Development and Evaluation of A Patient Centered Cardiovascular Health Education Program For Insured Patients in Rural Nigeria (Quick-Ii)
Development and Evaluation of A Patient Centered Cardiovascular Health Education Program For Insured Patients in Rural Nigeria (Quick-Ii)
Development and Evaluation of A Patient Centered Cardiovascular Health Education Program For Insured Patients in Rural Nigeria (Quick-Ii)
Abstract
Background: In Sub Saharan Africa, the incidence of hypertension and other modifiable cardiovascular risk factors
is growing rapidly. Poor adherence to prescribed prevention and treatment regimens by patients can compromise
treatment outcomes. Patient-centered cardiovascular health education is likely to improve shortcomings in
adherence. This paper describes a study that aims to develop a cardiovascular health education program for
patients participating in a subsidized insurance plan in Nigeria and to evaluate the applicability and effectiveness in
patients at increased risk for cardiovascular disease.
Methods/Design: Design: The study has two parts. Part 1 will develop a cardiovascular health education program,
using qualitative interviews with stakeholders. Part 2 will evaluate the effectiveness of the program in patients,
using a prospective (pre-post) observational design.
Setting: A rural primary health center in Kwara State, Nigeria.
Population: For part 1: 40 patients, 10 healthcare professionals, and 5 insurance managers. For part 2: 150 patients
with uncontrolled hypertension or other cardiovascular risk factors after one year of treatment.
Intervention: Part 2: patient-centered cardiovascular health education program.
Measurements: Part 1: Semi-structured interviews to identify stakeholder perspectives. Part 2: Pre- and post-
intervention assessments including patients’ demographic and socioeconomic data, blood pressure, body mass
index and self-reporting measures on medication adherence and perception of care. Feasibility of the intervention
will be measured using process data.
Outcomes: For program development (part 1): overview of healthcare professionals’ perceptions on barriers and
facilitators to care, protocol for patient education, and protocol implementation plan.
For program evaluation (part 2): changes in patients’ scores on adherence to medication and life style changes,
blood pressure, and other physiological and self-reporting measures at six months past baseline.
Analysis: Part 1: content analytic technique utilizing MAXQDA software. Part 2: univariate and multilevel analysis to
assess outcomes of intervention.
Discussion: Diligent implementation of patient-centered education should enhance adherence to cardiovascular
disease prevention and management programs in low income countries.
Trial Registration: ISRCTN47894401
* Correspondence: [email protected]
1
Dept of Global Health, Academic Medical Center, University of Amsterdam,
Pietersbergweg 17, Amsterdam, 1105 BM, The Netherlands
Full list of author information is available at the end of the article
© 2011 Odusola et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
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Background Methods
Sub Saharan African (SSA) countries are currently Project design
experiencing a rapid increase in the incidence of cardio- QUICK - II consist of two consecutive parts
vascular diseases (CVD) [1,2]. Hypertension is an impor- In part 1 of the study, we will develop a stakeholder
tant risk factor for CVD. Poor adherence to prescribed based Cardiovascular Health Education Program
medication regimens or lifestyle advices can severely (CHEP) that is to be used to educate patients at risk of
compromise the effectiveness of CVD prevention and CVD who are enrolled in a private health insurance
treatment [3]. For that reason, the World Health Orga- plan in rural Nigeria. To develop CHEP, we will use the
nization (WHO) emphasizes in a recent report that any following step-wise approach: (i) open qualitative inter-
attempt to improve cardiovascular care should also views will be conducted with key stakeholders in CVD
address the issue on non-adherence [3]. The views and care to explore their perceptions on CVD, CVD risk fac-
beliefs of patients regarding disease conditions and tor management and CVD prevention and care. These
treatment may differ from medical perceptions, and it is stakeholders include patients at risks for CVD, health-
well documented that patients do have significant roles care providers (HCP), and health insurance managers of
to play in adherence to medications and lifestyle mea- HCHP; (ii) on the basis of the outcomes of interviews
sures [4-6]. Evidence to date indicates that patient edu- with patients, CHEP will be developed; (iii) supportive
cation is one of the most successful interventions to strategies needed to implement CHEP successfully will
improve adherence and patient self-management of be identified on the basis of the outcomes of the inter-
chronic diseases, especially if the education addresses views with HCP and health insurance managers.
patients’ beliefs and concerns about the condition and In Part 2 of the study we aim to evaluate the effect of
treatment, identifies social cultural and individual bar- CHEP through a prospective hospital-based study, using
riers to adherence and enhances patients’ confidence in a pre-post intervention design. Measurements will be
their ability to overcome those barriers [7]. conducted in a subset of patients included in QUICK -
In this paper, we describe the design of a study that I: those who have uncontrolled hypertension or other
has the aim to develop and test a program for cardiovas- CVD risk factors, or are non adherent to medication
cular health education for patients who are enrolled in a after 12 months of treatment.
subsidized, community-based health insurance program In addition, case file data will be reviewed and inter-
in Nigeria and are at an increased risk of developing views with health care professionals in the participating
CVD. This study is part of the project “QUality clinic will be held and analyzed to evaluate the feasibility
Improvement for Cardiovascular care Kwara (QUICK)”. of the application of CHEP in practice.
