Cardiovascular-kidney-metabolic SyndromeSWAP-CKMNCT07910968
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
A study testing Real-Time EHR Prompts and Audit-and-Feedback Reports in people with Cardiovascular-kidney-metabolic Syndrome and Diabete Type 2, run by Kaiser Permanente at 1 site in United States.
Trial summary
SWAP-CKM (SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome) is a pragmatic, cluster-randomized clinical trial designed to evaluate whether electronic health record (EHR)-based alerts can improve medication prescribing among adults with cardiovascular, kidney, and metabolic (CKM)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2, Chronic Kidney Disease
- What is being tested?
- Real-Time EHR Prompts and Audit-and-Feedback Reports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2026to 4 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- Presence of appropriate CKM condition
- Eligible for at least one therapeutic swap
- Outpatient encounter, including in-person or telehealth care, with an eligible clinician during the study period.
Who cannot join
- Membership at KPNC < 6 months
- Currently on dialysis
- Receiving hospice care
- Prior history of LVAD, heart transplantation, or any solid organ transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permenante Division of Research
Pleasanton, California, 94588
About this study
SWAP-CKM (SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome) is a pragmatic, cluster-randomized clinical trial designed to evaluate whether electronic health record (EHR)-based alerts can improve medication prescribing among adults with cardiovascular, kidney, and metabolic (CKM) conditions.
The study will include all eligible adult patients receiving care within Kaiser Permanente Northern California (KPNC) who have CKM conditions and opportunities for therapeutic medication substitution. Fifteen service areas are randomly assigned to either an intervention group or a usual care group.
Read more
Clinicians in the intervention group will receive EHR-based Best Practice Advisories (BPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The intervention may also include audit-and-feedback reports to support medication optimization. Clinicians retain full discretion over treatment decisions.
The primary outcome is the proportion of eligible therapeutic optimization opportunities achieved at 9 months. Secondary outcomes include medication initiation and discontinuation, medication optimization at 18 months, and polypharmacy burden.
Read the detailed description
SWAP-CKM is a pragmatic, prospective, parallel-group, cluster-randomized effectiveness-implementation trial evaluating a strategy that combines implementation of evidence-based therapies with de-implementation of potentially inappropriate or harmful medications among adults with cardiovascular-kidney-metabolic (CKM) conditions.
The study is conducted within Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system serving more than 4.6 million members. Service areas are randomized in a parallel-group design, with seven assigned to intervention and eight to usual care. Eligible adult patients with CKM conditions and therapeutic substitution opportunities during the study period will be included. The randomized evaluation period is planned for 9 months, with a potential subsequent open-label implementation extension to usual care service areas if the intervention is successful.
The intervention primarily consists of real-time EHR-based Best Practice Advisories (BPAs), implemented as OurPractice Advisories (OPAs), that identify opportunities for therapeutic substitution during eligible outpatient encounters. These advisories provide linked actions to discontinue potentially ineffective medications and order guideline-recommended alternatives through pre-populated order sets, while preserving clinician discretion. Audit-and-feedback reports identifying unfulfilled therapeutic substitution opportunities may also be incorporated as a supplementary intervention component.
Four categories of therapeutic substitution are supported: (1) replacement of non-evidence-based beta blockers or non-dihydropyridine calcium channel blockers with evidence-based beta blockers in eligible patients with heart failure and reduced left ventricular ejection fraction; (2) replacement of DPP-4 inhibitors or thiazolidinediones with SGLT2 inhibitors in eligible patients with heart failure or chronic kidney disease and type 2 diabetes; (3) replacement of potassium supplementation with mineralocorticoid receptor antagonists in eligible patients receiving loop diuretics; and (4) replacement of nonsteroidal anti-inflammatory drugs with acetaminophen in eligible patients with heart failure or chronic kidney disease.
The primary objective is to evaluate whether the intervention increases the proportion of eligible therapeutic optimization opportunities achieved at 9 months compared with usual care. Each potential therapeutic swap comprises two optimization opportunities: discontinuation of a potentially inappropriate medication and initiation of the corresponding evidence-based medication. Individual patients may contribute multiple eligible opportunities, and analyses will account for within-patient correlation and clustering at the service-area level.
Secondary outcomes include implementation and de-implementation optimization opportunities assessed separately at 9 months, outcomes by calss of SWAP opportunities at 8 months, overall therapeutic optimization at 18 months, and polypharmacy burden at 9 and 18 months. Exploratory outcomes include all-cause hospitalization and mortality. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
- Conditions
- Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2, Chronic Kidney Disease, Heart Failure
- Being tested
- Real-Time EHR Prompts and Audit-and-Feedback Reports
- Keywords
- Pragmatic, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Heart Failure, Behavioral Science, Implementation Science, Guideline-Directed Medical Therapy, Nudges
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time EHR Prompts and Audit-and-Feedback ReportsBehavioural
The intervention includes two components designed to facilitate optimization of guideline-concordant therapy among patients with cardiovascular-kidney-metabolic (CKM) conditions:
- EHR Best Practice Advisories (BPAs) Facilitating Therapeutic Swaps: Clinicians receive real-time electronic health record (EHR)-based OurPractice Advisories (OPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The advisories provide linked actions to discontinue existing medications and order recommended alternatives through pre-populated order sets, while preserving clinician discretion.
