A Multi-component Intervention to Reduce Gaps in Hypertension Care and Control in Medellin, Colombia
Phase: NA
Conditions: Hypertension
Sponsor: Institute of Tropical Medicine, Belgium

A Multi-component Intervention to 
Reduce Gaps in Hypertension Care and 
Control in Medellin, Colombia 
 
 
 
STUDY PROTOCOL AND STATISTICAL 
ANALYSIS PLAN 
dated: 29-Apr-2019 

 
Institute of Tropical Medicine - Nationalestraat 155, 2000 Antwerp, Belgium 
www.itg.be -  Foundation of Public Utility 0410.057.701 -  IBAN BE38 2200 5311 1172 
 
 
 
 
 
Institutional Review Board 
Dr. Tullia Battaglioli / Dr. E. Londoño Agudelo 
Department of Public Health 
IRB/AB/AC/101 
OUR REF. 
ATTACHMENT(S) 
ANTWERP 
1294/19 
9/05/2019 
 
 
 
Concerns: A multi-component intervention to reduce gaps in hypertension care and control in 
Medellin, Colombia; version 2.0, dated 29/04/2019 
 
Dear Colleague, 
I am pleased to inform you that after review by the Chair, the above mentioned protocol has been 
approved.  
We wish to remind you of the following important aspects: 
• 
It is the researchers’ responsibility to secure ethics approval in the study country(ies) as 
required by local regulations, before any study-related activities are started. 
• 
The IRB (+ EC UZA when applicable) should receive a yearly update report to the IRB at the 
latest one year after the approval date, and an end-of-study report.   
• 
In case you have any questions about data protection or the GDPR, please contact ITMs Data 
Protection Officer via informatieveiligheid@itg.be.  
• 
Research studies prospectively involving human participants should be registered in one of the 
WHO-accepted primary registers (e.g. www.clinicaltrials.gov).  
 
Kind regards, 
 
Dr. Raffaella Ravinetto 
Chairperson Institutional Review Board 
 

 
RESEARCH STUDY PROTOCOL  
 
A multi-component intervention to reduce gaps in hypertension care and 
control in Medellin, Colombia 
Version 2.0, Dated 29 APRIL 2019 
 
 
 
 
 
 
 
    
Sponsor/Coordinator: 
Institute of Tropical Medicine 
Nationalestraat 155 
B-2000 Antwerpen - Belgium 
Principal Investigator: 
Esteban Londoño. MD. MPH. ITM PhD 
Student 
 
 
 

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Title: 
A multi-component intervention to reduce gaps in hypertension care 
and control in Medellin, Colombia 
Version: 
Version 2.0 dated 29 APRIL 2019 
Partnering institutions: 
 
- 
Facultad Nacional de Salud Pública - Universidad de 
Antioquia, Medellín-Colombia: Prof. Rubén Darío Gómez, 
Prof. Paula Díaz, Gesis Viviana Pérez. 
- 
E.S.E. Metrosalud, Medellín-Colombia: Dr. Francisco 
López, Dr. Hernán Aguilar, Dr. José Manuel Vásquez, Dra. 
Norma Palacio. 
- 
Instituto Pedro Kouri (IPK), La Habana-Cuba. Dennis 
Pérez. 
- 
Gent University, Gent-Belgium: Prof. Patrick Van der 
Stuyft. 
 
 
 
Funder: 
Institute of Tropical Medicine, Antwerp-Belgium, with partial support 
from Metrosalud E.S.E., Medellin-Colombia. 
Sponsor: 
Institute of Tropical Medicine, Antwerp, Belgium 
ITM 
Coordinating 
Investigator: 
Tullia Battaglioli, Bruno Marchal. 
Department: 
Public Health 
Address: 
Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, 
Belgium 
Telephone: 
+32 3 247 07 81 
Fax: 
+32 3 247 62 58 
Email: 
tbattaglioli@itg.be 
 
 
 

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Contents 
STATEMENT OF COMPLIANCE & CONFIDENTIALITY ....................................................................... 5 
1.1 Background ................................................................................................................................... 7 
1.2 Rationale ....................................................................................................................................... 9 
2. STUDY OBJECTIVES ................................................................................................................. 11 
4. METHODS ............................................................................................................................... 13 
4.1 Study Setting, Population and Sampling Strategy .................................................................... 13 
4.1.1 Study setting ........................................................................................................................ 13 
4.1.2 Study population, Sampling, Sample Size and Power ......................................................... 13 
4.1.3 Inclusion and Exclusion Criteria ........................................................................................... 14 
4.1.4 Definitions ............................................................................................................................ 15 
4.2 Procedures .................................................................................................................................. 15 
4.2.1 Intervention ......................................................................................................................... 16 
4.2.2 Data Collection .................................................................................................................... 19 
4.2.2.1 Quantitative Data Collection ............................................................................................ 19 
4.2.3 Qualitative component ........................................................................................................ 20 
4.3 Data Analysis .............................................................................................................................. 21 
4.3.1 Quantitative Data Analysis .................................................................................................. 21 
4.3.2 Qualitative Data Analysis ..................................................................................................... 34 
5. ETHICAL ISSUES ...................................................................................................................... 35 
5.1 Ethical (and regulatory) Review ................................................................................................. 36 
5.2 Obtaining Informed Consents .................................................................................................... 36 
6. MONITORING AND QUALITY CONTROL ................................................................................... 37 
7. TIMELINE ................................................................................................................................ 37 
8. DATA MANAGEMENT AND ARCHIVING ................................................................................... 38 

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8.1 Data Management...................................................................................................................... 38 
8.2 Archiving ..................................................................................................................................... 38 
9. DISSEMINATION OF RESULTS .................................................................................................. 39 
10. REFERENCES ......................................................................................................................... 40 
11. LIST OF ABBREVIATIONS ....................................................................................................... 42 
12. ANNEXES .............................................................................................................................. 42 
 
 
 
 

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Statement of Compliance & Confidentiality 
 
The information contained in this study protocol is privileged and confidential. As such, it may not be 
disclosed unless specific permission is given in writing by the ITM or when such disclosure is required by 
federal or other laws or regulations. These restrictions on disclosure will apply equally to all future 
information supplied which is privileged or confidential. 
 
Once the final protocol has been issued and signed by the Investigator(s) and the authorized signatories, 
it cannot be informally altered. Protocol amendments have the same legal status and must pass 
through the mandatory steps of review and approval before being implemented. 
 
By signing this document, the Investigator commits to carry out the study in compliance with the 
protocol, the applicable ethical guidelines like the Declaration of Helsinki, the ESF/ALLEA Code of 
Conduct for Research Integrity, and consistent with international scientific standards as well as all 
applicable regulatory requirements. The Investigator will also make every reasonable effort to complete 
the study within the timelines designated. 
 
 
 
PRINCIPAL INVESTIGATOR: 
 
 
Title, Name: Esteban Londoño. MD. MPH. PhD Student 
Date: 
05/02/2019 
 
Signed: 
 
 
 
 
 
 
 
ITM COORDINATING INVESTIGATOR: 
 
 
Title, Name: Tullia Battaglioli. MD. MSc. PhD. 
Date: 
05/02/2019 
 
Signed: 
 
 
 
 
 
 
 
 
 

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Synopsis 
Uncontrolled hypertension is a key factor in the rising epidemic of cardiovascular diseases (CVD), 
especially in low and middle income countries (LMIC). Nevertheless, research on the main gaps in 
hypertension care and control and studies evaluating health services interventions to improve 
hypertension care in LMIC remain scarce. The US Centers for Disease control and Prevention and the 
Pan American Health Organization recently developed the Standardized Hypertension Treatment and 
Prevention (SHTP) Project, which was followed by the World Health Organization’s initiative “Hearts in 
the Americas”. Both projects provide a practical approach to improve CVD prevention and management 
using hypertension as the entry point.  
In Colombia, 30% of all deaths and 16% of Years of Life Lost can be attributed to CVD. A cross-sectional 
survey carried out in 2016 in a low-income community in Medellin, aimed to estimate the prevalence of 
hypertension among the population aged 35 years or older and the magnitude and the determinants of 
the main gaps in hypertension care and control (utilization of health services, diagnosis, treatment, 
follow-up) showed a prevalence of hypertension of 43.4%. Among all hypertensive individuals, 36.7% 
were unaware of their diagnosis. Among the aware hypertensives, 41% had uncontrolled hypertension; 
55% of unaware hypertensives had accessed health care in the previous year but health services had 
failed to diagnose them. 
Based on the technical recommendations contained in the SHTP Project, the Technical Package of the 
“Hearts in the Americas” initiative, on the results of the above-mentioned cross-sectional survey and in 
consultation with the local partners (Metrosalud and the University of Antioquia) and community 
leaders, a multi-component intervention for the improvement of hypertension care and control was 
designed. The components of the intervention integrate activities related to: A) Health services 
organization, B) Training of clinical staff and C) Patients and community engagement.  
The effectiveness of the intervention in reducing the gaps in hypertension care and control will be 
evaluated in a quasi-experimental, controlled before-after trial, with an intervention arm (a commune 
of Medellin) where the intervention is deployed and a control arm (another commune of Medellin, with 
similar socio-economic characteristics) where routine care is implemented. As baseline, the results of 
the population-based cross-sectional study “Gaps in hypertension care and control in Medellin, 
Colombia: cross-sectional survey in two Communes”, Version 2.0, dated 26-AUG-2018, approved by the 
UZA Ethics committee on 15/10/2018, will be used. Two years after the start of the intervention, a 
repeat survey using the same methodology as in the baseline will be carried out in the two communes. 
The main outcomes (gaps in hypertension care and control) will be assessed with difference in 
difference measures (endline-baseline changes in the intervention minus endline-baseline changes in 
the control commune).  
The study aims at contributing to the improvement of hypertension care and control in Colombia and 
may inspire and inform with scientific evidence other initiatives for better chronic care in LMIC, 
especially 
in 
Latin 
America.

