Design and study protocol for a cluster randomized trial of a multi-faceted implementation strategy to increase the uptake of the USPSTF hypertension screening recommendations: the EMBRACE study

Nathalie Moise, Erica Phillips, Eileen Carter, Carmela Alcantara, Jacob Julian, Anusorn Thanataveerat, Joseph E Schwartz, Siqin Ye, Andrea Duran, Daichi Shimbo, Ian M Kronish, Nathalie Moise, Erica Phillips, Eileen Carter, Carmela Alcantara, Jacob Julian, Anusorn Thanataveerat, Joseph E Schwartz, Siqin Ye, Andrea Duran, Daichi Shimbo, Ian M Kronish

Abstract

Background: The US Preventive Services Task Force (USPSTF) recommends out-of-office blood pressure (BP) testing to exclude white coat hypertension prior to hypertension diagnosis. Despite improved availability and coverage of home and 24-h ambulatory BP monitoring (HBPM, ABPM), both are infrequently used to confirm diagnoses. We used the Behavior Change Wheel (BCW) framework, a multi-step process for mapping barriers to theory-informed behavior change techniques, to develop a multi-component implementation strategy for increasing out-of-office BP testing for hypertension diagnosis. Informed by geographically diverse provider focus groups (n = 63) exploring barriers to out-of-office testing and key informant interviews (n = 12), a multi-disciplinary team (medicine, psychology, nursing) used rigorous mixed methods to develop, refine, locally adapt, and finalize intervention components. The purpose of this report is to describe the protocol of the Effects of a Multi-faceted intervention on Blood pRessure Actions in the primary Care Environment (EMBRACE) trial, a cluster randomized control trial evaluating whether a theory-informed multi-component strategy increased out-of-office testing for hypertension diagnosis.

Methods/design: The EMBRACE Trial patient sample will include all adults ≥ 18 years of age with a newly elevated office BP (≥ 140/90 mmHg) at a scheduled visit with a primary care provider from a study clinic. All providers with scheduled visits with adult primary care patients at enrolled ACN primary care clinics were included. We determined that the most feasible, effective implementation strategy would include delivering education about out-of-office testing, demonstration/instruction on how to perform out-of-office HBPM and ABPM testing, feedback on completion rates of out-of-office testing, environmental prompts/cues via computerized clinical decision support (CDS) tool, and a culturally tailored, locally accessible ABPM testing service. We are currently comparing the effect of this locally adapted multi-component strategy with usual care on the change in the proportion of eligible patients who complete out-of-office BP testing in a 1:1 cluster randomized trial across 8 socioeconomically diverse clinics.

Conclusions: The EMBRACE trial is the first trial to test an implementation strategy for improving out-of-office testing for hypertension diagnosis. It will elucidate the degree to which targeting provider behavior via education, reminders, and decision support in addition to providing an ABPM testing service will improve referral to and completion of ABPM and HBPMs.

Trial registration: Clinicaltrials.gov , NCT03480217 , Registered on 29 March 2018.

Keywords: Hypertension; Out-of-office testing; Primary health care.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study timeline

