Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial

Alejandra Paniagua-Avila, Meredith P Fort, Russell E Glasgow, Pablo Gulayin, Diego Hernández-Galdamez, Kristyne Mansilla, Eduardo Palacios, Ana Lucia Peralta, Dina Roche, Adolfo Rubinstein, Jiang He, Manuel Ramirez-Zea, Vilma Irazola, Alejandra Paniagua-Avila, Meredith P Fort, Russell E Glasgow, Pablo Gulayin, Diego Hernández-Galdamez, Kristyne Mansilla, Eduardo Palacios, Ana Lucia Peralta, Dina Roche, Adolfo Rubinstein, Jiang He, Manuel Ramirez-Zea, Vilma Irazola

Abstract

Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.

Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.

Discussion: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.

Trial registration: ClinicalTrials.gov: NCT03504124. Registered on 20 April 2018.

Keywords: Cardiovascular disease; Guatemala; Health systems; Hypertension; Implementation science; Implementation strategies; Low-income and middle-income countries; Multicomponent program; Non-communicable diseases; Primary care.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study sites: intervention and control health districts
Fig. 2
Fig. 2
Trial flow chart. BP, blood pressure
Fig. 3
Fig. 3
Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) figure
Fig. 4
Fig. 4
Multicomponent hypertension control program: core intervention and implementation strategies. HTN, hypertension; BP, blood pressure

