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Chronic Kidney DiseasesALMA-CKDNCT06386172

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

A study testing Clinical decision support trigger in people with Chronic Kidney Diseases, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Clinical decision support trigger
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteSweden
Study dates
9 Sep 2023to 1 Oct 2025
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska Institutet

    Stockholm, Stockholm County

Other trials in Sweden

About this study

Official title: An Electronic Triggering Decision-support System to Improve Detection, Management and Nephrologist Referral of Patients With Chronic Kidney Disease in Primary Care: A Pragmatic Cluster Randomized Controlled Trial

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.

Read more

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.

Read the detailed description

A large proportion of persons in our region suffer from CKD and are not adequately identified and cared for.

The hypothesis tested in this trial is that providing a structured framework of advice in the form of an electronic clinical decision support (CDS) triggering system to general practitioners has the potential to improve the identification, recognition and care of persons with CKD.

About 10% of adults in Stockholm suffer from CKD, a condition characterized by reduced kidney function or signs of kidney damage that are sustained over time. CKD is disproportionally present in older adults (in 18% of persons aged 66-74, and 41% of persons aged >75 years) and in those with non-communicable diseases like hypertension (in 29% of patients), diabetes (26%) and cardiovascular disease (37%).

CKD can be identified and diagnosed with two simple and inexpensive laboratory analyses:

  • serum/plasma creatinine, which serves to estimate glomerular filtration rate (eGFR) as a marker of kidney function,
  • and albumin in urine (albuminuria), which serves as a marker of kidney damage.

Despite the low cost and widespread availability of these tests, they are not measured or interpreted to a desirable degree in primary health care. This leads to a high degree of under-detection and under-recognition of CKD. In Stockholm, only 9% of people with laboratory-detected CKD carried a clinical diagnosis or visited a nephrologist.

Patients with CKD have increased risks of all-cause mortality, cardiovascular mortality and morbidity, and kidney failure requiring dialysis or transplantation. They are also prone to suffer from medication errors, given that the loss of kidney function requires careful consideration of drug dosages and represents a contraindication for many common therapies. The management of CKD is costly: dialysis and transplantation alone, which affects to only 1-2% of the total population with CKD, typically represents 2-3% of the total healthcare expenditure of developed countries.

Many patients with CKD are at low risk of progression to kidney failure and are ideally managed in primary care settings. This is the current model of decentralized CKD care of most health systems including Region Stockholm. Regional, national and international guidelines provide clear recommendations regarding the screening, identification, management of patients with CKD in primary care as well as criteria for referral to nephrologist care. The goal of these recommendations is to improve detection and recognition, as well as to reduce the risk of adverse consequences of kidney failure and cardiovascular disease.

Despite the presence of clear guidelines, international reports suggest that most adults with CKD remain under detected, undiagnosed, improperly risk stratified, and undertreated. Even when laboratory data is present to substantiate a CKD diagnosis, clinicians often do not recognize or diagnose it, and, as a result, medication errors can occur. Another missed opportunity of poor identification and recognition of CKD is that patients with advanced CKD often are not referred to nephrology early enough to have meaningful discussions about preparation for kidney replacement therapy.

Barriers that hinder effective CKD identification and care in primary care settings include lack of awareness and/or understanding of guidelines for risk stratification and management of CKD, confusion regarding appropriate referral criteria and timing, lack of confidence in managing CKD and limited communication channels with specialists in nephrology. Additionally, general practitioners may have limited time to manage complex visit agendas. Programs that facilitate the processes of CKD identification and management as well as enhanced cooperation between general and specialist care have thus the potential to improve these identified care gaps.

Widespread use of electronic health records offers new opportunities to identify and address such care gaps, by implementation of electronic clinical decision support (CDS) systems. CDS systems are designed to aid clinician decision making during the process of care. When well designed and effectively used, they can be powerful tools for improving the quality of patient care and preventing errors and omissions.

CDS triggers, that is, CDS systems that automatically activate upon a "trigger" (e.g. when the patient journal is opened or a laboratory test is ordered), have advantages compared with CDS systems that require active engagement of the clinician (i.e. having to access a specific website or platform to consult advice). CDS triggers can facilitate actions and promote proactive preventive care, such as opportunistic disease screening; they can also serve as reminders to staff and clinicians to take action to improve care delivery to a patient, alerting them while they're working in the electronic healthcare records, and linking them to the appropriate place to take the preferred action.

Since November 2022, a new platform for CDS triggers called ALMA has been implemented in the 66 public primary healthcare centers of Region Stockholm. ALMA is connected to patient records and uses CDS triggers to identify medical problems, issue alerts and propose solutions. At present, ALMA provides basic advice for the management of CKD, which consists of the recommendation to "measure albuminuria once annually in patients with diabetes". This trial will use the already-established ALMA platform to conduct a pragmatic RCT with the goals above mentioned.

Being tested
Clinical decision support trigger
Keywords
Chronic Kidney Disease, Clinical Decision Support system, Pragmatic cluster-Randomized controlled trial, SCREAM, Guidelines, processes of care
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical decision support triggerOther

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

Study groups in NCT06386172
Study groupRoleWhat they receive
InterventionExperimentalCenters which have been randomized to recieve the intervention with CKD clinical decision support triggers will be administered via ALMA
Receives: Other: Clinical decision support trigger
Care as usualNo interventionCenters 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 18 months

  2. 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.

    Measured: Through study completion, an average of 18 months

Secondary outcomes (3)
  1. Number of participants with laboratory-determined CKD receiving a clinical diagnosis

    Among those fulfilling criteria of outcome 2 (i.e. sustained signs of CKD over time), proportion of clinical diagnoses issued

    Measured: Through study completion, an average of 18 months

  2. Number of participants receiving CKD-modifying agents

    Among people fulfilling criteria 2, proportion of initiation of CKD-modifying agents

    Measured: Through study completion, an average of 18 months

  3. Number of participants referred to nephrologist care

    Among those fulfilling National Criteria for referral.

    Measured: Through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start9 Sep 2023
  3. Primary completion30 Sep 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06386172
Sponsor's protocol ID
2023-03537-01
Other IDs
FoUI-986028, 2023
Acronym
ALMA-CKD
Status last verified
Dec 2025
First submitted
26 Jan 2024
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not allowed by hospital, institutional and GDPR regulations

Publications

  • 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.

    PubMed 39538192

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