Automated Clinical Reminders in the Care of Chronic Kidney Disease Patients (ACRinCKD)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
automated clinical alerts
provider education
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Kidney Disease focused on measuring chronic kidney disease, clinical alerts, late referral, electronic medical record, Computerized clinical decision support systems (CDSS)
Eligibility Criteria
Inclusion Criteria:
- For PCPs: all GIM attending physicians with a weekly continuity clinic.
- For patients: >= 18 years-old with an eGFR<45ml/min/1.73m2 being seen in the UPMC GIM clinic by a faculty member during the 10-month intervention period
Exclusion Criteria:
- for PCPs: imminent plans to leave the department
- patients with a renal transplant, on any form of dialysis, or with a previous nephrology evaluation.
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
education and automated clinical alerts
education session alone
Outcomes
Primary Outcome Measures
referral to a nephrologist
Referral to a nephrologist within the 12 months following decision support system activation.
Secondary Outcome Measures
Use of ACE/ARB
Active use of ACE/ARB at the end of the 12 month period following decision support system activation.
Annual ACR or PCR check
ACR or PCR within 12months of the decision support system activation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00688285
Brief Title
Automated Clinical Reminders in the Care of Chronic Kidney Disease Patients
Acronym
ACRinCKD
Official Title
Automated Clinical Reminders in the Care of Chronic Kidney Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine whether the use of educational sessions and computerized clinical reminders can improve primary care doctors' delivery of care to CKD patients compared to educational sessions alone. Hypothesis: Clinical reminders will improve the care delivered to CKD patients
Detailed Description
Literature supports that most chronic kidney disease (CKD) patients are cared for by primary care physicians (PCP) without the help of a kidney specialist. Many of these patients fail to achieve targeted outcomes and late referral to a nephrologist has been associated with an increased risk of death. Automated computerized clinical reminders have been shown to improve physician compliance with recommended guidelines in other settings.
Aims: To determine if clinical reminders can help PCPs decrease the rate of late referrals, improve urine albumin checks in CKD patients
Design: prospective randomized controlled, single-blinded study with additional historical control
Methods: Two 20-minute teaching sessions aimed at all GIM PCPs in the UPMC clinic followed by randomization of the eligible GIM providers to receive automated clinical reminders (CR) for their CKD stage 3b-5 patients versus routine care.
Outcomes: Using a database search, individuals with an eGFR<45ml/min/1.73m2 (not seen by a nephrologist) will have data collected on: PCP referral to a nephrologist, urinary albumin (or protein) quantification in the past year, PCP recognition of patients with eGFR<45ml/min, ACE/ARB usage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, clinical alerts, late referral, electronic medical record, Computerized clinical decision support systems (CDSS)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
education and automated clinical alerts
Arm Title
2
Arm Type
Active Comparator
Arm Description
education session alone
Intervention Type
Other
Intervention Name(s)
automated clinical alerts
Intervention Description
automated clinical alerts in the electronic medical record
Intervention Type
Other
Intervention Name(s)
provider education
Intervention Description
PCP education session on CKD
Primary Outcome Measure Information:
Title
referral to a nephrologist
Description
Referral to a nephrologist within the 12 months following decision support system activation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Use of ACE/ARB
Description
Active use of ACE/ARB at the end of the 12 month period following decision support system activation.
Time Frame
12 months
Title
Annual ACR or PCR check
Description
ACR or PCR within 12months of the decision support system activation
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For PCPs: all GIM attending physicians with a weekly continuity clinic.
For patients: >= 18 years-old with an eGFR<45ml/min/1.73m2 being seen in the UPMC GIM clinic by a faculty member during the 10-month intervention period
Exclusion Criteria:
for PCPs: imminent plans to leave the department
patients with a renal transplant, on any form of dialysis, or with a previous nephrology evaluation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Abdel-Kader, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Unruh, MD, MSc
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21982456
Citation
Abdel-Kader K, Fischer GS, Li J, Moore CG, Hess R, Unruh ML. Automated clinical reminders for primary care providers in the care of CKD: a small cluster-randomized controlled trial. Am J Kidney Dis. 2011 Dec;58(6):894-902. doi: 10.1053/j.ajkd.2011.08.028. Epub 2011 Oct 7.
Results Reference
derived
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Automated Clinical Reminders in the Care of Chronic Kidney Disease Patients
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