Study protocol of the ALMA-CKD trial; an electronic triggering decision-support system to improve the detection, recognition, and management of patients with chronic kidney disease in primary care.

Abstract

Background: Chronic kidney disease (CKD) is a global health problem affected by under-recognition and under-treatment in primary care settings. Electronic clinical decision support (CDS) triggering systems have the potential to improve detection and management of people with CKD by assisting clinicians in adhering to guideline recommendations. We aimed to test whether an electronic CDS triggering system would improve the detection, recognition, and management of patients with CKD in primary care.

Method/design: This is a pragmatic cluster-randomized controlled trial where 66 primary healthcare centers from the Stockholm Region, Sweden were randomized 1:1 to receive either a new expanded CDS-triggering system offering kidney-specific advice or to continue with their current CDS-triggering system. The expanded CDS system reminds and provides practical facilitators of the processes of CKD screening, recognition with a diagnosis, management and referral to specialist care. The trial duration is 24 months and it is embedded into the Stockholm CREAtinine measurements (SCREAM) project, a repository of healthcare data from the region, which minimizes disturbances with healthcare praxis due to the trial and makes it fully pragmatic. The primary outcomes are the number of eligible patients screened for creatinine and albuminuria once annually and the re-testing of these labs within 6 months in patients with abnormal eGFR or albuminuria. Secondary outcomes are the proportions of issued clinical diagnoses among those fulfilling criteria, proportions of patients with significant albuminuria receiving prescribed nephroprotective medications, proportions of accepted referrals to nephrologist care among those fulfilling criteria and proportion of referrals for ultrasound of the kidneys.

Discussion: Prior pragmatic trials of CDS-systems in CKD has shown an improvement in quality indicators primarily in patients already diagnosed with CKD. This study expands this evidence by focusing on the process of screening, identification, monitoring and diagnostic work-up.

Conclusion: This pragmatic trial will assess the value of CDS for improved adherence to CKD guidelines in primary care.

Clinicaltrials: gov registration: NCT06386172, submitted 2024-04-23.