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1. INTRODUCTION 
1.1 Background 
Non-communicable diseases (NCD) are estimated to account for 63% of global mortality nowadays 
and it is predicted that they will account for around 70% of global deaths by 2030(1). NCD are 
especially worrying for developing countries, where their incidence is increasing disproportionately. 
Four out of five deaths caused by chronic conditions occur in low and middle-income countries 
(LMIC)(2). NCD are also the first cause of mortality and disability in Latin America and the Caribbean 
(LAC)(3). Notwithstanding, the majority of health systems provide inadequate chronic diseases 
management, with health services mainly designed for acute curative care. Chronic care, especially 
in developing countries, is often reduced to the belated management of acute exacerbations of 
chronic illnesses in specialized settings and at high costs. Consequently, only about one in ten people 
with chronic conditions are treated successfully(3) and most out-of-pocket health payments and 
catastrophic expenditure are related to these conditions(4).  
Uncontrolled hypertension is the main modifiable risk factor for cardiovascular diseases (CVD) and 
the related cause of more than 10 million deaths each year(2). Approximately 65% of deaths due to 
stroke and 50% of deaths due to ischemic heart disease are attributable to uncontrolled 
hypertension. Furthermore, almost three quarters of people suffering from hypertension (650 
million people) live in developing countries, where disease awareness is very low and access to 
health care is very limited(2;5). Hence, the risk of dying from hypertension at all ages is more than 
double in LMIC compared to high income countries (HIC)(6). 
CVD are significantly related to premature mortality and disability, hampering economic growth and 
social development. Current epidemiological data point to CVD striking the working middle-age 
population in LMIC(7). An estimated 1.6 million people die from CVD every year in LAC (38% of all 
deaths), half a million of them before 70 years of age(8). High disease prevalence and poor 
hypertension control are pivotal factors in the rising epidemic of CVD in LMIC(5). Nevertheless, very 
limited descriptive research in this field has been conducted in LMIC(9). A more in depth assessment 
of the actual hypertension care and control coverage in LMIC is necessary. Such health coverage 
evaluation, as stated by Tanahashi(10), requires an assessment at population level. 
The recent Prospective Urban Rural Epidemiology (PURE) study in 3 HIC and 14 LMIC(11), found an 
average age-standardized prevalence of hypertension of 27.7% in adults aged 35 to 70 years. Only 
46.5% of participants were aware of their condition; among those aware, 87.5% were receiving 

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pharmacological treatment but only a minority of treated patients (32.5%) were controlled. The 
PURE study provided relevant information regarding international rates of hypertension awareness, 
treatment and control. However, it did not explore the health coverage gaps throughout the 
hypertension continuum of care nor their determinants. The hypertension continuum of care is a 
dynamic and interrelated process, from detection to control, that includes access to health services, 
diagnosis, treatment and follow-up. We define gaps in hypertension care and control as the 
differences between the actual state of the main components of the continuum of care in a given 
context and time, compared to the optimal state of each of these components, according to the 
available evidence and/or the international standards. 
There are studies trying to identify patient and health care provider barriers to hypertension care(9), 
most of them carried-out in HIC and gathering information at health facility level, without including 
any population assessment. As a result, there is scarce evidence on the main determinants of the 
gaps in hypertension care and control, especially regarding access to health services and 
hypertension diagnosis in LMIC. 
The Chronic Care Model(12) and its expanded version(3) are the main international references to 
guide interventions for improving chronic disease management. Nevertheless, studies evaluating 
health services interventions to improve hypertension care in LMIC are still much more scanty than 
purely descriptive research. Notwithstanding, in order to provide a practical approach to improve 
CVD prevention and management using hypertension as the entry point, the US Centers for Disease 
control and Prevention and the Pan American Health Organization developed the Standardized 
Hypertension Treatment and Prevention (SHTP) Project(2). The SHTP Project identified six key 
elements of standardized hypertension management to be addressed to strengthen health systems 
at primary care level and to improve hypertension control, using evidence-based interventions(2): 
guideline-based standardized treatment protocols; medications; registries for cohort monitoring and 
evaluation; patient empowerment; team-based care system; community engagement. This 
approach was reinforced by the World Health Organization global initiative “Global Hearts” through 
the Technical Package for Cardiovascular Disease Management in Primary Health Care(13). 
In summary, research to document the main gaps and barriers hampering hypertension care and 
control at population level in LMIC is needed. Furthermore, operational research aimed to improve 
hypertension care and control and to reduce CVD morbidity and mortality is urgently required 
throughout the Latin America region. 

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1.2 Rationale 
In Colombia, the death rate from CVD in 2014 was 146.9 per 100.000 population. In this country, 30% 
of all deaths and 16.3% of Years of Life Lost can be attributed to CVD (14). The Colombian health 
system is divided in two different regimes, according to individuals’ payment capacity. People able to 
contribute to the social security system and their beneficiaries are affiliated to the Contributory 
Regime, which is compulsory for formal employees and pensioners. The Subsidized Regime is 
financed by the State and covers the poor un-employed or informal-employed population. In 
Colombia, in the context of a market-oriented health system, cost-containment mechanisms 
imposed by health insurance companies often hamper timely access to health care, especially for 
those chronically ill, generating harmful consequences to people’s lives (15).  
In 2016 we carried out a cross-sectional survey in a low-income urban community in Medellin, aimed 
to estimate the prevalence of hypertension among the population aged 35 years or older and the 
magnitude and the determinants of the main gaps in hypertension care and control (Table 1).  
Table 1. Main Gaps in hypertension care and control – definitions. 
Gap 
Numerator 
Denominator 
Remarks 
Diagnosis  
Number of unaware 
hypertensive 
individuals 
The total surveyed 
population 
Also calculated for 
hypertensives (nr. 
unaware /total 
hypertensives) 
Pharmacological 
treatment 
Number of aware 
hypertensive 
individuals who 
received prescription 
of antihypertensive 
medications but do 
not take any 
antihypertensive 
drug 
Aware hypertensive 
individuals who 
received prescription 
of antihypertensive 
medications  
 
Follow-up 
Number 
of 
aware 
hypertensive 
individuals who did 
not receive a follow-
up consultation in the 
last year 
Number 
of 
aware 
hypertensive 
individuals 
 

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Control  
Number of aware 
hypertensives with 
uncontrolled 
hypertension + 
Number of unaware 
hypertensives  
The total 
hypertensive 
population (aware + 
unaware) 
Also calculated in 
subgroup aware 
hypertensives  
 
The study showed a prevalence of hypertension of 43.4%. Among the total hypertensive individuals, 
36.7% were unaware of their diagnosis. Of the aware hypertensives, 93% had been prescribed 
pharmacological treatment, but 7% of those who had been prescribed treatment were not taking any 
medication and only 65% of those taking treatment referred treatment compliance. Moreover, 15% 
of the aware hypertensives did not have any follow-up consultation during the previous year. Among 
the aware hypertensives, 41% had uncontrolled hypertension. Nineteen percent of aware 
hypertensives and 45% of unaware hypertensives did not have contact with formal health services in 
the last year, mainly because they did not feel the need. On the other hand, 55% of unaware 
hypertensives accessed to health care in the previous year but health services failed to diagnose 
them.  
Studies specifically aimed at reducing the gaps and barriers to hypertension care and control at 
population level in the country are needed.  
The results of the baseline study, the possible determinants of the identified gaps and potential 
solutions were discussed in a workshop held in Medellin-city, with the participation of ITM staff, the 
University of Antioquia and Metrosalud. A summary of the identified potential determinants of the 
main gaps, mainly related to disease detection and quality of care, is presented in Table 2. 
 
 

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Table 2. Potential determinants at health provider, population and health system level of the main 
health coverage gaps for hypertension care and control in the Santa Cruz Commune 
Hypertension 
Coverage Gap / 
Source of barriers 
Health Provision 
Population 
Health Services 
Diagnosis Gap 
- 
No measurement of 
blood pressure during 
health care contacts 
- 
High blood pressure is 
detected but 
confirmation of 
diagnosis fails due to 
lack of continuity of 
care 
- 
Low risk 
perception of 
hypertension 
- 
Mild or no 
symptoms 
determine health 
seeking  
- 
Passive and 
fragmented health 
services 
- 
Limited opening 
hours of services for 
hypertension 
detection  
Quality 
of 
care 
(treatment 
and 
follow-up) 
- 
No pharmacological 
advise/consultation 
- 
Limited communication 
skills of health staff and 
poor doctor-patient 
relationship 
- 
Interrupted delivery of 
essential anti-
hypertensive drugs  
- 
Low awareness of 
the importance of 
non-
pharmacological 
measures 
- 
Low educational 
level 
 
- 
Scarcity of essential 
anti-hypertensive 
drugs 
- 
Administrative 
barriers imposed to 
patients and health 
providers 
Based on the technical recommendations contained in the SHTP Project and the “Hearts in the 
Americas” initiative, on the results of the baseline study and in consultation with the local partners 
(Metrosalud - the main public health care provider of Medellin city - and the University of Antioquia) 
and community leaders, we designed, during repeated workshops, a multi-component intervention 
for the improvement of hypertension care and control in individuals aged 35 years or older in 
Medellin.  
 
