Pilot Study of Health Information Technology for Chronic Kidney Disease Management

Chronic Kidney Disease Clinical Trial

Official title:

Pilot Study of Health Information Technology for Chronic Kidney Disease Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990897
• Other study ID #: 0
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 14, 2022

Study information

• Verified date: August 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 14, 2022
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• clinical 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.

Locations

Country	Name	City	State
United States	North Shore Physicians Group	Danvers	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory tests completed	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.	6 months following primary care visit
Secondary	Urine microalbumin to creatinine ratio test completed	Dichotomous 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.	6 months following primary care visit
Secondary	Referral of patient from PCP to nephrologist	Dichotomous measure of whether a patient was seen by a nephrologist for patients who did not previously have these tests done in the prior year.	6 months following primary care visit