Adler, Alma J; Laar, Amos; Prieto-Merino, David; Der, Reina MM; Mangortey, Debbie; Dirks, Rebecca; Lamptey, Peter; Perel, Pablo (2019) Can a nurse-led community-based model of hypertension care improve hypertension control in Ghana? Results from the ComHIP cohort study. BMJ open, 9 (4). e026799. ISSN 2044-6055 DOI: https://doi.org/10.1136/bmjopen-2018-026799 Downloaded from: http://researchonline.lshtm.ac.uk/4652694/ DOI: 10.1136/bmjopen-2018-026799 Usage Guidelines Please refer to usage guidelines at http://researchonline.lshtm.ac.uk/policies.html or alterna- tively contact researchonline@lshtm.ac.uk. Available under license: Creative Commons Attribution Non-commercial http://creativecommons.org/licenses/by-nc/3.0/ Open access Research Can a nurse-led community-based model of hypertension care improve hypertension control in Ghana? Results from the ComHIP cohort study Alma J Adler,1,2 Amos Laar,3 David Prieto-Merino,1 Reina M M Der,4 Debbie Mangortey,4 Rebecca Dirks,5 Peter Lamptey,1 Pablo Perel1 To cite: Adler AJ, Laar A, AbstrACt Prieto-Merino D, et al. Can a Objectives To evaluate the effectiveness of the strengths and limitations of this study nurse-led community-based Community-based Hypertension Improvement Project model of hypertension care ► The community-based Hypertension Improvement (ComHIP) in increasing hypertension control. improve hypertension control Project is a large cohort study testing a communi- setting Lower Manya Krobo, Eastern Region, Ghana. in Ghana? Results from the ty-based model of hypertension care. ComHIP cohort study. BMJ Open Participants All adult hypertensive community ► Trained community-based cardiovascular nurses 2019;9:e026799. doi:10.1136/ members, except pregnant women, were eligible for conducted screening, diagnosis and management of bmjopen-2018-026799 inclusion in the study. We enrolled 1339 participants, hypertension patients. 69% of whom were female. A total of 552 had a ► Prepublication history and ► Patients were sent three types of short message 6-month visit, and 338 had a 12-month visit. additional material for this service (SMS), daily reminders to take their medi- Interventions We report on a package of interventions paper are available online. To cations, appointment reminders and weekly health view these files, please visit where community-based cardiovascular disease (CVD) education messages. the journal online (http:// dx.d oi. nurses were trained by FHI 360. CVD nurses confirmed ► Protocol stated that blood pressure would be org/1 0.1 136/b mjopen-2 018- diagnoses of known hypertensives and newly screened checked with a minimum of three serial readings 026799). individuals. Participants were treated according to the at regular intervals, but at a minimum of 6-monthly clinical guidelines established through the project’s AJA and AL contributed equally. intervals.Technical Steering Committee. Patients received ► A limitation of the study was that it did not include three types of reminder and adherence messages. We Received 2 October 2018 a control group. used CommCare, a cloud-based system, as a case Revised 6 February 2019 Accepted 11 February 2019 management and referral tool. Primary outcome Hypertension control defined as blood pressure (BP) under 140/90 mm Hg. Secondary IntrOduCtIOn    outcomes: changes in BP and knowledge of risk factors for Globally, raised systolic blood pressure (SBP) hypertension. is one of the greatest risk factors for disability.1 results After 1 year of intervention, 72% (95% CI: 67% to 77%) of participants had their hypertension Hypertension is generally considered to be under control. Systolic BP was reduced by 12.2 mm the level of raised BP where medications show Hg (95% CI: 14.4 to 10.1) and diastolic BP by 7.5 mm a reduction in clinical events in randomised Hg (95% CI: 9.9 to 6.1). Due to low retention, we were trials. This is generally accepted as ≥140 SBP 2 unable to look at knowledge of risk factors. Factors mm Hg or ≥90 diastolic mm Hg (DBP). associated with remaining in the programme for Evidence shows that lowering hyperten- 12 months included education, older age, hypertension sive individual’s BP with antihypertensive under control at enrolment and enrolment date. The drugs reduces the risk of further cardio- majority of patients who remained in the programme vascular events; with a reduction in stroke were on treatment, with two-thirds taking at least two by an estimated 35%–40% and a 20-25% © Author(s) (or their medications. reduction in myocardial infarction and heart employer(s)) 2019. Re-use Conclusions Patients retained in ComHIP had increased BP control. However, high loss to follow-up failure. 3–5 While average age-standardised permitted under CC BY-NC. No commercial re-use. See rights limits potential public health impact of these types of BP is decreasing in most high-income coun- and permissions. Published by programmes. To minimise the impact of externalities, tries, it is increasing in most low-income and BMJ. 6programmes should include standard procedures middle-income countries with 32%–50% of For numbered affiliations see and backup systems to maximise the possibility that adults estimated to be hypertensive in sub-Sa- end of article. patients stay in the programme. haran Africa.7 Correspondence to The Prospective Urban Rural Epidemi- Dr Alma J Adler; ology study showed that despite high levels A lma.A dler@l shtm. ac.u k of hypertension worldwide, only 34% of Adler AJ, et al. BMJ Open 2019;9:e026799. doi:10.1136/bmjopen-2018-026799 1 BMJ Open: first published as 10.1136/bmjopen-2018-026799 on 2 April 2019. Downloaded from http://bmjopen.bmj.com/ on 18 April 2019 by guest. Protected by copyright. Open access Africans are aware of their hypertension status, only MethOds 31.3% receive any treatment and only 6.5% have their BP study design under control.8 