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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258674
• Other study ID #: 000-113
• Status: Completed
• Phase: N/A
• First received: November 23, 2005
• Last updated: June 9, 2017
• Start date: January 2000
• Est. completion date: December 2001

Study information

• Verified date: June 2017
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1891
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Baylor Health Care System Institute for Health Care Research and Improvement	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	American Diabetes Association

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Ce — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Change Score for "HbA1c Level"	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Diastolic Blood Pressure"	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "LDL Level"	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Systolic Blood Pressure"	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual HbA1c Assessment" (as Determined From Medical Record Review)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual Lipid Assessment" (as Determined From Medical Record Review)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual Blood Pressure Assessment" (as Determined From Medical Record Review)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual Foot Exam" (as Determined by Medical Record Review)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual Eye Exam" (as Determined From Medical Record Review)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual Renal Function Assessment" (as Determined From Medical Record Review)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual HbA1c Assessment" (as Determined From Medicare Claims Data)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual Eye Exam" (as Determined From Medicare Claims Data)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Annual Lipid Assessment" (as Determined From Medicare Claims Data)	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 from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)
Secondary	Change Score for "Semiannual HbA1c Assessment" (as Determined From Medicare Claims Data)	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.	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)