References

    1. Yang Q, Cogswell ME, Flanders WD, et al. Trends in cardiovascular health metrics and associations with all-cause and CVD mortality among US adults. JAMA. 2012;307(12):1273–1283.
    1. Clement FM, Chen G, Khan N, et al. Primary care physician visits by patients with incident hypertension. Can J Cardiol. 2014;30(6):653–660.
    1. Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014;129(3):e28–e292.
    1. Nwankwo T, Yoon SS, Burt V, Gu Q. Hypertension among adults in the United States: National Health and nutrition examination survey, 2011-2012. NCHS Data Brief. 2013(133):1–8.
    1. Frieden TR, Berwick DM. The "million hearts" initiative--preventing heart attacks and strokes. N Engl J Med. 2011;365(13):e27.
    1. Lovibond K, Jowett S, Barton P, et al. Cost-effectiveness of options for the diagnosis of high blood pressure in primary care: a modelling study. Lancet. 2011;378(9798):1219–1230.
    1. Krakoff LR. Cost-effectiveness of ambulatory blood pressure: a reanalysis. Hypertension. 2006;47(1):29–34.
    1. Wang YC, Koval AM, Nakamura M, Newman JD, Schwartz JE, Stone PW. Cost-effectiveness of secondary screening modalities for hypertension. Blood Press Monit. 2013;18(1):1–7.
    1. Piper MA, Evans CV, Burda BU, Margolis KL, O'Connor E, Whitlock EP. Diagnostic and predictive accuracy of blood pressure screening methods with consideration of rescreening intervals: an updated systematic review for the U.S. preventive services task force. Ann Intern Med. 2015;162(3):192–204.
    1. Pickering TG, James GD, Boddie C, Harshfield GA, Blank S, Laragh JH. How common is white coat hypertension? JAMA. 1988;259(2):225–228.
    1. Franklin SS, Thijs L, Hansen TW, O'Brien E, Staessen JA. White-coat hypertension: new insights from recent studies. Hypertension. 2013;62(6):982–987.
    1. Pickering TG, Levenstein M, Walmsley P. Differential effects of doxazosin on clinic and ambulatory pressure according to age, gender, and presence of white coat hypertension. Results of the HALT study. Hypertension and lipid trial study group. Am J Hypertens. 1994;7(9 Pt 1):848–852.
    1. Fagard RH, Staessen JA, Thijs L, et al. Response to antihypertensive therapy in older patients with sustained and nonsustained systolic hypertension. Systolic hypertension in Europe (Syst-Eur) trial investigators. Circulation. 2000;102(10):1139–1144.
    1. Mancia G, Fagard R, Narkiewicz K, et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) J Hypertens. 2013;31(7):1281–1357.
    1. Pickering TG, White WB, American Society of Hypertension Writing G ASH position paper: home and ambulatory blood pressure monitoring. When and how to use self (home) and ambulatory blood pressure monitoring. J Clin Hypertens (Greenwich) 2008;10(11):850–855.
    1. Krause T, Lovibond K, Caulfield M, McCormack T, Williams B, Guideline Development G Management of hypertension: summary of NICE guidance. BMJ. 2011;343:d4891.
    1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and Management of High Blood Pressure in adults. A report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Hypertension. 2018;71(19):e127–e248.
    1. Pickering TG, Miller NH, Ogedegbe G, Krakoff LR, Artinian NT, Goff D. Call to action on use and reimbursement for home blood pressure monitoring: executive summary. A joint scientific statement from the American Heart Association, American Society of Hypertension, and preventive cardiovascular nurses association. J Clin Hypertens (Greenwich). 2008;10(6):467–476.
    1. Turner JR, Viera AJ, Shimbo D. Ambulatory blood pressure monitoring in clinical practice: a review. Am J Med. 2015;128(1):14–20.
    1. Shimbo D, Kent ST, Diaz KM, et al. The use of ambulatory blood pressure monitoring among Medicare beneficiaries in 2007-2010. J Am Soc Hypertens. 2014;8(12):891–897.
    1. Kent ST, Shimbo D, Huang L, et al. Rates, amounts, and determinants of ambulatory blood pressure monitoring claim reimbursements among Medicare beneficiaries. J Am Soc Hypertens. 2014;8(12):898–908.
    1. Vasan RS, Beiser A, Seshadri S, et al. Residual lifetime risk for developing hypertension in middle-aged women and men: the Framingham heart study. JAMA. 2002;287(8):1003–1010.
