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

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Richard A. Parker ◽  
Jillian Manner ◽  
Divya Sivaramakrishnan ◽  
Graham Baker ◽  
Andrew Stoddart ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Data Collection ◽  
Sedentary Behaviour ◽  
Feasibility Study ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Stepped Wedge Design ◽  
Stepped Wedge Trials ◽  
Contact Centre

Abstract Background Contact 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. Methods The 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. Discussion To 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 registration The trial has been registered on the ISRCTN database: http://www.isrctn.com/ISRCTN11580369

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

2020 ◽  
Author(s):  
Richard A. Parker ◽  
Jillian Manner ◽  
Divya Sivaramakrishnan ◽  
Graham Baker ◽  
Andrew Stoddart ◽  
...  
Keyword(s):  
Data Collection ◽  
Sedentary Behaviour ◽  
Feasibility Study ◽  
Randomised Trial ◽  
Health Study ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Stepped Wedge Design ◽  
Time Points ◽  
Contact Centre

Abstract Background: Contact 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. Methods: The 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. Discussion: This is the first stepped wedge feasibility study seeking to reduce sedentary behaviour in call centres. We employ an incomplete stepped wedge design to restrict data collection to certain time points to make data collection feasible. This trial will potentially inform the design of a future large multi-centre stepped wedge trial.

scholarly journals Saving babies’ lives (SBL) – a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kaajal Patel ◽  
Sopheakneary Say ◽  
Daly Leng ◽  
Manila Prak ◽  
Koung Lo ◽  
...  
Keyword(s):  
Data Collection ◽  
Neonatal Mortality ◽  
Rural Areas ◽  
Health Workers ◽  
Randomised Trial ◽  
Scale Up ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
The Continuum

Abstract Background Neonatal mortality remains unacceptably high. Many studies successful at reducing neonatal mortality have failed to realise similar gains at scale. Effective implementation and scale-up of interventions designed to tackle neonatal mortality is a global health priority. Multifaceted programmes targeting the continuum of neonatal care, with sustainability and scalability built into the design, can provide practical insights to solve this challenge. Cambodia has amongst the highest neonatal mortality rates in South-East Asia, with rural areas particularly affected. The primary objective of this study is the design, implementation, and assessment of the Saving Babies’ Lives programme, a package of interventions designed to reduce neonatal mortality in rural Cambodia. Methods This study is a five-year stepped-wedge cluster-randomised trial conducted in a rural Cambodian province with an estimated annual delivery rate of 6615. The study is designed to implement and evaluate the Saving Babies’ Lives programme, which is the intervention. The Saving Babies’ Lives programme is an iterative package of neonatal interventions spanning the continuum of care and integrating into the existing health system. The Saving Babies’ Lives programme comprises two major components: participatory learning and action with community health workers, and capacity building of primary care facilities involving facility-based mentorship. Standard government service continues in control arms. Data collection covering the whole study area includes surveillance of all pregnancies, verbal and social autopsies, and quality of care surveys. Mixed methods data collection supports iteration of the complex intervention, and facilitates impact, outcome, process and economic evaluation. Discussion Our study uses a robust study design to evaluate and develop a holistic, innovative, contextually relevant and sustainable programme that can be scaled-up to reduce neonatal mortality. Trial registration ClinicalTrials.gov: NCT04663620. Registered on 11th December 2020, retrospectively registered.

scholarly journals PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Marcos Augusto Bastos Dias ◽  
◽  
Leandro De Oliveira ◽  
Arundhanthi Jeyabalan ◽  
Beth Payne ◽  
...  
Keyword(s):  
Knowledge Transfer ◽  
Adverse Events ◽  
Risk Stratification ◽  
Risk Reduction ◽  
Randomised Trial ◽  
Adverse Outcomes ◽  
Cluster Randomised Trial ◽  
Care Providers ◽  
Stepped Wedge ◽  
Number Of Patients

Abstract Background Preeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB. Methods This is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded. Discussion The PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries. Trial registration ClinicalTrials.gov: NCT03073317.

scholarly journals Correction: Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial

PLoS Medicine ◽  
2019 ◽  
Vol 16 (12) ◽  
pp. e1002993
Author(s):  
Nina Østerås ◽  
Tuva Moseng ◽  
Leti van Bodegom-Vos ◽  
Krysia Dziedzic ◽  
Ibrahim Mdala ◽  
...  
Keyword(s):  
Primary Healthcare ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Structured Model ◽  
Cluster Randomised

scholarly journals Effectiveness of Seasonal Malaria Chemoprevention in Children under Ten Years of Age in Senegal: A Stepped-Wedge Cluster-Randomised Trial

