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Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers

Por: Vaughn · V. M. · Horowitz · J. · Gandhi · T. · Neetz · R. A. · Petty · L. · Hersh · A. · Lindenauer · P. · Bernstein · S. J. · Flanders · S. A. · Harrison · J. D. · Smith · J. D. · White · A. T. · Szymczak · J. E.
Objectives

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

Design

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

Setting

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Participants

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Interventions

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

Primary and secondary outcomes

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

Results

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

Conclusions

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

Trial registration number

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

Exposure to in utero cannabis is linked to a higher risk of low birthweight, prematurity and admission to a neonatal unit

Por: Petty · J.

Commentary on: Avalos LA, Adams SR, Alexeeff SE, et al. Neonatal outcomes associated with in utero cannabis exposure: a population-based retrospective cohort. Am J Obstet Gynecol. 2023; Nov 27. doi: 10.1016/j.ajog.2023.11.1232.

Implications for practice and research

  • Healthcare professionals should provide counselling for anyone who is pregnant about how prenatal cannabis use can lead to adverse infant health outcomes.

  • Further exploration is needed of the potential impact of prenatal cannabis on longer term outcomes, including the effects of cannabis strength and usage frequency.

  • Context

    In the USA, the incidence of cannabis use in pregnancy has increased from 3% (2002) to 7% (2017),1 with a higher occurrence in young people and adolescents.2 There is a perception that cannabis is lower risk compared with other prescribed medicines during pregnancy,3 leading to increased accessibility and acceptance. However, there are safety concerns...

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