2. STUDY OBJECTIVES 
Main objective:  
To implement and evaluate the effectiveness of a multi-component intervention with evidence-
based activities, to reduce the gaps in hypertension care and control at population level 
Secondary objectives: 

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- 
To improve the quality of hypertension care provided by the public primary health care services 
in the Commune 2-Santa Cruz.  
- 
To increase detection of hypertension by blood pressure screening outside the clinical settings 
and contribute to the public awareness on the importance of healthy behaviour and self-care to 
prevent cardiovascular diseases. 
- 
To carry out a process evaluation of the intervention and its implementation fidelity in order to 
assess to which degree the components of the intervention were implemented as intended and 
how the intervention actually influenced hypertension control outcomes.  
 
3. STUDY DESIGN 
A multi-component intervention for the improvement of hypertension care and control in 
individuals aged 35 years or older will be implemented and evaluated. The components of the 
intervention integrate activities related to: A) Health services organization, B) Training of clinical 
staff, and C) Patients and community engagement. The effectiveness of the intervention in reducing 
the gaps in hypertension care and control will be evaluated in a quasi-experimental, controlled 
before-after trial, with an intervention arm (a commune of Medellin) where the intervention is 
deployed, and a control arm (another commune of Medellin, with similar characteristics) where 
routine care is implemented. As baseline, the results of the population-based cross-sectional study 
“Gaps in hypertension care and control in Medellin, Colombia: cross-sectional survey in two 
Communes”, Version 2.0, dated 26-AUG-2018 approved by the UZA Ethics committee on 
15/10/2018, will be used. Twenty-four months after the start of the intervention, a population-
based cross-sectional survey with similar methodology as the baseline survey will be carried out in 
the intervention and control commune. The main outcomes (magnitude of the gaps in hypertension 
care and control) will be assessed with difference in difference measures (endline-baseline changes 
in the intervention minus endline-baseline changes in the control commune). The total duration of 
the study will be 32 months, of which 24 allocated to the implementation of the intervention. 
Implementation fidelity will be evaluated  in order to assess to which degree the components of the 
intervention were implemented as intended and how the intervention actually influenced 
hypertension control outcomes. 

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The proposed research is part of a concerted effort within the Latin American Network for 
Multidisciplinary Research on Chronic Diseases, which is co-coordinated by the principal investigator 
of the study, Dr Esteban Londoño. This is a regional network for multidisciplinary research on the 
prevention and control of chronic non-communicable diseases in Latin America, comprised of 
partner institutions and supported by ITM (Unit of General Epidemiology and Disease Control). 
Parallel studies, following comparable research protocols and applying data collection tools with a 
common core part, are being conducted in Havana-Cuba and Quito-Ecuador. 
The study is part of the PhD research of Dr Esteban Londoño entitled “Addressing gaps in 
hypertension care and control in Medellin, Colombia: formative research, multi component quasi-
experimental intervention”. 
 
4. METHODS 
4.1 Study Setting, Population and Sampling Strategy 
4.1.1 Study setting 
Medellin is the capital of the department of Antioquia, in Colombia. It has a population of 2,5 million 
people and 16 Communes. The intervention will be implemented in the “Santa Cruz” Commune, 
located in the northeast side of Medellin. It has 11 neighbourhoods, an area of 2.2 Km2, a total 
population of 113.024 inhabitants (53% women and 47% men) in 2018. In Santa Cruz, Metrosalud 
counts with a Hospital Unit and two health centers. In Metrosalud diagnosed hypertensive patients 
are enrolled in the Cardiovascular Risk Program (CVRP) that foresees periodic consultations for the 
management of their hypertension, called cardiovascular risk consultations. Different community 
organizations, represented by community leaders, have been supporting Metrosalud´s work in 
community- and health-related activities for many years. The Commune 6-“Doce de Octubre” has 
been selected as control area. It is located in the northwest side of Medellin, has 12 neighbourhoods, 
an area of 3.8 km2, and a total 2018 population of 193.657 inhabitants (53% women and 47% men). 
The commune was chosen purposively, especially due to its socio-economic similarities with the 
Santa Cruz Commune and after discussion with the Director General of Metrosalud, who approved 
the selection of these two areas.  
4.1.2 Study population, Sampling, Sample Size and Power 

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The study communes are chosen purposively according to the following inclusion criteria: urban 
setting; low and/or middle-income population; typical functioning of the national health system; 
commitment of the main actors in health care provision in the area to develop improvement 
programmes based on research results.  
All health structures and their catchment population aged 35 years or older will be involved in the 
study.  
For the endline survey, the same methodology applied for the aforementioned baseline survey will 
be used. Expecting a baseline hypertension control gap of 45%, a sample of 280 hypertensive 
individuals 35 years or older is required to estimate a 10% difference in the magnitude of the control 
gap in the intervention vs the control area at endline, with power 0.75 and alfa 0.10. Given a 40% 
prevalence of hypertension (see 4.1.4 for definitions) in individuals aged 35 years or older, screening 
around 700 individuals 35 years or older in each Commune, will allow to find the needed number of 
hypertensive individuals. This is increased to 1150 individuals, assuming a percentage of non-
response of 10% and a design effect of 1.5, given the sampling strategy outlined below. From a 
sampling frame containing the addresses of all homes of the Communes, provided by the Planning 
Office of the Municipality, a stratified one-stage cluster sampling will be implemented in order to 
obtain a representative sample of the population aged 35 years or older living in the selected 
Communes. Considering that in households there are on average 1.5 individuals 35 years old or 
older, 765 households will be included in each Commune. In each Commune, clusters of 15 
contiguous households will be defined with the help of maps and 51 clusters will be selected by 
randomly sampling each neighbourhood of the Commune. The number of randomly selected 
clusters in each neighbourhood will be proportional to the neighbourhood size (weights assigned to 
each neighbourhood according to its total number of households). The module for complex samples 
of the Statistical Package for Social Sciences (SPSS) V.24 (SPSS Inc., Chicago, IL, USA) will be used. 
Door to door visits to every single household of each selected cluster will be made by a group of 
trained surveyors. All identified eligible consenting individuals aged 35 years or older will be 
interviewed. 
4.1.3 Inclusion and Exclusion Criteria  
- In order to be eligible for the endline survey, study participants must meet the following criteria: 
» Aged 35 years or older 

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» Permanent inhabitant of the selected Commune 
» Willing and able to provide written informed consent. 
 
 

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- In order to be eligible for in-depth interviews and non-participant observation (qualitative 
component): 
» Adult patient aged 35 years or older or health staff of Metrosalud. 
» Active participant of any component of the intervention or subject of any intervention 
activity. 
» Willing and able to provide written informed consent. 
 
Potential participants meeting any of the following criteria will not be enrolled in the study: 
» Mental disability or unable to answer the questionnaire. 
4.1.4 Definitions  
Hypertensive individual (operational definition for survey): self-report of previously diagnosed 
hypertension or without previous diagnosis but presenting an average blood pressure (BP) 
measurement higher than 140/90 mmHg(11;16).  
Presumptive hypertensive individual: no self-report of previously diagnosed hypertension but 
presenting an average BP measurement higher than 140/90 mmHg. 
Controlled hypertensive individual: self-report of previously diagnosed hypertension and an average 
BP less than 140/90 mm Hg for patients between 35 and 59 years old or diabetics and 150/90 mm 
Hg for patients aged 60 years or older (17).  
 
