Pilot Study of Health Information Technology for Chronic Kidney Disease Management

NCT ID: NCT02990897

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2022-07-14

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

Patients with Stage 3,4, or 5 CKD who are randomized to the control arm will receive standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Patients with Stage 3,4, or 5 CKD who are randomized to the intervention group will receive care from a physician who has been exposed to the intervention: a clinical decision support message. This clinical decision support message shows the patient's risk of kidney failure over the next 5 years.

Group Type: EXPERIMENTAL

clinical decision support message

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lipika Samal

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lipika Samal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

North Shore Physicians Group

Danvers, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35866010 (View on PubMed)

Other Identifiers

0

Identifier Type: -

Identifier Source: org_study_id