- Audit and Feedback Reports: The intervention may also include structured reports identifying patients with unfulfilled therapeutic substitution opportunities. These reports would provide patient-specific information and eligible therapeutic swaps to support medication optimization and clinical decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Best Practice Advisory (BPA) Facilitating Therapeutic Swaps | Experimental | Clinicians in intervention service areas will receive electronic health record (EHR)-based OurPractice Advisories (OPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The advisories facilitate medication discontinuation and initiation through linked order sets while preserving clinician discretion. The intervention may also include audit-and-feedback reports identifying unfulfilled therapeutic optimization opportunities. Receives: Behavioral: Real-Time EHR Prompts and Audit-and-Feedback Reports |
| Usual Care | No intervention | The usual care arm will receive standard clinical care without any study-related interventions. Providers will not receive visible OPA advisories, associated order sets, or study-specific audit-and-feedback reports, and routine care processes will remain unchanged. Control OPAs will operate silently for monitoring purposes without displaying recommendations to clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Therapeutic Optimization Opportunities Achieved
Proportion of eligible therapeutic optimization opportunities achieved, defined as the number of achieved opportunities divided by the total number of eligible opportunities. Each therapeutic swap includes two opportunities: discontinuation of a potentially inappropriate medication and initiation of the corresponding evidence-based medication. Individual patients may contribute multiple opportunities.
Measured: 9 months
Secondary outcomes (4)
Proportion of Implementation Optimization Opportunities Achieved
Proportion of eligible implementation opportunities achieved, defined as the number of achieved opportunities divided by the total number of eligible implementation opportunities. Implementation refers to initiation of the corresponding evidence-based medication. Individual patients may contribute multiple opportunities. This will be assessed overall and by SWAP type.
Measured: 9 months
Proportion of De-implementation Optimization Opportunities Achieved
Proportion of eligible de-implementation opportunities achieved, defined as the number of achieved opportunities divided by the total number of eligible de-implementation opportunities. De-implementation refers to discontinuation of a potentially inappropriate or harmful medication. Individual patients may contribute multiple opportunities. This will be assessed overall and by SWAP type.
Measured: 9 months
Proportion of Patients With Polypharmacy
Proportion of patients with polypharmacy, defined as concurrent use of five or more medications at the 9-month and 18-month assessments.
Measured: 9 & 18 months
Proportion of Patients With Hyper-polypharmacy
Proportion of patients with hyper-polypharmacy, defined as concurrent use of ten or more medications at the 9-month and 18-month assessments.
Measured: 9 & 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start4 Nov 2026 (estimated)
- Primary completion4 Aug 2027 (estimated)
- Study completion4 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular-kidney-metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ankeet S Bhatt, Kaiser Permanente
- Investigators
- Ankeet S Bhatt, MD, MBA, ScM, Principal investigator, Kaiser San Francisco Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910968
- Sponsor's protocol ID
- 2346771
- Acronym
- SWAP-CKM
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07910968
- Acronym / sponsor ID
- SWAP-CKM / 2346771
- Conditions
- Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2, Chronic Kidney Disease, Heart Failure
- Keywords
- Pragmatic, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Heart Failure, Behavioral Science, Implementation Science, Guideline-Directed Medical Therapy, Nudges
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 4 Aug 2027 (estimated)
- Study completion
- 4 May 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SWAP-CKM (SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome) is a pragmatic, cluster-randomized clinical trial designed to evaluate whether electronic health record (EHR)-based alerts can improve medication prescribing among adults with cardiovascular, kidney, and metabolic (CKM) conditions.
The study will include all eligible adult patients receiving care within Kaiser Permanente Northern California (KPNC) who have CKM conditions and opportunities for therapeutic medication substitution. Fifteen service areas are randomly assigned to either an intervention group or a usual care group.
Clinicians in the intervention group will receive EHR-based Best Practice Advisories (BPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The intervention may also include audit-and-feedback reports to support medication optimization. Clinicians retain full discretion over treatment decisions.
The primary outcome is the proportion of eligible therapeutic optimization opportunities achieved at 9 months. Secondary outcomes include medication initiation and discontinuation, medication optimization at 18 months, and polypharmacy burden.
Detailed description
SWAP-CKM is a pragmatic, prospective, parallel-group, cluster-randomized effectiveness-implementation trial evaluating a strategy that combines implementation of evidence-based therapies with de-implementation of potentially inappropriate or harmful medications among adults with cardiovascular-kidney-metabolic (CKM) conditions.
The study is conducted within Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system serving more than 4.6 million members. Service areas are randomized in a parallel-group design, with seven assigned to intervention and eight to usual care. Eligible adult patients with CKM conditions and therapeutic substitution opportunities during the study period will be included. The randomized evaluation period is planned for 9 months, with a potential subsequent open-label implementation extension to usual care service areas if the intervention is successful.
