Wedge Cluster Randomised Trial Design Research Articles

The thriving kids and parents schools project: protocol of an incomplete stepped wedged cluster randomised trial evaluating the effectiveness of a Triple P seminar series

BackgroundThe COVID-19 pandemic disrupted the normality of daily life for many children, their families, and schools, resulting in heightened levels of anxiety, depression, social isolation, and loneliness among young people. An integrated public health model of interventions is needed to address the problem and to safeguard the mental health and wellbeing of children. The Triple P – Positive Parenting Program is one system of parenting support with a strong evidence-base and wide international reach. When implemented as a public health approach, Triple P has demonstrated population level positive effects on child wellbeing. This study will be the first large-scale, multi-site randomised controlled trial of a newly developed, low-intensity variant of Triple P, a school-based seminar series, as a response to the impacts of the pandemic.MethodsThe evaluation will employ an Incomplete Batched Stepped Wedge Cluster Randomised Trial Design. At least 300 Australian primary schools, from South Australia, Queensland, and Victoria will be recruited and randomised in three batches. Within each batch, schools will be randomly assigned to either start the intervention immediately or start in six weeks. Parents will be recruited from participating schools. The Triple P seminar series includes three seminars titled: “The Power of Positive Parenting”, “Helping Your Child to Manage Anxiety”, and “Keeping your Child Safe from Bullying”. Parents will complete measures about child wellbeing, parenting, parenting self-regulation and other key intervention targets at baseline, six weeks after baseline, and 12 weeks after baseline. Intervention effectiveness will be evaluated with a Multilevel Piecewise Latent Growth Curve Modelling approach. Data collection is currently underway, and the current phase of the project is anticipated to be completed in January 2024.DiscussionThe findings from this study will extend the current knowledge of the effects of evidence-based parenting support delivered through brief, universally offered, low intensity, school-based parenting seminars in a post pandemic world.Trial registrationThe trial is registered at the Australian New Zealand Clinical Trials Registry (Trial Registration Number: ACTRN12623000852651).

Effect of Midwife-Provided Orientation of Birth Companions on Maternal Anxiety and Coping during Labor: A Stepped Wedge Cluster Randomized Control Trial in Eastern Uganda.

The study aimed to assess the effect of midwife-provided orientation of birth companions on maternal anxiety and coping during labor. A stepped wedge cluster randomized trial design was conducted among 475 participants (control n = 240), intervention n = 235) from four clusters. Midwives in the intervention period provided an orientation session for the birth companions on supportive labor techniques. Coping was assessed throughout labor and anxiety scores were measured after birth. Independent t-test and Chi-Square tests were used to assess the differences by study period. Anxiety scores were reduced among women in the intervention period (p = 0.001). The proportion of women able to cope during early active labor was higher during the intervention period (p = 0.031). Women in the intervention period had 80% higher odds of coping (p = 0.032) compared to those in the control period. Notable differences in anxiety and coping with labor were observed among first-time mothers, younger women, and when siblings provided support. Midwife-provided orientation of birth companions on labor support lowers maternal anxiety and improves coping during labor. Findings could inform the planning and development of policies for the implementation of the presence of birth companions in similar low-resource settings.

Effectiveness and implementation of an online intervention (MINDxYOU) for reducing stress and promote mental health among healthcare workers in Spain: a study protocol for a stepped-wedge cluster randomized trial

