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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00258674
First Posted: November 28, 2005
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Baylor Research Institute
Results First Submitted: October 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Diabetes Mellitus
Interventions: Other: Medicare Claims Feedback
Other: Medical Record Review
Other: Diabetes Resource Nurse

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Claims Physician feedback of patient process measures using Medicare claims data
Claims+MR Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
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.

Participant Flow:   Overall Study
    Claims   Claims+MR   Claims+MR+Diabetes Resource Nurse
STARTED   597   811   602 
COMPLETED   565   758   568 
NOT COMPLETED   32   53   34 
Death                32                53                34 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Claims Physician feedback of patient process measures using Medicare claims data
Claims+MR Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
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.
Total Total of all reporting groups

Baseline Measures
   Claims   Claims+MR   Claims+MR+Diabetes Resource Nurse   Total 
Overall Participants Analyzed 
[Units: Participants]
 565   758   568   1891 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      565 100.0%      758 100.0%      568 100.0%      1891 100.0% 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 73.1  (0.1)   72.6  (0.1)   73.2  (0.1)   72.9  (0.1) 
[1] Patient characteristics were only described by study arm for the 1891 patients who survived to final follow-up.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
       
Female      290  51.3%      380  50.1%      279  49.1%      949  50.2% 
Male      275  48.7%      378  49.9%      289  50.9%      942  49.8% 
[1] Patient characteristics were only calculated by study arm for the 1891 patients who survived to final follow-up.
number of patients with HbA1c <9 percent [1] 
[Units: Participants]
 461   630   481   1572 
[1] This measure reports the number of patients in each study arm who had achieved the recommended level of glycemic control, as demonstrated by an HbA1c value of <9%. As not all patients achieved this level of control, the numbers differ from the Overall Number of Baseline Participants.
Number of patients with LDL cholesterol <100mg/dL [1] 
[Units: Participants]
 158   244   198   600 
[1] This measure reports the number of patients in each study arm who had achieved the recommended level of LDL cholesterol control, as demonstrated by value <100 mg/dL. As not all patients achieved this level of control, the numbers differ from the Overall Number of Baseline Participants.
Number of patients with blood pressure <130/80 mmHg [1] 
[Units: Participants]
 110   136   99   345 
[1] This measure reports the number of patients in each study arm who had achieved the recommended level of blood pressure control, as demonstrated by a value <130/80 mmHg. As not all patients achieved this level of control, the numbers differ from the Overall Number of Baseline Participants.
Mean HbA1c level 
[Units: Percent]
Mean (Standard Deviation)
 7.2  (1.5)   7.2  (1.4)   7.1  (1.4)   7.2  (0.03) 
mean LDL level 
[Units: mg/dL]
Mean (Standard Deviation)
 106.9  (32.9)   104.6  (32.6)   104.3  (33.9)   104.9  (0.9) 
mean diastolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 76.0  (9.9)   77.7  (9.5)   77.1  (9.8)   76.8  (0.2) 
mean systolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 139.5  (18.5)   139.7  (18.6)   140.2  (18.0)   139.6  (0.4) 
number of patients with annual HbA1c assessment (as determined from medical record review) [1] 
[Units: Participants]
 508   693   562   1763 
[1] Not all patients had an HbA1c test documented in the medical record within the past 12 months. As such, the number of participants in each study arm that have an annual HbA1c assessment is lower than the total number of baseline participants in that study arm.
Number of patients with an annual lipid assessment (as determined from medical record review) [1] 
[Units: Participants]
 380   567   441   1388 
[1] As not all patients had a lipid assessment documented in the medical record for the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.
Number of patients with annual blood pressure assessment (as determined from medical record review) [1] 
[Units: Participants]
 562   751   561   1874 
[1] As not all patients had a blood pressure assessment documented in the medical record for the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.
Number of patients with an annual eye exam (as determined from medical record review) [1] 
[Units: Participants]
 61   127   119   307 
[1] As not all patients had an eye assessment documented in the medical record for the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.
Number of patients with an annual foot exam (as determined from medical record review) [1] 
[Units: Participants]
 229   409   363   1001 
[1] As not all patients had an eye exam documented in the medical record for the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.
Number of patients with annual renal function test (as determined from medical record review) [1] 
[Units: Participants]
 168   304   234   706 
[1] As not all patients had a renal function test documented in the medical record for the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.
Number of patients with annual HbA1c assessment (as determined from Medicare claims data) [1] 
[Units: Participants]
 512   680   533   1725 
[1] As not all patients had a claim history for an HbA1c test in the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.
Number of patients with an annual eye exam (as determined from Medicare claims data) [1] 
[Units: Participants]
 350   497   353   1200 
[1] As not all patients had a claim history for an eye exam in the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.
Number of patients with an annual lipid assessment (as determined from Medicare claims data) [1] 
[Units: Participants]
 398   582   448   1428 
[1] As not all patients had a claim history for a lipid assessment in the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.
Number of patients with a semi-annual HbA1c assessment (as determined form Medicare claims data) [1] 
[Units: Participants]
 394   540   434   1368 
[1] As not all patients had claims histories for 2 HbA1c tests in the previous 12 months, the number of patients reported in each study arm for this measure is lower than the total number of baseline participants in that study arm.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   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) ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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) ]

12.  Secondary:   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) ]

13.  Secondary:   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) ]

14.  Secondary:   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) ]

15.  Secondary:   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) ]

16.  Secondary:   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) ]

17.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Baylor Research Institute
Organization: Baylor Research Institute
phone: 214-820-9991
e-mail: Elizabeth.Cothran@baylorhealth.edu


Publications of Results:

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00258674     History of Changes
Other Study ID Numbers: 000-113
First Submitted: November 23, 2005
First Posted: November 28, 2005
Results First Submitted: October 21, 2011
Results First Posted: October 23, 2012
Last Update Posted: June 14, 2017