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HELSEFORSKNING-HELSEFORSKNING

Implementation of Patients Safety Checklist (PASC) in Surgery, a Stepped Wedge Cluster RCT - Effects on Patient and Implementation Outcomes

Alternative title: Pasientens helsetjeneste: Effekt og implementering av pasientenes kirurgiske sjekkliste - en stegvis kluster randomisert kontrollert studie

Awarded: NOK 12.4 mill.

Building on the Norwegian Patient Safety Program target areas, the Patients Surgical Checklist (PASC) aims to empower patient involvement in patient safety collaborative and to prevent patient harm in the surgical pathway. By using the checklist patients actively prepare themselves for the operation and for the time after discharge. The PASC has been developed together with patients, patient representatives, surgeons, nurses, general practitioners, pharmacists, nutritional experts, and patient safety researchers. Feasibility of the PASC intervention (paper and digital checklist) has been tested and validated by surgical patients. The PASC study is carried out over a period of 4 year in two Norwegian hospitals. In a stepped wedge cluster randomized controlled trial designed study, we compare control and intervention groups of surgical patients from seven surgical departments. The study has included more than 8500 patients. In the control steps patients received care as usual and they will be compared with patients in the intervention steps of the trial. Primary endpoints of the PASC study are postoperative complications, length of stay, and readmissions to hospital. Patient experiences with the checklist and receiving nutritional support prior to admission are also investigated. Further, we will study the implementation process and attain knowledge on how to implement patient safety interventions involving patients and patient representatives. We study the PASC implementation through interviewing patients and healthcare personnel, measuring process indicators and surveying patients who have used the checklists. Finally, the PASC study will evaluate health economic impacts of the patient checklist implementation.

Building on the Norwegian Patient Safety Program’s target areas, the Patients’ Surgical Checklist (PASC) will be addressing preventive measures and empowering patients to become more involved in their safety, before and after surgery. PASC will be the first checklist study using a RCT design to examine effects of patients using their own checklists to avoid preventable patient harm. The project will re-use existing health and personal data collected from patient records as outcome measures. A consortium of all relevant stakeholders and users will participate: two hospitals with seven surgical clusters, patient representatives, representatives of general practitioners, and interdisciplinary in-hospital professionals. The project has also reference groups from the Norwegian Healthcare Investigation Board (UKOM) and the Norwegian National Advisory Unit on Disease Related Undernutrition. Further, important project partners are information and communications technology companies (Helse-Vest IKT and CheckWare service delivery), general practitioners, and national and international research partners leading in the field of patient safety, implementation science and health economics. The Norwegian Directorate of Health endorses the application.

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HELSEFORSKNING-HELSEFORSKNING