Article Text

Download PDFPDF

Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention
  1. Rebecca Lawton1,2,
  2. Jane Kathryn O'Hara3,
  3. Laura Sheard4,
  4. Gerry Armitage5,
  5. Kim Cocks6,
  6. Hannah Buckley7,
  7. Belen Corbacho7,
  8. Caroline Reynolds8,
  9. Claire Marsh8,
  10. Sally Moore2,
  11. Ian Watt9,
  12. John Wright10
  1. 1Institute of Psychological Sciences, University of Leeds, Leeds, UK
  2. 2Department of Quality and Safety Research, Bradford Institute for Health Research, Bradford, UK
  3. 3Leeds Institute of Medical Education, University of Leeds, Leeds, Leeds, UK
  4. 4Quality and Safety Research Group, Bradford Institute for Health Research, Bradford, Bradford, UK
  5. 5School of Health, University of Bradford, Bradford, Bradford, UK
  6. 6York Trials Unit, Department of Health Sciences, University of York, York, UK
  7. 7York Trials Unit, University of York, York, UK
  8. 8Department of Quality and Safety, Bradford Institute for Health Research, Bradford, UK
  9. 9Department of Health Sciences, The University of York, York, North Yorkshire, UK
  10. 10Department of Epidemiology and Public Health, Royal Infirmary Bradford, Bradford, UK
  1. Correspondence to Dr Rebecca Lawton, Institute of Psychological Sciences, University of Leeds, Leeds LS2 9JT, UK; r.j.lawton{at}


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

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See:

View Full Text

Statistics from


  • Twitter Follow Jane O'Hara at @janekohara

  • 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.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.