Our recent study of hypertension prev- The study was a prospective cohort study, which included alence in the Lower Manya Krobo, Ghana, showed that all patients recruited into the ComHIP programme. only 2.1% of hypertensives had their BP under control.9 Because of the great burden of hypertension in sub-Sa- setting haran Africa and the poor rate of hypertension control, The study was conducted in Lower Manya Krobo, a munic- innovative methods for hypertension management are ipality in the Eastern Region of Ghana. This is a peri- needed. Launched in 2015, the Community-based Hyper- urban setting approximately 2 hours from the national tension Improvement Project (ComHIP) introduced capital, Accra, with a population of approximately 89 246, 10 as an innovative model for hypertension control at the of whom 84% live in urban areas. Recruitment began community level. ComHIP is a public–private partnership in October 2015 and ended in December 2016. between the Ghana Health Service (GHS), FHI 360 and the Novartis Foundation. Training The aim of ComHIP is to improve hypertension FHI 360 and the Ministry of health (MoH) conducted management and control in the Lower Manya Krobo training. Training duration ranged from 3 days for LCS District in the Eastern Region of Ghana. The programme and physicians, to 6 days for CVD nurses. Aside from includes a package of interventions composed of six the general training package (BP screening including components (online supplementary figure 1), aimed at the recommended standard operating procedures for increasing access to hypertension services at the commu- BP checking, lifestyle modification counselling, inter- nity level. Screening in the community is provided by viewing/counselling techniques and treatment adher- cardiovascular disease (CVD) nurses and community ence counselling) offered to all personnel, CVD nurses health officers (CHOs), as well as through local private and physicians received additional training on hyperten- sector drug shops called licensed chemical sellers (LCS). sion diagnosis, assessing the risk of patients, assessing for Ongoing hypertension management is provided by CVD target organ damages (TODs), and training on drugs for nurses or, for those with comorbidities or severe condi- the management of hypertension and their side effects tions, at district hospitals. Patients are encouraged to and contraindications. routinely monitor their BP by having their BP measured Participants were issued a certificate of participation at an LCS. The various service providers are linked signed by the cardiologist specialist who conducted the through a cloud-based system, which revolves around training and the director general of the GHS. Also, as is bringing hypertension care into the community. Physi- done by the GHS, the continuous learning logbooks of cians, community-based CVD nurses, CHOs and LCS staff the GHS personnel were endorsed by the project to docu- were trained by FHI 360 to provide specific services. ment the training received. For instance, CVD nurses conduct hypertension Participants screening, and confirmation of hypertension diagnosis, Patients were enrolled in the programme if (1) they were staging of the degree of hypertension, assessment of other known hypertensives or (2) had an elevated BP reading CVD risk factors, counselling, monitoring and follow-up, at any ComHIP screening. Any individual living in Lower and trained LCS conduct community BP screening and Manya Krobo, 18 years or older, was eligible, except preg- awareness raising. Further information can be found in nant women. Patients had to have access to a mobile phone the online supplementary material. to be enrolled in the programme. However, in order to The ComHIP programme is being independently eval- negate the loss of patients, patients without phones were uated by the University of Ghana School of Public Health not necessarily excluded based on this; rather, they were and the London School of Hygiene & Tropical Medi- encouraged to provide phone numbers of a willing third cine with a mixed-methods approach through a series of party who lived nearby. quantitative and qualitative studies. These studies include repeat cross-sectional surveys within the intervention and Intervention comparison districts to track overall awareness and prev- Community members were screened by CHOs, LCS or alence of hypertension; a cohort of hypertensive persons CVD nurses, using Omron M6 BP monitors that came included in ComHIP to assess hypertension control; a with a cuff size of 42 cm, the second largest cuff size cost-effectiveness evaluation; a study to assess the level of in the market for those machines. Though the project patient-centeredness within the programme and a quali- requested for nurses to report cases of patient with bigger tative assessment of ComHIP stakeholders. In this paper, upper arms that required bigger cuff sizes, throughout we report the results of the cohort study. the implementation, no such reports were received. The average of three serial readings was used to confirm hyper- Objectives tension diagnosis. Patients who were at risk of hyperten- The objective of this study was to evaluate the effective- sion (SBP≥120, but <140) were given health education. ness of ComHIP for controlling hypertension in patients All patients with SBP≥140 or DBP≥90 were referred to with hypertension enrolled in the ComHIP programme. a CVD nurse for diagnosis. Patients with SBP≥180 or 2 Adler AJ, et al. BMJ Open 2019;9:e026799. doi:10.1136/bmjopen-2018-026799 BMJ Open: first published as 10.1136/bmjopen-2018-026799 on 2 April 2019. Downloaded from http://bmjopen.bmj.com/ on 18 April 2019 by guest. Protected by copyright. Open access DBP≥110 were enrolled and referred to the physician for diagnosed with severe hypertension or coexisting condi- urgent