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Headline
This programme of research involved staff and patients in the codesign of novel interventions to improve patient safety that were found to be feasible and acceptable, but showed no effect on routinely collected quality and safety measures.
Abstract
Background:
Estimates suggest that, in NHS hospitals, incidents causing harm to patients occur in 10% of admissions, with costs to the NHS of > £2B. About one-third of harmful events are believed to be preventable. Strategies to reduce patient safety incidents (PSIs) have mostly focused on changing systems of care and professional behaviour, with the role that patients can play in enhancing the safety of care being relatively unexplored. However, although the role and effectiveness of patient involvement in safety initiatives is unclear, previous work has identified a general willingness among patients to contribute to initiatives to improve health-care safety.
Aim:
Our aim in this programme was to design, develop and evaluate four innovative approaches to engage patients in preventing PSIs: assessing risk, reporting incidents, direct engagement in preventing harm and education and training.
Methods and results:
We developed tools to report PSIs [patient incident reporting tool (PIRT)] and provide feedback on factors that might contribute to PSIs in the future [Patient Measure of Safety (PMOS)]. These were combined into a single instrument and evaluated in the Patient Reporting and Action for a Safe Environment (PRASE) intervention using a randomised design. Although take-up of the intervention by, and retention of, participating hospital wards was 100% and patient participation was high at 86%, compliance with the intervention, particularly the implementation of action plans, was poor. We found no significant effect of the intervention on outcomes at 6 or 12 months. The ThinkSAFE project involved the development and evaluation of an intervention to support patients to directly engage with health-care staff to enhance their safety through strategies such as checking their care and speaking up to staff if they had any concerns. The piloting of ThinkSAFE showed that the approach is feasible and acceptable to users and may have the potential to improve patient safety. We also developed a patient safety training programme for junior doctors based on patients who had experienced PSIs recounting their own stories. This approach was compared with traditional methods of patient safety teaching in a randomised controlled trial. The study showed that delivering patient safety training based on patient narratives is feasible and had an effect on emotional engagement and learning about communication. However, there was no effect on changing general attitudes to safety compared with the control.
Conclusion:
This research programme has developed a number of novel interventions to engage patients in preventing PSIs and protecting them against unintended harm. In our evaluations of these interventions we have been unable to demonstrate any improvement in patient safety although this conclusion comes with a number of caveats, mainly about the difficulty of measuring patient safety outcomes. Reflecting this difficulty, one of our recommendations for future research is to develop reliable and valid measures to help efficiently evaluate safety improvement interventions. The programme found patients to be willing to codesign, coproduce and participate in initiatives to prevent PSIs and the approaches used were feasible and acceptable. These factors together with recent calls to strengthen the patient voice in health care could suggest that the tools and interventions from this programme would benefit from further development and evaluation.
Trial registration:
Current Controlled Trials ISRCTN07689702.
Funding:
The National Institute for Health Research Programme Grants for Applied Research programme.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Introduction
- Chapter 2. Assessing risk: a systematic review of factors contributing to patient safety incidents in hospital settings
- Chapter 3. Assessing risk: developing and validating the Patient Measure of Safety
- Chapter 4. Learning from error: a systematic review of the evidence on patient reporting of patient safety in hospital settings
- Chapter 5. Learning from error: testing three mechanisms for capturing patient-reported safety concerns
- Chapter 6. Learning from error: a comparative study of patient-reported patient safety incidents and existing sources of patient safety data
- Chapter 7. Assessing risk and learning from error: the Patient Reporting and Action for a Safe Environment intervention – a feasibility study
- Chapter 8. Assessing risk and learning from error: evaluating the Patient Reporting and Action for a Safe Environment intervention – a cluster randomised controlled trial
- Chapter 9. Direct engagement: developing and piloting the ThinkSAFE intervention
- Abstract
- Chapter rationale
- Introduction
- Phase 1: comprehensive evidence collation of resources to inform the content and form of a prototype intervention
- Phase 2: iterative codevelopment and design of the study intervention
- Phase 3: development and piloting of the prototype intervention materials
- Discussion
- Chapter 10. Education and training: using patient narratives within medical education – a randomised controlled trial
- Chapter 11. Lessons from patient and public involvement: development of a model of coproduction
- Chapter 12. Conclusions and recommendations
- Acknowledgements
- References
- Appendix 1 Further details of the search strategy for the systematic review of factors contributing to patient safety incidents in hospital settings
- Appendix 2 Patient Measure of Safety
- Appendix 3 Search terms used for the systematic review of the evidence on patient reporting of patient safety in hospital settings
- Appendix 4 Questions designed to elicit safety concerns from patients
- Appendix 5 Reporting a safety concern or experience
- Appendix 6 Patient Reporting and Action for a Safe Environment action plan
- Appendix 7 Unadjusted Patient Measure of Safety domain scores at each time point by allocation group
- Appendix 8 Examples of the types of action plans made by different wards
- Appendix 9 Patient/relative interview topic guide
- Appendix 10 Logbook contents
- Appendix 11 Patient and staff questionnaires
- Appendix 12 Patient safety project tracer topic data collection form
- Appendix 13 Ward staff interview topic guide
- Appendix 14 The Attitude to Patient Safety Questionnaire and Positive and Negative Affect Schedule
- Appendix 15 Content of the staff educational session
- List of abbreviations
Article history
The research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0108-10049. The contractual start date was in September 2014. The final report began editorial review in April 2015 and was accepted for publication in November 2015. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors
Kim Cocks declares money for employment outside the submitted work from University of York and Adelphi Values.
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