BackgroundThe World Health Organization has formally recognized that healthcare professionals are at risk of developing mental health problems; finding ways to reduce their stress is mandatory to improve both their quality of life and, indirectly, their job performance. In recent years, particularly since the COVID-19 pandemic outbreak, there has been a proliferation of online interventions with promising results. The purpose of the present study is twofold: to test the effectiveness of an online, self-guided intervention, MINDxYOU, to reduce the stress levels of healthcare workers; and to conduct an implementation study of this intervention. Additionally, an economic evaluation of the intervention will be conducted.MethodsThe current study has a hybrid effectiveness-implementation type 2 design. A stepped wedge cluster randomized trial design will be used, with a cohort of 180 healthcare workers recruited in two Spanish provinces (Malaga and Zaragoza). The recruitment stage will commence in October 2022. Frontline health workers who provide direct care to people in a hospital, primary care center, or nursing home setting in both regions will participate. The effectiveness of the intervention will be studied, with perceived stress as the main outcome (Perceived Stress Scale), while other psychopathological symptoms and process variables (e.g., mindfulness, compassion, resilience, and psychological flexibility) will be also assessed as secondary outcomes. The implementation study will include analysis of feasibility, acceptability, adoption, appropriateness, fidelity, penetration, and sustainability. The incremental costs and benefits, in terms of quality-adjusted life years, will be examined by means of cost-utility and cost-effectiveness analyses.DiscussionMINDxYOU is designed to reduce healthcare workers’ stress levels through the practice of mindfulness, acceptance, and compassion, with a special focus on how to apply these skills to healthy habits and considering the particular stressors that these professionals face on a daily basis. The present study will show how implementation studies are useful for establishing the framework in which to address barriers to and promote facilitators for acceptability, appropriateness, adoption, feasibility, fidelity, penetration, and sustainability of online interventions. The ultimate goal is to reduce the research-to-practice gap.Trial registrationThis study was registered in ClinicalTrials.gov on 29/06/2022; registration number: NCT05436717.

Family-based improvement for health literacy among the Yi nationality (FAMILY) in Liangshan: protocol of an open cohort stepped wedge cluster randomized controlled trial

BackgroundImprovement of health literacy constitutes a cornerstone to improving public health. However, the overall health literacy of Liangshan Yi Autonomous Prefecture (Liangshan Prefecture) in the southwest Sichuan Province of China has kept extremely low for a long time. How to improve health literacy of the Yi nationality residents is key to be urgently solved. Notably, Family Branch System is a distinctive patrilineal bloodline organization of Yi nationality, which plays an important role in the daily life of Yi nationality. Meanwhile, Contracted Family Doctor Services is conducted in Liangshan Prefecture. Therefore, this study proposes an intervention model of health education based on Family Branch System and Contracted Family Doctor Services, which is a Family-based Improvement for Health Literacy among the Yi nationality (FAMILY) in Liangshan, when improving traditional Innovative Care for Chronic Conditions Framework (ICCC) framework.MethodsAn open cohort stepped wedge cluster randomized trial design is used to implement health literacy education interventions including project preparation, core group building, promotion within family branch and competition between family branches while using Contracted Family Doctor Services as control measure. The study will be conducted among Yi nationality residents in Meigu County and Yanyuan County, with health literacy level of residents as the primary outcome. Finally, mixed-effects model and causal inference method will be used to evaluate intervention effect.DiscussionThis study highlights family, using the unique Family Branch System and Contracted Family Doctor Services in Liangshan Prefecture to design intervention among improved ICCC framework, and combines the mixed-effects model with complier average causal effects (CACE) to estimate the intervention effect under non-compliance for the first time. Besides, other key technologies to be adopted include construction of electronic questionnaire quality control system, with quality control based on artificial intelligence. This trial contributes to exploring an effective way to improve health literacy of Yi nationality residents in Liangshan Prefecture, which will provide reference for other areas, especially poor areas, to improve residents’ health literacy.Trial registrationISRCTN11299863 on June 1, 2022; https://www.isrctn.com/.

PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial

BackgroundDespite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation.MethodsA stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed.DiscussionThe effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice.Trial registrationClinicalTrials.govNCT04678752. Registered on December 21, 2020.

Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial

BackgroundMedication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC.MethodsThis study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes.DiscussionThis study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults.Trial registrationNCT04762303, Registered February 21, 2021.

