protocolSection identificationModule nctId: NCT06386172, orgStudyIdInfo id: 2023-03537-01, secondaryIdInfos id: FoUI-986028, type: OTHER_GRANT, domain: ALF Medicin, Region Stockholm, briefTitle: Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm, acronym: ALMA-CKD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-09, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Danderyd Hospital, collaborators name: Region Stockholm, descriptionModule briefSummary: One in 10 adults in Region Stockholm have chronic kidney disease (CKD), which dramatically increases healthcare costs and the risk of medication errors or adverse health outcomes, including cardiovascular disease and death. Identification and early management of these patients is done in primary care settings. However, most adults with CKD in our region are under detected, undiagnosed and undertreated, with low rates of referral to nephrology-specialist care.This is a pragmatic cluster randomized controlled trial (RCT) involving 66 primary healthcare centers in Region Stockholm, and testing the effect of an electronic clinical decision support (CDS) triggering system to assist general practitioners through the guideline-recommended processes of CKD care.The centers, providing healthcare to approximately 780.000 citizens, will be randomized 50:50 to this CDS trigger (vs basic advice) for 18 months. Study outcomes will consider the improvement in the indicators of CKD care.As a pragmatic trial there is no active recruitment or active data collection. The trial is embedded into the ongoing Stockholm CREAtinine Measurements (SCREAM) project, a database collection of healthcare use for the complete population of Stockholm. Using this real-world healthcare data collection, the investigators will be able to measure with precision the impact of our CDS trigger and its potential to improve clinical care., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The primary healthcare network system of the region of Stockholm coordinates 66 public primary healthcare centers. Collectively, these centers offer care to an estimated population of 780.000. Since November 2022, a new platform for CDS (clinical decision support) triggers called ALMA has been implemented in these centers. ALMA is connected to patient records and uses CDS triggers to identify medical problems, issue alerts and propose solutions.Using the ALMA platform, this project has the following objectives:Objective 1: to develop a CDS trigger connected with the electronic healthcare records specific to the processes of screening, diagnosis, and nephrologist referral of patients with CKD, including individualized CKD management optimization, in primary care.Objective 2: to evaluate the effectiveness of this CDS trigger (versus current basic advice) through a 2-arm pragmatic cluster RCT., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 780000, type: ESTIMATED, armsInterventionsModule interventions name: Clinical decision support trigger, outcomesModule primaryOutcomes measure: Number of participants screened for creatinine and albuminuria, primaryOutcomes measure: Number of screened participants with retesting for creatinine and albuminuria, secondaryOutcomes measure: Number of participants with laboratory-determined CKD receiving a clinical diagnosis, secondaryOutcomes measure: Number of participants receiving CKD-modifying agents, secondaryOutcomes measure: Number of participants referred to nephrologist care, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Juan J Carrero, Prof, role: CONTACT, phone: 0046739636948, email: juan.jesus.carrero@ki.se, geoPoint lat: 59.33258, lon: 18.0649, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-04-01, uploadDate: 2024-04-23T02:35, filename: SAP_000.pdf, size: 292236, hasResults: False