Blood pressure checks and diagnosing hypertension (BP-CHECK): Design and methods of a randomized controlled diagnostic study comparing clinic, home, kiosk, and 24-hour ambulatory BP monitoring.
Adolescent
Adult
Aged
Aged, 80 and over
Ambulatory Care Facilities
Blood Pressure
Blood Pressure Determination
/ methods
Blood Pressure Monitoring, Ambulatory
/ methods
Community Pharmacy Services
Female
Humans
Hypertension
/ diagnosis
Male
Middle Aged
Research Design
Single-Blind Method
United States
Young Adult
Blood pressure
Blood pressure monitoring
Hypertension
Patient reported outcomes
Primary care
Randomized controlled trial
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
04 2019
04 2019
Historique:
received:
24
07
2018
revised:
14
12
2018
accepted:
04
01
2019
pubmed:
12
1
2019
medline:
17
6
2020
entrez:
12
1
2019
Statut:
ppublish
Résumé
The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols. Adults aged 18-85 without diagnosed hypertension and on no hypertension medication with elevated BPs in clinic and at the baseline research visit are randomized to one of 3 regimens for diagnosing hypertension: (1) clinic BPs, (2) home BPs, or (3) kiosk BPs; all participants subsequently complete ABPM. The primary outcomes are the comparability (with daytime ABPM mean systolic and diastolic BP as the reference standard) and acceptability (e.g., adherence to, patient-reported outcomes) of each method compared to ABPM. Longer-term outcomes are assessed at 6-months including: patient-reported outcomes, primary care providers' diagnosis of hypertension; and BP control. We report challenges experienced and our response to these. Enrollment began in May of 2017 with a target of randomizing 510 participants. BP thresholds for diagnosing hypertension in the US changed after the trial started. We discuss the stakeholder process used to assess and respond to these changes. BP-CHECK will inform which hypertension diagnostic methods are most accurate, acceptable, and feasible to implement in primary care.
Sections du résumé
BACKGROUND
The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols.
METHODS
Adults aged 18-85 without diagnosed hypertension and on no hypertension medication with elevated BPs in clinic and at the baseline research visit are randomized to one of 3 regimens for diagnosing hypertension: (1) clinic BPs, (2) home BPs, or (3) kiosk BPs; all participants subsequently complete ABPM. The primary outcomes are the comparability (with daytime ABPM mean systolic and diastolic BP as the reference standard) and acceptability (e.g., adherence to, patient-reported outcomes) of each method compared to ABPM. Longer-term outcomes are assessed at 6-months including: patient-reported outcomes, primary care providers' diagnosis of hypertension; and BP control. We report challenges experienced and our response to these.
RESULTS
Enrollment began in May of 2017 with a target of randomizing 510 participants. BP thresholds for diagnosing hypertension in the US changed after the trial started. We discuss the stakeholder process used to assess and respond to these changes.
CONCLUSION AND PUBLIC HEALTH IMPACT
BP-CHECK will inform which hypertension diagnostic methods are most accurate, acceptable, and feasible to implement in primary care.
Identifiants
pubmed: 30634036
pii: S1551-7144(18)30443-9
doi: 10.1016/j.cct.2019.01.003
pmc: PMC7067555
mid: NIHMS1559171
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03130257']
Types de publication
Clinical Trial Protocol
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-13Subventions
Organisme : Patient-Centered Outcomes Research Institute
ID : CER-1511-32979
Pays : United States
Informations de copyright
Copyright © 2019. Published by Elsevier Inc.
Références
Blood Press Monit. 2010 Aug;15(4):225-8
pubmed: 20216407
Qual Life Res. 2009 Sep;18(7):873-80
pubmed: 19543809
JAMA. 2014 Feb 5;311(5):507-20
pubmed: 24352797
Circulation. 2016 Jan 26;133(4):e38-360
pubmed: 26673558
Health Educ Q. 1988 Winter;15(4):351-77
pubmed: 3068205
Ann Intern Med. 2015 Feb 3;162(3):192-204
pubmed: 25531400
MMWR Suppl. 2013 Nov 22;62(3):144-8
pubmed: 24264505
Lancet. 2012 Dec 15;380(9859):2224-60
pubmed: 23245609
Am J Prev Med. 2005 Dec;29(5 Suppl 1):107-12
pubmed: 16389135
JAMA. 2003 May 21;289(19):2560-72
pubmed: 12748199
Blood Press Monit. 2004 Feb;9(1):19-23
pubmed: 15021074
J Am Coll Cardiol. 2018 May 15;71(19):e127-e248
pubmed: 29146535
Cochrane Database Syst Rev. 2009 Jul 08;(3):CD001841
pubmed: 19588327
Prev Med. 2001 Mar;32(3):230-8
pubmed: 11277680
Blood Press Monit. 2002 Aug;7(4):237-41
pubmed: 12198340
Blood Press Monit. 2008 Feb;13(1):49-54
pubmed: 18199924
J Clin Hypertens (Greenwich). 2014 Jan;16(1):14-26
pubmed: 24341872
Blood Press Monit. 2007 Aug;12(4):219-25
pubmed: 17625394
J Biopharm Stat. 2007;17(4):571-82
pubmed: 17613642
Nicotine Tob Res. 2009 Apr;11(4):394-403
pubmed: 19299409
Ann Intern Med. 2015 Nov 3;163(9):691-700
pubmed: 26457954
Ann Intern Med. 2015 Nov 17;163(10):778-86
pubmed: 26458123
J Am Soc Hypertens. 2015 Feb;9(2):123-9
pubmed: 25600420
J Clin Hypertens (Greenwich). 2008 Jun;10(6):467-76
pubmed: 18550937
Hypertens Res. 2014 Apr;37(4):253-390
pubmed: 24705419
Am J Prev Med. 2008 May;34(5):382-8
pubmed: 18407004
J Hypertens. 2015 Apr;33(4):755-62; discussion 762
pubmed: 25915880
J Clin Hypertens (Greenwich). 2014 May;16(5):320-2
pubmed: 24811572
Can J Cardiol. 2017 May;33(5):557-576
pubmed: 28449828
J Clin Hypertens (Greenwich). 2017 Jun;19(6):614-619
pubmed: 28452119
BMJ. 2002 Aug 3;325(7358):258-9
pubmed: 12153924
Blood Press Monit. 2018 Apr;23(2):103-111
pubmed: 29240564
Ann Intern Med. 2015 Feb 3;162(3):184-91
pubmed: 25531552
Res Q Exerc Sport. 1992 Mar;63(1):60-6
pubmed: 1574662
Blood Press. 2014 Feb;23(1):3-16
pubmed: 24359485
Can J Cardiol. 2015 May;31(5):549-68
pubmed: 25936483
Natl Health Stat Report. 2010 Nov 3;(27):1-32
pubmed: 21089986
Biom J. 2006 Apr;48(2):302-18
pubmed: 16708780
JAMA. 2014 Nov 19;312(19):1973-4
pubmed: 25399269