care. Patients that were considered to have severe tions are automatically referred to a physician. All patients hypertension (SBP≥180 or DBP≥110 or SBP between enrolled in ComHIP receive SMS daily for medication 160 and 179 or DBP 100 and 109 with one or more risk reminders, weekly for health education and appoint- factors, or any evidence of organ damage see online ment and screening reminders. CommCare also provides supplementary appendix A) were referred for manage- a cloud-based health records system that links patients’ ment by a physician at one of the district hospitals, until records with the SMS system. The SMS component of their BP was stable, and then they were returned to CVD the project was implemented by a third party Viamo; to nurses for care. All other patients were managed by CVD facilitate the link between the two systems, a bridge was nurses. built to automatically relay relevant information from Patients with hypertension were enrolled and followed the projects cloud-based health records to the Viamo for at least 1 year. All patients’ interactions (with LCS, messaging platform. To ensure confidentiality, only infor- CHOs, CVD nurses, and community and hospital pharma- mation relevant to schedule appointments is relayed to cist and doctors) were recorded and uploaded through the the Viamo platform (ie, patient code, date of visit, type of CommCare platform. Patients were requested to present visit, next review or refill appointment, patient’s phone for appointments at the following intervals: monthly BP number, preferred language, time of receipt of message monitoring appointments; monthly, bi-monthly or quar- and format of the message, referral details and BP). When terly review visits (depending on risk factors and personal a visit is missed, the system automatically relays back to the factors) and 6-monthly follow-up assessments. Partici- CVD nurse who enrolled the patient or is managing the pants were recruited from October 2015 until December patient via text message for the nurse to trace the patient. 2016, and followed through December 2017. Guidelines Due to operational problems, there was a break in service for patient visits can be found in the supplementary mate- in CommCare that began on 12 May 2016 for a period of rials (online supplementary table 1, online supplemen- at least 3 months. tary figure 2, online supplementary appendix A). All enrolled participants were treated based on the Variables same clinical guidelines established through the project’s Main outcomes Technical Steering Committee, which included senior The main outcomes of interest were hypertension control members of the GHS. The treatment goal was to improve (<140/90 mm Hg) and changes in SBP and DBP. Because BP of all patients to below 140/90 mm Hg. Participants of the low follow-up rate, we also used appointment were initiated onto drug therapy and supplemented around 6 months, and appointment around 12 months as with non-drug therapy (lifestyle modification including outcomes of interest. low-salt diets, increased fruit and vegetable diet, reduc- tion in alcohol consumption, smoking cessation and Other variables regular aerobic exercise) irrespective of their risk level. Other variables included knowledge of risk factors for The decision to initiate monotherapy or multiple drug hypertension, demographic factors including age, gender therapy depended largely on the level at which the partic- and marital status, risk factors, such as body mass index ipant's BP was above goal and the overall risk level of (BMI), awareness of hypertension (defined as having patients. Recommended drugs and dosages are found knowledge of a previous diagnosis of hypertension), in online supplementary table 2. Patient’s response to having hypertension under control prior to enrolment antihypertensives was reviewed every 3 months if possible and having previous diagnoses of other heart diseases, and modified based on recommended guidelines if and socioeconomic factors. A full list of variables is found required. In Ghana, there is a system of National Health in table 1. Insurance (NHI) in which every Ghanaian is required to enrol. The scheme provides select medications at no data collection cost for anyone who has a valid NHI card. Although the Data were collected on BP using standardised proto- NHI scheme (NHIS) does not attempt to treat all diseases cols. At 6 and 12 months, forms were administered by suffered by insured members, over 95% of disease condi- healthcare providers to collect information on patient tions that afflict us are covered by the NHIS. Services can knowledge of risk factors for hypertension and health be accessed at accredited health facilities. behaviours. CommCare is a vital component of ComHIP. It serves All data were collected and downloaded from the as a case management system, referral tool and job aid CommCare platform. Initially, data were intended to be for providers. The CommCare database is linked with analysed from the patient knowledge/behaviour forms an SMS platform to automatically send daily adherence used at 6-month and 12-month follow-up appointments. reminders, weekly healthy living tips, and consultation Due to poor levels of follow-up, any appointment between and prescription refill reminders to enrolled patients. 