PLoS Medicine ◽  
2016 ◽  
Vol 13 (11) ◽  
pp. e1002175 ◽  
Author(s):  
Badara Cissé ◽  
El Hadj Ba ◽  
Cheikh Sokhna ◽  
Jean Louis NDiaye ◽  
Jules F. Gomis ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
Seasonal Malaria Chemoprevention

Comparison of Statistical Models For Estimating Intervention Effects Based On Time-To-Recurrent-Event In Stepped Wedge Cluster Randomized Trial Using Open Cohort Design

2021 ◽  
Author(s):  
Shunsuke Oyamada ◽  
Shih-Wei Chiu ◽  
Takuhiro Yamaguchi
Keyword(s):  
Monte Carlo ◽  
Monte Carlo Simulations ◽  
Statistical Models ◽  
Randomised Trial ◽  
Recurrent Event ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Intervention Effects ◽  
Cohort Design

Abstract Background: There are currently no methodological studies on the performance of the statistical models for estimating intervention effects based on the time-to-recurrent-event (TTRE) in stepped wedge cluster randomised trial (SWCRT) using an open cohort design. This study aims to address this by evaluating the performance of these statistical models using an open cohort design with the Monte Carlo simulation in various settings and their application using an actual example.Methods: Using Monte Carlo simulations, we evaluated the performance of the existing extended Cox proportional hazard models, i.e., the Andersen-Gill (AG), Prentice-Williams-Peterson Total-Time (PWP-TT), and Prentice-Williams-Peterson Gap-time (PWP-GT) models, using the settings of several event generation models and true intervention effects, with and without stratification by clusters. Unidirectional switching in SWCRT was represented using time-dependent covariates.Results: Using Monte Carlo simulations with the various described settings, the PWP-GT model with stratification by clusters showed the best performance in most settings and reasonable performance in the others. The only situation in which the performance of the PWP-TT model with stratification by clusters was not inferior to that of the PWP-GT model with stratification by clusters was when there was a certain amount of follow-up period, and the timing of the trial entry was random within the trial period, including the follow-up period. The AG model performed well only in a specific setting. By analysing actual examples, it was found that almost all the statistical models suggested that the risk of events during the intervention condition may be somewhat higher than in the control, although the difference was not statistically significant.Conclusions: The PWP-GT model with stratification by clusters had the most reasonable performance when estimating intervention effects based on the TTRE in SWCRT in various settings using an open cohort design.

scholarly journals Improving quality of care during childbirth in primary health centres: a stepped-wedge cluster-randomised trial in India

2018 ◽  
Vol 3 (5) ◽  
pp. e000907 ◽  
Author(s):  
Ramesh Agarwal ◽  
Deepak Chawla ◽  
Minakshi Sharma ◽  
Shyama Nagaranjan ◽  
Suresh K Dalpath ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Management Strategy ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Primary Health ◽  
Cluster Randomised ◽  
Primary Health Centres ◽  
Health Centres

BackgroundLow/middle-income countries need a large-scale improvement in the quality of care (QoC) around the time of childbirth in order to reduce high maternal, fetal and neonatal mortality. However, there is a paucity of scalable models.MethodsWe conducted a stepped-wedge cluster-randomised trial in 15 primary health centres (PHC) of the state of Haryana in India to test the effectiveness of a multipronged quality management strategy comprising capacity building of providers, periodic assessments of the PHCs to identify quality gaps and undertaking improvement activities for closure of the gaps. The 21-month duration of the study was divided into seven periods (steps) of 3  months each. Starting from the second period, a set of randomly selected three PHCs (cluster) crossed over to the intervention arm for rest of the period of the study. The primary outcomes included the number of women approaching the PHCs for childbirth and 12 directly observed essential practices related to the childbirth. Outcomes were adjusted with random effect for cluster (PHC) and fixed effect for ‘months of intervention’.ResultsThe intervention strategy led to increase in the number of women approaching PHCs for childbirth (26 vs 21 women per PHC-month, adjusted incidence rate ratio: 1.22; 95% CI 1.17 to 1.28). Of the 12 practices, 6 improved modestly, 2 remained near universal during both intervention and control periods, 3 did not change and 1 worsened. There was no evidence of change in mortality with a majority of deaths occurring either during referral transport or at the referral facilities.ConclusionA multipronged quality management strategy enhanced utilisation of services and modestly improved key practices around the time of childbirth in PHCs in India.Trial registration numberCTRI/2016/05/006963.

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