Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm

NCT06386172 | Completed

• 2 other identifiers: 2023-03537-01FoUI-986028
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease; Clinical Decision Support system; Pragmatic cluster-Randomized controlled trial; SCREAM; Guidelines, processes of care

Outcome Measures

Primary Outcomes (2)

• Number of participants screened for creatinine and albuminuria

  The number of eligible persons (i.e with an indication for screening) screened for creatinine and albuminuria once annually. Patients eligible for screening are, according to current guidelines those with hypertension, diabetes or history of cardiovascular disease.

  Through study completion, an average of 18 months

• Number of screened participants with retesting for creatinine and albuminuria

  The re-testing of these labs within 3-6 months among people with abnormal eGFR (\<60 ml/min/1.73 m2) or albuminuria (\>30 mg/g) at screening.

  Through study completion, an average of 18 months

Secondary Outcomes (3)

• Number of participants with laboratory-determined CKD receiving a clinical diagnosis

  Through study completion, an average of 18 months

• Number of participants receiving CKD-modifying agents

  Through study completion, an average of 18 months

• Number of participants referred to nephrologist care

  Through study completion, an average of 18 months

Study Arms (2)

Intervention

EXPERIMENTAL

Centers which have been randomized to recieve the intervention with CKD clinical decision support triggers will be administered via ALMA

Other: Clinical decision support trigger

Care as usual

NO INTERVENTION

Centers which have been randomized to no intervention and receive only prior/general clinical decision support triggers currently available in the ALMA platform. They do not receive the specific clinical decision support triggers for CKD.

Interventions

Clinical decision support trigger OTHER

Investigation of CDS-triggers effect on primary care physicians detection and management of chronic kidney disease

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People with conditions for which clinical guidelines recommend annual screening for kidney disease:
• Diabetes
• Hypertension
• People with a chronic kidney disease diagnosis.
• People with a rapidly declining eGFR (loss of 15% in the last 3 months or \> 5 ml/min/1.73m2 per year).
• People with albuminuria (\>3 mg/mmol)

You may not qualify if:

• None

Sponsors & Collaborators

• Karolinska Institutet: lead
• Danderyd Hospital: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, Sweden

Location

Related Publications (1)

• Andersson-Emad J, Thunholm A, Nash S, Evans M, Lind Af Hageby S, Arnlov J, Hilderman M, Forseth M, Sjolander A, Jacobson SH, Carrero JJ. 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. BMC Nephrol. 2024 Nov 13;25(1):408. doi: 10.1186/s12882-024-03852-z.

  PMID: 39538192 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan J Carrero, Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiorenal Epidemiology

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: April 26, 2024
• Study Start: September 9, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)