References

    1. Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet (London, England) 2012;380(9859):2224–2260. doi: 10.1016/S0140-6736(12)61766-8.
    1. GBD 2015 Risk Factors Collaborators Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet (London, England) 2016;388(10053):1659–1724. doi: 10.1016/S0140-6736(16)31679-8.
    1. Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, et al. Global disparities of hypertension prevalence and control: a systematic analysis of population-based Studies from 90 countries. Circulation. 2016;134(6):441–450. doi: 10.1161/CIRCULATIONAHA.115.018912.
    1. Danaei G, Finucane MM, Lin JK, Singh GM, Paciorek CJ, Cowan MJ, et al. National, regional, and global trends in systolic blood pressure since 1980: systematic analysis of health examination surveys and epidemiological studies with 786 country-years and 5·4 million participants. Lancet (London, England) 2011;377(9765):568–577. doi: 10.1016/S0140-6736(10)62036-3.
    1. Lanas F, Avezum A, Bautista LE, Diaz R, Luna M, Islam S, et al. Risk factors for acute myocardial infarction in Latin America: the INTERHEART Latin American study. Circulation. 2007;115(9):1067–1074. doi: 10.1161/CIRCULATIONAHA.106.633552.
    1. Pan American Health Organization. Central America Diabetes Initiative (CAMDI): survey of diabetes, hypertension and chronic disease risk factors. Villa Nueva, Guatemala 2006. Washington D.C: Panamerican Health Organization; 2007.
    1. Horvath K, Jeitler K, Siering U, Stich AK, Skipka G, Gratzer TW, et al. Long-term effects of weight-reducing interventions in hypertensive patients: systematic review and meta-analysis. Arch Intern Med. 2008;168(6):571–580. doi: 10.1001/archinte.168.6.571.
    1. Parker ED, Schmitz KH, Jacobs DR, Dengel DR, Schreiner PJ, Schreiner PJ. Physical activity in young adults and incident hypertension over 15 years of follow-up: the CARDIA study. Am J Public Health. 2007;97(4):703–709. doi: 10.2105/AJPH.2004.055889.
    1. Xin X, He J, Frontini M, Ogden L, Motsamai O, Whelton P. Effects of alcohol reduction on blood pressure: a meta-analysis of randomized controlled trials. Hypertens (Dallas, Tex 1979). 2001;38(5) [cited 2020 Jan 15]. Available from: .
    1. He FJ, MacGregor GA. Effect of longer-term modest salt reduction on blood pressure. Cochrane database Syst Rev. 2004;3:CD004937.
    1. Appel L, Moore T, Obarzanek E, Vollmer W, Svetkey L, Sacks F, et al. A clinical trial of the Effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997;336(16) [cited 2020 Jan 15]. Available from: .
    1. Steinberg D, Bennett GG, Svetkey L. The DASH diet, 20 years later. JAMA. 2017;317(15):1529. doi: 10.1001/jama.2017.1628.
    1. Fort MP, Paniagua-Avila A, Beratarrechea A, Cardona S, Figueroa JC, Martinez-Folgar K, et al. Stakeholder engagement in the translation of a hypertension control program to Guatemala’s public primary health care system: lessons learned, challenges, and opportunities. Glob Heart. 2019;14(2):155–163. doi: 10.1016/j.gheart.2019.05.005.
    1. Jaén CR, Stange KC, Nutting PA. Competing demands of primary care: a model for the delivery of clinical preventive services. J Fam Pract. 1994;38(2):166–171.
    1. Hickling J, Rogers S, Nazareth I. Barriers to detecting and treating hypercholesterolaemia in patients with ischaemic heart disease: primary care perceptions. Br J Gen Pract. 2005;55(516):534–538.
    1. Mills KT, Obst KM, Shen W, Molina S, Zhang H-J, He H, et al. Comparative effectiveness of implementation strategies for blood pressure control in hypertensive patients: a systematic review and meta-analysis. Ann Intern Med. 2018;168(2):110–120. doi: 10.7326/M17-1805.
    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. doi: 10.1097/MLR.0b013e3182408812.
    1. Victor B-M, Lopez-Davila L. The health system of Guatemala. Salud Publica Mex. 2011;53(2):S197–S208.
    1. Gaziano TA, Abrahams-gessel S, Denman CA, Montano M, Khanam M, Puoane T, et al. An assessment of community health workers’ ability to screen for cardiovascular disease risk with a simple, non-invasive risk assessment instrument in Bangladesh, Guatemala, Mexico, and South Africa: an observational study Thomas. Lancet Glob Health. 2015;3(9):e556-63.
    1. Gaziano TA, Young CR, Fitzmaurice G, Atwood S, Gaziano JM. Laboratory-based versus non-laboratory-based method for assessment of cardiovascular disease risk: the NHANES I follow-up study cohort. Lancet (London, England) 2008;371(9616):923–931. doi: 10.1016/S0140-6736(08)60418-3.
    1. Kirchner JE, Waltz TJ, Powell BJ, Smith J, Proctor EK. Dissemination and implementation research in health: translating science to practice. 2. New York: Oxford University Press; 2017. Implementation strategies; pp. 245–266.
    1. Whelton PK, Carey RM, Aronow WS, Casey DE, Collins KJ, Dennison Himmelfarb C, 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(6) [cited 2020 Jan 15]. Available from: .
    1. Ministerio de Salud Pública y Asistencia Social. Normas de Atencion Salud Integral para primero y segundo nivel 2018. Guatemala; 2018.
    1. Mendoza C, Fort M, deRamirez M, Cruz J, Ramirez-Zea M. Evaluation of a pilot hypertension management programme for Guatemalan adults. Health Promot Int. 2015:1–12 Available from: .
    1. Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, et al. Measurement of blood pressure in humans: a scientific statement from the American Heart Association. Hypertens (Dallas, Tex 1979) 2019;73(5):e35–e66.
    1. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons BG, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2) [cited 2020 Jan 15]. Available from: .
    1. He J, Irazola V, Mills KT, Poggio R, Beratarrechea A, Dolan J, et al. Effect of a community health worker-led multicomponent intervention on blood pressure control in low-income patients in Argentina: a randomized clinical trial. Jiang. 2018;318(11):1016–1025.
    1. Mills KT, Rubinstein A, Irazola V, Chen J, Beratarrechea A, Poggio R, et al. Comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertension control program in argentina. Am J Med Sci. 2014;348(2):139–145. doi: 10.1097/MAJ.0000000000000298.
    1. Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, et al. RE-AIM Planning and evaluation framework: adapting to new science and practice with a 20-year review. Front Public Health. 2019;7:64. doi: 10.3389/fpubh.2019.00064.
    1. McCreight MS, Rabin BA, Glasgow RE, Ayele RA, Leonard CA, Gilmartin HM, et al. Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs. Transl Behav Med. 2019;9(6):1002–1011. doi: 10.1093/tbm/ibz085.
    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. doi: 10.2105/AJPH.89.9.1322.
    1. Ramsey SD, Willke RJ, Glick H, Reed SD, Augustovski F, Jonsson B, et al. Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report. Value Health. 2015;18(2):161–172. doi: 10.1016/j.jval.2015.02.001.
    1. Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ. 1997;6(4):327–340. doi: 10.1002/(SICI)1099-1050(199707)6:4<327::AID-HEC282>;2-W.
    1. Augustovski F, Chaparro M, Palacios A, Shi L, Beratarrechea A, Irazola V, et al. Cost-effectiveness of a comprehensive approach for hypertension control in low-income settings in Argentina: trial-based analysis of the Hypertension Control Program in Argentina. Value Health. 2018;21(12):1357–1364. doi: 10.1016/j.jval.2018.06.003.
    1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289(19):2560–2572. doi: 10.1001/jama.289.19.2560.
    1. Fagard RH, Grassi G, Hall J, Harrap S, Lindholm LH, Schiffrin EL, et al. International Society of Hypertension Low and Middle Income Countries Committee: review of the goals of the Committee and of 5 years of ISH activities in low and middle income countries. J Hypertens. 2010;28(3):635–636. doi: 10.1097/01.hjh.0000368700.79444.c1.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel