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Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana.

ABSTRACT: Background: Poor access to care and physician shortage are major barriers to hypertension control in sub-Saharan Africa. Implementation of evidence-based systems-level strategies targeted at these barriers are lacking. We conducted a study to evaluate the comparative effectiveness of provision of health insurance coverage (HIC) alone versus a nurse-led task shifting strategy for hypertension control (TASSH) plus HIC on systolic blood pressure (SBP) reduction among patients with uncontrolled hypertension in Ghana.

Methods and findings: Using a pragmatic cluster randomized trial, 32 community health centers within Ghana's public healthcare system were randomly assigned to either HIC alone or TASSH + HIC. A total of 757 patients with uncontrolled hypertension were recruited between November 28, 2012, and June 11, 2014, and followed up to October 7, 2016. Both intervention groups received health insurance coverage plus scheduled nurse visits, while TASSH + HIC comprised cardiovascular risk assessment, lifestyle counseling, and initiation/titration of antihypertensive medications for 12 months, delivered by trained nurses within the healthcare system. The primary outcome was change in SBP from baseline to 12 months. Secondary outcomes included lifestyle behaviors and blood pressure control at 12 months and sustainability of SBP reduction at 24 months. Of the 757 patients (389 in the HIC group and 368 in the TASSH + HIC group), 85% had 12-month data available (60% women, mean BP 155.9/89.6 mm Hg). In intention-to-treat analyses adjusted for clustering, the TASSH + HIC group had a greater SBP reduction (-20.4 mm Hg; 95% CI -25.2 to -15.6) than the HIC group (-16.8 mm Hg; 95% CI -19.2 to -15.6), with a statistically significant between-group difference of -3.6 mm Hg (95% CI -6.1 to -0.5; p = 0.021). Blood pressure control improved significantly in both groups (55.2%, 95% CI 50.0% to 60.3%, for the TASSH + HIC group versus 49.9%, 95% CI 44.9% to 54.9%, for the HIC group), with a non-significant between-group difference of 5.2% (95% CI -1.8% to 12.4%; p = 0.29). Lifestyle behaviors did not change appreciably in either group. Twenty-one adverse events were reported (9 and 12 in the TASSH + HIC and HIC groups, respectively). The main study limitation is the lack of cost-effectiveness analysis to determine the additional costs and benefits, if any, of the TASSH + HIC group.

Conclusions: Provision of health insurance coverage plus a nurse-led task shifting strategy was associated with a greater reduction in SBP than provision of health insurance coverage alone, among patients with uncontrolled hypertension in Ghana. Future scale-up of these systems-level strategies for hypertension control in sub-Saharan Africa requires a cost-benefit analysis.

Trial registration: ClinicalTrials.gov NCT01802372.

SUBMITTER: Ogedegbe G

PROVIDER: S-EPMC5929500 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana.

Ogedegbe Gbenga G Plange-Rhule Jacob J Gyamfi Joyce J Chaplin William W Ntim Michael M Apusiga Kingsley K Iwelunmor Juliet J Awudzi Kwasi Yeboah KY Quakyi Kofi Nana KN Mogaverro Jazmin J Khurshid Kiran K Tayo Bamidele B Cooper Richard R

PLoS medicine 20180501 5

<h4>Background</h4>Poor access to care and physician shortage are major barriers to hypertension control in sub-Saharan Africa. Implementation of evidence-based systems-level strategies targeted at these barriers are lacking. We conducted a study to evaluate the comparative effectiveness of provision of health insurance coverage (HIC) alone versus a nurse-led task shifting strategy for hypertension control (TASSH) plus HIC on systolic blood pressure (SBP) reduction among patients with uncontroll ...[more]

PMID: 29715303

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Project description:BackgroundCountries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular disease (CVD) propelled by rapidly increasing rates of hypertension. Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs. Although SSA bears 24% of the global disease burden, it has only 3% of the global health workforce. Given such limited resources, cost-effective strategies, such as task shifting, are needed to mitigate the rising CVD epidemic in SSA. Ghana, a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization (WHO) task-shifting strategy. This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage, on blood pressure (BP) reduction.MethodsUsing a cluster randomized design, 32 community health centers (CHCs) and district hospitals in Ghana will be randomized to either the intervention group (16 CHCs) or the control group (16 CHCs). A total of 640 patients with uncomplicated hypertension (BP 140-179/90-99 mm Hg and absence of target organ damage) will be enrolled in this study (20 patients per CHC). The intervention consists of WHO Package of CV risk assessment, patient education, initiation and titration of antihypertensive medications, behavioral counseling on lifestyle behaviors, and medication adherence every three months for 12 months. The primary outcome is the mean change in systolic BP from baseline to 12 months. The secondary outcomes are rates of BP control at 12 months; levels of physical activity, percent change in weight, and dietary intake of fruits and vegetables at 12 months; and sustainability of intervention effects at 24 months. All outcomes will be assessed at baseline, six months and 12 months. Trained community health nurses will deliver the intervention as part of Ghana's community-based health planning and services (CHPS) program.DiscussionFindings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in resource-poor settings.Trial registrationNCT01802372.