5 and 7 months after enrolment was used for the 6-month These messages are sent via text or voice SMS with four appointment analysis, and any appointment between 11 language choices. The programme is described in more and 13 months after enrolment was used for the 12-month detail elsewhere.9 Briefly, through CommCare, patients appointment analysis. Adler AJ, et al. BMJ Open 2019;9:e026799. doi:10.1136/bmjopen-2018-026799 3 BMJ Open: first published as 10.1136/bmjopen-2018-026799 on 2 April 2019. Downloaded from http://bmjopen.bmj.com/ on 18 April 2019 by guest. Protected by copyright. Open access Table 1 Characteristics of participants in the study at Table 1 Continued baseline % all % 6 month % 12 month % all % 6 month % 12 month Characteristic patients* appointment† appointment‡ Characteristic patients* appointment† appointment‡ 1021–1098 GHC 6.4 5.3 6.5 Number 1339 552 338 1099–1263 GHC 5.0 4.9 4.7 Referred by More than 1263 GHC 12.3 11.1 11.8 L CS 23.9 23.4 24.3 D o not know/no 40.2 40.9 39.9 CHO 45.0 40.8 38.5 response CVD nurse 23.3 25.4 26.9 Aware of hypertension status O ther 7.8 10.5 10.4 N ever had BP 18.7 17.6 16.3 Sex measured M ale 30.8 32.3 30.7 W as not aware 12.9 11.4 10.7 Female 69.2 67.8 69.3 A ware 68.5 70.8 73.1 Age class Taking treatment 30–44 17.9 14.7 13.6 Never diagnosed 31.5 29.2 26.9 45–54 23.5 21.7 24.3 D iagnosed and no 18 15.0 16.0 treatment 55–64 27.3 31.9 32.0 Treatment 50.3 55.6 56.8 65+ 31.4 31.7 30.2 Do not know 0.2 0.2 0.3 Hypertension stage BMI Normal 26.4 38.6 41.7 Underweight 5.4 4.9 5.0 S tage I 39 39.9 39.4 (BMI<18.5) Stage II 19.6 14.5 13.0 Normal weight (BMI 43.7 44.8 43.2 S tage III 14.9 7.1 5.9 18.5–24.9) Mean BP Overweight (BMI 29.2 30.1 32.5 25–29.9) D BP 90.8 87.6 86.9 O bese (BMI 30+) 21.7 20.3 19.2 SBP 149.0 143.3 141.2 Education *All patients with hypertension enrolled in the cohort. †Patients with hypertension with 6-month appointment/follow-up. N o formal education 37.0 32.3 31.4 ‡Patients with hypertension with a 12-month appointment/follow- Primary 41.7 431 45.6 up. BMI, body mass index; BP, blood pressure; CHO, community S econdary 16.1 18.5 14.8 health officers; CVD, cardiovascular disease; DBP, diastolic blood H igher 5.2 6.2 8.3 pressure; LCS, licensed chemical sellers; SBP, systolic blood Ethnicity pressure. Akan 4.2 28.6 21.4 Dangme 69.5 42.2 26 sample size Ewe 22 39.3 22.4 This cohort study included all the patients recruited in Other or do not know 4.3 the ComHIP programme and a specific sample size was Religion not calculated. However, in the protocol, we assumed Christian 96 97.6 97.9 that the total district population is about 90 000; about M uslim 3.2 1.5 1.2 30 000 of whom are adults, and about 36% (12 000) are Traditional 0.5 0.4 0.3 estimated to be hypertensive. Assuming that about 10% of the adults with hypertension in the district will be N one 0.3 0.5 0.6 included in the ComHIP programme, we would have a Marital status cohort of 1200 patients with hypertension. N ever married 5.7 5.1 3.6 We estimated that a cohort study of 1200 patients with Married/cohabiting 54.4 54.7 57.7 hypertension would provide a power greater than 90% S eparated/divorced 5.5 14.1 15.4 (with an alpha error of 0.05) to detect a twofold increase Widowed 26.1 25.9 23.1 of control of hypertension (from 4% to 8%). N o response 0.2 0.2 0.3 Patient and public involvement Household income Community members, including community leaders, Less than 728 GHC 18.7 17.0 17.2 were first involved through a stakeholder workshop. 728–1020 GHC 17.4 20.8 19.8 In this workshop, community members shared their Continued thoughts, knowledge and concerns about health in 4 Adler AJ, et al. BMJ Open 2019;9:e026799. doi:10.1136/bmjopen-2018-026799 BMJ Open: first published as 10.1136/bmjopen-2018-026799 on 2 April 2019. Downloaded from http://bmjopen.bmj.com/ on 18 April 2019 by guest. Protected by copyright. Open access general, Non-communicable disease-related conditions the distribution of hypertension stages between groups, and access to healthcare. Furthermore, community we used χ2 tests. To test the changes of variables within members were made aware of the hypertension project groups, we used paired t-tests for continuous variables and planned to be initiated in their community. This informa- marginal homogeneity tests for categorical variables. tion was considered in finalising the design of the service delivery model and the development of prevention, results education and behaviour change messages. Participants Patients were recruited into the project through free A total of 18 339 individuals, 18 years and older, were screening offered at (1) local drug shops, names LCS; screened, 4118 were referred to CVD nurses to confirm (2) Community Health Planning Service (CHPS) sites diagnosis, and of those 1339 were enrolled, 76 (5.7%) or (3) community pharmacies. There were commu- were considered low-risk (stage 1 BP, which is SBP 140–159 nity screening activities and radio programmes through or DBP 90–99 without any TODs, comorbidities or ≥2 risk which community members were educated on the project factors), 559 (41.7%) were moderate risk (stage 2, which is and hypertension in general. In addition, ComHIP staff SBP 160–179 or DBP 100–109 without any TODs, comorbid- conducted annual stakeholder meetings to provide ities or ≥2 risk factors or stage 1 BP with TODs, comorbidities updates to community members on the project progress. or ≥2 risk factors) and 704 (52.6%) were considered high- risk (stage 3, which is SBP≥180 or DBP≥101 without any statistical methods TODs, comorbidities or ≥2 risk factors or stage 2 BP with We recoded exposures to reduce the number of levels TODs, comorbidities or ≥2 risk factors). and for missing values, for all the previous diagnosis/ awareness, we have coded ‘missing’ or ‘not known’ or ‘no General characteristics of the cohort answer’ as 0, so that value 1 always means ‘patient knows The average age of the cohort was 58 years. Everyone was of a previous diagnosis’ while value 0 means anything else enrolled into the cohort by CVD nurses. Of the 1339 people (patient does not know or answer is missing). Because enrolled in the cohort, 24% were referred to ComHIP by there were few previous diagnoses of each specific event LCS, 45% were referred by CHO, 23% were referred by (MI, stroke, diabetes etc), we created a variable with value CVD nurses, 