Hypertension
Conditions
Brief summary
The overall hypothesis of this trial is that screening for chronic kidney disease, followed by education or treatment program will improve blood pressure control among hypertensive non-diabetic persons.
Detailed description
To evaluate a CKD screen-and-educate program in primary care for improving blood pressure management compared with usual care, among non-diabetic adults with hypertension.
Interventions
OTHERScreen-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.
OTHERScreen-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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
The entire primary care medical practice at SFVAMC will be considered. Randomization will occur at the team (nurse) level. Within each team, individual patients will be considered eligible for chronic kidney disease screening by this protocol and inclusion in our trial if they have hypertension without concomitant diabetes, and no prior recorded diagnosis of chronic kidney disease. Hypertension will be defined as systolic blood pressure \>140 or diastolic blood pressure \>90 mmHg at more than two encounters (any encounter) within the previous 3 years or a documented diagnosis of hypertension (listed in problem list or ICD-9 code). Diagnosed chronic kidney disease will be defined as a documentation of chronic kidney disease in the problem list or ICD-9 code or on-going nephrology follow up. We define diagnosed chronic kidney disease without consideration of estimated glomerular filtration rate by creatinine or albumin-creatinine-ratio in the laboratory section of the medical record, since work from our group and others has shown that awareness and recognition of chronic kidney disease is extremely low, even among persons with documented reduced estimated glomerular filtration rate or albuminuria. Persons will be required to have seen their physician at least one time within the past 18 months.
Exclusion criteria
Kidney transplant recipients, pregnant women, and individuals with an estimated glomerular filtration rate \<15 ml/min/1.73 m2 will be excluded from this study as they likely need specialty care for uncontrolled hypertension. Persons aged \>80 will be excluded because data on aggressive blood pressure lowering in this population are less clear and adverse effects associated with aggressive blood pressure control have been well documented. We will exclude persons with New York Heart Association class III or IV heart failure, known ejection fraction \<25%, or documented allergy to Angiotensin-Converting Enzyme/Angiotensin II Receptor Blockers. Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | baseline, 12 months | Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACE/ARB Prescription by a Clinician | 12 months | New use by end of the study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Testing Time | 24 months | Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists. |
| Testing Cost | 24 months | Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care The patients in this arm will receive normal primary care. | 604 |
| 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. | 599 |
| Screen-Educate and Intensify Treatment 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. | 616 |
| Total | 1,819 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not get tested | 0 | 330 | 358 |
Baseline characteristics
| Characteristic | Usual Care | Total | Screen-Educate and Intensify Treatment | Screen-Educate |
|---|---|---|---|---|
| Age, Continuous | 68 years | 68 years | 68 years | 68 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 11 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 52 Participants | 150 Participants | 50 Participants | 48 Participants |
| Race (NIH/OMB) Black or African American | 87 Participants | 298 Participants | 104 Participants | 107 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 119 Participants | 351 Participants | 122 Participants | 110 Participants |
| Race (NIH/OMB) White | 344 Participants | 1009 Participants | 336 Participants | 329 Participants |
| Region of Enrollment United States | 604 participants | 1819 participants | 616 participants | 599 participants |
| Sex: Female, Male Female | 1 Participants | 8 Participants | 6 Participants | 1 Participants |
| Sex: Female, Male Male | 603 Participants | 1811 Participants | 610 Participants | 598 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 604 | 0 / 599 | 0 / 616 |
| other Total, other adverse events | 0 / 604 | 0 / 599 | 0 / 616 |
| serious Total, serious adverse events | 0 / 604 | 0 / 599 | 0 / 616 |
Outcome results
Primary
Change in Blood Pressure
Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,
Time frame: baseline, 12 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Care | Change in Blood Pressure | Change in SBP | -1 mmHg |
| Usual Care | Change in Blood Pressure | Change in DBP | -2 mmHg |
| Screen-Educate | Change in Blood Pressure | Change in SBP | -2 mmHg |
| Screen-Educate | Change in Blood Pressure | Change in DBP | -2 mmHg |
| Screen-Educate and Intensify Treatment | Change in Blood Pressure | Change in SBP | -2 mmHg |
| Screen-Educate and Intensify Treatment | Change in Blood Pressure | Change in DBP | -1 mmHg |
Secondary
ACE/ARB Prescription by a Clinician
New use by end of the study
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | ACE/ARB Prescription by a Clinician | 26 Participants |
| Screen-Educate | ACE/ARB Prescription by a Clinician | 38 Participants |
| Screen-Educate and Intensify Treatment | ACE/ARB Prescription by a Clinician | 39 Participants |
Other Pre-specified
Testing Cost
Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time.
Time frame: 24 months
Population: Not feasible to collect data for this outcome.
Other Pre-specified
Testing Time
Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists.
Time frame: 24 months
Population: Data were not collected for this outcome. It was not feasible.