Project description:ObjectiveTo report the results of a nurse-led pre-exposure prophylaxis (PrEP) delivery service.DesignThis was a prospective cohort study conducted from 5 August 2018 to 4 March 2020. It involved manual chart review to collect data. Variables were described using frequencies and percentages and analysed using χ2 testing. Those significant in bivariate analysis were retained and entered into a binary multiple logistic regression. Hierarchical modelling was used, and only significant factors were retained.SettingThis study occurred in an urban public health unit and community-based sexually transmitted infection (STI) clinic in Ottawa, Canada.ParticipantsOf all persons who were diagnosed with a bacterial STI in Ottawa and everyone who presented to our STI clinic during the study period, there were 347 patients who met our high-risk criteria for PrEP; these criteria included patients who newly presented with any of the following: HIV contacts, diagnosed with a bacterial STI or single use of HIV PEP. Further, eligibility could be determined based on clinical judgement. Patients who met the foregoing criteria were appropriate for PrEP-RN, while lower-risk patients were referred to elsewhere. Of the 347 patients who met our high-risk criteria, 47% accepted and 53% declined. Of those who accepted, 80% selected PrEP-registered nurse (RN).Primary and secondary outcome measuresUptake, acceptance, engagement and attrition factors of participants who obtained PrEP through PrEP-RN.Findings69% of participants who were eligible attended their intake PrEP-RN visit. 66% were retained in care. Half of participants continued PrEP and half were lost to follow-up. We found no significant differences in the uptake, acceptance, engagement and attrition factors of participants who accessed PrEP-RN regarding reason for referral, age, ethnicity, sexual orientation, annual income, education attainted, insurance status, if they have a primary care provider, presence or absence of depression or anxiety and evidence of newly acquired STI during the study period.ConclusionsNurse-led PrEP is an appropriate strategy for PrEP delivery.

Project description:ObjectivesTo evaluate the effectiveness of the Community-based Hypertension Improvement Project (ComHIP) in increasing hypertension control.SettingLower Manya Krobo, Eastern Region, Ghana.ParticipantsAll adult hypertensive community members, except pregnant women, were eligible for inclusion in the study. We enrolled 1339 participants, 69% of whom were female. A total of 552 had a 6-month visit, and 338 had a 12-month visit.InterventionsWe report on a package of interventions where community-based cardiovascular disease (CVD) nurses were trained by FHI 360. CVD nurses confirmed diagnoses of known hypertensives and newly screened individuals. Participants were treated according to the clinical guidelines established through the project's Technical Steering Committee. Patients received three types of reminder and adherence messages. We used CommCare, a cloud-based system, as a case management and referral tool.Primary outcomeHypertension control defined as blood pressure (BP) under 140/90?mm Hg.Secondary outcomeschanges in BP and knowledge of risk factors for hypertension.ResultsAfter 1?year of intervention, 72% (95% CI: 67% to 77%) of participants had their hypertension under control. Systolic BP was reduced by 12.2?mm Hg (95%?CI: 14.4 to 10.1) and diastolic BP by 7.5?mm Hg (95%?CI: 9.9 to 6.1). Due to low retention, we were unable to look at knowledge of risk factors. Factors associated with remaining in the programme for 12?months included education, older age, hypertension under control at enrolment and enrolment date. The majority of patients who remained in the programme were on treatment, with two-thirds taking at least two medications.ConclusionsPatients retained in ComHIP had increased BP control. However, high loss to follow-up limits potential public health impact of these types of programmes. To minimise the impact of externalities, programmes should include standard procedures and backup systems to maximise the possibility that patients stay in the programme.

