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Clinical Trials/NCT02990897
NCT02990897
Completed
Not Applicable

Pilot Study of Health Information Technology for Chronic Kidney Disease Management

Brigham and Women's Hospital1 site in 1 country115 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Brigham and Women's Hospital
Enrollment
115
Locations
1
Primary Endpoint
Laboratory tests completed
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Researchers now know that treating chronic kidney disease (CKD) in its early stages can prevent dialysis and reduce heart problems that go along with kidney disease. Computerized tools may help primary care doctors to diagnose the disease earlier and computer reminders may help doctors to prescribe the best treatments. In this project the investigators will test computer reminders in primary care clinics to see if they improve treatment of early chronic kidney disease and to see if it can promote referral to nephrology.

Detailed Description

The investigators are conducting a randomized trial to determine the effect of a health information technology (HIT) application to calculate risk progression of end stage renal disease (ESRD). The primary outcome is the completion of the necessary tests for the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) for CKD patients in primary care. Secondary outcomes will include nephrology referrals, doubling of serum creatinine, initiation of hemodialysis, and primary care provider (PCP) satisfaction. In the analysis, all patients over the age of 18 who have a visit with one of physicians involved in the trial during the intervention period will be eligible and patients with stage 3-5 CKD will be included. Physicians are the subjects in this study, as the intervention is a behavioral intervention for physicians. The physicians' patients will not actively be recruited and will only indirectly be affected by the study. The application creates blocks of patient appointments for each physician and randomly assigns patients to intervention and control arms within these blocks.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
July 14, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lipika Samal

Associate Physician

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • patients who are 18 years or older
  • patients of primary care providers who are included in the study
  • patients with CKD (defined as two estimated glomerular filtration rate (GFR) values under 60 mL/min per 1.73 m\^2 90 days apart)

Exclusion Criteria

  • patients without CKD (defined as two GFR values under 60 mL/min per 1.73 m\^2 90 days apart)
  • patients under the age of 18

Outcomes

Primary Outcomes

Laboratory tests completed

Time Frame: 6 months following primary care visit

Dichotomous measure of whether laboratory tests necessary to calculate the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) were resulted in the electronic health record for patients who did not previously have all of these tests done in the prior year.

Secondary Outcomes

  • Referral of patient from PCP to nephrologist(6 months following primary care visit)
  • Urine microalbumin to creatinine ratio test completed(6 months following primary care visit)

Study Sites (1)

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