The intervention primarily consists of real-time EHR-based Best Practice Advisories (BPAs), implemented as OurPractice Advisories (OPAs), that identify opportunities for therapeutic substitution during eligible outpatient encounters. These advisories provide linked actions to discontinue potentially ineffective medications and order guideline-recommended alternatives through pre-populated order sets, while preserving clinician discretion. Audit-and-feedback reports identifying unfulfilled therapeutic substitution opportunities may also be incorporated as a supplementary intervention component.
Four categories of therapeutic substitution are supported: (1) replacement of non-evidence-based beta blockers or non-dihydropyridine calcium channel blockers with evidence-based beta blockers in eligible patients with heart failure and reduced left ventricular ejection fraction; (2) replacement of DPP-4 inhibitors or thiazolidinediones with SGLT2 inhibitors in eligible patients with heart failure or chronic kidney disease and type 2 diabetes; (3) replacement of potassium supplementation with mineralocorticoid receptor antagonists in eligible patients receiving loop diuretics; and (4) replacement of nonsteroidal anti-inflammatory drugs with acetaminophen in eligible patients with heart failure or chronic kidney disease.
The primary objective is to evaluate whether the intervention increases the proportion of eligible therapeutic optimization opportunities achieved at 9 months compared with usual care. Each potential therapeutic swap comprises two optimization opportunities: discontinuation of a potentially inappropriate medication and initiation of the corresponding evidence-based medication. Individual patients may contribute multiple eligible opportunities, and analyses will account for within-patient correlation and clustering at the service-area level.
Secondary outcomes include implementation and de-implementation optimization opportunities assessed separately at 9 months, outcomes by calss of SWAP opportunities at 8 months, overall therapeutic optimization at 18 months, and polypharmacy burden at 9 and 18 months. Exploratory outcomes include all-cause hospitalization and mortality. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Practice Advisory (BPA) Facilitating Therapeutic Swaps | Experimental | Behavioral: Real-Time EHR Prompts and Audit-and-Feedback ReportsClinicians in intervention service areas will receive electronic health record (EHR)-based OurPractice Advisories (OPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The advisories facilitate medication discontinuation and initiation through linked order sets while preserving clinician discretion. The intervention may also include audit-and-feedback reports identifying unfulfilled therapeutic optimization opportunities. |
| Usual Care | No intervention | –The usual care arm will receive standard clinical care without any study-related interventions. Providers will not receive visible OPA advisories, associated order sets, or study-specific audit-and-feedback reports, and routine care processes will remain unchanged. Control OPAs will operate silently for monitoring purposes without displaying recommendations to clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=18 years
- Presence of appropriate CKM condition
- Eligible for at least one therapeutic swap
- Outpatient encounter, including in-person or telehealth care, with an eligible clinician during the study period.
Key exclusion criteria (4 listed)
- Membership at KPNC < 6 months
- Currently on dialysis
- Receiving hospice care
- Prior history of LVAD, heart transplantation, or any solid organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-Time EHR Prompts and Audit-and-Feedback ReportsThe intervention includes two components designed to facilitate optimization of guideline-concordant therapy among patients with cardiovascular-kidney-metabolic (CKM) conditions: 1. EHR Best Practice Advisories (BPAs) Facilitating Therapeutic Swaps: Clinicians receive real-time electronic health record (EHR)-based OurPractice Advisories (OPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The advisories provide linked actions to discontinue existing medications and order recommended alternatives through pre-populated order sets, while preserving clinician discretion. 2. Audit and Feedback Reports: The intervention may also include structured reports identifying patients with unfulfilled therapeutic substitution opportunities. These reports would provide patient-specific information and eligible therapeutic swaps to support medication optimization and clinical decision-making. | Behavioural | Best Practice Advisory (BPA) Facilitating Therapeutic Swaps |
Primary outcome
Proportion of Therapeutic Optimization Opportunities Achieved
Time frame: 9 months
Proportion of eligible therapeutic optimization opportunities achieved, defined as the number of achieved opportunities divided by the total number of eligible opportunities. Each therapeutic swap includes two opportunities: discontinuation of a potentially inappropriate medication and initiation of the corresponding evidence-based medication. Individual patients may contribute multiple opportunities.
4 secondary outcomes
Proportion of Implementation Optimization Opportunities Achieved
Time frame: 9 months
Proportion of De-implementation Optimization Opportunities Achieved
Time frame: 9 months
Proportion of Patients With Polypharmacy
Time frame: 9 & 18 months
Proportion of Patients With Hyper-polypharmacy
Time frame: 9 & 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ankeet S Bhatt, MD, MBA, ScM principal investigator
Kaiser San Francisco Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time EHR Prompts and Audit-and-Feedback Reports in people with Cardiovascular-kidney-metabolic Syndrome and Diabete Type 2, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ankeet S Bhatt, MD, MBA, ScM (415-407-1754, Ankeet.S.Bhatt@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Therapeutic Optimization Opportunities Achieved (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.