Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): a stepped wedge cluster randomised trial within the EFFECTS trial

Abstract Background: Two out of three randomised controlled trials fail to meet their recruitment goals. Recruitment to EFFECTS, a trial of fluoxetine for stroke recovery was slower than anticipated. We aimed to evaluate an intervention to improve recruitment to EFFECTS.Methods: We performed a stepped wedge, cluster randomised trial embedded in the ongoing EFFECTS trial. The Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC) comprised a structured teleconference with the study personnel and the head of department supplemented by a commitment contract. ERUTECC’s primary outcome was the number of patients recruited into EFFECTS per 60 days per site. We compared the recruitment 60 days before the intervention with 60 days after and considered at least a 20% increase to be a positive outcome. All centres started as controls and were followed by 60 days observation. The order in which the centres began was decided through block randomisation.Results: At randomisation, EFFECTS had 29 active centres. ERUTECC recruited 20 centres between 9th Nov 2017 and 30th June 2018, providing 80 site months of observation for the primary analysis.The inclusion rate was 1.9 patient/centre/60 days before the intervention and 2.1 patient/centre/60 days after the intervention, representing a 10% overall increase. However, the recruitment increased more than 20% the first 30 days after the intervention. We also noted that inclusion rate increased directly after the first contact with the centres, announcing a future telephone conference. Some centres changed their screening process, transferring the task from doctors to nurses.Conclusions: Although a teleconference with the study personnel and the head of department accompanied by a commitment contract did not increase recruitment to an RCT by more than 20%, 60 days post intervention, recruitment improved during the first month, especially at low-recruitment centres.Trial registration : The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial Repository (SWAT58) 30 April 2017. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/Repositories/SWATStore/EFFECTS was retrospectively registered 2 February 2016 in ClinicalTrials.gov: NCT02683213.