4.2 Procedures 
A multi-component intervention, detailed below, will be implemented in the intervention area, 
while standard hypertension care will be provided in the control area.  
Each intervention component will be standardized and described in a field manual for the 
improvement of hypertension management. For each component we will clearly define: 
subcomponents or activities specifying implementation level and units, responsible, target 
population, content, methodology and way of delivery, time, duration, key improvement factors, 
functioning principles and expected results per activity. 
A logic model of the intervention will be elaborated to provide a graphical depiction of the inputs, 
processes, immediate, short-term, and long-term outcomes, and the relationship and sequence 
between the different intervention components and critical points in the implementation process as 
a whole. Critical points are stages or activities in the process, susceptible to be measured, in the 

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absence of which other stages or activities cannot be implemented. The intervention activities will be 
implemented by Metrosalud staff of the health structures in the Commune with technical assistance 
from the investigation team. 
4.2.1 Intervention 
The components of the intervention aim to integrate activities related to: A) Health services 
organization, B) Training of clinical staff, and C) Patients and community engagement. Taken 
together, through these components, most elements of the SHTP project and the Technical Package 
for Cardiovascular Disease Management in Primary Health Care(13) will be covered in a context-
adapted intervention.  
A. Health services organization 
A.1. Hypertension screening: 1) all adults aged 35 years or older presenting to any health service 
(including clinical and support services) will be asked if they had their BP measured in the 
previous year. If not, they will be referred to a specific nursing hypertension service 
(“Healthy Hearts” service, see A.2 below) for a BP measurement, using a ticket stub for 
referral. 2) Doctors and nurses encountering presumptive hypertensive patients (individuals 
not reporting a previous diagnosis of hypertension but presenting BP higher than 140/90), 
will refer them to the “Healthy Hearts” service for confirmation of the diagnosis with serial 
BP measurement. 3) The entire health care flow for patients with a high BP measurement 
within health facilities will be standardized in order to guarantee continuity of care and 
correct diagnosis.  
A.2. “Healthy Hearts” service: an auxiliary nursing station with extended opening hours and 
providing services such as BP measurement, global cardiovascular risk assessment and 
preventive counselling. It oversees serial self-measured BP monitoring within the health 
facility premises to exclude white coat hypertension, providing devices and patient 
education on self BP measurement. It will ensure retention and follow-up of all people with 
a high BP measurement at screening (at service level or in the community - see C.2 below) in 
order to guarantee that final diagnosis (hypertensive or not) is reached. It will refer to 
clinicians of the CVRP all newly diagnosed hypertensive patients. Through phone calls 
and/or SMS to patients and linkage with community agents, it will promote effective referral  
and manage non-attendance to follow-up CVRP consultations. It will administer periodical 
anonymous exit-questionnaires (annex 6) to hypertensive patients exiting from CVRP 

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consultations in order to assess effective BP measurement and the quality of 
pharmacological and non-pharmacological advice during medical consultations. Results will 
be transmitted to the cardiovascular risk team (see A.3.1 below). 
A.3. Improvement of clinical management of patients with hypertension 
A.3.1. Creation of the cardiovascular risk team (CVRT), which will include the head and one 
leading medical doctor of the hospital unit,  and the coordinating doctors of the two 
health centres. The CVRT will be responsible of supervising good clinical management 
of hypertension. It will conduct audits of clinical records, periodically selecting a 
representative sample of clinical records of hypertensive patients and using a 
structured questionnaire – see annex 5 - to evaluate if the clinical records fulfil the 
requirements of a complete cardiovascular risk assessment interview and physical 
examination, doctors’ adherence to the hypertension management guideline and some 
parameters to assess the quality of the provided health care. The CVRT will also provide 
regular active feedback and support to health professionals involved in the CVRP. It will 
also supervise the Healthy Hearts service. 
A.3.2. Guideline-based standardized diagnostic and treatment protocols: before the start of 
the intervention, the diagnostic algorithm will be standardized and a simplified and 
implementable drug treatment algorithm will be defined, based on the national clinical 
guidelines and in agreement with the general direction of Metrosalud, the direction of 
the health area and the clinical staff. A core set of antihypertensive medications will be 
identified and primary and secondary options will be defined for each of the major 
pharmacologic classes of antihypertensive drugs (diuretics, angiotensin-converting 
enzyme inhibitors/angiotensin II receptor blockers, calcium channel blockers and Beta-
blockers). 
A.4. Availability of antihypertensive medications: the availability of the defined core set of 
antihypertensive medications will be assured through the central store of Metrosalud. Any 
(un-)availability of antihypertensive medications will be communicated to clinicians at the 
beginning of each week and ad hoc in case of intervening stock-out, in order to timely 
inform them on possible alternative prescription. 
 
 

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B. Staff Training 
B.1. Training of clinical staff on good clinical management of hypertension focused on correct BP 
measurement, use of evidence-based guidelines, cardiovascular risk assessment, use of 
standardized diagnostic and treatment algorithm, correct prescription of non-
pharmacological treatment and anti-hypertensive drugs, patient counselling, and how to 
tackle clinical inertia. The content, duration, responsible staff and target groups for the 
training component of the intervention is outlined in annex 1. 
B.2. Training of all health workers involved in hypertension care (doctor, nurses, pharmacists and 
other non-medical staff) on communication skills and patients’ needs assessment. This 
training will be designed under the “patient-centered medicine” framework (14), aiming at 
equipping health providers with tools for understanding patients’ unique feelings and 
experience of illness, and to improve their capacity to detect and address social, 
psychological and behavioural dimensions of hypertension care and control. 
C. Patients and community engagement 
C.1. Patient empowerment: sessions where “expert hypertensive patients” will provide support 
and peer-education to other patients in need, such as those newly diagnosed or non-
adherent to treatment or with uncontrolled hypertension, under the supervision of a social 
worker. 
C.2. Community engagement: A Community Hypertension Outreach Group (CHOG) will be set 
up, composed by three voluntary community health workers who will be trained and 
certified. The CHOG will be created in partnership with the patients’ association, which is a 
very dynamic organization already present in the Commune and interested in engaging in 
the project. The CHOG will conduct screening activities with measurements of BP in selected 
public areas of the commune on a weekly rotation basis, for all adults without BP readings in 
the previous year and referral of those with a positive screening to the nearest health 
facility for diagnosis confirmation. The CHOG will provide health education with emphasis 
on healthy lifestyles (tobacco cessation, physical activity and healthy diet). It will contribute 
to increase community awareness on the importance of hypertension control and on 
cardiovascular risk detection and prevention. Existing local communication channels such as 
the community radio and the local newspaper will also be used.  
 
 

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4.2.2 Data Collection 
4.2.2.1 Quantitative Data Collection 
 
4.2.2.1.1 Endline population based survey: 
The structured questionnaire “Gaps in hypertension care and control in Medellin, Colombia” (annex 
2 to this protocol and Annex 12.1 in protocol “Gaps in hypertension care and control in Medellin, 
Colombia: cross-sectional survey in two Communes”, Version 2.0, dated 26-AUG-2018,) will be used. 
The survey questionnaire has been standardized within the Latin American Network for Research on 
Chronic Diseases for being applied in Colombia, Cuba and Ecuador and has also be validated for each 
country.  
Participants will be interviewed on their socio-demographic characteristics, health seeking 
behaviour, risk factors (e.g. smoking, alcohol abuse, physical inactivity) and previous and current 
health problems (e.g. diabetes, dyslipidaemia). Those referring previous diagnosis of hypertension 
will be asked on their treatment, follow-up, anti-hypertensive pharmacological and non-
pharmacological treatment and compliance with the treatment.  
4.2.2.1.2. Data collection at health services: 
 
Data sources: databases of the Subsidized Regimen and of the non-insured poor population, 
electronic clinical and billing records of Metrosalud, registers of the “Healthy Hearts” service (Annex 
3, 4 and 5), exit-interview forms (Annex 6), audit form (Annex 7, an adapted format for the audit of 
clinical records in use at Metrosalud), lists of participants and minutes of meetings and training 
activities, test results during trainings, registers and inventory at the pharmacy service, and report of 
activities by health professionals. 
Besides the data explicitly mentioned in the annexes and tables of this protocol, we will collect the 
data mentioned below. 
Data extracted from the databases of the Subsidized Regimen and of the non-insured poor 
population (data will be extracted either in the intervention and in the control commune): 
- 
the total adult population (by sex, age, place of living and health insurance affiliation)for whom 
Metrosalud is responsible in the catchment area (target population). 

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Data extracted from the billing and electronic clinical records of Metrosalud (data will be extracted 
either in the intervention and in the control commune): 
-number of patients enrolled in the CVRP. 
-regarding patients enrolled in the CVRP: sex, age, frequency and results of cardiovascular risk 
assessment, prescribed pharmacological/non-pharmacological treatment, BP figures, major 
comorbidities and complications. 
-number of patients who have missed a hypertension-related appointment 
 4.2.3 Qualitative componentThe qualitative component will be carried out by a social scientist with 
previous experience in the use of qualitative methods, under the supervision of a senior sociologist 
from the Latin American Network for Multidisciplinary Research on Chronic Diseases with expertise 
in implementation fidelity.  
We will collect data concerning the implementation process and its fidelity, following the modified 
version of the Conceptual Framework for Implementation Fidelity (18; 19). This framework defines 
fidelity as a measurement of adherence, with its subcategories: content, frequency, duration, and 
coverage (dose). It identifies six moderating factors: comprehensiveness of intervention description, 
strategies to facilitate implementation, quality of delivery, recruitment, participant responsiveness, 
and context (20). The nature of adaptations that are likely to occur during implementation and their 
implication for fidelity should be also analysed prospectively for each intervention (21). 
Our fidelity assessment will focus on all intervention components. Data collection methods will 
include non-participant observations, key informant interviews and document analysis. To measure 
the subcategories of adherence, specific forms will be created for self-registration for each 
component of the intervention. All actors responsible with the implementation will be trained in self-
registration of all the activities. Self-registration forms will be collected monthly.  
This information will be used to monitor the process and identify those activities and relevant actors 
that will be subject of interviews and non-participant observations. The observation will have the 
purpose to triangulate self-registration information by providing real-time information on whether 
actual implementation is done according to the plan. Observations will be accompanied by semi-
structured interviews to clarify the observed practices, moderating factors, adaptations introduced 
by the different stakeholders and possible explanations for adaptations. Observation and semi-
structured interviews will be systematically applied to a purposive heterogeneous sample of 

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implementation units and actors. While exploring moderating factors, a specific section will be 
added to the semi-structured interview guide to explore socio-economic evolutions, health system & 
service changes and other activities and events that might bear on the outcomes. Similar aspects will 
be explored also in the control area.  
The overall experience of patients with the implementation of the intervention will be explored 
through in-depth interviews, carried out at different phases of implementation. The estimated 
sample size for the interviews will be 25 – 30 for each phase. Data saturation will be taken into 
consideration. The qualitative data collection will fit the overall process evaluation plan.  
4.3 Data Analysis 
4.3.1 Quantitative Data Analysis 
The main outcomes (dependent variables) of the analysis at population level will be the gaps in 
hypertension care and control (Table 1). Uni, bi- and multivariate analysis will be performed. For the 
main outcomes, difference in difference measures will be calculated (endline-baseline changes in the 
intervention minus endline-baseline changes in the control commune). Where relevant, we will 
stratify on affiliation to Subsidized or Contributory insurance schemes. Logistic regression models 
adjusting for potential confounding variables will be fitted. Unadjusted and adjusted Odds Ratios 
(ORs) and their 95%CI will be calculated.  
The indicators for monitoring the implementation and measuring the results and effects of the 
intervention at health service level are listed in the following table (Table 3). They have been 
elaborated also taking into account the standardized performance indicators proposed by the SHTP 
and Global Hearts project (2). The indicators will be measured both in the intervention and in the 
control area, at baseline, at regular intervals during implementation, and at endline.  
 
