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

Trials. 2018 Jan 8;19(1):14. doi: 10.1186/s13063-017-2367-8.

Abstract

Background: Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT.

Methods: ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT.

Discussion: EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke.

Trial registrations: The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.

Keywords: RCT; Randomised controlled trial; Randomised stepped-wedge cluster trial; Recruitment; Stroke.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Contracts*
  • Fluoxetine / administration & dosage*
  • Fluoxetine / adverse effects
  • Humans
  • Multicenter Studies as Topic
  • Patient Selection*
  • Pragmatic Clinical Trials as Topic
  • Recovery of Function
  • Research Personnel / psychology*
  • Sample Size
  • Serotonin Uptake Inhibitors / administration & dosage*
  • Serotonin Uptake Inhibitors / adverse effects
  • Stroke / diagnosis
  • Stroke / physiopathology
  • Stroke / therapy*
  • Stroke Rehabilitation / adverse effects
  • Stroke Rehabilitation / methods*
  • Sweden
  • Telecommunications*
  • Time Factors
  • Treatment Outcome

Substances

  • Serotonin Uptake Inhibitors
  • Fluoxetine

Associated data

  • ClinicalTrials.gov/NCT02683213