title: Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards.
  
  
  METHODS
  A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results.
  
  
  METHODS
  fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection of key data about intervention wards. Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework.
  
  
  CONCLUSIONS
  This study will be one of the largest patient safety trials ever conducted, involving 32 hospital wards. The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level. Incorporating the 'patient voice' is critical if patient feedback is to be situated as an integral part of patient safety improvements.
  
  
  BACKGROUND
  ISRCTN07689702, 16 Aug 2013.
authors.affiliation: Yorkshire Quality & Safety Research Group, Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford BD9 6RJ, England. laura.sheard@bthft.nhs.uk.
authors.forename: Laura
authors.initials: L
authors.lastname: Sheard
authors.forename: Jane
authors.initials: J
authors.lastname: O'Hara
authors.forename: Gerry
authors.initials: G
authors.lastname: Armitage
authors.forename: John
authors.initials: J
authors.lastname: Wright
authors.forename: Kim
authors.initials: K
authors.lastname: Cocks
authors.forename: Rosemary
authors.initials: R
authors.lastname: McEachan
authors.forename: Ian
authors.initials: I
authors.lastname: Watt
authors.forename: Rebecca
authors.initials: R
authors.lastname: Lawton
mesh_terms: D004739:England; D030141:Feedback, Psychological; D006761:Hospitals; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control*; D010358:Patient Participation; D061214:Patient Safety; D010361:Patients / Q000523:psychology*; D010465:Perception; D017064:Process Assessment, Health Care; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D017751:Safety Management / Q000379:methods*; D011795:Surveys and Questionnaires; D013997:Time Factors