RACE-IT – Rapid Acute Coronary Syndrome Exclusion using the Beckman Coulter Access high-sensitivity cardiac troponin I: A stepped-wedge cluster randomized trial

BackgroundProtocols utilizing high-sensitivity cardiac troponin (hs-cTn) assays for the evaluation of suspected acute coronary syndrome (ACS) in the emergency department (ED) have been gaining popularity across the US and the world. These protocols more rapidly rule-out ACS and more accurately identify the presence of acute myocardial injury. At this time, few randomized trials have evaluated the safety and operational impact of these assays, resulting in limited evidence to guide the use and implementation of hs-cTn in the ED. ObjectiveThe main study objective is to test the effectiveness of a rapid ACS rule-out pathway using hs-cTnI in safely discharging patients from the ED for whom clinical suspicion for ACS exists. DesignThis prospective, implementation trial (n = 11,070) will utilize a stepped wedge cluster randomized trial design. The design will allow for all participating sites to capture benefit from the implementation of the hs-cTnI pathway while providing data evaluating the effectiveness in providing safe and rapid evaluation of patients with clinical suspicion for ACS. SummaryDemonstrating that clinical pathways using hs-cTnI can be effectively implemented to rapidly rule-out ACS while conserving costly hospital resources has significant implications for the care of patients with possible acute cardiac conditions in EDs across the US. Clinicaltrials.gov identifierNCT04488913.

Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial

BackgroundSkilled nursing facility (SNF) patients are medically complex with multiple, advanced chronic conditions. They are dependent on caregivers and have experienced recent acute illnesses. Among SNF patients, the rate of mortality or acute care use is over 50% within 90 days of discharge, yet these patients and their caregivers often do not receive the quality of transitional care that prepares them to manage serious illnesses at home.MethodsThe study will test the efficacy of Connect-Home, a successfully piloted transitional care intervention targeting seriously ill SNF patients discharged to home and their caregivers. The study setting will be SNFs in North Carolina, USA, and, following discharge, in patients’ home. Using a stepped wedge cluster randomized trial design, six SNFs will transition at randomly assigned intervals from standard discharge planning to the Connect-Home intervention. The SNFs will contribute data for patients (N = 360) and their caregivers (N = 360), during both the standard discharge planning and Connect-Home time periods. Connect-Home is a two-step intervention: (a) SNF staff create an individualized Transition Plan of Care to manage the patient’s illness at home; and (b) a Connect-Home Activation RN visits the patient’s home to implement the written Transition Plan of Care. A key feature of the trial includes training of the SNF and Home Care Agency staff to complete the transition plan rather than using study interventionists. The primary outcomes will be patient preparedness for discharge and caregiver preparedness for caregiving role. With the proposed sample and using a two-sided test at the 5% significance level, we have 80% power to detect a 18% increase in the patient’s preparedness for discharge score. We will employ linear mixed models to compare observations between intervention and usual care periods to assess primary outcomes. Secondary outcomes include (a) patients’ quality of life, functional status, and days of acute care use and (b) caregivers’ burden and distress.DiscussionStudy results will determine the efficacy of an intervention using existing clinical staff to (a) improve transitional care for seriously ill SNF patients and their caregivers, (b) prevent avoidable days of acute care use in a population with persistent risks from chronic conditions, and (c) advance the science of transitional care within end-of-life and palliative care trajectories of SNF patients and their caregivers. While this study protocol was being implemented, the COVID-19 pandemic occurred and this protocol was revised to mitigate COVID-related risks of patients, their caregivers, SNF staff, and the study team. Thus, this paper includes additional material describing these modifications.Trial registrationClinicalTrials.gov NCT03810534. Registered on January 18, 2019.

Design, rationale and analysis plan for the Stand Up for Health trial in contact centres: a stepped wedge feasibility study

BackgroundContact centres are one of the most sedentary workplaces, with employees spending a very high proportion of their working day sitting down. About a quarter of contact centre staff regularly experience musculoskeletal health problems due to high levels of sedentary behaviour, including lower back pain. There have been no previous randomised studies specifically aiming to reduce sedentary behaviour in contact centre staff. To address this gap, the Stand Up for Health (SUH) study aims to test the feasibility and acceptability of a complex theory-based intervention to reduce sedentary behaviour in contact centres.MethodsThe Stand Up for Health study has a stepped wedge cluster randomised trial design, which is a pragmatic design whereby clusters (contact centres) are randomised to time points at which they will begin to receive the intervention. All contact centre staff have the opportunity to experience the intervention. To minimise the resource burden in this feasibility study, data collection is not continuous, but undertaken on a selective number of occasions, so the stepped wedge design is “incomplete”. Eleven contact centres in England and Scotland have been recruited, and the sample size is approximately 27 per centre (270 in total). The statistical analysis will predominantly focus on assessing feasibility, including the calculation of recruitment rates and rates of attrition. Exploratory analysis will be performed to compare objectively measured sedentary time in the workplace (measured using an activPAL™ device) between intervention and control conditions using a linear mixed effects regression model.DiscussionTo our knowledge, this is the first stepped wedge feasibility study conducted in call centres. The rationale and justification of our novel staircase stepped wedge design has been presented, and we hope that by presenting our study design and statistical analysis plan, it will contribute to the literature on stepped wedge trials, and in particular feasibility stepped wedge trials. The findings of the study will also help inform whether this is a suitable design for other settings where data collection is challenging.Trial registrationThe trial has been registered on the ISRCTN database: http://www.isrctn.com/ISRCTN11580369

