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Pilot Study of Health Information Technology for Chronic Kidney Disease Management

Pilot Study of Health Information Technology for Chronic Kidney Disease Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02990897
Enrollment
115
Registered
2016-12-13
Start date
2015-12-31
Completion date
2022-07-14
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Medical informatics, Quality of care, Referral

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.

Interventions

BEHAVIORALclinical decision support message

The intervention patient's physician is shown an estimate of the patient's 5 year risk of ESRD with a link for further information.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Laboratory tests completed6 months following primary care visitDichotomous 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

MeasureTime frameDescription
Urine microalbumin to creatinine ratio test completed6 months following primary care visitDichotomous measure of whether urine microalbumin to creatinine ratio test was completed for patients who did not previously have these tests done in the prior year.
Referral of patient from PCP to nephrologist6 months following primary care visitDichotomous measure of whether a patient was seen by a nephrologist for patients who did not previously have these tests done in the prior year.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026