Table 3. Performance indicators at health facility level.  
Indicator 
Numerator 
Denominator 
Data Source 
Breakdown 
Frequency 
of 
collection 
1. Number of 
hypertensive 
patients enrolled 
in the 
Cardiovascular 
Number 
of 
hypertensive 
patients enrolled 
in the CVRP  
NA 
Billing and 
electronic 
clinical 
records  
Cardiovascular 
risk level (low, 
medium, 
high),grade of 
hypertension (I, 
Monthly 

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Risk Program 
(CVRP)  
II, resistant), sex, 
age, 
pharmacological 
treatment (yes, 
no), co-
morbidities, 
complications, 
health care 
setting 
2. Prevalence 
of 
diagnosed 
hypertension 
in 
Metrosalud’s 
catchment area 
Number of 
hypertensive 
patients enrolled 
in the CVRP  
Total 
population 
for whom 
Metrosalud is 
responsible 
in the studied 
Commune 
For the 
numerator: 
Billing and 
electronic 
clinical 
records  
For the 
denominator
: Database of 
the 
Subsidized 
Regime and 
non-insured 
assigned 
population 
Cardiovascular 
risk level (low, 
medium, high), 
grade of 
hypertension (I, 
II, resistant), sex, 
age, 
pharmacological 
treatment (yes, 
no), co-
morbidities, 
complications, 
health care 
setting 
Quarterly 
3. Ratio 
of 
prevalence 
of 
diagnosed 
hypertension 
to 
the 
expected 
prevalence 
of 
hypertension 
in 
Metrosalud’s 
catchment area 
Prevalence of 
diagnosed 
hypertension in 
Metrosalud’s 
catchment area 
Expected 
prevalence of 
hypertension 
in the 
population 
for whom 
Metrosalud is 
responsible 
in the 
catchment 
area 
For the 
numerator: 
Billing and 
electronic 
clinical 
records  
For the 
denominator
: Survey 
“Gaps in 
hypertension 
care and 
control in 
two 
Communes”. 
Sex, age, health 
care setting 
Quarterly 
4. New 
hypertensive 
Total number of 
new 
NA 
Billing and 
electronic 
Cardiovascular 
risk level (low, 
Monthly 

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patients enrolled 
in the CVRP  
hypertensive 
patients enrolled 
in the CVRP 
during a month 
clinical 
records  
medium, high), 
grade of 
hypertension (I, 
II, resistant), sex, 
age, 
pharmacological 
treatment (yes, 
no), co-
morbidities, 
complications, 
health care 
setting 
5. Cardiovascular 
risk assessment 
Hypertensive 
patients with a 
recorded 
cardiovascular 
assessment in 
the last 1 year 
Number of 
hypertensive 
patients 
enrolled in 
the CVRP 
Billing and 
electronic 
clinical 
records  
Cardiovascular 
risk level (low, 
medium, high), 
grade of 
hypertension (I, 
II, resistant), sex, 
age, 
pharmacological 
treatment (yes, 
no), co-
morbidities, 
complications, 
health care 
setting 
Annual 
6. High 
calculated 
cardiovascular 
risk 
Hypertensive 
patients with 
calculated 
cardiovascular 
disease risk 
≥20% in 10 years 
and systolic 
blood pressure 
(BP) ≥140/90 
mm Hg at last BP 
measurement 
during the last 
year. 
Number of 
hypertensive 
patients 
enrolled in 
the CVRP  
Billing and 
electronic 
clinical 
records 
Pharmacological 
treatment (yes, 
no), sex, age 
Biannual 
7. Prevalence 
of 
controlled 
Hypertensive 
patients with 
documented 
Number of 
hypertensive 
patients 
Billing and 
electronic 
clinical 
Pharmacological 
treatment (yes, 
Biannual 

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hypertension 
systolic BP <140 
mm Hg and 
diastolic BP <90 
mm Hg in at the 
most recent BP 
measurement 
during the last 
year. 
enrolled in 
the CVRP  
records 
no), sex, age 
8. Prevalence 
of 
controlled 
hypertension 
6 
months 
after 
enrolment in the 
CVRP 
Hypertensive 
patients who 
started 
treatment 6 
months before 
the reporting 
trimester and 
have systolic BP 
<140 mm Hg and 
diastolic BP <90 
mm Hg at 
follow-up visit 
during the 
reporting 
trimester 
Number of 
hypertensive 
patients 
enrolled in 
the CVRP 
who started 
treatment 6 
months 
before the 
reporting 
trimester 
Electronic 
clinical 
records 
Sex, age, 
pharmacological 
treatment (yes, 
no), non-
pharmacological 
treatment (yes, 
no) 
Quarterly 
9. Uncontrolled 
hypertension in 
patients with 
cardiovascular 
disease, renal 
disease or 
diabetes 
Hypertensive 
patients 
diagnosed ≥ 6 
months before 
the start of the 
reporting period, 
and 
cardiovascular 
disease, renal 
disease, or 
diabetes 
mellitus, who 
had systolic BP 
≥140 mm Hg or 
diastolic BP ≥90 
mm Hg at the 
most recent BP 
measurement 
during the last 
Number of 
hypertensive 
patients 
enrolled in 
the CVRP ≥ 6 
months 
before the 
start of the 
reporting 
period  
Electronic 
clinical 
records 
Pharmacological 
treatment (yes, 
no), sex, age 
Quarterly 

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year  
10. Uncontrolled 
hypertension 2 
Hypertensive 
patients 
diagnosed ≥ 6 
months before 
the start of the 
reporting period  
who had systolic 
BP ≥160 mm Hg 
or diastolic BP 
≥100 mm Hg at 
the most recent 
BP 
measurement 
during the last 
year  
Number of 
hypertensive 
patients 
enrolled in 
the CVRP ≥ 6 
months 
before the 
start of the 
reporting 
period  
Electronic 
clinical 
records 
Pharmacological 
treatment (yes, 
no), sex, age 
Quarterly 
11. Resistant 
hypertension 
Hypertensive 
patients 
diagnosed ≥6 
months before 
the start of the 
reporting period 
and who are 
treated with 
three or more 
antihypertensive 
drugs,  who had 
systolic BP ≥160 
mm Hg or 
diastolic BP ≥100 
mm Hg at the 
most recent BP 
measurement 
during the last 
year  
Number of 
hypertensive 
patients 
enrolled in 
the CVRP ≥ 6 
months 
before the 
start of the 
reporting 
period 
Electronic 
clinical 
records 
Sex, age 
Quarterly 
12. Six-monthly 
control of blood 
pressure among 
people started on 
pharmacological 
treatment  for 
Number of 
patients started 
on 
pharmacological 
treatment of 
hypertension 
during the 
Number of 
patients 
started on 
pharmacologi
cal treatment 
of 
hypertension 
Electronic 
clinical 
records 
Sex, age 
Quarterly 

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hypertension 
quarter that 
ended 6 months 
before, with 
controlled blood 
pressure 
(SBP<140 and 
DBP<90) at the 
last clinical visit 
in the most 
recent quarter 
(just before the 
reporting 
quarter) 
 
during the 
quarter that 
ended 6 
months 
before  
 
The indicators for measuring the process implementation of different components of the 
intervention are listed in Table 4. 
 