The project will be evaluated by two studies: QUICK-I
and QUICK-II. This paper describes the design of the Setting
QUICK-II study that focuses on patient education. A Ogo Oluwa Hospital (OOH) in Bacita (Kwara State). A
detailed description of the insurance program and the detailed description of this setting can be found in the
QUICK-I study can be found elsewhere [8]. accompanying paper describing the QUICK-I study
design [8].
Aim of the study Because part 1 and part 2 of this study have different
The World Health Organization/International Society of designs, we will describe the study procedures in differ-
Hypertension (WHO/ISH) guidelines recommend ent sections.
patient education as part of CVD prevention care [9],
but they do not provide clear recommendations on how Part 1: Development of Chep
this education should be delivered and tailored to the Study Population
specific target groups in the region. We hypothesize that The study population for Part 1 will consist of four
tailored patient education will improve adherence to groups: Group 1 - A purposeful sample of 20 patients
cardiovascular care among patients. with ‘controlled hypertension’ equally distributed by
For that reason, the main aims of QUality Improve- gender (50% male and female), and age (18-35 yrs, 36-
ment Cardiovascular care Kwara II (QUICK - II) are: 55 yrs, 56 yrs and over) who were included in the
1. To develop and implement a targeted cardiovascu- QUICK - I study; Group 2 - A purposeful sample of 20
lar health education program (CHEP) for patients parti- patients with ‘uncontrolled hypertension’ equally distrib-
cipating in the Hygeia Community Health Plan (HCHP) uted by gender (50% male and female), and age (18-35
2. To evaluate the newly developed program with yrs, 36-55 yrs, 56 yrs and over) who were included in
respect to its applicability and effectiveness in patients QUICK - I study; Group 3 - Eight to ten healthcare pro-
at an increased risk for CVD fessionals treating patients with hypertension (HTN),
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diabetes mellitus (DM) or CVD at OOH; and Group 4 - Data management and analysis
Five to ten managers and doctors of the Health Mainte- Data entry and cleaning
nance Organization (HMO) Hygeia. The researcher will transcribe the semi-structured inter-
views conducted in part 1 and check unclear passages
Sample size and Recruitment with respondents, if needed.
Sample size Data analysis
For qualitative interviews, data saturation is a criterion The transcribed qualitative interview data will be ana-
for calculation of the sample size. In general, about 20 lyzed using content analytical techniques: fragments
interviews are required until saturation is reached and containing the respondents’ ideas about major themes,
no new information on the major themes is collected for example inhibitors or facilitators of cardiovascular
[10,11]. For that reason we decided to interview 40 diseases care, will be identified from each interview and
patients (20 with controlled and 20 with uncontrolled coded. Similar codes will be assigned to related state-
hypertension). The number of interviews for HCP is ments, resulting in a code list for each interview. Code
less because the number of health care professionals lists will be compared to identify common and unique
working in the region is limited. The same accounts themes, leading to a thematic matrix for each group of
for health insurance managers and doctors of Hygeia respondents. Similarities, variations and patterns
HMO. between groups will be compared, using these matrices.
Patient recruitment Data entry and analysis will be supported by MAXQDA
The patients in Groups 1 and 2 will be recruited among software http://www.maxqda.com. MAXQDA facilitates
participants in the QUICK - I study in the first month data management, the assignment of labels, codes and
after their inclusion. Health care professionals (Group themes to text fragments and the generation of thematic
3); and managers and doctors working for Hygeia HMO matrices containing these elements. In the past,
(Group 4) will be included in the first 3 months of MAXQDA software has been successfully used in similar
QUICK - I. Eligible respondents will be adequately studies [13].
informed of the objectives of the qualitative study. Per-
mission for the interview and written or tape-recorded Part 2: Evaluation of Chep
informed consents will be taken. Study population
To be included in the evaluation study of the effect of
Outcomes CHEP (part 2), patients have to meet the following
The outcomes envisaged for part 1 include: (i) an over- inclusion criteria. They must: (i) be enrolled in HCHP;
view of patients’ perceptions on CVD, CVD risk factors (ii) be registered as a patient in OOH; (iii) be included
and inhibiting or facilitating factors for CVD prevention in the QUICK - I study for at least 12 months; (iv) have
and care; (ii) an overview of perceptions of HCP, and a diagnosis of hypertension; (v) have uncontrolled BP
health insurance managers and doctors of Hygeia HMO (≥140 mmHg systolic or ≥90 mmHg diastolic) or be non
on barriers and facilitators to implementation of CVD adherent to prescribed medication or any other recom-
prevention and care; (iii) a protocol for CHEP; and (iv) mended life style changes according to their score on
a plan of supportive strategies for implementation of the Morisky scale [14]; and (vi) be ≥18 years of age.
CHEP, including training for HCP. Patients who meet these inclusion criteria will be
excluded if their treating health care professional judges
Materials and measurements them unfit for participation (e.g. due to co morbidity) or
In part one, patients allocated to Groups 1 and 2 will be if they are not capable or unwilling to give informed
interviewed using a semi-structured questionnaire that consent. Female patients who are pregnant or lactating
is based on a topic list used in a similar study by Beune will be excluded from the entire study because the etiol-
et al [12], but modified to suit the Nigerian setting. ogy, prognosis and treatment regimes of gestational dia-
Healthcare professionals from Groups 3 and 4 will simi- betes and pregnancy-induced hypertension are different
larly be interviewed using semi structured question- compared to hypertension and diabetes in non-pregnant
naires based on topic lists specifically designed to women.
address the particular concerns of these groups. A To be included in the qualitative interviews for the
researcher who speaks English and Yoruba fluently, feasibility analysis, healthcare professionals must: (i) be a
assisted by interpreters in Nupe, the other dominant HCP in OOH who participated in the implementation
local language, will conduct interviews. CHEP will be of CHEP, or be managers and doctors of HCHP; and (ii)
developed based on a systematic review of literature on give informed consent.
similar past patient education programs, and analysis of Table 1 shows an overview of the inclusion and exclu-
the interview data. sion criteria for CHEP study. For an overview of the
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Figure 1 Project populations and relationship between QUICK - I and CHEP study in QUICK - II.
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Table 2 Definitions of significant improvement per sessions spaced over a period of 4 months and one
outcome measure final assessment interview six months after baseline.
Outcomes Significant improvement
Adherence to medication and life Using the distribution on the To encourage participation, all included patients will
style recommendations (Primary Morisky scale [14] of low, medium, be reimbursed for extra travel costs incurred in visiting
outcomes) and high adherence ratios, a post
CHEP effect shift of 10% to a higher
for assessments and CHEP sessions outside their normal
category will be defined as a clinic days.
significant improvement in
adherence.
Intervention
Blood pressure (Secondary Blood pressure decrease of >10% The intervention (CHEP) will be developed in part 1 of
outcome) systolic or diastolic or blood
pressure at target level (patients this project. Subsequently, patients will be given (i)
without diabetes or established three CHEP sessions over a period of four months con-
CVD: <140 mmHg systolic and <90 ducted by a trained nurse; (ii) audio-visual or written
mmHg diastolic, patients with
diabetes, renal disease or educational materials containing specific information for
established CVD: <130 mm Hg the target group and (iii) if necessary, referrals to regio-
systolic and <80 mmHg diastolic). nal facilities or initiatives that may help patients to
Body mass index (kg/m2 ) No CVD risk: <25 adopt healthier lifestyles.
Moderate CVD risk: 25-30
High CVD risk: >30
Sessions
In patients with a BMI >25 any The first session will take place two weeks after the base-
reduction of BMI at 6 months will line assessment interview, and the next two sessions will
be regarded as an improvement.
occur one and three months thereafter. Clinical guide-
lines generally recommend a patient centred approach as
the preferred strategy for supporting patients in achieving
Sample size and Recruitment CVD treatment goals, such as adherence to prescribed
Sample size calculation medication, dietary changes, and weight reduction,
The power analysis for sample size is based on the dif- reduced sodium intake, increased physical activity and
ference between the adherence score after implementa- moderate use of alcohol [3]. While CHEP will use this
tion of CHEP and the adherence score at baseline using framework, it will have the additional aim of eliciting and
the 5-item Morisky adherence scale. Using the Morisky discussing culturally and socially specific aspects of
distribution of low, medium, and high adherence ratios patients’ perceptions of cardiovascular risk factors and
of 32%, 52% and 16% respectively [14], and an estimated treatment. This method is based on the work of Arthur
post CHEP effect shift of 10% to a higher category, we Kleinman [15], as well as more recent approaches to
will need a minimum sample size of 150 patients. improving adherence in hypertensive patients of various
Patient recruitment ethnic and geographical background, such as those
The following steps will be applied in recruiting patients recently developed in The Netherlands [16]. In short,
for the CHEP study: after identifying potential communication barriers and
establishing a rapport with the patient, it is expected that
1. Researchers will use the records of the QUICK - I the first session will focus on the patient’s beliefs about
study to identify all patients with uncontrolled hypertension. The next two sessions will deal with the
hypertension or with low or medium adherence daily challenges they face in achieving hypertension treat-
scores for medication or other life style measures on ment goals within the broader context of their lives. Edu-
the Morisky Scale at 12 months after inclusion into cation will take place in group training sessions.