Cardiovascular risk factor mapping and distribution among adults in Mukono and Buikwe districts in Uganda: small area analysis

BackgroundSub-Saharan Africa (SSA) is experiencing an increasing burden of Cardiovascular Diseases (CVDs). Modifiable risk factors including hypertension, diabetes, obesity, central obesity, sedentary behaviours, smoking, poor diet (characterised by inadequate vegetable and fruit consumption), and psychosocial stress are attributable to the growing burden of CVDs. Small geographical area mapping and analysis of these risk factors for CVD is lacking in most of sub-Saharan Africa and yet such data has the potential to inform monitoring and exploration of patterns of morbidity, health-care use, and mortality, as well as the epidemiology of risk factors. In the current study, we map and describe the distribution of the CVD risk factors in 20 parishes in two neighbouring districts in Uganda.MethodsA baseline survey benchmarking a type-2 hybrid stepped wedge cluster randomised trial design was conducted in December 2018 and January 2019. A sample of 4372 adults aged 25–70 years was drawn from 3689 randomly selected households across 80 villages in 20 parishes in Mukono and Buikwe districts in Uganda. Descriptive statistics and generalized linear modelling controlled for clustering were conducted for this analysis in Stata 13.0, and a visual map showing risk factor distribution developed in QGIS.ResultsMapping the prevalence of selected CVD risk factors indicated substantial gender and small area geographic heterogeneity which was masked on aggregate analysis. Patterns and clustering were observed for hypertension, physical inactivity, smoking, alcohol consumption and risk factor combination. Prevalence of unhealthy diet was very high across all parishes with no significant observable differences across areas.ConclusionModifiable cardiovascular risk factors are common in this low-income context. Moreover, across small area geographic setting, it appears significant differences in distribution of risk factors exist. These differences suggest that underlying drivers such as sociocultural, environmental and economic determinants may be promoting or inhibiting the observed risk factor prevalences which should be further explored. In addition, the differences emphasize the value of small geographical area mapping and analysis to inform more targeted risk reduction interventions.

A stepped wedge trial of efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities

BackgroundMedication errors are a leading cause of mortality and morbidity. Clinical pharmacy services provided in hospital can reduce medication errors and medication related harm. However, few rural or remote hospitals in Australia have a clinical pharmacy service. This study will evaluate a virtual clinical pharmacy service (VCPS) provided via telehealth to eight rural and remote hospitals in NSW, Australia.MethodsA stepped wedge cluster randomised trial design will use routinely collected data from patients’ electronic medical records (n = 2080) to evaluate the VCPS at eight facilities. The sequence of steps is randomised, allowing for control of potential confounding temporal trends. Primary outcomes are number of medication reconciliations completed on admission and discharge. Secondary outcomes are length of stay, falls and 28 day readmissions. A cost-effectiveness analysis (CEA) and cost-benefit analysis (CBA) will be conducted. The CEA will answer the question of whether the VCPS is more cost-effective compared to treatment as usual; the CBA will consider the rate of return on investing in the VCPS. A patient experience measure (n = 500) and medication adherence questionnaire (n = 100 pre and post) will also be used to identify patient responses to the virtual service. Focus groups will investigate implementation from hospital staff perspectives at each site.Analyses of routine data will comprise generalised linear mixed models. Descriptive statistical analysis will summarise patient experience responses. Differences in medication adherence will be compared using linear regression models. Thematic analysis of focus groups will identify barriers and facilitators to VCPS implementation.DiscussionWe aim to demonstrate the effectiveness of virtual pharmacy interventions for rural populations, and inform best practice for using virtual healthcare to improve access to pharmacy services. It is widely recognised that clinical pharmacists are best placed to reduce medication errors. However, pharmacy services are limited in rural and remote hospitals. This project will provide evidence about ways in which the benefits of hospital pharmacists can be maximised utilising telehealth technology. If successful, this project can provide a model for pharmacy delivery in rural and remote locations.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) -ACTRN12619001757101 Prospectively registered on 11 December 2019. Record available from: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378878&isReview=true

Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial.

BackgroundPhysical inactivity is associated with increased health risks. Primary care providers (PCPs) are well positioned to support increased physical activity (PA) levels through screening and provision of PA prescriptions. However, PCP counseling on PA is not common.ObjectiveThis study aimed to assess the feasibility of implementing an electronic health (eHealth) tool to support PA counseling by PCPs and estimate intervention effectiveness on patients’ PA levels.MethodsA pragmatic pilot study was conducted using a stepped wedge cluster randomized trial design. The study was conducted at a single primary care clinic, with 4 pre-existing PCP teams. Adult patients who had a periodic health review (PHR) scheduled during the study period were invited to participate. The eHealth tool involved an electronic survey sent to participants before their PHR via an email or a tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants in the intervention arm. Participants assigned to the control arm received usual care from their PCP. Feasibility was assessed by the proportion of completed surveys and patient-reported acceptability and fidelity measures. The primary effectiveness outcome was patient-reported PA at 4 months post-PHR, measured as metabolic equivalent of task (MET) minutes per week. Secondary outcomes assessed determinants of PA, including self-efficacy and intention to change based on the Health Action Process Approach behavior change theory.ResultsA total of 1028 patients receiving care from 34 PCPs were invited to participate and 530 (51.55%) consented (intervention [n=296] and control [n=234]). Of the participants who completed a process evaluation, almost half (88/178, 49.4%) stated they received a PA prescription, with only 42 receiving the full intervention including tailored resources from their PCP. A cluster-level linear regression analysis yielded a non–statistically significant positive difference in MET-minutes reported per week at follow-up between intervention and control conditions (mean difference 1027; 95% CI −155 to 2209; P=.09). No statistically significant differences were observed for secondary outcomes.ConclusionsOur results suggest that it is feasible to build an eHealth tool that screens and provides tailored resources for PA in a primary care setting but suboptimal intervention fidelity suggests greater work must be done to address PCP barriers to resource distribution. Participant responses to the primary effectiveness outcome (MET-minutes) were highly variable, reflecting a need for more robust measures of PA in future trials to address limitations in patient-reported data.Trial RegistrationClinicalTrials.gov NCT03181295; https://clinicaltrials.gov/ct2/show/NCT03181295

Knowledge to action: Rationale and design of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized trial

IntroductionHeart Failure (HF) is a common cause of hospitalization in older adults. The transition from hospital to home is high-risk, and gaps in transitional care can increase the risk of re-hospitalization and death. Combining health care services supported by meta-analyses, we designed the PACT-HF transitional care model. MethodsAdopting an integrated Knowledge Translation (iKT) approach in which decision-makers and clinicians are partners in research, we implement and test the effectiveness of PACT-HF among patients hospitalized for HF. We use a pragmatic stepped wedge cluster randomized trial design to introduce the complex health service intervention to 10 large hospitals in a randomized sequence until all hospitals initiate the intervention. The goal is for all patients hospitalized with HF to receive self-care education, multidisciplinary care, and early follow-up with their health care providers; and in addition, for high-risk patients to receive post-discharge nurse-led home visits and outpatient care in Heart Function clinics. This requires integration of care across hospitals, home care agencies, and outpatient clinics in our publicly funded health care system. While hospitals are the unit of recruitment and analysis, patients (estimated sample size of 3200) are the unit of analysis. Primary outcomes are hierarchically ordered as time to composite all-cause readmissions / emergency department (ED) visits / death at 3 months and time to composite all-cause readmissions / ED visits at 30 days. In a nested study of 8 hospitals, we measure the patient-centered outcomes of Discharge Preparedness, Care Transitions Quality, and Quality Adjusted Life Years (QALY); and the 6-month health care resource use and costs. We obtain all clinical and cost outcomes via linkages to provincial administrative databases. ConclusionsThis protocol describes the implementation and testing of a transitional care model comprising health care services informed by high-level evidence. The study adopts an iKT and pragmatic approach, uses a robust study design, links clinical trial data with outcomes held in administrative databases, and includes patient-reported outcomes. Findings will have implications on clinical practice, health care policy, and Knowledge Translation (KT) research methodology.

