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Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes

ConditionsType 2 Diabetes MellitusAcute Kidney InjuryChronic Kidney DiseasesSGLT2 Inhibitor Use
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorUniversity of Minnesota

About this trial

This pilot study will evaluate the feasibility of using a clinical decision support(CDS) message to support consideration of SGLT2 inhibitor prescribing in patients with type 2 diabetes who recently had acute kidney injury.

Participating M Health Fairview primary care clinics will be randomized to either receive the clinical decision support intervention or continue usual care. In intervention clinics, providers or clinic pharmacists will receive a message before a scheduled encounter with an eligible patient. The message is intended to support clinical decision-making about SGLT2 inhibitor use, but prescribing decisions will remain with the patient's usual clinical care team.

The study will assess feasibility outcomes, including identification of eligible patients, delivery of clinical decision support (CDS) messages, provider/pharmacist receipt of CDS messages, SGLT2i consideration, SGLT2i prescribing, and availability of follow-up kidney function data in the electronic health record.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Assigned to work in a primary care specialty as a medical provider or assigned to work as a clinic pharmacist

Assigned to work in one of the participating study clinics

Scheduled to be seen in a participating clinic with a physician or advanced practice provider in a primary care specialty or a clinic pharmacist

Medical history of acute kidney injury during a hospitalization with discharge within 1 year before the scheduled appointment

Disqualifiers

None

Opted out of research use of AHC/M Health Fairview data shelter data

History of kidney transplantation as a recipient(by billing code)

Pregnancy documented in AHC/M Health Fairview data shelter data (by billing code)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clinical Decision Support Message

    Other intervention

    The clinical decision support intervention is a message sent to primary care providers or clinic pharmacists before a scheduled encounter with an eligible patient. The message provides key information to support consideration of SGLT2i prescribing in patients with type 2 diabetes and recent acute kidney injury. The study team will not provide study medication, and prescribing decisions will remain with the usual clinical care team.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Clinical Decision SupportExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility of Identifying Eligible Patients

Feasibility will be assessed by the number of patients meeting study inclusion and exclusion criteria who are identified as having a qualifying scheduled primary care or clinic pharmacist appointment in participating clinics.

Time frame
From study start through completion of eligible patient identification, up to 4 years
2

Feasibility of Clinical Decision Support Message Delivery

Feasibility of CDS delivery will be assessed by the number of CDS messages sent for first qualifying appointments, the number of intervention messages sent for all qualifying appointments, and the number of unique providers or pharmacists receiving CDS messages.

Time frame
From study start through completion of the CDS intervention period, up to 4 years
3

SGLT2i Consideration After Clinical Decision Support

SGLT2i consideration will be assessed by the number of patients with any mention of SGLT2i in encounter notes or related clinical documentation for the first qualifying primary care encounter.

Time frame
At the first qualifying primary care encounter
4

Follow-up Kidney Function Data Availability

Feasibility of outcome data capture will be assessed by the number of patients with follow-up serum creatinine values available in the electronic health record for follow-up eGFR calculation after the intervention.

Time frame
Within 1 year after the qualifying encounter

Secondary outcomes

1

Forty Percent eGFR Reduction

The number of patients with a 40% reduction in eGFR at the final available eGFR within 1 year of AKI onset will be assessed, including time to event from AKI onset.

Time frame
Within 1 year after AKI onset
2

Urine Albumin-to-Creatinine Ratio Follow-up and Relative Reduction

The number of patients with follow-up urine albumin-to-creatinine ratio measured will be assessed. Among patients with a known pre-AKI value, relative reduction in urine albumin-to-creatinine ratio will be calculated using available electronic health record laboratory data.

Time frame
Within 1 year after study enrollment
3

Hospitalization

Hospitalization will be assessed using electronic health record data as the number of patients with an event and time to event.

Time frame
Within 1 year after study enrollment
4

Recurrent Acute Kidney Injury

Recurrent acute kidney injury will be assessed using electronic health record data as the number of patients with an event and time to event.

Time frame
Within 1 year after study enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: