Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention.
OBJECTIVE
To evaluate the efficacy of the Patient Reporting and Action for a Safe Environment intervention.


METHODS
A multicentre cluster randomised controlled trial.


METHODS
Clusters were 33 hospital wards within five hospitals in the UK.


METHODS
All patients able to give informed consent were eligible to take part. Wards were allocated to the intervention or control condition.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
ISRCTN07689702; pre-results.
Institute of Psychological Sciences, University of Leeds, Leeds, UK.|Department of Quality and Safety Research, Bradford Institute for Health Research, Bradford, UK.
Rebecca
R
Lawton
Leeds Institute of Medical Education, University of Leeds, Leeds, Leeds, UK.
Jane Kathryn
http://orcid.org/0000-0001-5551-9975
JK
O'Hara
Quality and Safety Research Group, Bradford Institute for Health Research, Bradford, Bradford, UK.
Laura
L
Sheard
School of Health, University of Bradford, Bradford, Bradford, UK.
Gerry
G
Armitage
York Trials Unit, Department of Health Sciences, University of York, York, UK.
Kim
K
Cocks
York Trials Unit, University of York, York, UK.
Hannah
H
Buckley
York Trials Unit, University of York, York, UK.
Belen
B
Corbacho
Department of Quality and Safety, Bradford Institute for Health Research, Bradford, UK.
Caroline
C
Reynolds
Department of Quality and Safety, Bradford Institute for Health Research, Bradford, UK.
Claire
C
Marsh
Department of Quality and Safety Research, Bradford Institute for Health Research, Bradford, UK.
Sally
S
Moore
Department of Health Sciences, The University of York, York, North Yorkshire, UK.
Ian
I
Watt
Department of Epidemiology and Public Health, Royal Infirmary Bradford, Bradford, UK.
John
J
Wright
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D005246:Feedback; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010348:Patient Care Team / Q000458:organization & administration; D010358:Patient Participation / Q000191:economics / Q000379:methods*; D061214:Patient Safety; D017751:Safety Management / Q000379:methods*; D013222:State Medicine / Q000191:economics / Q000458:organization & administration* / Q000592:standards; D006113:United Kingdom
Cluster trials; Healthcare quality improvement; Patient safety; Patient-centred care; Randomised controlled trial