3% were through physicians and 5% were 1 if any diagnosis was present and 0 if none was present. referred through other channels. About 69% of the cohort For education, we assumed that those that did not was female and 31% male. Other characteristics of people know (48) or did not respond (26) did not have previous enrolled in the cohort are found in table 1. formal education (the largest group). We then grouped education in four levels: (1) no formal education, (2) Other risk factors primary (completed or not), (3) secondary (completed About 5.4% of the sample was underweight, 43.7% was or not) and (4) higher (university). normal, 29.2% was overweight and 21.7% was obese. The For marital status, we made four categories: (1) never mean BMI at enrolment in the cohort was 26.1 (95% CI: married, (2) married or cohabiting, (3) separated or 25.82 to 26.4). divorced and (4) widowed. We did not analyse smoking, cholesterol or diabetes as We described the distribution of each variable at only 1% of the sample were smokers, 3.5% reported having baseline, 6 months and 12 months follow-up, although had a previous cholesterol test and only 28% had a previous comparisons cannot be done directly due to the large diabetes test. number of individuals that did not have a follow-up. To BP at enrolment study what variables might affect the patient staying for The average SBP was 147.2 (SD 22.1) mm Hg, and average 12 months in the programme, we ran a logistic regression DBP was 89.9 (SD 13.3) mm Hg. At enrolment, 917 (68.5%) for the binary outcome variable: ‘patient had 12-month had a previous diagnosis of hypertension, of which 654 visit (Y/N)’. To consider the loss to follow-up (patterns (71.3%) were already taking some antihypertensives, and of visits), we separated the individuals into four different 297 (32.4%) had their BP under control. groups: (A) those individuals that did not come to any follow-up visit, (B) those that came only to the 6-month BP management visit, (C) those that came only to the 12-month visit and Of 1339 enrolled in the study, 712 (53.2%) did not come for (D) those that came to both follow-up visits. a follow-up (group A), 289 (21.6%) had only a 6-month visit We described the absolute values of BP (SBP and DBP), (group B), 75 (5.6%) had only the 12-month visit (group C) the proportion of patients with BP under control and the and 263 (19.6%) had both visits (group D). In total, only 552 distribution of hypertension stages for each of these groups (41%) had a 6-month follow-up appointment, and only 338 in each of the visits. We estimated the average changes of (25%) had a 12-month follow-up appointment. BP for each group at each follow-up visit and we compared the changes between groups with Student’s t-tests. We Loss to follow-up and characteristics of those who stayed in the compared the mean of SBP and DBP between the groups study with analysis of variance (ANOVA) models. To compare Patients with their hypertension already under control were the proportion of patients with hypertension control or more likely to present for care. The variable that showed the Adler AJ, et al. BMJ Open 2019;9:e026799. doi:10.1136/bmjopen-2018-026799 5 BMJ Open: first published as 10.1136/bmjopen-2018-026799 on 2 April 2019. Downloaded from http://bmjopen.bmj.com/ on 18 April 2019 by guest. Protected by copyright. Open access Table 2 Multivariate analysis of baseline characteristics education and hypertension under control in the first visit associated with staying in the programme for 12 months showed significant associations with having a 12-month appointment. Recruitment after 12 May 2016 reduced the OR (95% CI) P value chances of coming to further visits, the older the patient and Enrolled year prior to the break 0.46 (0.35 to 0.60) 0.00 the higher the education level, the higher the chances that Sex 0.88 (0.63 to 1.24) 0.48 the patient would come to the follow-up visits. Patients with Age (1-year increments) 1.01 (1.00 to 1.02) 0.03 controlled hypertension at enrolment were nearly twice as BMI 1.00 (0.97 to 1.02) 0.90 likely to come to follow-up visits. None of the other variables Education reference category: no formal education showed significant associations (table 2). Primary education 1.41 (1.03 to 1.93) 0.03 Secondary education 1.13 (0.73 to 1.73) 0.59 Changes in BP Because 12-month follow-up was below 30%, we did not look H igher education 2.42 (1.33 to 4.43) 0.004 at overall changes in BP, but we did look at overall changes in Reference category: never married BP in those that remained in the study at 6 and 12 months. On average, patients who enrolled and presented Married/cohabitating 1.77 (0.90 to 3.48) 0.10 for a follow-up appointment at around 6 months had Separated/divorced 1.86 (0.90 to 3.87) 0.10 a 10.3 mm Hg reduction in SBP (95% CI: 12.0 to 8.6) Widowed 1.27 (0.61 to 2.64) 0.52 and a 6.3 mm Hg reduction in DBP (95% CI: 7.2 to 5.2) H ousehold size 1.01 (0.95 to 1.07) 0.69 (table 3). There was a greater reduction in those patients H ypertension control 1.93 (1.47 to 2.54) <0.001 who had a follow-up appointment at 1 year, when there Awareness of hypertension 1.00 (1.00 to 1.00) 0.97 was a 12.2 mm Hg reduction (95% CI: 14.4 to 10.1) in SBP Hypertension treatment 1.00 (0.99 to 1.00) 0.33 and a 7.5 mm Hg (95% CI: 9.9 to 6.1) reduction in DBP after 1 year in the programme. Not all patients who had a Any other previous diagnosis 0.86 (0.69 to 1.07) 0.18 12-month appointment also had a 6-month appointment, C onfidence in management 1.00 (1.00 to 1.01) 0.63 of hypertension 263 had both, and they had an 11.9 mm Hg reduction (95% CI: −14.3 to –9.5) in SBP and 7.1 mm Hg reduction BMI, body mass index. (95% CI: −8.6 to –5.5) in DBP (table 3). greatest association with likelihood of having a 6-month or Knowledge of risk factors 12-month appointment was enrolment