In for a penny, in for a pound: the effect of pre-engaging healthcare organizations on their subsequent participation in trials

Abstract

Background: Participant recruitment in clinical trials is often challenging. Building partnerships with healthcare organizations during proposal development facilitates access to the community and may influence its subsequent organization participation and participant recruitment. We aimed to assess how pre-engaging directors of homecare organizations influenced organization participation in a subsequent trial.

Findings: Repeated cross-sectional study prior to a cluster randomized controlled trial involving 33 eligible Health and Social Services Centres (HSSCs). During proposal development, we asked eligible HSSC directors in a randomized order about their willingness to participate in our trial, if funded. In the pre-engagement phase, 23 directors were contacted until we met sample size requirements (n ≥ 16); 19 of whom wrote letters of intent. Once funded, we contacted all 33 eligible HSSC directors in a randomized order to enroll them. Of the 19 directors who provided letters of intent, 15 agreed to participate (79 %); of the four who did not provide letters, one agreed to participate (25 %); and of the ten who had not been approached in the pre-engagement phase, two agreed to participate (20 %). Fisher exact tests indicated that providing letters of intent was associated with subsequent participation (p = 0.003).

Conclusions: Given that significantly more HSSCs directors who signed letters of intent followed through with study participation, pre-engagement with trial sites during proposal development appears to improve recruitment.

Trial registration: ClinicalTrials.gov NCT02244359.

Figures

Fig. 1

Recruitment flow chart. * All 33 eligible HSSCs were contacted once the project was funded