Pilot Study of Health Information Technology for Chronic Kidney Disease Management

NCT02990897 | Completed

• 1 other identifier: 0
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Medical informatics; Quality of care; Referral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Urine microalbumin to creatinine ratio test completed

  6 months following primary care visit

• Referral of patient from PCP to nephrologist

  6 months following primary care visit

Study Arms (2)

Control Group

NO INTERVENTION

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

Intervention Group

EXPERIMENTAL

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.

Behavioral: clinical decision support message

Interventions

clinical decision support message 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

North Shore Physicians Group

Danvers, Massachusetts, 01923, United States

Location

Related Publications (1)

• 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.

  PMID: 35866010 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lipika Samal, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: July 14, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)