Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease
ConditionChronic Kidney Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
This study is a cluster-randomized clinical trial to evaluate whether a tailored, user-centered, clinical decision support (CDS) tool can positively influence prescriber behavior and increase prescription of guideline-directed medical therapy (GDMT) among patients with Chronic Kidney Disease (CKD) across a single healthcare center.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged ≥18 years
Diagnosed with CKD defined by an eGFR ≤60 mL/min/1.732 on two occasions at least ≥3 months apart with most recent being ≤60 or eGFR 60-90 mL/min/1.73m2 with an uACR ≥30 mg/g or eGFR >90 mL/min/1.73m2 with an uACR ≥30 mg/g.
Eligible to receive at least 1 of the following CKD GDMT: ACEi/ARB, SGLT2i, MRA or GLP-1 RA based on the following criteria.
To receive an ACEi/ARB: eGFR ≥15 ml/min/1.732 and have diagnosis of hypertension based on ICD10 code or proteinuria (uACR ≥30 mg/g).
Disqualifiers
Allergy to the GDMT for which the patient is eligible
End-stage kidney disease
CKD stage 5 (eGFR <15 ml/min/1.73m2)
Glomerulonephritis (by ICD-10 code)
Trial design
Design model
Parallel
Treatments tested in this trial
Best practice alert and order set for CKD
Other interventionProviders are exposed to a best practice alert upon opening of the order entry screen in a patient's medical record. The alert informs the provider of the presence of CKD, details the patient's current relevant labs and medications, and provides a list of recommended indicated GDMT for CKD which the patient is currently not prescribed. The alert includes an order set with all indicated medications with additional prescribing information. The alerts additionally includes a link to updated guidelines for GDMT prescription for CKD. Providers will be given the option to dismiss the alert and to indicate reasons for dismissing.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Exposure to clinical decision support toolExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
New GDMT prescription within 90 days
Proportion of patient subjects with one or more new eligible GDMT prescriptions within 90 days of randomization.
Time frame
Up to 90 days of randomizationSecondary outcomes
1
Time to Major Adverse Kidney Events (MAKE)
Measure of the statistical difference between study arms in the time to develop any Major Adverse Kidney Events within one year-post randomization, to include: 1. Death OR 2. 40% reduction in eGFR as defined by 2 measurements at least 30 days apart OR 3. Development of end-stage kidney disease (ESKD) defined by ICD10 code n18.6 OR 4. Receipt of dialysis OR 5. Receipt of kidney transplant
Time frame
Up to 365 days post-randomization2
Time to all-cause mortality
Measure of the statistical difference between study arms in the time to death from any cause within one year-post randomization.
Time frame
Up to 365 days post-randomization3
Time to reduction in estimated glomerular filtration rate (eGFR)
Measure of the statistical difference between study arms in the time to achieve reduction of eGFR by greater than 40% within one year-post randomization.
Time frame
Up to 365 days post-randomization4
Time to end-stage kidney disease (ESKD)
Measure of the statistical difference between study arms in the time to develop ESKD within one year-post randomization.
Time frame
Up to 365 days post-randomizationSponsors and contacts
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Source ClinicalTrials.gov
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