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

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.

Conflict of interest statement

Authors’ information

Not applicable

Ethics approval and consent to participate

Ethics approval for ERUTECC, Stockholm Ethical Review Board, Sweden on 8 August 2017, ref. number 2017/1285-31/1. We plan to communicate important protocol modifications (e.g. changes to eligibility criteria, outcomes, analyses) to relevant parties (e.g. investigators, REC/IRBs, trial participants, trial registries, journals and regulators). The PI at each centre has to give their oral and written consent to participate in ERUTECC. If a PI refuses to participate, the reason for this is noted. We will include the centre as intention-to-treat.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Consolidated Standards of Reporting Trials (CONSORT) flow diagram for the ERUTECC study. ERUTECC is a randomised, stepped-wedged trial within the EFFECTS study. EFFECTS has initiated 35 centres, of which 32 are active. We will exclude the five top recruiting centres because we believe they have reached their full potential, and the planned intervention is too weak

Fig. 2

The randomised, stepped-wedge cluster design for the ERUTECC study. In ERUTECC, we use a stepped-wedge cluster design. First the centre is classified as low or medium recruiting. Second, the centres are randomised in each class ensuring that at least one low and one medium recruiting centre is included in every step. Each centre has a 60-day running-in period (yellow), followed by a 60-day post-intervention period (blue). The intervention (teleconference) is done after the 60-day running-in period, and every step provides data before and after intervention, but not at the same point in time. We will add up all patients for all 11 steps in the 60-day running-in period and compare this with the inclusion rate for all centres’ 60-day post randomisation period

Fig. 3

The flow of participants in the ERUTECC study. In ERUTECC, each centre follows the same flow, with a 60-day period of running in, and a 60-day post-intervention period (teleconference). The figure shows one step. We will add up all patients for all 11 steps in the 60-day running-in period and compare this with the inclusion rate for all centres’ 60-day post randomisation period