Evaluating the PRASE intervention – a multi-centre, cluster, wait list design, randomised controlled trial with a qualitative process evaluation

Laura Sheard (laura.sheard@bthft.nhs.uk)

Objectives and brief methodology
Objective: To assess the efficacy of the PRASE (Patient Reporting and Action for a Safe Environment) patient safety intervention, in achieving patient safety improvements over a 12 month period.

Brief methodology:
Trial: A multi-centre, cluster, wait list randomised controlled trial of a patient safety intervention with a qualitative process evaluation.

Trial methods consists of three stages:

i) Measurement
Over a 2-3 week period, 25 patients per ward complete the 48 item PMOS questionnaire, and report any safety concerns (or specific positive experiences of care) using the PIRT incident reporting tool. Patients will be given a choice of whether they would prefer to self-complete the questionnaire or have it facilitated by the researcher. There are three measurement periods – at baseline, 6 months and 12 months.

ii) Feedback
Information for each ward is collated and presented to the ward in the form of a ‘Feedback Report’. PMOS questionnaire scores are shown graphically using a traffic light system to allow staff to see easily which areas they are performing in well, and those areas perhaps in need of improvement.

iii) Action planning and change
Ward staff form an Action Planning Team and identify areas to target for improvement based on patient feedback detailed in the report. The APT is facilitated by a PRASE researcher. Nominated people within the APT takes responsibility for delivering the action plan.

Process evaluation
The key elements of the process evaluation are:

  • Analysis of documented action plans
  • In depth ethnographic observation of the APM
  • Structured interviews with key members of the APM
  • Detailed fieldworker diaries

First patient recruitment was 7th May 2013. Patient recruitment is in three cycles: May to July 2013, January to March 2014 and July to September 2014.

Participant criteria
Inclusion criteria

Male or female
Aged 16 or over
Able to give informed consent
Minimum period of two hours on the ward before questionnaire administered

Exclusion criteria
Does not have capacity to consent
Children under the age of 16
Has capacity but is too ill/distressed to take part e.g. breathlessness, pain, bleeding, immediately post-op etc
Has taken part in the study within the previous month

Patient recruitment and on-going engagement for the current projects
Three Trusts are taking part in this study: Harrogate & District NHS Foundation Trust, Calderdale & Huddersfield NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust. At the end of the first phase of data collection, 800 participants were recruited in total. It is projected that 800 participants will also be recruited in each of the two remaining data collection phases meaning the overall total for the trial will be 2400 patients.

Sheard, L., O’Hara, J., Armitage, G., Wright, J., Cocks, K., McEachan, R., Watt, I., Lawton, R. (2014). Evaluating the PRASE patient safety intervention-a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial. Trials, 15(1), 420. http://www.trialsjournal.com/content/15/1/420

Armitage G, Ward J, Birks Y (2013) Patients as reviewers of quality and safety. The Joint Commission Journal on Quality and Patient Safety. 39(1) 5-6

Ward, J.K., Giles S., Hrisos S., et al. (2012). Chapter 3: Involving patients in their safety: Initiatives, innovations and recommendations for developing your practice. In: Lawton R.L and Armitage G, (Eds). Innovating for Patient Safety. Sage: Learning Matters.

Ward J.K., Armitage G (2012) Can patients report patient safety incidents in a hospital setting? A systematic review. BMJ Quality and Safety in Health Care. 21(8):685-99.

Ward, J.K., McEachan, R.R.C., Lawton, R., Armitage, G., Watt, I., & Wright, J. (2011). Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting. BMC Health Services Research 2011, 11:130 (27 May 2011).

O’Hara J, Isden R. (2013) Identifying Risks and Monitoring Safety: the Role of Patients and Citizens. London, UK: Health Foundation; October 2013.