    change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)

  • Change Score for "Diastolic Blood Pressure"

    change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)

  • Change Score for "LDL Level"

    change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)

  • Change Score for "Systolic Blood Pressure"

    change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)

  • Change Score for "Annual HbA1c Assessment" (as Determined From Medical Record Review)

    change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)

  • +9 more secondary outcomes

Study Arms (3)

Medicare Claims Feedback

ACTIVE COMPARATOR

Practices randomised to the Medicare Claims Feedback arm received period feedback on their performance on selected diabetes quality of care measures as reflected in the claims data for their diabetes patients.

Other: Medicare Claims Feedback

Medicare Claims+Medical Record Feedback

EXPERIMENTAL

Practices randomised to the Medicare Claims + Medical Record Review Feedback arm received periodic feedback on their performance on selected diabetes quality of care measures as reflected in both the Medicare claims for the diabetes patients AND review/audit of their diabetes patients' medical records.

Other: Medicare Claims FeedbackOther: Medical Record Review

Medicare Claims+Medical Chart Review+DRN

EXPERIMENTAL

In addition to the performance data from both Medicare Claims data and from review of patients' medical records, practices randomised to the Medicare Claims + Medical Record review + Diabetes Resource Nurse (DRN) had a diabetes resource nurse assigned to them, who was available to provide diabetes education and care-coordination type services for their diabetes patients.

Other: Medicare Claims FeedbackOther: Medical Record ReviewOther: Diabetes Resource Nurse

Interventions

Physician practices received period feedback on their performance on selected diabetes quality of care measures, as reflected by data collected from their patients' medical records. These data were compiled by trained nurse abstractors using a standardized data collection tool developed for this study.

Medicare Claims+Medical Chart Review+DRNMedicare Claims+Medical Record Feedback

Diabetes Resource Nurses (DRNs) were registered nurses with 3-5 years of experience as certified diabetes educations who performed initial patient assessments, developed plans of care, administered screening tools, and monitored clinical outcomes. Physicians at the practices randomised to this intervention had could access the DRN's services for their diabetes patients, but neither physicians nor patients had to take advantage of this resource.

Medicare Claims+Medical Chart Review+DRN

Physician practices received periodic feedback on their performance on selected diabetes quality of care measures as reflected by the Medicare claims data for their patients.

Medicare Claims FeedbackMedicare Claims+Medical Chart Review+DRNMedicare Claims+Medical Record Feedback

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age ≥ 65 years on January 1, 2000
  • diagnosis of diabetes mellitus
  • diabetes related visit to HTPN physician within the past year
  • Resident of Texas
  • Medicare insurance coverage

You may not qualify if:

  • Patient chart not available for abstraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Health Care System Institute for Health Care Research and Improvement

Dallas, Texas, 75206, United States

Location

Related Publications (2)

  • Hollander P, Nicewander D, Couch C, Winter D, Herrin J, Haydar Z, Ballard DJ. Quality of care of Medicare patients with diabetes in a metropolitan fee-for-service primary care integrated delivery system. Am J Med Qual. 2005 Nov-Dec;20(6):344-52. doi: 10.1177/1062860605280205.

  • Herrin J, Nicewander DA, Hollander PA, Couch CE, Winter FD, Haydar ZR, Warren SS, Ballard DJ. Effectiveness of diabetes resource nurse case management and physician profiling in a fee-for-service setting: a cluster randomized trial. Proc (Bayl Univ Med Cent). 2006 Apr;19(2):95-102. doi: 10.1080/08998280.2006.11928137.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

All participating practices belonged to the same network of fee-for-service practices, which may reduce generalizability. Neither physicians nor patients could be blinded; but data were collected by individuals blinded to study arm assignments.

Results Point of Contact

Title
Baylor Research Institute
Organization
Baylor Research Institute

Study Officials

  • David J Ballard, MD,MSPH,PhD

    Baylor Health Care System Institute for Health Care Research and Improvement

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 28, 2005

Study Start

January 1, 2000

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

March 3, 2026

Results First Posted

October 23, 2012

Record last verified: 2026-02

Locations