Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design

Background For patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (decisional conflict), which may be lessened with patient decision aids (PDA). PRIMETIME (ISRCTN 41579286) is a UK-led biomarker-directed study evaluating omission of adjuvant radiotherapy in breast cancer; an embedded Study Within A Trial (SWAT) investigated whether PDA reduces decisional conflict using a cluster stepped-wedge trial design. Methods PDA diagrams and a video explaining risks and benefits of radiotherapy were developed in close collaboration between patient advocates and PRIMETIME trialists. The SWAT used a cluster stepped-wedge trial design, where each cluster represented the radiotherapy centre and referring peripheral centres. All clusters began in the standard information group (patient information and diagrams) and were randomised to cross-over to the enhanced information group (standard information plus video) at 2, 4 or 6 months. Primary endpoint was the decisional conflict scale (0–100, higher scores indicating greater conflict) which was assessed on an individual participant level. Multilevel mixed effects models used a random effect for cluster and a fixed effect for each step to adjust for calendar time and clustering. Robust standard errors were also adjusted for the clustering effect. Results Five hundred twenty-one evaluable questionnaires were returned from 809 eligible patients (64%) in 24 clusters between April 2018 and October 2019. Mean decisional conflict scores in the standard group (N = 184) were 10.88 (SD 11.82) and 8.99 (SD 11.82) in the enhanced group (N = 337), with no statistically significant difference [mean difference − 1.78, 95%CI − 3.82–0.25, p = 0.09]. Compliance with patient information and diagrams was high in both groups although in the enhanced group only 121/337 (36%) reported watching the video. Conclusion The low levels of decisional conflict in PRIMETIME are reassuring and may reflect the high-quality information provision, such that not everyone required the video. This reinforces the importance of working with patients as partners in clinical trials especially in the development of patient-centred information and decision aids.

Handoff improvement and adverse event reduction programme implementation in paediatric intensive care units in Argentina: a stepped-wedge trial

BackgroundThere are only a few studies on handoff quality and adverse events (AEs) rigorously evaluating handoff improvement programmes’ effectiveness. None of them have been conducted in low and middle-income countries. We aimed to evaluate the effect of a handoff programme implementation in reducing AE frequency in paediatric intensive care units (PICUs).MethodsFacility-based, cluster-randomised, stepped-wedge trial in six Argentine PICUs in five hospitals, with >20 admissions per month. The study was conducted from July 2018 to May 2019, and all units at least were involved for 3 months in the control period and 4 months in the intervention period. The intervention comprised a Spanish version of the I-PASS handoff bundle consisting of a written and verbal handoff using mnemonics, an introductory workshop with teamwork training, an advertising campaign, simulation exercises, observation and standardised feedback of handoffs. Medical records (MR) were reviewed using trigger tool methodology to identify AEs (primary outcome). Handoff compliance and duration were evaluated by direct observation.ResultsWe reviewed 1465 MRs: 767 in the control period and 698 in the intervention period. We did not observe differences in the rates of preventable AE per 1000 days of hospitalisation (control 60.4 (37.5–97.4) vs intervention 60.4 (33.2–109.9), p=0.99, risk ratio: 1.0 (0.74–1.34)), and no changes in the categories or AE types. We evaluated 841 handoffs: 396 in the control period and 445 in the intervention period. Compliance with all items in the verbal and written handoffs was significantly higher in the intervention group. We observed no difference in the handoff time in both periods (control 35.7 min (29.6–41.8) vs intervention 34.7 min (26.5–42.1); difference 1.43 min (95% CI −2.63 to 5.49, p=0.49)). The providers’ perception of improved communication did not change.ConclusionsAfter the implementation of the I-PASS bundle, compliance with handoff items improved. Nevertheless, no differences were observed in the AEs’ frequency or the perception of enhanced communication.Trial registration numberNCT03924570