Objective To evaluate the efficacy of the Patient Reporting and Action for a Safe Environment intervention.
Design A multicentre cluster randomised controlled trial.
Setting Clusters were 33 hospital wards within five hospitals in the UK.
Participants All patients able to give informed consent were eligible to take part. Wards were allocated to the intervention or control condition.
Intervention The ward-level intervention comprised two tools: (1) a questionnaire that asked patients about factors contributing to safety (patient measure of safety (PMOS)) and (2) a proforma for patients to report both safety concerns and positive experiences (patient incident reporting tool). Feedback was considered in multidisciplinary action planning meetings.
Measurements Primary outcomes were routinely collected ward-level harm-free care (HFC) scores and patient-level feedback on safety (PMOS).
Results Intervention uptake and retention of wards was 100% and patient participation was high (86%). We found no significant effect of the intervention on any outcomes at 6 or 12 months. However, for new harms (ie, those for which the wards were directly accountable) intervention wards did show greater, though non-significant, improvement compared with control wards. Analyses also indicated that improvements were largest for wards that showed the greatest compliance with the intervention.
Limitations Adherence to the intervention, particularly the implementation of action plans, was poor. Patient safety outcomes may represent too blunt a measure.
Conclusions Patients are willing to provide feedback about the safety of their care. However, we were unable to demonstrate any overall effect of this intervention on either measure of patient safety and therefore cannot recommend this intervention for wider uptake. Findings indicate promise for increasing HFC where wards implement ≥75% of the intervention components.
Trial registration number ISRCTN07689702; pre-results.
- Patient safety
- Randomised controlled trial
- Patient-centred care
- Cluster trials
- Healthcare quality improvement
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Contributors RL, JKW, IW and GA conceived the project and led the programme of work. RL produced a first draft of the manuscript. JKO, LS and CM were responsible for the delivery of the trial, data collection for the trial and fidelity analysis. SM and CR collected data and extracted routinely collected data and input to the trial design. KC, HB and BC influenced the design, conducted power calculations, randomisation, statistical analysis and cost-effectiveness analysis. They provided significant input to the writing of the manuscript. All authors edited the draft and other versions of the manuscript.
Funding National Institute for Health Research (NIHR) Programme Grant for Applied Research.
Competing interests None declared.
Patient consent Obtained.
Ethics approval South Yorkshire NHS Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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