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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00258674

Enrollment

1891

Registered

2005-11-28

Start date

2000-01-01

Completion date

2001-12-01

Last updated

2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes, Care coordination, Case management, Physician profiling

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.

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.

Interventions

OTHERMedicare 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.

OTHERMedical 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.

OTHERDiabetes 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change Score for "HbA1c <9 Percent"	This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)	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"	change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001)	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"	change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001)	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

Measure	Time frame	Description
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 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"	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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"	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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"	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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)	change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid J Ballard, MD,MSPH,PhD

Baylor Health Care System Institute for Health Care Research and Improvement

Participant flow

Participants by arm

Arm	Count
Claims Physician feedback of patient process measures using Medicare claims data	565
Claims+MR Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures	758
Claims+MR+Diabetes Resource Nurse Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.	568
Total	1,891

Baseline characteristics

Characteristic	Claims+MR+Diabetes Resource Nurse	Total	Claims	Claims+MR
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	568 Participants	1891 Participants	565 Participants	758 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Continuous	73.2 years STANDARD_DEVIATION 0.1	72.9 years STANDARD_DEVIATION 0.1	73.1 years STANDARD_DEVIATION 0.1	72.6 years STANDARD_DEVIATION 0.1
mean diastolic blood pressure	77.1 mmHg STANDARD_DEVIATION 9.8	76.8 mmHg STANDARD_DEVIATION 0.2	76.0 mmHg STANDARD_DEVIATION 9.9	77.7 mmHg STANDARD_DEVIATION 9.5
Mean HbA1c level	7.1 percent STANDARD_DEVIATION 1.4	7.2 percent STANDARD_DEVIATION 0.03	7.2 percent STANDARD_DEVIATION 1.5	7.2 percent STANDARD_DEVIATION 1.4
mean LDL level	104.3 mg/dL STANDARD_DEVIATION 33.9	104.9 mg/dL STANDARD_DEVIATION 0.9	106.9 mg/dL STANDARD_DEVIATION 32.9	104.6 mg/dL STANDARD_DEVIATION 32.6
mean systolic blood pressure	140.2 mmHg STANDARD_DEVIATION 18	139.6 mmHg STANDARD_DEVIATION 0.4	139.5 mmHg STANDARD_DEVIATION 18.5	139.7 mmHg STANDARD_DEVIATION 18.6
Number of patients with an annual eye exam (as determined from medical record review)	119 participants	307 participants	61 participants	127 participants
Number of patients with an annual eye exam (as determined from Medicare claims data)	353 participants	1200 participants	350 participants	497 participants
Number of patients with an annual foot exam (as determined from medical record review)	363 participants	1001 participants	229 participants	409 participants
Number of patients with an annual lipid assessment (as determined from medical record review)	441 participants	1388 participants	380 participants	567 participants
Number of patients with an annual lipid assessment (as determined from Medicare claims data)	448 participants	1428 participants	398 participants	582 participants
Number of patients with annual blood pressure assessment (as determined from medical record review)	561 participants	1874 participants	562 participants	751 participants
number of patients with annual HbA1c assessment (as determined from medical record review)	562 participants	1763 participants	508 participants	693 participants
Number of patients with annual HbA1c assessment (as determined from Medicare claims data)	533 participants	1725 participants	512 participants	680 participants
Number of patients with annual renal function test (as determined from medical record review)	234 participants	706 participants	168 participants	304 participants
Number of patients with a semi-annual HbA1c assessment (as determined form Medicare claims data)	434 participants	1368 participants	394 participants	540 participants
Number of patients with blood pressure <130/80 mmHg	99 participants	345 participants	110 participants	136 participants
number of patients with HbA1c <9 percent	481 participants	1572 participants	461 participants	630 participants
Number of patients with LDL cholesterol <100mg/dL	198 participants	600 participants	158 participants	244 participants
Sex: Female, Male Female	279 Participants	949 Participants	290 Participants	380 Participants
Sex: Female, Male Male	289 Participants	942 Participants	275 Participants	378 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
other Total, other adverse events	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0

Outcome results

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.

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

Population: Patients missing either a baseline or follow-up blood pressure value were excluded.

Arm	Measure	Value (MEAN)	Dispersion
Claims	Change Score for Blood Pressure (b.p.) <130/80 mmHg	0.05 units on a scale	Standard Deviation 0.47
Claims+MR	Change Score for Blood Pressure (b.p.) <130/80 mmHg	0.03 units on a scale	Standard Deviation 0.5
Claims+MR+Diabetes Resource Nurse	Change Score for Blood Pressure (b.p.) <130/80 mmHg	0.04 units on a scale	Standard Deviation 0.45

Comparison: We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.p-value: 0.927Regression, Logistic

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.

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

Population: Patients missing either baseline or follow-up values for HbA1c were excluded.

Arm	Measure	Value (MEAN)	Dispersion
Claims	Change Score for HbA1c <9 Percent	0.01 units on a scale	Standard Deviation 0.34
Claims+MR	Change Score for HbA1c <9 Percent	0.02 units on a scale	Standard Deviation 0.32
Claims+MR+Diabetes Resource Nurse	Change Score for HbA1c <9 Percent	0.04 units on a scale	Standard Deviation 0.32

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.

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

Population: Patients missing either baseline or follow-up LDL values were excluded.

Arm	Measure	Value (MEAN)	Dispersion
Claims	Change Score for LDL <100 mg/dL	-0.01 units on a scale	Standard Deviation 0.52
Claims+MR	Change Score for LDL <100 mg/dL	0.07 units on a scale	Standard Deviation 0.5
Claims+MR+Diabetes Resource Nurse	Change Score for LDL <100 mg/dL	0.02 units on a scale	Standard Deviation 0.52

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.