scholarly journals Integrated Sustainable Childhood Pneumonia and Infectious Disease Reduction in Nigeria (INSPIRING) Through Whole System Strengthening in Jigawa, Nigeria: Study Protocol For a Cluster Randomised Controlled Trial

2021 ◽  
Author(s):  
Carina King ◽  
Rochelle Burgess ◽  
Ayobami Bakare ◽  
Funmilayo Shittu ◽  
Julius Salako ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health System ◽  
Child Mortality ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Health System Strengthening ◽  
Economic Evaluations ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
Whole Systems

Abstract BackgroundChild mortality remains unacceptably high, with Northern Nigeria reporting some of the highest rates globally (e.g. 192/1000 live births in Jigawa State). Coverage of key protect and prevent interventions, such as vaccination and clean cooking fuel use, are low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality.MethodsThis is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 – September 2022. The trial will be conducted in Kiyawa Local Government Area, Jigawa State, Nigeria, with an estimated population of 230,000. Clusters are defined as primary government health facility catchment areas (n=33). The 33 clusters will be randomly allocated (1:1) in a public ceremony, and 32 clusters included in the impact evaluation. The trial will evaluate a locally adapted ‘whole systems strengthening’ package of three evidence-based methods: community men’s and women’s groups; Partnership Defined Quality Scorecard; healthcare worker training, mentorship and provision of basic essential equipment and commodities. The primary outcome is mortality of children aged 7 days to 59 months. Mortality will be recorded prospectively using a cohort design, and secondary outcomes measured through baseline and endline cross-sectional surveys. Assuming the following, we will have a minimum detectable effect size of 30%: a) baseline mortality of 100 per 1000 livebirths; b) 4,480 compounds with 3 eligible children per compound; c) 80% power; d) 5% significance; e) intra-cluster correlation of 0.007; f) coefficient of variance of cluster size of 0.74. Analysis will be by intention-to-treat, comparing intervention and control clusters, adjusting for compound and trial clustering. DiscussionThis study will provide robust evidence of the effectiveness and cost-effectiveness of community-based participatory learning and action, with integrated health system strengthening and accountability mechanisms, to reduce child mortality. The ethnographic process evaluation will allow for a rich understanding of how the intervention works in this context. However, we encountered a key challenge in calculating the sample size, given the lack of timely and reliable mortality data, and the uncertain impacts of the COVID-19 pandemic. Trial registrationISRCTN 39213655, registered 11th December 2019

scholarly journals Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial.

2019 ◽  
Author(s):  
Hillary Rono ◽  
Andrew Bastawrous ◽  
David Macleod ◽  
Emmanuel Wanjala ◽  
Stephene Gichuhi ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health System ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Eye Care ◽  
Community Screening ◽  
Eye Health ◽  
Cluster Randomised ◽  
Eye Problems ◽  
Randomised Controlled

Abstract Background: Globally eye care provision is currently insufficient to meet the requirement for eye care services. Lack of access and awareness are key barriers to specialist services, in addition, specialist services are over utilised by people with conditions that could be managed in the community or primary care. In combination, these lead to a large unmet need for eye health provision. We have developed a validated smart phone-based screening algorithm (Peek Community Screening App). The application (app) is part of the Peek Community Eye Health system (Peek CEH) that enables Community Volunteer (CVs) to make referral decisions about patients with eye problems. It generates referrals, automated short messages service (SMS) notifications to patients and carers and has a program dashboard for visualizing service delivery. We hypothesize that a greater proportion of people with eye problems will be identified using the Peek CEH system and that there will be increased uptake of referrals, compared to those identified and referred using the current community screening approaches. Methods: A single masked, cluster-randomised controlled trial. The unit of randomisation will be the “community units”, defined as a dispensary or health centres with its catchment population. The community units will be allocated to receive either the intervention (Peek CEH system) or the current care (periodic health centre-based outreach clinics with onward referral for further treatment). In both arms, a triage clinic will be held at the link health facility four weeks from sensitization, where attendance will be ascertained. During triage participants will be assessed and treated, and if necessary referred onwards to Kitale eye unit. Discussion: We aim to evaluate a M-health system (Peek CEH) geared towards reducing avoidable blindness through early identification and improved adherence to referral for those with eye problems and reducing demand at secondary care for conditions that can be managed effectively at primary care level. Trial registration: The Pan African Clinical Trials Registry (PACTR), 201807329096632. Registered 8th june 2018, https://pactr.samrc.ac.za. Keywords: Eye problems, Visual Impairement, Access, Primary eye care , Community Eye Health system, Community volunteres, Peek community screening app., cluster randomised controlled trial.

scholarly journals Protocol for an economic evaluation alongside a cluster randomised controlled trial: cost-effectiveness of Learning Clubs, a multicomponent intervention to improve women’s health and infant’s health and development in Vietnam

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031721
Author(s):  
Trang Nguyen ◽  
Kim Sweeny ◽  
Thach Tran ◽  
Stanley Luchters ◽  
David B Hipgrave ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Economic Evaluations ◽  
Cluster Randomised ◽  
Life Years ◽  
Randomised Controlled ◽  
The Impact

IntroductionEconomic evaluations of complex interventions in early child development are required to guide policy and programme development, but a few are yet available.Methods and analysisAlthough significant gains have been made in maternal and child health in resource-constrained environments, this has mainly been concentrated on improving physical health. The Learning Clubs programme addresses both physical and mental child and maternal health. This study is an economic evaluation of a cluster randomised controlled trial of the impact of the Learning Clubs programme in Vietnam. It will be conducted from a societal perspective and aims to identify the cost-effectiveness and the economic and social returns of the intervention. A total of 1008 pregnant women recruited from 84 communes in a rural province in Vietnam will be included in the evaluation. Health and cost data will be gathered at three stages of the trial and used to calculate incremental cost-effectiveness ratios per percentage point improvement of infant’s development, infant’s health and maternal common mental disorders expressed in quality-adjusted life years gained. The return on investment will be calculated based on improvements in productivity, the results being expressed as benefit–cost ratios.Ethics and disseminationThe trial was approved by Monash University Human Research Ethics Committee (Certificate Number 2016–0683), Australia, and approval was extended to include the economic evaluation (Amendment Review Number 2018-0683-23806); and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Vietnam. Results will be disseminated through academic journals and conference presentations.Trial registration numberACTRN12617000442303.

scholarly journals COVID-NURSE: evaluation of a fundamental nursing care protocol compared with care as usual on experience of care for noninvasively ventilated patients in hospital with the SARS-CoV-2 virus—protocol for a cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e046436
Author(s):  
David A Richards ◽  
Holly VR Sugg ◽  
Emma Cockcroft ◽  
Joanne Cooper ◽  
Susanne Cruickshank ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Nursing Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Care Quality ◽  
Economic Evaluations ◽  
Cluster Randomised ◽  
Care Protocol ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionPatient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse–patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs.Methods and analysiswe aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual and a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared with care as usual. Our coprimary outcomes are patient-reported experience (Quality from the Patients’ Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression Patient Health Questionnaire-2 (PHQ-2), anxiety General Anxiety Disorder-2 (GAD-2), health utility (EQ5D) and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis, we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned subgroup analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations.Ethics and disseminationResearch governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer-reviewed scientific journals, study website, press and online media, including free online training materials on the Open University’s FutureLearn web platform.Trial registration numberISRCTN13177364; Pre-results.

Sign in / Sign up

Export Citation Format

Share Document