Clinical trial NCT02990897: Pilot Study of Health Information Technology for Chronic Kidney Disease Management
Official title: Pilot Study of Health Information Technology for Chronic Kidney Disease Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Medical informatics
Quality of care
Referral
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Laboratory tests completed
timeFrame: 6 months following primary care visit
Secondary outcomes:
measure: Urine microalbumin to creatinine ratio test completed
timeFrame: 6 months following primary care visit
measure: Referral of patient from PCP to nephrologist
timeFrame: 6 months following primary care visit
Other outcomes:
Locations:
city: Danvers
country: United States
facility: North Shore Physicians Group
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Lipika Samal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samal L, D'Amore JD, Gannon MP, Kilgallon JL, Charles JP, Mann DM, Siegel LC, Burdge K, Shaykevich S, Lipsitz S, Waikar SS, Bates DW, Wright A. Impact of Kidney Failure Risk Prediction Clinical Decision Support on Monitoring and Referral in Primary Care Management of CKD: A Randomized Pragmatic Clinical Trial. Kidney Med. 2022 May 28;4(7):100493. doi: 10.1016/j.xkme.2022.100493. eCollection 2022 Jul.