month. Participants Because of the poor retention, we were unable to comment who enrolled earlier were much more likely to stay in the on knowledge or risk factors. programme than those who enrolled later (table 1). There was also a significant reduction in hypertension Multivariate analysis suggested that recruitment before stage, with a lower percentage of patients with hypertension 12 May 2016 (1 year before the break in service), age, having stage III hypertension over time (table 4). Table 3 Changes in BP means and hypertension control by patterns of visits SBP DBP HT control Mean difference Mean difference Groups N Visit Mean (SE) (95% CI) Mean (SE) (95% CI) % (95% CI) All patients 1339 E 147.2 (0.60) 89.9 (0.36) 31% (29% to 34%) 552 6 m 132.9 (0.80) −10.3 (−12.0 to −8.6) 81.3 (0.47) −6.3 (−7.3 to −5.2) 69% (65% to 73%) 338 12 m 128.9 (1.05) −12.2 (−14.4 to −10.1) 79.4 (0.61) −7.5 (−8.9 to −6.1) 72% (67% to 77%) (A) No visits 712 E 150.4 (0.85) 91.7 (0.49) 25% (21% to 28%) (B) Only 6 m 289 E 146.4 (1.28) 89.0 (0.77) 34% (29% to 40%) 6 m 135.7 (1.15) −10.1 (−13.2 to −8.1) 82.7 (0.68) −6.3 (−7.8 to −4.8) 61% (55% to 67%)* (C) Only 12 m 75 E 145.9 (2.62) 90.2 (1.63) 36% (25% to 48%) 12 m 132.5 (2.56) −13.5 (−18.5 to −8.6) 81.0 (1.38) −9.2 (−12.4 to −6.0) 71% (59% to 81%)* (D) 6 and 12 m 263 E 139.8 (1.18) 86.1 (0.80) 43% (37% to 50%) 6 m 129.8 (1.08) −10.0 (−12.2 to −7.7) 79.8 (0.63) −6.3 (−7.8 to −4.8) 77% (72% to 82%)* 12 m 127.9 (1.13) −11.9 (−14.3 to −9.5) 79.0 (0.67) −7.1 (−8.6 to −5.5) 72% (66% to 78%)* *The comparison of these intervals with enrolment visit of the same group produces all p values <0.0001. BP, blood pressure; DBP, diastolic blood pressure; E, enrolment; HT, hypertension, m, month; SBP, systolic blood pressure; SE, standard error 6 Adler AJ, et al. BMJ Open 2019;9:e026799. doi:10.1136/bmjopen-2018-026799 BMJ Open: first published as 10.1136/bmjopen-2018-026799 on 2 April 2019. Downloaded from http://bmjopen.bmj.com/ on 18 April 2019 by guest. Protected by copyright. Open access Table 4 Distribution of hypertension stage in each group in each visit. The p values are extracted from: (1) Χ2 tests to compare that row with group A of no follow-up and (2) from marginal homogeneity tests comparing the distribution of the same group in enrolment visit Groups by patterns of visits N Visit No HT Stage I Stage II Stage III P value All patients 1339 1 m 31.0% 39.0% 18.4% 11.6% 552 6 m 68.7% 19.7% 9.4% 2.2% <0.001 (2) 338 12 m 71.9% 19.5% 6.5% 2.1% <0.001 (2) (A) No follow-up 712 1 m 24.6% 38.7% 21.5% 15.2% (B) Only 6-m visit 289 1 m 34.3% 39.4% 17.0% 9.3% 0.002 (1) 289 6 m 60.9% 24.2% 12.1% 2.8% <0.001 (2) (C) Only 12-m visit 75 1 m 36.0% 36.0% 17.3% 10.7% 0.167 (1) 75 12 m 70.7% 14.7% 10.7% 4.0% <0.001 (2) (D) 6-m and 12-m visit 263 1 m 43.4% 40.3% 11.8% 4.5% <0.001 (1) 263 6 m 77.2% 14.8% 6.5% 2.2% <0.001 (2) 263 12 m 72.3% 20.9% 5.3% 1.5% <0.001 (2) m, month. Awareness on treatment were taking a calcium channel blocker (CCB) Overall awareness of hypertension status in the overall (36% of all patients), but at 6 months, the majority were on cohort was 68.5% at enrolment. Individuals who stayed diuretics (75.9%) followed by a CCB (69.5%). The same in the programme longer were more likely to be aware of pattern was found at 12 months with 79.8% taking diuretics, their hypertension status. About 70.8% of individuals who and 71.5% taking a CCB (table 5). stayed in the programme for 6 months were aware of their In patients who had a 6-month appointment, 24.1% were hypertension status, and 73.1% of those who stayed in the taking only one medication, 32% were taking two medica- programme for 12 months were aware of their hypertension tions and over 30% were taking more than two medications. status (table 1). In patients who had a 12-month appointment, 23% were Treatment taking one medication, 32.6% were taking two medications Treatment increased between enrolment and 6-month and and over 32% were taking more than two medications. 12-month appointments. Although only 44.2% of patients Control were receiving any medication at enrolment, the majority There was an increase in BP control in patients who were being treated at 6 months (90.4%) and at 12 months remained in the programme (table 3); however, patients (92.2%). At enrolment, the majority of patients who were who stayed in the programme were more likely to have Table 5 Treatment pattern in the cohort at enrolment, 6 months and 12 months with p values for differences Treatment Enrolment 6 months P change 12 months P change Diuretic 21.66% 75.89% 0.00000 79.83% <0.00001 Calcium CB 36.07% 69.46% 0.00000 71.47% <0.00001 Beta-blocker 3.14% 8.93% 0.00000 9.51% 0.00001 ACE inhibitor 6.72% 22.5% 0.00000 21.61% <0.00001 ARB 2.54% 12.5% 0.00000 13.54% <0.00001 Other 3.66% 15.89% 0.00000 17.87% <0.00001 Any 44.29% 90.36% 0.00000 92.22% <0.00001 0 medications 55.71% 9.64% 0.00000 7.78% <0.00001 One medication 19.42% 24.11% 0.21013 23.05% 0.62722 Two medications 20.46% 31.96% 0.00040 32.56% 0.00811 Three medications 4.18% 23.93% 0.00000 24.78% <0.00001 Four medications 0.22% 6.96% 0.00000 8.07% <0.00001 Mean 0.74 2.05 0.00000 2.14 <0.00001 ACE, angiotensin converting enzyme; ARB, angiotensin receptor blockers; CB, channel blocker. Adler AJ, et al. BMJ Open 2019;9:e026799. doi:10.1136/bmjopen-2018-026799 7 BMJ Open: first published as 10.1136/bmjopen-2018-026799 on 2 April 2019. Downloaded from http://bmjopen.bmj.com/ on 18 April 2019 by guest. Protected by copyright. Open access their BP under control on enrolment. In the group of Of those, patients who remained in the programme over patients that did not have a second appointment (group 6 months, they found 63% adherence to appointments.13 A), the baseline BP control was 25% while in the other In a study conducted in the slums of Nairobi, only 3.4% groups (B, C and