Table 4. Quantitative indicators for measuring process implementation. 
A. Indicators related with the performance of the “Healthy Hearts” service in the quality 
improvement of BP screening and hypertension diagnosis 
 
Indicator 
Numerator 
Denominator 
Data Source 
Breakdown 
Frequency 
of 
collection 
13. Effective 
availability 
of 
the 
Healthy 
Hearts 
service 
Number 
of 
effective 
opening hours 
of the Healthy 
Hearts service 
in a week 
Number of 
programmed 
opening hours of 
the Healthy 
Hearts service per 
week 
Register of 
opening hours of 
the Healthy 
Hearts service. 
Staff shift chart 
(initial and final)  
Days, time  
Weekly 
14. Effective 
referral 
to 
the Healthy 
Hearts 
service and 
BP screening  
Number of 
people without 
BP 
measurement 
in the last 1 
year and 
referred for BP 
Total number of 
people without 
BP measurement 
in the last 1 year 
referred for BP 
measurement to 
the Healthy 
Numerator: 
register of people 
without BP 
measurement in 
the last 1 year 
who receive BP 
measurement at 
Referring service, 
age, sex, health 
insurance 
scheme, patient 
or caretaker, 
result of BP 
measurement 
Monthly 

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measurement 
that reach and 
receive BP 
screening at 
the Healthy 
Hearts service 
Hearts service 
the Healthy 
Hearts service 
Denominator: 
ticket stubs for 
referral to 
Healthy hearts 
service 
(high BP or not) 
 
15. Referral for 
serial 
BP 
measureme
nt 
to 
the 
Healthy 
Hearts 
service 
Number of 
patients not 
previously 
enrolled in the 
CVRP, with high 
BP at doctor or 
nurse 
consultation, 
referred for 
serial BP 
measurement 
to the Healthy 
Hearts service 
during the 
reporting 
month 
Total number of 
patients not 
previously 
enrolled to the 
CVRP with high 
BP at doctors or 
nurses 
consultation 
during the 
reporting month  
Electronic clinical 
record (referral 
to Healthy Hearts 
services) 
Type of 
consultation, age, 
sex, chronic 
patient (yes, no) 
 
Monthly 
16.  Realization 
of serial BP 
measureme
nts at Health 
hearts 
service 
Number of 
individuals with 
high BP 
detected by BP 
screening at 
the Healthy 
Hearts service 
who receive 
serial BP 
measurements 
Total number of 
individuals with 
high BP detected 
by BP screening at 
the Healthy 
Hearts service 
Electronic clinical 
records. 
Register of 
individuals who 
receive serial BP 
measurements at 
the Healthy 
Hearts service  
Referring service 
(Healthy Hearts 
service, clinical 
services or A 
Community 
Hypertension 
Outreach Group 
(CHOG)) 
Age, sex, patient 
or caretaker, 
chronic patient 
(yes, no)  
Monthly 
17. Result of 
serial BP 
measureme
nt 
Number of 
patients with 
average systolic 
BP ≥140 mm Hg 
or diastolic BP 
≥90 mm Hg at 
Number of 
individuals 
receiving serial BP 
measurements 
Register of serial 
BP 
measurements at 
Healthy Hearts 
service 
Referral service 
(Healthy Hearts 
service, clinical 
services or 
CHOG) 
Monthly 

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serial BP 
measurement 
Age, sex, patient 
or caretaker, 
chronic patient 
(yes, no)  
Cardiovascular 
risk level. 
18. Indication of 
serial self-
measured BP 
monitoring  
Number of 
individuals with 
indication of 
serial self-
measured BP 
monitoring 
Number of 
individuals with 
average systolic 
BP ≥140 mm Hg 
or diastolic BP 
≥90 mm Hg as 
result of a serial 
BP measurement 
Register of serial 
self-measured BP 
monitoring at 
Healthy Hearts 
service 
Age, sex, patient 
or caretaker, 
health insurance 
scheme 
Monthly 
19. Realization of 
serial self-
measured BP 
monitoring  
Number of 
patients with 
serial self-
measured BP 
monitoring  
Number of 
patients with 
indication of 
serial self-
measured BP 
monitoring 
Register of serial 
self-measured BP 
monitoring at 
Healthy Hearts 
services 
Age, sex, patient 
or caretaker, 
health insurance 
scheme 
Monthly 
20. 
Result 
of 
serial 
self-
measured 
BP 
monitoring 
Number of 
patients with 
average systolic 
BP ≥140 mm Hg 
or diastolic BP 
≥90 mm Hg as 
result of a serial 
self-measured 
BP monitoring 
Number of 
patients with 
serial self-
measured BP 
monitoring 
Register of serial 
self-measured BP 
monitoring at 
Healthy Hearts 
services 
Age, sex, patient 
or caretaker, 
Monthly 
 
B. Indicators related with the clinical management of the cardiovascular risk program for 
hypertensive patients 
Indicator 
Numerator 
Denominator 
Data Source 
Breakdown 
Frequency 
of 
collection 
21. Realisation of  
BP measurements 
by medical and 
Number of 
interviewed 
individuals 
referring they 
Total number of  
exit-interviews 
 
Annex 4 (Exit-
interview on 
adherence of 
clinical staff to 
Age, sex, patient 
or caretaker, 
chronic patient 
(yes, no), kind of 
Every 2 
months 

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nursing staff  
 
had BP 
measurement   
 
 
 
 
cardiovascular 
duties  
consultation / 
service 
 
22. Missed 
hypertension-
related 
appointment 
  
Number of 
patients who 
missed their last 
hypertension-
related 
appointment 
during the 
reporting week 
 
 
 
Patients with 
scheduled 
hypertension 
follow-up visit 
during the 
reporting week  
 
 
Electronic 
records of 
Metrosalud 
Sex, age, 
pharmacological 
treatment (yes, 
no)  
Weekly 
23. Management of 
missed 
hypertension-
related 
appointment 1 
 
Patients who 
missed a 
hypertension-
related 
appointment in 
the reporting 
week that were 
contacted  
and provided 
with a new 
appointment  
Patients who 
missed a 
hypertension-
related 
appointment in 
the reporting 
week 
 
Register of 
missed 
hypertension-
related 
appointment 
in the Healthy 
Hearts service 
Sex, age, 
pharmacological 
treatment (yes, 
no) 
Weekly 
24. Management of 
missed 
hypertension-
related 
appointment 2 
Patients who 
missed a 
hypertension-
related 
appointment 
that presented 
at the new 
appointment 
provided by 
health services 
 
Patients who 
missed a 
hypertension-
related 
appointment that 
were contacted 
and provided 
with a new 
appointment 
 
-Register 
of 
missed 
hypertension-
related 
appointment 
at CVRP  
- 
clinical 
records 
Kind of contact 
to provide the 
new 
appointment (by 
phone or 
through 
community 
leaders) 
Weekly 

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25. Effective 
meetings of CVRT 
for programme 
follow-up 
Number of 
meetings 
realized 
Number of 
programmed 
meetings 
List of 
participants. 
Minutes of the 
meetings. 
NA 
Quarterly 
26. Audits of clinical 
records of patients 
enrolled in the CVRP 
Number of 
audits of clinical 
records realized 
Number of 
programmed 
audits to clinical 
records  
Audit format: 
Audit of 
clinical records 
of 
hypertension 
CVRT audit 
plan of the 
NA 
Every 2 
months 
27. Collective 
feedback to health 
professionals of the 
CVRP 
 
Number 
of 
feedback 
meetings 
involving health 
professionals of 
the CVRP 
 
Number of 
programmed 
meetings 
List of 
participants. 
Minutes of the 
meetings. 
CVRT meetings 
schedule  
NA 
Every 2 
months 
28. Correct 
prescription of 
pharmacological 
treatment  
 
Number of 
patients who 
received a 
correct 
prescription of 
pharmacological 
treatment 
according to 
clinical condition 
and defined 
algorithm  
 
 
Total number of 
audited clinical 
records 
 
 
 
Report of audit 
of clinical 
records 
Age, sex, health 
facility, 
cardiovascular 
risk level 
Every 2 
months 
29. Use of 
recommended 
antihypertensive 
drugs  
Number of 
patients who 
received 
prescription of 
antihypertensive 
drugs included 
in the  
standardized 
Sample of 
hypertensive 
patients receiving 
pharmacological 
treatment 
 Electronic 
clinical records 
Name of anti-
hypertensive, 
age, sex, health 
facility, 
cardiovascular 
risk level, time 
of diagnosis 
Quarterly 

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algorithm  
 
 
30. Pharmacological 
advice by the 
medical doctor 
during consultation 
Number of 
interviewed 
hypertensive 
patients who 
referred they 
received 
pharmacological 
advice by the 
medical doctor 
Total number of 
interviewed 
patients during 
the audit 
 
Annex 4 (Exit 
interview on 
adherence of 
clinical staff to 
cardiovascular 
duties) 
Age, sex, health 
facility, 
cardiovascular 
risk level 
 
 
Every 2 
months 
31. Percentage of 
hypertensive 
patients who 
received 
prescription of 
non-
pharmacological 
treatment 
Number of 
interviewed  
who refer they 
received 
prescription of 
non-
pharmacological 
treatment by 
the doctor 
Total number of 
exit interviews  
 
Annex 4 (Exit-
interview on 
adherence of 
clinical staff to 
cardiovascular 
duties) 
Age, sex, health 
facility, 
cardiovascular 
risk level 
 
 
Every 2 
months 
 
C. Indicators related with the clinical training of health care staff for improvement of 
hypertension care 
Indicator 
Numerator 
Denominator 
Data Source 
Breakdown 
Frequency 
of 
collection 
32.Realized 
trainings  
 
Number of 
realized training 
sessions for 
health care staff  
Number of 
programmed 
training sessions 
for health care 
staff  
Training plan  
List of 
attendance  
Type of training 
Annual 
33. Trained 
health care 
professionals 
Number of 
trained 
professionals  
Total number of 
professionals   
Training plan 
List of 
attendance 
Type of health 
professional 
Type of training  
Health facility 
 
