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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | The patients in this arm will receive normal primary care. | |
| Screen-Educate | Active Comparator | 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 and Intensify Treatment | Active Comparator | Education and treatment program to improve blood pressure control among hypertensive non-diabetic persons. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screen-Educate | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome, | baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ACE/ARB Prescription by a Clinician | New use by end of the study | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Testing Time | Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists. | 24 months |
| Testing Cost | Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time. |
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 exclusion criteria relate to the required ability to communicate with providers and provide informed consent: prevalent dementia, impaired cognition or severe mental illness; expected life expectancy <6 months; severe visual impairment in the absence of an available caretaker who can read.
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| Name | Affiliation | Role |
|---|---|---|
| Carmen A Peralta, MD, MAS | San Francisco Veterans Affairs Medical Center | Principal Investigator |
| Erica Day, MPH | San Francisco Veterans Affairs Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Veteran Affairs Medical Center | San Francisco | California | 94121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15563563 | Background | Coresh J, Byrd-Holt D, Astor BC, Briggs JP, Eggers PW, Lacher DA, Hostetter TH. Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. J Am Soc Nephrol. 2005 Jan;16(1):180-8. doi: 10.1681/ASN.2004070539. Epub 2004 Nov 24. | |
| 21482744 | Background | Peralta CA, Shlipak MG, Judd S, Cushman M, McClellan W, Zakai NA, Safford MM, Zhang X, Muntner P, Warnock D. Detection of chronic kidney disease with creatinine, cystatin C, and urine albumin-to-creatinine ratio and association with progression to end-stage renal disease and mortality. JAMA. 2011 Apr 20;305(15):1545-52. doi: 10.1001/jama.2011.468. Epub 2011 Apr 11. |
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There is not currently a plan to make the IDP data available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | The patients in this arm will receive normal primary care. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | The patients in this arm will receive normal primary care. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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, | Posted | Median | Inter-Quartile Range | mmHg | baseline, 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | The patients in this arm will receive normal primary care. | 0 |
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A limitation in this study was that over 50% of eligible patients were not tested.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmen Peralta, Professor of Medicine | University of California, San Francisco | 415-221-4810 | 23678 | carmenalicia.peralta@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2019 | Nov 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Screen-Educate and Intensify Treatment | Other | 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. |
|
| 24 months |
| 24350959 | Background | Shlipak MG, Coresh J, Gansevoort RT. Cystatin C versus creatinine for kidney function-based risk. N Engl J Med. 2013 Dec 19;369(25):2459. doi: 10.1056/NEJMc1312801. No abstract available. |
| 23732715 | Background | Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007. |
| 28399844 | Derived | Peralta CA, Frigaard M, Rubinsky AD, Rolon L, Lo L, Voora S, Seal K, Tuot D, Chao S, Lui K, Chiao P, Powe N, Shlipak M. Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans. BMC Nephrol. 2017 Apr 12;18(1):132. doi: 10.1186/s12882-017-0541-6. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Screen-Educate and Intensify Treatment | 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. |
|
|
| Secondary | ACE/ARB Prescription by a Clinician | New use by end of the study | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Testing Time | Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists. | Data were not collected for this outcome. It was not feasible. | Posted | 24 months |
|
|
| Other Pre-specified | Testing Cost | Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time. | Not feasible to collect data for this outcome. | Posted | 24 months |
|
|
| 604 |
| 0 |
| 604 |
| 0 |
| 604 |
| EG001 | 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. | 0 | 599 | 0 | 599 | 0 | 599 |
| EG002 | Screen-Educate and Intensify Treatment | Education and treatment program to improve blood pressure control among hypertensive non-diabetic persons. 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. 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: 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. | 0 | 616 | 0 | 616 | 0 | 616 |
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