D) was 34%, 36% and 43%, respectively. of participants showed completed compliance with the These differences were statistically significant (table 4). programme. About 30% only showed up for one appoint- The BP control increased to 69% (95% CI: 65% to 73%) ment, and 5% only had two visits. Similar to our study, in the individuals that visited at 6 months. In the patients they found that patients who remained in the programme that had the 12-month visit, the control increased to showed significant reductions in SBP and DBP.14 72% (95% CI: 67% to 77%). Of patients who had both In a study done in two sites (one rural and one urban) a 6-month and 12-month follow-up appointment, the in Malawi, of 4075 patients referred for clinical care, only control increased to 77% (95% CI: 72% to 82%) at 61% attended their referral appointments. Of those, 47% 6 months, but slightly decreased to 72% at 12 months of patients with hypertension were still in contact after (95% CI: 66% to 78%) (table 3, table 4). 24 months. Similar to our findings, they found uptake in care to be higher in older patients, being on antihyper- tensives prior to enrolment, and not being in employ- ment. Unlike our study, they found that females were dIsCussIOn more likely to be retained in care.15 summary of results Similarly, a study of hypertensive and diabetic patients Of 1339 patients enrolled in ComHIP, only 552 (41%) in rural Cameroon found that only 18.1% of participants had a follow-up appointment at 6 months, 338 (25.2%) were still in care after 1 year. However, similar to our had a follow-up appointment at 12months and 263 (20%) study, they found significant decreases in SBP and DBP in had both 6-month and 12-month appointments. Partic- patients with hypertension with at least two documented ipants who had more education, were older, had their visits. hypertension under control at enrolment, or who had the opportunity to spend at least a year in the programme strengths and limitations before the break in service were more likely to attend A major strength of this study is unlike most other hyper- appointments at 6 and/or 12 months. tension programmes, ComHIP uses existing GHS proto- Among the group of patients who continued in the cols and medications and does not require outside funds programme for 6 or 12 months, we found strong evidence or intervention for medications. This means that there of a reduction in DBP and SBP, and an increase (from is a much greater chance of long-term sustainability of under half to more than two-thirds) of hypertension the programme as it does not rely on outside sources for control. We also found strong evidence of an increase of medications. the patients under treatment, of the number of medica- Limitations of the study include that data were only tions received per patient and a decrease in the number available for encounters with service providers within the of individuals with severe hypertension. ComHIP network. Any appointments with doctors and pharmacists (licensed or unlicensed) that were not part Comparison with other studies of ComHIP would not have been registered, so it is Other studies evaluating task sharing for hypertension possible that patients were obtaining antihypertensives management have shown modest levels of success. For from non-licensed sellers, which would not be captured example, one randomised controlled study conducted in the ComHIP database. Another limitation of ComHIP in Ghana using task sharing (but supplying free medi- was that the cohort did not have a control. cations) showed greater reductions in SBP in patients Due to the extremely poor follow-up, it is not possible randomised to the arm that included trained nurses, as to generalise our findings regarding the impact on BP compared with the one that just provided free medica- control to other studies, other than to emphasise the tions and health insurance.11 importance of effective strategies to promote follow-up. The poor follow-up reported in our study is not unex- Finally, it is important to remember that nearly 70% of pected. Many studies have shown poor levels of follow-up the initial cohort was aware of their hypertension status or adherence to clinic appointments. In one study and about half were taking medications, which is a much conducted in three primary care clinics in Kibera, Kenya, higher proportion than in the general population. While between 2010 and 2012, 1465 hypertensive or diabetic this was done in ComHIP to ensure access to hyperten- patients were identified. Of these, 31% of patients were sion management to community members who other- lost to follow-up. Of these, 55% of non-diabetic patients wise would not have been able to access services, it is an had their BP under control by 24 months, but only 28% important consideration when considering generalis- of diabetic patients.12 ability to the overall population. In another study conducted in Kibera, Kenya, between 2015 and 2016, 3861 patients with hypertension were Interpretation identified in health centres or clinics. Of those, 3069 In 25% of people who had a 12-month appointment, patients did not complete 6 months of follow-up (79%). there was strong evidence of an increase of the patients 8 Adler AJ, et al. BMJ Open 2019;9:e026799. doi:10.1136/bmjopen-2018-026799 BMJ Open: first published as 10.1136/bmjopen-2018-026799 on 2 April 2019. Downloaded from http://bmjopen.bmj.com/ on 18 April 2019 by guest. Protected by copyright. Open access receiving medications, the average number of medi- However, the high loss to follow-up of patients recruited cations received per patient and the level of hyperten- limits the potential public health impact of these types of sion control; we also found a reduction in both BP and programmes. In order to minimise the impact of exter- hypertension status. However, like most