cluster randomized controlled trials
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Author(s):  
Lilian Barras ◽  
Maike Neuhaus ◽  
Elizabeth Cyarto ◽  
Natasha Reid

Retirement living (RL) communities may be an ideal setting in which to utilize peer-leaders to implement or support health and wellbeing interventions. To date, this literature has not been systematically summarized. The purpose of this study was to fill this gap with a particular focus on describing the extent to which interventions addressed each level of the social ecological model of behavior change. This review utilized established frameworks for assessing methodological quality of studies, including the CONSORT guidelines and RoB2 bias assessment for cluster randomized controlled trials. A total of 153 records were identified from database searches, and seven studies met inclusion criteria. Overall, there is emerging evidence that peer-led health and wellbeing programs in RL communities can positively impact both health behavior, such as increased physical activity or nutrition, and health status, such as lower blood pressure. The study quality was modest to very good, but only one study was deemed not to have a high risk of bias. Peers are generally cost-effective, more accessible, and relatable leaders for health interventions that can still produce impactful changes. Future studies are needed to better understand how to sustain promising interventions.


Author(s):  
John M. Ferron ◽  
Diep Nguyen ◽  
Robert F. Dedrick ◽  
Shannon M. Suldo ◽  
Elizabeth Shaunessy-Dedrick

2021 ◽  
pp. 174077452110015
Author(s):  
Arielle Weir ◽  
Justin Presseau ◽  
Simon Kitto ◽  
Ian Colman ◽  
Simon Hatcher

Background Recruitment and engagement of clusters in a cluster randomized controlled trial can sometimes prove challenging. Identification of successful or unsuccessful strategies may be beneficial in guiding future researchers in conducting their cluster randomized controlled trial. This study aimed to identify strategies that could be used to facilitate the delivery of cluster randomized controlled trials in hospitals. Methods The study employed the Consolidated Framework for Implementation Research–Expert Recommendations for Implementing Change matching tool. The barriers and enablers to cluster randomized controlled trial conduct identified in our previously conducted studies served as a means of determinant identification for the conduct of cluster randomized controlled trials. These determinants were mapped to Consolidated Framework for Implementation Research constructs and then matched to Expert Recommendations for Implementing Change compilation strategies using the Consolidated Framework for Implementation Research–Expert Recommendations for Implementing Change matching tool. Results The Expert Recommendations for Implementing Change strategies matched to at least one determinant Consolidated Framework for Implementation Research construct were as follows: (1) ‘Identify and prepare champions’, (2) ‘Conduct local needs assessment’, (3) ‘Conduct educational meetings’, (4) ‘Inform local opinion leaders’, (5) ‘Build a coalition’, (6) ‘Promote adaptability’, (7) ‘Develop a formal implementation blueprint’, (8) ‘Involve patients/consumers and family members’, (9) ‘Obtain and use patients/consumers and family feedback’, (10) ‘Develop educational materials’, (11) ‘Promote network weaving’, (12) ‘Distribute educational materials’, (13) ‘Access new funding’ and (14) ‘Develop academic partnerships’. Conclusion This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jin Huang ◽  
David L. Roth

Abstract Background Pragmatic trials often consist of cluster-randomized controlled trials (C-RCTs), where staff of existing clinics or sites deliver interventions and randomization occurs at the site level. Covariate-constrained randomization (CCR) methods are often recommended to minimize imbalance on important site characteristics across intervention and control arms because sizable imbalances can occur by chance in simple randomizations when the number of units to be randomized is relatively small. CCR methods involve multiple random assignments initially, an assessment of balance achieved on site-level covariates from each randomization, and the final selection of an allocation that produces acceptable balance. However, no clear consensus exists on how to assess imbalance or identify allocations with sufficient balance. In this article, we describe an overall imbalance index (I) that is based on the mean of the absolute value of the standardized differences in means on the site characteristics. Methods We derive the theoretical distribution of I, then conduct simulation studies to examine its empirical properties under the varying covariate distributions and inter-correlations. Results I has an expected value of 0.798 and, assuming independent site characteristics, a variance of 0.363/k, where k is the number of site characteristics being balanced. Simulations indicated that the properties of I are robust under varying covariate circumstances as long as k is greater than 3 and the covariates are not too highly inter-correlated. Conclusions We recommend that values of I below the 10th percentile indicate sufficient overall site balance in CCRs. Definitions of acceptable randomizations might also include individual covariate criteria specified in advance, in addition to overall balance criteria.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Aaron M. Woolsey ◽  
Ryan A. Simmons ◽  
Meley Woldeghebriel ◽  
Yunji Zhou ◽  
Oluwatosin Ogunsola ◽  
...  

