Pilot Study of Health Information Technology for Chronic Kidney Disease Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Health Information Technology for Chronic Kidney Disease Management

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: clinical decision support message


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients with Stage 3,4, or 5 CKD who are randomized to the control arm will receive standard care. | |
| Experimental: Intervention Group<br>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<br>* The intervention patient's physician is shown an estimate of the patient's 5 year risk of ESRD with a link for further information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical informatics, Quality of care, Referral