Trials / Not Yet Recruiting
Not Yet RecruitingNCT07430930
Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PROMPT-CKD is a single-system, cluster-randomized clinical trial to evaluate the effectiveness of a tailored, user-centered, clinical decision support (CDS) tool for the prescription of guideline-directed medical therapy (GDMT) in patients with Chronic Kidney Disease (CKD). Consented providers (physicians, DOs, PA, APRNs, and PharmDs within internal medicine, family medicine and nephrology departments) will be randomized to either an intervention group that will be exposed to the CDS tool, or to a control (usual care) group that will not be exposed to the CDS tool. Upon opening of the order entry screen in the patient's medical record, the CDS tool will automatically and immediately evaluate inclusion and exclusion criteria for the patient, and if all criteria are met, the patient will be automatically enrolled into the study under the randomization group of the provider who opened the chart. The CDS tool is a best practice alert that appears for each eligible patient with CKD at the level of the order entry screen in the patient's medical record. The alert informs the provider of the presence of CKD, details the patient's most current relevant lab values, and lists current GDMT prescribed. Additionally, the alert lists GDMT which is indicated for the patient but which is not currently prescribed. The alert will also contain an order set containing the indicated medications. Providers may choose to dismiss the alert and indicate the reason. Those in the control arm of the trial will not see alerts, however a "silent alert" will be generated that registers the patient into the study. These patients will receive care as usual. The primary outcome will assess the proportion of patients with one or more new eligible GDMT prescriptions within 90 days of randomization. Secondary outcomes include time to Major Adverse Kidney Events (MAKE), time to all-cause mortality, time to greater than 40% reduction in eGFR, time to end stage kidney disease (ESKD), time to all-cause hospitalization, and time to worsening of CKD stage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Best practice alert and order set for CKD | Providers 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-06-01
- Completion
- 2028-03-01
- First posted
- 2026-02-24
- Last updated
- 2026-02-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07430930. Inclusion in this directory is not an endorsement.