An interventional study of Real-Time EHR Prompts and Audit-and-Feedback Reports in Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2 and Chronic Kidney Disease, sponsored by Kaiser Permanente. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Real-Time EHR Prompts and Audit-and-Feedback Reports
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.
The 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.
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.
Time frame: 9 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 & 18 months
Number of Participants With All-Cause Hospitalization
Number of participants experiencing at least one hospitalization for any cause during the follow-up period, identified using electronic health record data.
Time frame: 9 & 18 months
Number of Participants with All-Cause Mortality
Number of participants who died from any cause during the follow-up period, ascertained using routinely collected health system data.
Time frame: 9 & 18 months
Proportion of Eligible Patients Included in SWAP-CKM
Proportion of patients included in SWAP-CKM among all patients meeting study eligibility criteria within Kaiser Permanente Northern California. Reach will also be characterized across demographic and clinical subgroups.
Time frame: 9 & 18 months
Proportion of Eligible Therapeutic Swaps Adopted by Clinicians
Proportion of eligible therapeutic swaps adopted by clinicians, defined as the number of recommended swaps implemented divided by the total number of eligible swaps. Adoption will be evaluated across patient characteristics, clinician types, and therapeutic swap categories.
Time frame: 9 & 18 months
Number of SWAP-CKM Electronic Advisory Firings
Total number of SWAP-CKM electronic OurPractice Advisory (OPA) firings recorded during the study period, summarized over time to assess patterns of intervention maintenance and health system learning.
Time frame: 9 & 18 months
Proportion of Long-term 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.
Time frame: 18 months
Plan to share: No
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Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 9 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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