- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02059408
Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons
Can a Targeted Screen-and-treat Program for Chronic Kidney Disease Improve Blood Pressure (BP) Management Among Persons at High Risk for Complications ?
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
California
-
San Francisco, California, Yhdysvallat, 94121
- San Francisco Veteran Affairs Medical Center
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Ei väliintuloa: Usual Care
The patients in this arm will receive normal primary care.
|
|
|
Active Comparator: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Blood Pressure
Aikaikkuna: baseline, 12 months
|
Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,
|
baseline, 12 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
ACE/ARB Prescription by a Clinician
Aikaikkuna: 12 months
|
New use by end of the study
|
12 months
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Testing Time
Aikaikkuna: 24 months
|
Time in minutes to order and interpret tests.
Reported by Primary Care Providers and pharmacists.
|
24 months
|
|
Testing Cost
Aikaikkuna: 24 months
|
Reported by Primary Care Providers and pharmacists.
Cost in dollars of testing and pharmacist time.
|
24 months
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Carmen A Peralta, MD, MAS, San Francisco Veterans Affairs Medical Center
- Opintojohtaja: Erica Day, MPH, San Francisco Veterans Affairs Medical Center
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CP2014R34
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .