Trial Outcomes & Findings for Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons (NCT NCT02059408)
NCT ID: NCT02059408
Last Updated: 2020-01-07
Results Overview
Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1819 participants
Primary outcome timeframe
baseline, 12 months
Results posted on
2020-01-07
Participant Flow
Participant milestones
| Measure |
Usual Care
The patients in this arm will receive normal primary care.
|
Screen-Educate
Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.
Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.
|
Screen-Educate and Intensify Treatment
The Screen-Educate and Intensify Treatment adds a pharmacist-led CKD management program and attempts to improve BP management and patient-centered outcomes among persons with newly stratified higher risk CKD based on creatinine, cystatin c and albuminuria.
|
|---|---|---|---|
|
Overall Study
STARTED
|
604
|
599
|
616
|
|
Overall Study
COMPLETED
|
604
|
269
|
258
|
|
Overall Study
NOT COMPLETED
|
0
|
330
|
358
|
Reasons for withdrawal
| Measure |
Usual Care
The patients in this arm will receive normal primary care.
|
Screen-Educate
Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.
Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.
|
Screen-Educate and Intensify Treatment
The Screen-Educate and Intensify Treatment adds a pharmacist-led CKD management program and attempts to improve BP management and patient-centered outcomes among persons with newly stratified higher risk CKD based on creatinine, cystatin c and albuminuria.
|
|---|---|---|---|
|
Overall Study
Did not get tested
|
0
|
330
|
358
|
Baseline Characteristics
Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons
Baseline characteristics by cohort
| Measure |
Usual Care
n=604 Participants
The patients in this arm will receive normal primary care.
|
Screen-Educate
n=599 Participants
Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.
Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.
|
Screen-Educate and Intensify Treatment
n=616 Participants
Screen-Educate and Intensify Treatment: This arm adds option of a pharmacist. PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education. A primary care clinical pharmacist will schedule a series of appointments with patients found to have confirmed higher-risk CKD (defined as eGFRcreat-cys \<45, or eGFR 45-59 and ACR ≥ 30 mg/g). The pharmacist will follow treatment algorithms recommended by the 2012 KDIGO international CKD guidelines, and designed by a team of internists and nephrologists.
|
Total
n=1819 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
68 years
n=7 Participants
|
68 years
n=5 Participants
|
68 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
603 Participants
n=5 Participants
|
598 Participants
n=7 Participants
|
610 Participants
n=5 Participants
|
1811 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
87 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
298 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
344 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
1009 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
119 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
351 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
604 participants
n=5 Participants
|
599 participants
n=7 Participants
|
616 participants
n=5 Participants
|
1819 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 monthsChange in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,
Outcome measures
| Measure |
Usual Care
n=604 Participants
The patients in this arm will receive normal primary care.
|
Screen-Educate
n=599 Participants
Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant chronic kidney disease (CKD) management appropriate for CKD stage.
Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.
|
Screen-Educate and Intensify Treatment
n=616 Participants
Screen-Educate and Intensify Treatment: Adds option of a pharmacist to what is described in the Screen-Educate arm. primary care physician (PCPs) randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education.
|
|---|---|---|---|
|
Change in Blood Pressure
Change in SBP
|
-1 mmHg
Interval -11.0 to 11.0
|
-2 mmHg
Interval -11.0 to 11.0
|
-2 mmHg
Interval -13.0 to 10.0
|
|
Change in Blood Pressure
Change in DBP
|
-2 mmHg
Interval -7.0 to 4.0
|
-2 mmHg
Interval -7.0 to 4.0
|
-1 mmHg
Interval -7.0 to 5.0
|
SECONDARY outcome
Timeframe: 12 monthsNew use by end of the study
Outcome measures
| Measure |
Usual Care
n=604 Participants
The patients in this arm will receive normal primary care.
|
Screen-Educate
n=599 Participants
Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant chronic kidney disease (CKD) management appropriate for CKD stage.
Screen-Educate: Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.
|
Screen-Educate and Intensify Treatment
n=616 Participants
Screen-Educate and Intensify Treatment: Adds option of a pharmacist to what is described in the Screen-Educate arm. primary care physician (PCPs) randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education.
|
|---|---|---|---|
|
ACE/ARB Prescription by a Clinician
|
26 Participants
|
38 Participants
|
39 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: Data were not collected for this outcome. It was not feasible.
Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: Not feasible to collect data for this outcome.
Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time.
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Screen-Educate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Screen-Educate and Intensify Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carmen Peralta, Professor of Medicine
University of California, San Francisco
Phone: 415-221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place