Abstract Background A large proportion of artemisinin-combination therapy (ACT) anti-malarial medicines is consumed by individuals that do not have malaria. The over-consumption of ACTs is largely driven by retail sales in high malaria-endemic countries to clients who have not received a confirmatory diagnosis. This study aims to target ACT sales to clients receiving a confirmatory diagnosis using malaria rapid diagnostic tests (mRDTs) at retail outlets in Kenya and Nigeria. Methods This study comprises two linked four-arm 2 × 2 factorial cluster randomized controlled trials focused on malaria diagnostic testing and conditional ACT subsidies with the goal to evaluate provider-directed and client-directed interventions. The linked trials will be conducted at two contrasting study sites: a rural region around Webuye in western Kenya and the urban center of Lagos, Nigeria. Clusters are 41 and 48 participating retail outlets in Kenya and Nigeria, respectively. Clients seeking care at participating outlets across all arms will be given the option of paying for a mRDT—at a study-recommended price—to be conducted at the outlet. In the provider-directed intervention arm, the outlet owner receives a small monetary incentive to perform the mRDT. In the client-directed intervention arm, the client receives a free ACT if they purchase an mRDT and receive a positive test result. Finally, the fourth study arm combines both the provider- and client-directed interventions. The diagnosis and treatment choices made during each transaction will be captured using a mobile phone app. Study outcomes will be collected through exit interviews with clients, who sought care for febrile illness, at each of the enrolled retail outlets. Results The primary outcome measure is the proportion of all ACTs that are sold to malaria test-positive clients in each study arm. For all secondary outcomes, we will evaluate the degree to which the interventions affect purchasing behavior among people seeking care for a febrile illness at the retail outlet. Conclusions If our study demonstrates that malaria case management can be improved in the retail sector, it could reduce overconsumption of ACTs and enhance targeting of publicly funded treatment reimbursements, lowering the economic barrier to appropriate diagnosis and treatment for patients with malaria. Trial registration ClinicalTrials.govNCT04428307, registered June 9, 2020, and NCT04428385, registered June 9, 2020.


2020 ◽  
Author(s):  
Aaron M Woolsey ◽  
Ryan A Simmons ◽  
Meley Woldeghebriel ◽  
Yunji Zhou ◽  
Oluwatosin Ogunsola ◽  
...  

Abstract Background A large proportion of artemisinin-combination therapy (ACT) anti-malarial medicines is consumed by individuals that do not have malaria. The over-consumption of ACTs is largely driven by retail sales in high malaria-endemic countries to clients who have not received a confirmatory diagnosis. This study aims to target ACT sales to clients receiving a confirmatory diagnosis using malaria rapid diagnostic tests (mRDTs) at retail outlets in Kenya and Nigeria. Methods This study comprises two linked four-arm 2x2 factorial cluster randomized controlled trials focused on malaria diagnostic testing and conditional ACT subsidies with the goal to evaluate provider directed- and client-directed interventions. The study will be conducted at two contrasting study sites: a rural region around Webuye in western Kenya and the urban center of Lagos, Nigeria. Clusters are 41 and 48 participating retail outlets in Kenya and Nigeria, respectively. Clients seeking care at participating outlets across all arms will be given the option of paying for a mRDT – at a study-recommended price – to be conducted at the outlet. In the provider-directed intervention arm, the outlet owner receives a small monetary incentive to perform the mRDT. In the client-directed intervention arm, the client receives a free ACT if they purchase an mRDT and receive a positive test result. Finally, the fourth study arm combines both the provider- and client- directed interventions. The diagnosis and treatment choices made during each transaction will be captured using a mobile phone app. Study outcomes will be collected through exit interviews with clients, who sought care for febrile illness, at each of the enrolled retail outlets. Results The primary outcome measure is the proportion of all ACTs that are sold to malaria test-positive clients in each study arm. For all secondary outcomes we will evaluate the degree to which the interventions affect purchasing behavior among people seeking care for a febrile illness at the retail outlet. Conclusions If our study demonstrates that malaria case management can be improved in the retail sector, it could reduce overconsumption of ACTs and enhance targeting of publicly funded treatment reimbursements, lowering the economic barrier to appropriate diagnosis and treatment for patients with malaria.


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