Trial Outcomes & Findings for Chronic Kidney Disease Clinical Decision Support (NCT NCT03890588)
NCT ID: NCT03890588
Last Updated: 2022-12-01
Results Overview
Number of patients who had a CKD diagnosis document in the 18 months post index.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6295 participants
Primary outcome timeframe
18-month period post index
Results posted on
2022-12-01
Participant Flow
Clinics are randomly allocated 1:1 through a computer-generated program to either control or intervention. Patients who have their index visit at a control clinic are assigned to the usual care group and patients who have their index visit at an intervention clinic are assigned to the CKD-CDS intervention group.
Unit of analysis: Clinics
Participant milestones
| Measure |
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
Usual Care
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
|---|---|---|
|
Overall Study
STARTED
|
2923 16
|
3372 16
|
|
Overall Study
COMPLETED
|
2923 16
|
3372 16
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Kidney Disease Clinical Decision Support
Baseline characteristics by cohort
| Measure |
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
n=2923 Participants
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
Usual Care
n=3372 Participants
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
Total
n=6295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1078 Participants
n=5 Participants
|
1254 Participants
n=7 Participants
|
2332 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1845 Participants
n=5 Participants
|
2118 Participants
n=7 Participants
|
3963 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1602 Participants
n=5 Participants
|
1954 Participants
n=7 Participants
|
3556 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1321 Participants
n=5 Participants
|
1418 Participants
n=7 Participants
|
2739 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2838 Participants
n=5 Participants
|
3258 Participants
n=7 Participants
|
6096 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
119 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
274 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
524 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2439 Participants
n=5 Participants
|
2853 Participants
n=7 Participants
|
5292 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
72 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2923 participants
n=5 Participants
|
3372 participants
n=7 Participants
|
6295 participants
n=5 Participants
|
|
CKD Diagnosis
|
1355 Participants
n=5 Participants
|
1589 Participants
n=7 Participants
|
2944 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18-month period post indexNumber of patients who had a CKD diagnosis document in the 18 months post index.
Outcome measures
| Measure |
Usual Care
n=1783 Participants
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
n=1568 Participants
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
|---|---|---|
|
Number of Participants With CKD Diagnosis
|
389 Participants
|
417 Participants
|
PRIMARY outcome
Timeframe: 18-month period post indexNumber of patients who had an Angiotensin-converting enzyme inhibitors (ACEI) or Angiotension II reception blockers (ARB) order in the 18 months post index.
Outcome measures
| Measure |
Usual Care
n=1192 Participants
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
n=952 Participants
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
|---|---|---|
|
Number of Patients With Orders for Angiotensin-converting Enzyme Inhibitors (ACEI) or Angiotension II Reception Blockers (ARB)
|
192 Participants
|
151 Participants
|
PRIMARY outcome
Timeframe: 18-month period post indexNumber of patients for whom the average of the two most recent blood pressures prior to 18 months post index was \<130/80.
Outcome measures
| Measure |
Usual Care
n=1719 Participants
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
n=1633 Participants
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
|---|---|---|
|
Number of Patients With Optimal Blood Pressure Control
|
388 Participants
|
334 Participants
|
PRIMARY outcome
Timeframe: 1 to 18-month period post indexNumber of patients whose last A1c was \<7% in the 1-18 months post index.
Outcome measures
| Measure |
Usual Care
n=719 Participants
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
n=659 Participants
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
|---|---|---|
|
Number of Patients With Optimal Glucose Control
|
159 Participants
|
141 Participants
|
PRIMARY outcome
Timeframe: 18-month period post indexNumber of patients who have a referral to nephrology in the 18 months post index.
Outcome measures
| Measure |
Usual Care
n=263 Participants
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
n=238 Participants
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
|---|---|---|
|
Number of Patients With Referral to Nephrology
|
95 Participants
|
92 Participants
|
Adverse Events
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
Serious events: 541 serious events
Other events: 1039 other events
Deaths: 151 deaths
Usual Care
Serious events: 543 serious events
Other events: 1100 other events
Deaths: 175 deaths
Serious adverse events
| Measure |
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
n=2923 participants at risk
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
Usual Care
n=3372 participants at risk
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
|---|---|---|
|
General disorders
hospitalizations
|
18.5%
541/2923 • Number of events 2923 • 18 months
|
16.1%
543/3372 • Number of events 3372 • 18 months
|
Other adverse events
| Measure |
CKD Enhanced Clinical Decision Support (CKD-CDS Intervention)
n=2923 participants at risk
Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. This presents patients and their primary care providers (PCPs) multiple opportunities to consider an evolving array of timely, evidence-based treatment options to improve CKD care. The CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.
CKD enhanced clinical decision support: The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
|
Usual Care
n=3372 participants at risk
A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. Has no decision support specific to CKD care.
|
|---|---|---|
|
General disorders
Emergency Room Visits
|
35.5%
1039/2923 • 18 months
|
32.6%
1100/3372 • 18 months
|
|
Endocrine disorders
hypoglycemia
|
18.0%
202/1123 • 18 months
|
18.4%
232/1263 • 18 months
|
|
Vascular disorders
hypotension
|
18.7%
548/2923 • 18 months
|
24.1%
814/3372 • 18 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
29.2%
853/2923 • 18 months
|
31.5%
1061/3372 • 18 months
|
|
Metabolism and nutrition disorders
hyperkalemia
|
22.6%
660/2923 • 18 months
|
25.1%
847/3372 • 18 months
|
Additional Information
JoAnn Sperl-Hillen, MD, Senior Clinical Investigator
HealthPartners Institute
Phone: 952-967-5009
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place