other studies nalities (such as the CommCare service gap in ComHIP), in the region, the high loss to follow-up highlights that programmes should have standard procedures and innovative hypertension programmes, such as ComHIP, backup systems to maximise the possibility that patients need to develop better ways to retain patients within the stay in the programme, particularly younger and less programme. educated individuals. Also, appropriate incentives should Community-based hypertension programmes in be put in place to keep programme staff fully engaged resource-poor setting often are complex to carry out and and avoid programme fatigue. Future studies should are prone to poor follow-up. There are many possible further identify causes of loss to follow-up and find effec- reasons that follow-up in our study was low. tive ways to adapt programmes accordingly (eg, access to The factor most associated with retention in the treatment within the community and targeted behaviour programme was enrolment date. This is significant as due change messaging) to ensure that most of the patients to operational issues, there was a gap of CommCare util- recruited stay long-term in the programme. Future isation for 3 months. Anecdotally, FHI 360 ComHIP staff research may also want to focus on more difficult to reach learnt that this gap in CommCare service had caused both patients who have lower levels of awareness and treatment service providers and staff to believe that the interven- on enrolment. tion had stopped, which may have resulted in a low rate of completion of follow-up appointments. Considering Author affiliations difficulties associated with community-based studies in 1Department of Non-communicable Disease Epidemiology, London School of low-resource settings, it is imperative to ensure continuity Hygiene & Tropical Medicine, London, UK 2 of service. Other factors that could cause this association Department of Global Health and Social Medicine, Harvard Medical School, Boston, may be healthcare professional fatigue; engaging patients Massachusetts, USA3 to present for appointments may require considerable Department of Population, Family & Reproductive Health, School of Public Health, University of Ghana, Accra, Ghana effort, such as multiple phone calls and personal interac- 4FHI360, Accra, Ghana tion, for which the CVD nurses did not receive additional 5FHI360, Washington, DC, USA monetary compensation. It is possible that over time, the enthusiasm of the CVD nurses for the intervention may Acknowledgements We are grateful to all of the cohort clients. We are also have waned. Also, as in any low-resource settings, there is grateful to the leadership and political support of the Ghana Health Service (both a great deal of workforce turnover; FHI 360 recognised from the national and district levels) for their support. this early in the implementation and trained extra staff to Contributors PL conceived the idea of the project, and PL and RD designed the bridge the gaps; however, it is still possible that new health- interventions. PL, AA, AL and PP designed the research component of the project. DM and RMMD supervised the implementation of the programme. RMMD is the care providers who replaced them may not have had the programme data manager. AA and DP-M performed the statistical analyses. AA same level of training. A complementary component of drafted the manuscript, with inputs from all the authors. All authors read and the evaluation that includes qualitative research with approved the final version of the manuscript. different ComHIP stakeholders is underway to analyse in Funding Funds for the project were made available by Novartis Foundation, Basel, depth the possible reasons that may have caused people Switzerland. to not adhere to the programme. (See Adler et al Barriers disclaimer Novartis Foundation did not have any input or control over this and facilitators to the implementation of a communi- manuscript. ty-based hypertension improvement project in Ghana: Competing interests Co-authors PL, AA, AL, PP, and DP-M worked on the a qualitative study and Laar et al Health system challenges ComHIP Programme for which their institutions (LSHTM and UGSPH) have received grants from the Novartis Foundation. Co-authors RD, RMMD and to hypertension and related non-communicable diseases DM are staff of the FHI 360, which provided technical direction to ComHIP prevention and treatment: perspectives from Ghanaian implementation. stakeholders.) Patient consent for publication Not required. Lastly, our study found that older individuals were ethics approval Ethical approval was granted by the Institutional Review Boards more likely to continue in care, this was found in at (IRBs) of LSHTM (LSHTM Ethics Ref: 10152), the Ghana Health Service (ID No. least one other study15 but was not reported on in most GHS-ERC 04/01/15) and the University of Ghana at Noguchi Memorial Institute for studies. This could be because older patients may have Medical Research (Ethics clearance # IRB00001276). more time to attend clinics. Patients with their hyperten- Provenance and peer review Not commissioned; externally peer reviewed. sion under control were about twice as likely to stay in data sharing statement Summary statistics related to the data set used in the the programme. This is not surprising as they had already project are available by request. exhibited better health-seeking behaviours. Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, recommendations which permits others to distribute, remix, adapt, build upon this work For patients enrolled and who continued in the non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, programme, we found an important impact on the any changes made indicated, and the use is non-commercial. 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