Pilot Study of Health Information Technology for Chronic Kidney Disease Management
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
clinical decision support message
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Medical informatics, Quality of care, Referral
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
Sites / Locations
- North Shore Physicians Group
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
Patients with Stage 3,4, or 5 CKD who are randomized to the control arm will receive standard care.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02990897
First Posted
December 8, 2016
Last Updated
August 1, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02990897
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
July 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Medical informatics, Quality of care, Referral
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients with Stage 3,4, or 5 CKD who are randomized to the control arm will receive standard care.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
clinical decision support message
Intervention Description
The intervention patient's physician is shown an estimate of the patient's 5 year risk of ESRD with a link for further information.
Primary Outcome Measure Information:
Title
Laboratory tests completed
Description
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.
Time Frame
6 months following primary care visit
Secondary Outcome Measure Information:
Title
Urine microalbumin to creatinine ratio test completed
Description
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.
Time Frame
6 months following primary care visit
Title
Referral of patient from PCP to nephrologist
Description
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.
Time Frame
6 months following primary care visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lipika Samal, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore Physicians Group
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35866010
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.
Results Reference
derived
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Pilot Study of Health Information Technology for Chronic Kidney Disease Management
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