    1. Ostchega Y, Zhang G, Kit BK, Nwankwo T. Factors Associated With Home Blood Pressure Monitoring Among US Adults: National Health and Nutrition Examination Survey, 2011-2014. Am J Hypertens. 2017;30(11):1126-1132. 10.1093/ajh/hpx101.
    1. Davis K. Investing in health care reform. N Engl J Med. 2009;360(9):852–855.
    1. Powell BJ, Beidas RS, Lewis CC, et al. Methods to improve the selection and tailoring of implementation strategies. J Behav Health Serv Res. 2017;44(2):177–194.
    1. Waltz TJ, Powell BJ, Fernández ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019;14(1):42.
    1. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6:42.
    1. Mangurian C, Niu GC, Schillinger D, Newcomer JW, Dilley J, Handley MA. Utilization of the behavior change wheel framework to develop a model to improve cardiometabolic screening for people with severe mental illness. Implement Sci. 2017;12(1):134.
    1. Carter EJ, Moise N, Alcantara C, Sullivan AM, Kronish IM. Patient barriers and facilitators to ambulatory and home blood pressure monitoring: a qualitative study. Am J Hypertens. 2018;31(8):919–927.
    1. Moher D, Schulz KF, Altman D, Group C The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY) 2005;1(1):40–45.
    1. McMillan SS, King M, Tully MP. How to use the nominal group and Delphi techniques. Int J Clin Pharm. 2016;38(3):655–662.
    1. Kronish IM, Kent S, Moise N, et al. Barriers to conducting ambulatory and home blood pressure monitoring during hypertension screening in the United States. J Am Soc Hypertens. 2017;11(9):573–580.
    1. Fusch PI, Ness LR. Are we there yet? Data saturation in qualitative research. Qual Rep. 2015;20(9):1408–1416.
    1. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the eighth joint National Committee (JNC 8) JAMA. 2014;311(5):507–520.
    1. Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? Patient Educ Couns. 2001;44(2):119–127.
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–1327.
    1. Bakken S, Ruland CM. Translating clinical informatics interventions into routine clinical care: how can the RE-AIM framework help? J Am Med Inform Assoc. 2009;16(6):889–897.
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–226.
    1. Huijg J, Gebhardt W, Crone M, Dusseldorp E, Presseau J. Discriminant content validity of a theoretical domains framework questionnaire for use in implementation research. Implement Sci. 2014;9(1):11.
    1. Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Admin Pol Ment Health. 2011;38(2):65–76.
    1. Singer JD, Willett JB. It’s about time: using discrete-time survival analysis to study duration and thetiming of events. J Educ Stat. 1993;18:155–195.
    1. Hedeker D, Siddiqui O, Hu FB. Random-effects regression analysis of correlated grouped-time survival data. Stat Methods Med Res. 2000;9(2):161–179.
    1. Greenland P, Peterson E. The new 2017 ACC/AHA guidelines "up the pressure" on diagnosis and treatment of hypertension. JAMA. 2017;318(21):2083–2084.
    1. Powell BJ, Waltz TJ, Chinman MJ, et al. A refined compilation of implementation strategies: results from the expert recommendations for implementing change (ERIC) project. Implement Sci. 2015;10:21.
    1. French SD, Green SE, O'Connor DA, et al. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the theoretical domains framework. Implement Sci. 2012;7:38.
    1. Redon J, Lurbe E. Ambulatory blood pressure monitoring is ready to replace clinic blood pressure in the diagnosis of hypertension: con side of the argument. Hypertension. 2014;64(6):1169–1174.
    1. Gardner SF, Schneider EF. 24-Hour ambulatory blood pressure monitoring in primary care. J Am Board Fam Pract. 2001;14(3):166-71.
    1. Ernst ME, Bergus GR. Favorable patient acceptance of ambulatory blood pressure monitoring in a primary care setting in the United States: a cross-sectional survey. BMC Fam Pract. 2003;4(1):15.
    1. Carrera PM, Lambooij MS. Implementation of out-of-office blood pressure monitoring in the Netherlands: from clinical guidelines to Patients' adoption of innovation. Medicine. 2015;94(43):e1813.
    1. Services USDoHaH . Healthy people 2010: understanding and improving health. 2. Washington, D.C.: Government Printing Office; 2000.
    1. Hajjar I, Kotchen JM, Kotchen TA. Hypertension: trends in prevalence, incidence, and control. Annu Rev Public Health. 2006;27:465–490.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner