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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
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 28, 2008
Last Updated
March 24, 2011
Sponsor
University of Pittsburgh
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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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