Annual 

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34.Effectiveness of 
training in improving 
clinical knowledge 
  
Average post-
test score minus 
average pre-test 
score 
NA 
Pre- and post-
test 
Type of health 
professional 
Training session 
Health facility 
Once 
35. Effectiveness of 
training on acquiring 
BP measurement 
skills 
Number of 
trained 
professional 
passing post-
training 
practical test 
Total number of 
trained 
professionals 
undergoing post-
training practical 
test 
Post-training 
practical test 
for 
certification on 
BP 
measurement 
following 
international 
standards 
Type of health 
professional 
Health facility 
 
 
D. Indicators related with the management of the pharmacy service to guarantee the 
availability of the essential anti-hypertensive medication 
Indicator 
Numerator 
Denominator 
Data Source 
Breakdown 
Frequency 
of 
collection 
36. Notification 
on availability of 
core set of anti-
hypertensive 
drugs 
Total 
number 
of 
notifications made in 
a month 
Number of 
weeks in the 
respective 
month 
Register of 
notification 
at the 
pharmacy 
service 
 Type of health 
facility  
Monthly 
37. Number of 
weeks 
without 
availability 
of 
essential  
antihypertensive 
drugs 
Number of weeks 
without availability 
of one or more 
essential  
antihypertensive 
drugs 
NA 
Pharmacy 
inventory 
Type of health 
facility Name of 
the 
antihypertensive 
 
 
 

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E. Indicators related with patients and community engagement for improving hypertension 
care and the prevention of cardiovascular diseases 
Indicator 
Numerator 
Denominator 
Data Source 
Breakdown 
Frequency 
of 
collection 
38. Attendance 
to  peer support 
group 
Number of 
hypertensive 
patients who 
participate in 
the meetings of 
the peer 
support group 
Number of 
hypertensive 
patients enrolled 
in the CVRP 
eligible for peer 
support and 
referred  
Attendance list  
Denominator: 
Billing and 
electronic 
clinical records 
of Metrosalud 
Sex, age, 
pharmacological 
treatment (yes, 
no), 
hypertension 
control (yes, no), 
health facility, 
cardiovascular 
risk level 
 
Quarterly 
39. Prevalence 
of high BP 
among 
population 
screened  by the 
Community 
Hypertension 
Outreach Group 
(CHOG)  
Number of 
people with 
high BP 
readings during 
the screening 
Number of 
screened people 
for hypertension 
by the CHOG 
Report of 
activities by 
the social 
worker of 
Metrosalud 
Kind of 
environment, 
place, target 
population 
Monthly 
40. Meetings of 
the CHOG 
Number of 
meetings of the 
CHOG  
NA  
Report of 
activities by 
the social 
worker of 
Metrosalud 
List of 
attendance 
NA 
Quarterly 
41. Participation of 
community leaders 
in the meetings of 
the CHOG 
Number of 
community 
leaders 
participating in 
the meetings of 
the CHOG  
Total number of 
community 
leaders in the 
CHOG 
Report of 
activities by 
the social 
worker of 
Metrosalud 
List of 
attendance 
NA 
Quarterly 

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4.3.2 Qualitative Data Analysis 
Based on the logical model and the detailed description of the intervention, one to three process 
evaluation questions will be elaborated to determine whether each aspect of the intervention was 
implemented as intended (e.g. was each of the intervention components implemented as planned? 
Were the intervention components implemented as often and for as long as planned? Was the 
methodology and way of delivery followed as described?). 
Semi-structured interviews with health providers involved in the implementation and project leaders 
or coordinators, as well as patients, will be conducted by a social scientist (outline of interview guides 
in annex 8 and 9). To determine if each intervention component was implemented as specified, the 
content of collected documents, semi-structured interviews, and observation notes from the same 
level, unit and actor will be analysed independently by three independent researchers (evaluators). 
The components will be categorized according to the analytical framework mentioned above 
(content, frequency, duration, and coverage) and also by establishing at which level (individual, 
team, organizational) adaptations are introduced. The analysis will be conducted systematically for 
every previously identified critical point. 
Three types of adaptations to the original design of the intervention will be identified by the 
evaluators, following the categorization proposed by Rebchook et al.(22): deletion (when a 
component is omitted or modified so radically that the programme is no longer implemented as 
intended), modification (a component is implemented with minor or major modifications while still 
respecting the original purpose) and third, additional activities or components are added. The 
algorithm to categorize adaptation will be as follow: if all three evaluators independently agree that a 
given aspect of the intervention was implemented as specified, it will be classified as “implemented”. 
If all agree that a given component was not implemented, it will be classified as such. If any of the 
evaluators consider that a component was modified, it will be classified as such. Added components 
will be also identified. Modified and added aspects will be classified as positive or negative in relation 
to the expected outcome, taking into consideration the functioning principles. Those adaptions 
classified as negative will be corrected. 
Besides, an inductive thematic analysis of the semi-structured interviews will be conducted to 
identify, define and organize participant responses regarding reasons for introducing adaptations and 
general factors either positively or negatively affecting or moderating implementation. Then, 
transcripts will be reviewed, using a constant comparative technique to expand or merge themes. 
Finally, findings will interpreted according to the six moderating factors pre-established by the 

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theoretical framework. Factors not matching the deductive coding scheme will be classified as 
intervention-specific moderating factors.    
In depth interviews with patients will be analysed firstly inductively looking for experiences and 
views of the intervention across different stages and component of the intervention, as well as 
region and health centres within the commune. In a second stage, data will be reclassified according 
to the subcategories of fidelity and the moderating factors of the framework to triangulate with data 
provided by the implementers and with quantitative results.  
The qualitative data analysis will be conducted by the social scientist. To increase internal validity, 
the senior sociologist not involved in data collection will review the data and consistency of the 
coding system. Besides, findings from the data analysis and triangulation with quantitative results 
will be discussed systematically with a wider group of the research team, composed of professionals 
with diverse backgrounds (epidemiologists, public health practitioners, health care managers, nurses 
and general practitioners). 
To identify when and under which circumstances the intervention was successful we will used 
qualitative comparative analysis (QCA) by contrasting outcomes data with implementation data 
collected at different stages and critical points of the intervention along process evaluation. 
Qualitative analysis will be carried out using the software Nvivo v.10. 
 
5. ETHICAL ISSUES 
Confidentiality of the retrieved individual information will be guaranteed. The collected information 
will be used only for research purposes and at no time the identity of participating individuals will be 
disclosed.  
During the endline survey, confidentiality at the time of interview will be also guaranteed 
interviewing participants belonging to the same household one by one and in separate spaces. All 
surveyors will be trained in identifying patients with severe abnormal conditions. They will identify 
and refer to the nearest health center, individuals with very high BP figures or reporting health 
complications or acute symptoms. In Colombia, health care for hypertension is free of charge in both 
regimes of the health insurance system (Subsidized and Contributory). Patients found to be 
hypertensive without follow-up or treatment will be referred for care to the provider of the 
corresponding patients’ health insurance scheme. 
Exit-interviews to patients will be anonymous and the identity of the consulting medical doctor or 
nurse won’t be recorded. The results will be evaluated by the CVRT who will give collective 

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constructive feedback to the medical staff; the patient survey results won’t be used as an individual 
evaluation of the medical staff. 
The intervention does not pose any risk to beneficiaries and it implies the implementation into the 
routine setting of evidence based best practices. Any procedure that influences directly patient care 
has been agreed with the Metrosalud central authorities and site health staff. All activities are 
implemented under standard practice and, conditional on adjustment when needed, will continue 
beyond the end of the study period. 
Patients eligible for the qualitative component, will be asked by the local health staff if they would 
be interested in learning more and participate in the study. If they are interested, they will be 
invited to participate by the PI or the research assistant at the health setting. Health staff will be 
contacted directly by the research staff. The objectives and procedures will be explained as well as 
the benefits and risks and written informed consent will be obtained (see below).  
The research team will guarantee to allocate the most convenient place and time for interviews. A 
place as enclosed for privacy and as neutral as possible for participants will be chosen. Participants 
will be asked if they consent for the discussion to be tape-recorded.  
 
5.1 Ethical (and regulatory) Review  
This study protocol will be submitted for formal review and approval to the Institutional Review 
Board of ITM, the Ethics Committee of University of Antwerp Hospital and the Research Ethics 
Committee of Metrosalud E.S.E. No participants will be enrolled or participant related activities 
performed before written approval from these bodies is obtained.  
The study will be carried out according to the principles stated in the Declaration of Helsinki, all 
applicable regulations and according to established national and international scientific standards. 
 
5.2 Obtaining Informed Consents 
Informed consent for participation inf the study will be sought for the endline survey (Annex 10) and 
the qualitative component (Annexes 11 and 12). For the endline survey, during the household visit 
all eligible individuals will be explained about the study in lay language by the research team and 
handed over the informed consent form.  
Participant information sheets will describe the purpose of the study, the procedures to be followed, 
the risks and benefits of participation, etc. Study participants will be informed that participation on 

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the study is completely voluntary and that they can withdraw from the study at any time without 
any negative consequences. A copy of the informed consent will be handed over to participants.  
No informed consent will be sought for other intervention components, as all implemented activities 
are part of routine practice.  
 