Mass mosquito trapping for malaria control in western Kenya: study protocol for a stepped wedge cluster-randomised trial.

BackgroundIncreasing levels of insecticide resistance as well as outdoor, residual transmission of malaria threaten the efficacy of existing vector control tools used against malaria mosquitoes. The development of odour-baited mosquito traps has led to the possibility of controlling malaria through mass trapping of malaria vectors. Through daily removal trapping against a background of continued bed net use it is anticipated that vector populations could be suppressed to a level where continued transmission of malaria will no longer be possible.Methods/designA stepped wedge cluster-randomised trial design was used for the implementation of mass mosquito trapping on Rusinga Island, western Kenya (the SolarMal project). Over the course of 2 years (2013–2015) all households on the island were provided with a solar-powered mosquito trapping system. A continuous health and demographic surveillance system combined with parasitological surveys three times a year, successive rounds of mosquito monitoring and regular sociological studies allowed measurement of intervention outcomes before, during and at completion of the rollout of traps. Data collection continued after achieving mass coverage with traps in order to estimate the longer term effectiveness of this novel intervention. Solar energy was exploited to provide electric light and mobile phone charging for each household, and the impacts of these immediate tangible benefits upon acceptability of and adherence to the use of the intervention are being measured.DiscussionThis study will be the first to evaluate whether the principle of solar-powered mass mosquito trapping could be an effective tool for elimination of malaria. If proven to be effective, this novel approach to malaria control would be a valuable addition to the existing strategies of long-lasting insecticide-treated nets and case management. Sociological studies provide a knowledge base for understanding the usage of this novel tool.Trial registrationTrialregister.nl: NTR3496 – SolarMal. Registered on 20 June 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1469-z) contains supplementary material, which is available to authorized users.

The need to balance merits and limitations from different disciplines when considering the stepped wedge cluster randomized trial design.

BackgroundVarious papers have addressed pros and cons of the stepped wedge cluster randomized trial design (SWD). However, some issues have not or only limitedly been addressed. Our aim was to provide a comprehensive overview of all merits and limitations of the SWD to assist researchers, reviewers and medical ethics committees when deciding on the appropriateness of the SWD for a particular study.MethodsWe performed an initial search to identify articles with a methodological focus on the SWD, and categorized and discussed all reported advantages and disadvantages of the SWD. Additional aspects were identified during multidisciplinary meetings in which ethicists, biostatisticians, clinical epidemiologists and health economists participated. All aspects of the SWD were compared to the parallel group cluster randomized design. We categorized the merits and limitations of the SWD to distinct phases in the design and conduct of such studies, highlighting that their impact may vary depending on the context of the study or that benefits may be offset by drawbacks across study phases. Furthermore, a real-life illustration is provided.ResultsNew aspects are identified within all disciplines. Examples of newly identified aspects of an SWD are: the possibility to measure a treatment effect in each cluster to examine the (in)consistency in effects across clusters, the detrimental effect of lower than expected inclusion rates, deviation from the ordinary informed consent process and the question whether studies using the SWD are likely to have sufficient social value. Discussions are provided on e.g. clinical equipoise, social value, health economical decision making, number of study arms, and interim analyses.ConclusionsDeciding on the use of the SWD involves aspects and considerations from different disciplines not all of which have been discussed before. Pros and cons of this design should be balanced in comparison to other feasible design options as to choose the optimal design for a particular intervention study.