Project description:BackgroundPeople with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring.DesignPragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines' monitoring versus usual care.SettingFive UK private sector care homes.Participants41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.InterventionNurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.OutcomesProblems addressed and changes in medicines prescribed.Data collection and analysisInformation was collected from participants' notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.ResultsFive of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57-4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78-8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80-235.90] and 5.12 [1.45-18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15-17.22).ConclusionThe WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.Trial registrationISRCTN 48133332.

Project description:BackgroundNurses in Ghana play a vital role in the delivery of primary health care at both the household and community level. However, there is lack of information on task shifting the management and control of hypertension to community health nurses in low- and middle-income countries including Ghana. The purpose of this study was to assess nurses' knowledge and practice of hypertension management and control pre- and post-training utilizing task-shifting strategies for hypertension control in Ghana (TASSH).MethodsA pre- and post- test survey was administered to 64 community health nurses (CHNs) and enrolled nurses (ENs) employed in community health centers and district hospitals before and after the TASSH training, followed by semi-structured qualitative interviews that assessed nurses' satisfaction with the training, resultant changes in practice and barriers and facilitators to optimal hypertension management.ResultsA total of 64 CHNs and ENs participated in the TASSH training. The findings of the pre- and post-training assessments showed a marked improvement in nurses' knowledge and practice related to hypertension detection and treatment. At pre-assessment 26.9% of the nurses scored 80% or more on the hypertension knowledge test, whereas this improved significantly to 95.7% post-training. Improvement of interpersonal skills and patient education were also mentioned by the nurses as positive outcomes of participation in the intervention.ConclusionsFindings suggest that if all nurses receive even brief training in the management and control of hypertension, major public health benefits are likely to be achieved in low-income countries like Ghana. However, more research is needed to ascertain implementation fidelity and sustainability of interventions such as TASSH that highlight the potential role of nurses in mitigating barriers to optimal hypertension control in Ghana.Trial registrationTrial registration for parent TASSH study: NCT01802372 . Registered February 27, 2013.

Project description:IntroductionOlder patients raise therapeutic challenges, because they constitute a heterogeneous population with multimorbidity. To appraise this complexity, geriatricians have developed a multidimensional comprehensive geriatric assessment (CGA), which may be difficult to apply in primary care settings. Our primary objective was to compare the effect on morbimortality of usual care compared with two complex interventions combining educational seminars about CGA: a dedicated geriatric hotline for general practitioners (GPs) and CGA by trained nurses or GPs.Methods and analysisThe Clinical Epidemiology and Ageing study is an open-label, pragmatic, multicentre, three-arm, cluster randomised controlled trial comparing two intervention groups and one control group. Patients must be 70 years or older with a long-term illness or with unscheduled hospitalisation in the past 3 months (750 patients planned). This study involves volunteering GPs practising in French primary care centres, with randomisation at the practice level. The multifaceted interventions for interventional arms comprise an educational interactive multiprofessional seminar for GPs and nurses, a geriatric hotline dedicated to GPs in case of difficulties and the performance of a CGA updated to primary care. The CGA is systematically performed by a nurse in arm 1 but is GP-led on a case-by-case basis in arm 2. The primary endpoint is a composite criterion comprising overall death, unscheduled hospitalisations, emergency admissions and institutionalisation within 12 months after inclusion. Intention-to-treat analysis will be performed using mixed-effects logistic regression models, with adjustment for potential confounders.Ethics and disseminationThe protocol was approved by an appropriate ethics committee (CPP Ile-de-France IV, Paris, France, approval April 2015;15 664). This study is conducted according to principles of good clinical practice in the context of current care and will provide useful knowledge on the clinical benefits achievable by CGA in primary care.Trial registration numberNCT02664454; Pre-results.

Project description:BackgroundRobust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care.MethodsWe undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ?16 years) with CD4 counts of 350 cells per ?L or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853.Findings5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2-18·0) in cohort 1 and 18·0 months (18·0-18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76-1·15). In a preplanned subgroup analysis of patients with baseline CD4 counts of 201-350 cells per ?L, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54-1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per ?L or less (0·94, 0·76-1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI -2·4 to 4·6).InterpretationExpansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality.FundingUK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.

Project description:INTRODUCTION:India has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled 'm-Power Heart Project' is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial's process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research. METHODS AND ANALYSIS:The process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick's model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelli et al's framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations. TRIAL REGISTRATION NUMBER:NCT03164317; Pre-results.

Dataset Information

Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana.

Publications

Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana.

Similar Datasets

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