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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial of Strategies to Improve Diabetes Care: Effectiveness and Costs of Physician Profiling and Care Coordination by a Diabetes Resource Nurse

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Medicare Claims Feedback
* Other: Medical Record Review
* Other: Diabetes Resource Nurse


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medicare Claims Feedback<br>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<br>* 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.<br>|
| Experimental: Medicare Claims+Medical Record Feedback<br>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<br>* 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.<br>Other: Medical Record Review<br>* 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.<br>|
| Experimental: Medicare Claims+Medical Chart Review+DRN<br>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<br>* 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.<br>Other: Medical Record Review<br>* 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.<br>Other: Diabetes Resource Nurse<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Care coordination, Case management, Physician profiling