Improving Diabetes Care:Effectiveness of Physician Profiling and Care Coordination by a Diabetes Resource Nurse

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00258674
First received: November 23, 2005
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Other: Medicare Claims Feedback
Other: Medical Record Review
Other: Diabetes Resource Nurse

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of Strategies to Improve Diabetes Care: Effectiveness and Costs of Physician Profiling and Care Coordination by a Diabetes Resource Nurse

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Change Score for "HbA1c <9 Percent" [ Time Frame: This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001) ] [ Designated as safety issue: No ]
    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.

  • Change Score for "LDL <100 mg/dL" [ Time Frame: change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001) ] [ Designated as safety issue: No ]
    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 Score for "Blood Pressure (b.p.) <130/80 mmHg" [ Time Frame: change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change Score for "HbA1c Level" [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Change score was calculated by subtracting the follow-up HbA1c value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Diastolic Blood Pressure" [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "LDL Level" [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Change score was calculated by subtracting the follow-up LDL value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Systolic Blood Pressure" [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual HbA1c Assessment" (as Determined From Medical Record Review) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual Lipid Assessment" (as Determined From Medical Record Review) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual Blood Pressure Assessment" (as Determined From Medical Record Review) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual blood pressure assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual Foot Exam" (as Determined by Medical Record Review) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual foot exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual Eye Exam" (as Determined From Medical Record Review) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual Renal Function Assessment" (as Determined From Medical Record Review) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual renal function assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual HbA1c Assessment" (as Determined From Medicare Claims Data) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual Eye Exam" (as Determined From Medicare Claims Data) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Annual Lipid Assessment" (as Determined From Medicare Claims Data) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.

  • Change Score for "Semiannual HbA1c Assessment" (as Determined From Medicare Claims Data) [ Time Frame: change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001) ] [ Designated as safety issue: No ]
    Each patient was assigned a change score of -1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for a semi-annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.


Enrollment: 1891
Study Start Date: January 2000
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medicare Claims Feedback
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
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.
Experimental: Medicare Claims+Medical Record Feedback
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 Feedback
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.
Other: Medical Record Review
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.
Experimental: Medicare Claims+Medical Chart Review+DRN
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 Feedback
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.
Other: Medical Record Review
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.
Other: Diabetes Resource Nurse
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.

Detailed Description:

HealthTexas Provider Network primary care practices with at least 10 Medicare diabetes patients over the age of 65 were randomized to one of 3 intervention arms: physician feedback of process measures using Medicare claims data ("Claims"); feedback of Medicare claims data plus clinical measures from medical record abstraction ("Claims+MR"); or both types of feedback plus a practice-based DRN ("DRN"). For the 12 months prior to the intervention and 12 months post-intervention, performance data on diabetes related processes of care (annual HbA1c testing, annual LDL cholesterol screening, annual hypertension screening, annual eye, foot, and renal assessment) and patient outcomes (HbA1c level, LDL cholesterol level, blood pressure) were collected from medical record abstraction and Medicare claims data. Pre-post change scores will be compared between intervention arms to examine effectiveness of physician profiling and care coordination by a diabetes resource nurse.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient chart not available for abstraction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258674

Locations
United States, Texas
Baylor Health Care System Institute for Health Care Research and Improvement
Dallas, Texas, United States, 75206
Sponsors and Collaborators
Baylor Research Institute
American Diabetes Association
Investigators
Principal Investigator: David J Ballard, MD,MSPH,PhD Baylor Health Care System Institute for Health Care Research and Improvement
  More Information

Publications:
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00258674     History of Changes
Other Study ID Numbers: Baylor IRB #000-113
Study First Received: November 23, 2005
Results First Received: October 21, 2011
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
Diabetes
Care coordination
Case management
Physician profiling

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014