the study. Educational materials
2. Eligible patients will be informed about QUICK-II Patients will also be given information leaflets or audio
and invited for participation through a written visual materials that provide answers to frequently asked
invitation. questions about hypertension. These will be designed to
3. A research assistant will assess patients who are address the specific languages, customs, habits, norms
interested in participating for eligibility criteria and and dietary cultures that characterize the communities
eligible patients will be asked to give informed of the patients participating in the program.
consent. Supporting healthier lifestyles
4. Patients who give informed consent will be invited If necessary, patients will be referred to initiatives offer-
to a one-hour baseline assessment session. ing healthier lifestyle support that is tailored to the target
5. Included patients who have completed baseline group, based on a referral list that will be established for
assessments will be invited to have three CHEP this purpose in the first part of this study.
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having concluded that lack of time by physicians and The QUICK-I and QUICK- II studies are funded by the Health Insurance Fund
(HIF). HIF is not involved in the study design; in the collection, analysis, and
inadequate knowledge about hypertension by patients interpretation of data; in the writing of the manuscript nor in the decision
are some of the potent barriers to effective CVD preven- to submit the manuscript for publication.
tion and care [18]. Furthermore, with particular refer- Affiliations: 1,3 & 5 are part of the Amsterdam Institute for Global Health &
Development.
ence to SSA where deep routed cultural practices still
play prominent roles in people’s lives, health education Author details
1
to prevent CVD must be patient centered, and devel- Dept of Global Health, Academic Medical Center, University of Amsterdam,
Pietersbergweg 17, Amsterdam, 1105 BM, The Netherlands. 2PharmAccess
oped with due consideration for socio-cultural relevance Foundation, 1c Raymond Njoku Street, S.W. Ikoyi, Lagos, Nigeria. 3Dept of
in order for the intervention to be successful. By Neurology, Academic Medical Center, University of Amsterdam,
researching into the most optimal methods to imple- Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands. 4Oxford University
Clinical Research Unit, Hospital for Tropical Diseases, 190 Ben Ham Tu, Ho
ment an appropriately developed cardiovascular health Chi Min City, District 5, Vietnam. 5Dept of Public Health, Academic Medical
education program, our expectation is that the present Center, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The
study will provide insight into, and contribute substan- Netherlands. 6Dept of Community Health, Lagos University Teaching
Hospital, P.M.B.12003, Idi-Araba, Surulere, Lagos, Nigeria. 7Dept of
tially to the improvement in CVD management and out- Epidemiology and Community Health, University of Ilorin Teaching Hospital,
comes. We hope that the envisaged intervention, CHEP, P.M.B. 1459, Ilorin, postal code 240001, Nigeria. 8Dept of Cardiology, Lagoon
will become productively applicable not only in Nigeria, Hospitals, 8 Marine Road, Apapa, Lagos, Nigeria. 9Hygeia Nigeria Ltd, 13B
Idejo Street, Victoria Island, Lagos, Nigeria. 10Ogo Oluwa Hospital, 64/65
but also in other similar settings in SSA and across the Ahmadu Bello Way, Bacita, Kwara State, Nigeria. 11Dept of General Practice,
globe. Academic Medical Center, University of Amsterdam, Meibergdreef 9,
The study has one notable limitation: Amsterdam, 1105 AZ, The Netherlands.
The design of our evaluation of CHEP could have Authors’ contributions
been improved by using a control group and a rando- AOO drafted the manuscript, conducts the study and contributed to the
mized design. However, the study is conducted in a very design. MH, JH, CS, KS, and JL designed the study and they are members of
the supervising board. AO, TA, SA, PA, KA were involved in the design of the
specific context, where it is impossible to avoid contami- study. JH revised several early drafts of the paper and KS, CS and MH
nation. For example, patients have generally long waiting commented on the final draft. All authors read and approved the final
hours and may communicate about their condition or manuscript.
the treatment with each other. Moreover, the number of Competing interests
health care professionals in the clinic is limited such The authors declare that they have no competing interests.
that it would be impossible to randomize them into a
Received: 15 February 2011 Accepted: 21 March 2011
control and experimental condition. In addition, given Published: 21 March 2011
the context of the community health insurance program,
other clinics that provide standard cardiovascular care References
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Abbreviations of lifestyle-modification measures among adult hypertensives in Nigeria.
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Pre-publication history
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Cite this article as: Odusola et al.: Development and evaluation of a
patient centered cardiovascular health education program for insured
patients in rural Nigeria (QUICK-II). BMC Public Health 2011 11:171.