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

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Abstract

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.

Related collections

Most cited references 23

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Incidence and types of adverse events and negligent care in Utah and Colorado.

E Thomas, D M Studdert, H Burstin … (2000)

The ongoing debate on the incidence and types of iatrogenic injuries in American hospitals has been informed primarily by the Harvard Medical Practice Study, which analyzed hospitalizations in New York in 1984. The generalizability of these findings is unknown and has been questioned by other studies. We used methods similar to the Harvard Medical Practice Study to estimate the incidence and types of adverse events and negligent adverse events in Utah and Colorado in 1992. We selected a representative sample of hospitals from Utah and Colorado and then randomly sampled 15,000 nonpsychiatric 1992 discharges. Each record was screened by a trained nurse-reviewer for 1 of 18 criteria associated with adverse events. If > or =1 criteria were present, the record was reviewed by a trained physician to determine whether an adverse event or negligent adverse event occurred and to classify the type of adverse event. The measures were adverse events and negligent adverse events. Adverse events occurred in 2.9+/-0.2% (mean+/-SD) of hospitalizations in each state. In Utah, 32.6+/-4% of adverse events were due to negligence; in Colorado, 27.4+/-2.4%. Death occurred in 6.6+/-1.2% of adverse events and 8.8+/-2.5% of negligent adverse events. Operative adverse events comprised 44.9% of all adverse events; 16.9% were negligent, and 16.6% resulted in permanent disability. Adverse drug events were the leading cause of nonoperative adverse events (19.3% of all adverse events; 35.1% were negligent, and 9.7% caused permanent disability). Most adverse events were attributed to surgeons (46.1%, 22.3% negligent) and internists (23.2%, 44.9% negligent). The incidence and types of adverse events in Utah and Colorado in 1992 were similar to those in New York State in 1984. Iatrogenic injury continues to be a significant public health problem. Improving systems of surgical care and drug delivery could substantially reduce the burden of iatrogenic injury.

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Patient participation: current knowledge and applicability to patient safety.

Yves Longtin, Hugo Sax, Lucian L Leape … (2010)

Patient participation is increasingly recognized as a key component in the redesign of health care processes and is advocated as a means to improve patient safety. The concept has been successfully applied to various areas of patient care, such as decision making and the management of chronic diseases. We review the origins of patient participation, discuss the published evidence on its efficacy, and summarize the factors influencing its implementation. Patient-related factors, such as acceptance of the new patient role, lack of medical knowledge, lack of confidence, comorbidity, and various sociodemographic parameters, all affect willingness to participate in the health care process. Among health care workers, the acceptance and promotion of patient participation are influenced by other issues, including the desire to maintain control, lack of time, personal beliefs, type of illness, and training in patient-caregiver relationships. Social status, specialty, ethnic origin, and the stakes involved also influence patient and health care worker acceptance. The London Declaration, endorsed by the World Health Organization World Alliance for Patient Safety, calls for a greater role for patients to improve the safety of health care worldwide. Patient participation in hand hygiene promotion among staff to prevent health care-associated infection is discussed as an illustrative example. A conceptual model including key factors that influence participation and invite patients to contribute to error prevention is proposed. Further research is essential to establish key determinants for the success of patient participation in reducing medical errors and in improving patient safety.

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Patient involvement in patient safety: what factors influence patient participation and engagement?

Rachel E Davis, Rosamond Jacklin, Nick Sevdalis … (2007)

Patients can play an important role in improving patient safety by becoming actively involved in their health care. However, there is a paucity of empirical data on the extent to which patients take on such a role. In order to encourage patient participation in patient safety we first need to assess the full range of factors that may be implicated in such involvement. To delineate factors that could affect the participation of the patient in quality and safety issues in their health care. Literature review of patient involvement in health care, drawing from direct evidence (specifically from the safety context) and indirect evidence (extrapolated from treatment decision-making research and the wider patient involvement in health care literature); synthesis and conceptual framework developed, illustrating the known and putative factors that could affect the participation of the patient in safety issues in their health care. Five categories of factors emerged that could affect patient involvement in safety: patient-related (e.g. patients' demographic characteristics), illness-related (e.g. illness severity), health-care professional-related (e.g. health care professionals' knowledge and beliefs), health care setting-related (e.g. primary or secondary care), and task-related (e.g. whether the required patient safety behaviour challenges clinicians' clinical abilities). The potential for engaging patients in patient safety is considerable but further research is needed to examine the influences on patient involvement, the limits and the possible dangers. Patients can act as 'safety buffers' during their care but the responsibility for their safety must remain with the health care professionals.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Qual Saf

Journal ID (iso-abbrev): BMJ Qual Saf

Journal ID (hwp): qhc

Journal ID (publisher-id): bmjqs

Title: BMJ Quality & Safety

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Print): 2044-5415

ISSN (Electronic): 2044-5423

Publication date (Print): August 2017

Publication date (Electronic): 3 February 2017

Volume: 26

Issue: 8

Pages: 622-631

Affiliations

[1 ]Institute of Psychological Sciences, University of Leeds , Leeds, UK

[2 ]Department of Quality and Safety Research, Bradford Institute for Health Research , Bradford, UK

[3 ]Leeds Institute of Medical Education, University of Leeds , Leeds, Leeds, UK

[4 ]Quality and Safety Research Group, Bradford Institute for Health Research , Bradford, Bradford, UK

[5 ]School of Health, University of Bradford , Bradford, Bradford, UK

[6 ]York Trials Unit, Department of Health Sciences, University of York , York, UK

[7 ]York Trials Unit, University of York , York, UK

[8 ]Department of Quality and Safety, Bradford Institute for Health Research , Bradford, UK

[9 ]Department of Health Sciences, The University of York , York, North Yorkshire, UK

[10 ]Department of Epidemiology and Public Health, Royal Infirmary Bradford , Bradford, UK

Author notes

[Correspondence to ] Dr Rebecca Lawton, Institute of Psychological Sciences, University of Leeds, Leeds LS2 9JT, UK; r.j.lawton@ 123456leeds.ac.uk

Author information

Jane Kathryn O'Hara http://orcid.org/0000-0001-5551-9975

Article

Publisher ID: bmjqs-2016-005570

DOI: 10.1136/bmjqs-2016-005570

PMC ID: 5537521

PubMed ID: 28159854

SO-VID: b8b899b8-6c73-4f0d-8eab-1d5afbef5082

Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

License:

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: http://creativecommons.org/licenses/by/4.0/

History

Date received : 8 April 2016

Date revision received : 14 October 2016

Date accepted : 24 October 2016

Funding

Funded by: National Institute for Health Research, http://dx.doi.org/10.13039/501100000272;

Award ID: NIHR_PGfAR_RP_PG-0108-10049

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ScienceOpen disciplines: Public health

Keywords: patient safety,randomised controlled trial,patient-centred care,cluster trials,healthcare quality improvement

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ScienceOpen disciplines: Public health

Keywords: patient safety, randomised controlled trial, patient-centred care, cluster trials, healthcare quality improvement

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

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Abstract

Objective

Design

Setting

Participants

Intervention

Measurements

Results

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Conclusions

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Most cited references 23

Incidence and types of adverse events and negligent care in Utah and Colorado.

Patient participation: current knowledge and applicability to patient safety.

Patient involvement in patient safety: what factors influence patient participation and engagement?

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