5.3 Insurance 
The Coordinator of this study, the Antwerp Institute of Tropical Medicine, has obtained an umbrella 
insurance for low risk research to cover any potential damage or loss to study participants and which 
is caused directly or indirectly by their participation in the study. 
 
6. MONITORING AND QUALITY CONTROL  
All research staff will be trained in responsible conduct of research. For the endline survey, the 
surveyors will be trained on the study, the study tools and BP measuring. For the intervention at 
health services, the participant health staff will be trained on the study procedures tools for data 
collection and self-reporting. They also will be subject of random supervision visits and audits to 
check the implementation of the planned activities, its accuracy and reliability. The PI will be 
responsible of the monitoring and quality control of the implementation of study procedures, data 
collection, entry and analysis. The qualitative component will be carried out by trained research staff. 
7. TIMELINE 
Year 1  
Year 2  
Year 3 
 
Q1 Q2 Q3 
Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 
Q4 
Preparation of the 
Intervention 
 
 
 
 
 
 
 
 
 
Ethical Approval of 
intervention protocol 
 
 
 
 
 
 
 
 
 
Intervention 
 
 
 
 
 
 
 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
Endline survey 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
Dissemination of results  
 
 
 
 
 
 
 
 
 
 

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 = intervention activities continue to be implemented by Metrosalud as part of routine practice 
 
 
8. DATA MANAGEMENT AND ARCHIVING 
8.1 Data Management 
Data will be collected as described in section 4.  Databases will be electronically encrypted, and a 
single study code will be assigned to each participant and they will be password-protected, with a 
password known only to the research team. The list of participant names and their assigned study 
codes will be stored in a separate database with restricted access to the study investigators that did 
the process of identification. Data will be analysed as described in section 4. The obtained individual 
information will be known only by the research team, where information access levels will be 
established, in particular for personal identification data. For the endline survey, questionnaires will 
be filled in by using tablets, and the information will be consolidated through an electronic platform 
provided by a professional statistics enterprise. The access to each electronic questionnaire is 
restricted to specifically authorized surveyor. The software of the electronic platform will allow to 
record in real-time every applied single questionnaire, obtaining reliable databases. Only aggregate 
data will be extracted from the billing and electronic clinical records of Metrosalud and from the 
databases of the subsidized regimen and of the non-insured poor population.  Qualitative 
information will be transcribed verbatim by trained personnel. Transcripts and data will be 
stored in Nvivo v.10 and analysed as described in section 4.3.2. Anonymity of participants will 
be maintained, a code will be assigned to every participant and transcripts will be anonymous 
for transcribers. Data protection and confidentiality will be responsibility of the PI and the 
responsible for qualitative analysis. 
 
8.2 Archiving 
The Principal Investigator will ensure a secure and appropriate location for storage of the paper 
documents and any other study related documentation, as well as for ensuring that only research 
staff that is competent and delegated to work for the study has got access to the files.  
The paper documents will be kept locked and the electronic databases will be protected by a unique 
password accessible only to investigators and stored with a backup copy in a safe location accessible 

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only to the research staff. Data will be retained for a period of time in accordance to the local 
legislation. 
 
 

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9. DISSEMINATION OF RESULTS 
The results of the study will be shared with the local health authorities and staff. The study will be 
published in peer reviewed scientific journals and presented at national and international 
conferences and workshops. A summary of the results in an adapted language might be 
communicated to the involved communities and institutions. 
 
 

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10. REFERENCES 
 
(1)  Samb B, Desai N, Nishtar S, Mendis S, Bekedam H, Wright A et al. Prevention and 
management of chronic disease: a litmus test for health-systems strengthening in low-
income and middle-income countries. Lancet. 2010; 376(9754):1785-97. 
 
(2)  Patel P, Ordunez P, DiPette D, Escobar MC, Hassell T, Wyss F et al. Improved Blood Pressure 
Control to Reduce Cardiovascular Disease Morbidity and Mortality: The Standardized 
Hypertension Treatment and Prevention Project. J Clin Hypertens (Greenwich). 2016; 
18(12):1284-94. 
 
(3)  Pan American Health Organization. Innovative Care for Chronic Conditions: Organizing and 
Delivering High Quality Care for Chronic Noncommunicable Diseases in the Americas. 2013. 
 
(4)  Jaspers L, Colpani V, Chaker L, Van der Lee SJ, Muka T, Imo D et al. The global impact of non-
communicable diseases on households and impoverishment: a systematic review. Eur J 
Epidemiol. 2014; 30(3):163-188. 
 
(5)  Ibrahim M, Damasceno A. Hypertension in developing countries. Lancet. 2012; 
380(9841):611-619. 
 
(6)  World Health Organization. Global health risks: mortality and burden of disease attributable 
to selected major risks. 2009. 
 
(7)  De Maio F. Understanding chronic non-communicable diseases in Latin America: towards an 
equity-based research agenda. Global Health. 2011; 7:36. 
 
(8)  Ordunez P, Martinez R, Niebylski M, Campbell N. Hypertension Prevention and Control in 
Latin America and the Caribbean. J Clin Hypertens (Greenwich). 2015; 17(7):499-502. 
 
(9)  Khatib R, Schwalm J, Yusuf S, Haynes R, McKee M, Khan M et al. Patient and healthcare 
provider barriers to hypertension awareness, treatment and follow up: a systematic review 
and meta-analysis of qualitative and quantitative studies. PLoS One 2014; 9(1):e84238. 
 (10)  Tanahashi T. Health service coverage and its evaluation. Bull World Health Organ 1978; 
56(2):295-303. 
 (11)  Chow C, Teo K, Rangarajan S, Islam S, Gupta R, Avezum A et al. Prevalence, awareness, 
treatment, and control of hypertension in rural and urban communities in high-, middle-, and 
low-income countries. JAMA. 2013; 310(9):959-68. 
 (12)  Wagner E, Austin B, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness 
care: translating evidence into action. Health Aff (Millwood). 2001; 20(6):64-78. 
  (13)  World Health Organization. Hearts: technical package for cardiovascular disease management 
in primary health care. 2016. 

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(14)   Moira Stewart, Judith Belle Brown, W. Wayne Weston, Ian R. McWhinney CLM and TRF. 
Patient-centered medicine. Transforming the Clinical Method. Second Edi. Oxford: Radcliffe 
Medical Press; 2003. 1-376 p. 
 (15)  Ministerio de Salud y Protección Social. Análisis de Situación de Salud (ASIS) Colombia, 2016. 
 (16)  Abadia C, Oviedo D. Bureaucratic Itineraries in Colombia. A theoretical and methodological 
tool to assess managed-care health care systems. Soc Sci Med. 2009; 68(6):1153-1160.  
(17)   US National High Blood Pressure Education Program. Seventh Report of the Joint National 
Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. 
Report No.: 04-5230. US National Heart, Lung and Blood Institute. 2004. 
(18)   James P, Oparil S, Carter B, Cushman W, Dennison-Himmelfarb C, Handler J et al. 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. 
(19)  Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for 
implementation fidelity. Implement Sci [Internet]. 2007;2(1):40.  
(20) 
Hasson H. Systematic evaluation of implementation fidelity of complex interventions in health 
and social care. Implement Sci. 2010;5(1):67.  
(21) 
Pérez D, Van der Stuyft P, Zabala M del C, Castro M, Lefèvre P. A modified theoretical 
framework to assess implementation fidelity of adaptive public health interventions. 
Implement Sci. 2015;11(1):91. 
(22) 
Rebchook GM, Kegeles SM, Huebner D, TRIP Research Team. Translating Research Into 
Practice: The Dissemination and Initial Implementation of an Evidence–Based HIV Prevention 
Program. AIDS Educ Prev. 2006;18(supp):119–36. 
 
 
 
 
 

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11. LIST OF ABBREVIATIONS 
 
BP 
Blood Pressure 
CVD 
Cardiovascular diseases  
NCD 
Non-communicable diseases  
SHTP 
Standardized Hypertension Treatment and Prevention Project  
LMIC 
Low and Middle Income Countries 
LAC 
Latin America and Caribbean 
HIC 
High Income Countries 
PURE 
Prospective Urban Rural Epidemiology study 
CVRP 
Cardiovascular Risk Program  
CVRT 
Cardiovascular Risk Team  
CHOG 
Community Hypertension Outreach Group 
ESE 
[Empresa Social del Estado] 
IC(F) 
Informed Consent (Form) 
(I)EC 
(Independent) Ethics Committee 
IRB 
Institutional Review Board 
ITM 
Institute of Tropical Medicine 
PI 
Principal Investigator 
 
 
12. ANNEXES 
- 
Annex 1: Training of clinical staff for improving CVD management 
- 
Annex 2: Endline survey questionnaire 
- 
Annex 3: Outline of Healthy Hearts register 
- 
Annex 4: Register of opening hours of Healthy Hearts service 
- 
Annex 5: Register of missed appointments at CVR program 
- 
Annex 6:  Exit interview on adherence of clinical staff to cardiovascular duties 

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- 
Annex 7: Format for audit of electronic clinical records of CVRP 
- 
Annex 8: General questions for the evaluation of fidelity 
- 
Annex 9: Topics for in-depth interviews with patients 
- 
Annex 10: Informed Consent for endline population survey 
- 
Annex 11: Informed Consent for semi-structured interviews on health providers 
- 
Annex 12: Informed consent in-depth interviews