Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386172
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-01-26
Brief Title:
Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALMA-CKD
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 780000 citizens will be randomized 5050 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
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 780000 citizens will be randomized 5050 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
serumplasma 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 andor 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 eg 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 ie 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 theyre 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
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
serumplasma 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 andor 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 eg 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 ie 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 theyre 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FoUI-986028 | OTHER_GRANT | ALF Medicin Region Stockholm | None |