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

TY - JOUR

T1 - Can patient involvement improve patient safety?

T2 - A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention

AU - Lawton, Rebecca

AU - O'Hara, Jane Kathryn

AU - Sheard, Laura

AU - Armitage, Gerry

AU - Cocks, Kim

AU - Buckley, Hannah

AU - Corbacho Martín, Belén

AU - Reynolds, Caroline

AU - Marsh, Claire

AU - Moore, Sally

AU - Watt, Ian

AU - Wright, John

N1 - © 2017, The Author(s).

PY - 2017/7/20

Y1 - 2017/7/20

N2 - 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.

AB - 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.

KW - Cluster trials

KW - Healthcare quality improvement

KW - Patient safety

KW - Patient-centred care

KW - Randomised controlled trial

KW - Safety Management/methods

KW - Humans

KW - Middle Aged

KW - Male

KW - United Kingdom

KW - State Medicine/economics

KW - Patient Care Team/organization & administration

KW - Feedback

KW - Cost-Benefit Analysis

KW - Patient Safety

KW - Aged, 80 and over

KW - Adult

KW - Female

KW - Aged

KW - Patient Participation/economics

UR - http://www.scopus.com/inward/record.url?scp=85024400790&partnerID=8YFLogxK

U2 - 10.1136/bmjqs-2016-005570

DO - 10.1136/bmjqs-2016-005570

M3 - Article

C2 - 28159854

SN - 2044-5415

VL - 26

SP - 622

EP - 631

JO - BMJ Quality & Safety

JF - BMJ Quality & Safety

IS - 8

ER -