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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Number of participants screened for creatinine and albuminuria
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •People with conditions for which clinical guidelines recommend annual screening for kidney disease:
- •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)
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention
Centers which have been randomized to recieve the intervention with CKD clinical decision support triggers will be administered via ALMA
Intervention: Clinical decision support trigger (Other)
Care as usual
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.
Outcomes
Primary Outcomes
Number of participants screened for creatinine and albuminuria
Time Frame: Through study completion, an average of 18 months
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.
Number of screened participants with retesting for creatinine and albuminuria
Time Frame: Through study completion, an average of 18 months
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.
Secondary Outcomes
- Number of participants referred to nephrologist care(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 with laboratory-determined CKD receiving a clinical diagnosis(Through study completion, an average of 18 months)
Investigators
Juan Jesus Carrero
Professor of Cardiorenal Epidemiology
Karolinska Institutet