Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery
PASC
1 other identifier
interventional
8,559
1 country
2
Brief Summary
Building on the Norwegian Patient Safety Program's target areas, the Patients' Surgical Checklist (PASC) will empower surgical patients to become more involved in their own safety and contribute to preventive safety measures. A safety checklist for patients to use has been developed and validated for use in surgical patients. In a Stepped Wedge Cluster RCT effects of patients using their own checklists to avoid preventable patient harm are examined. The project will re-use existing health and personal data collected from patient records and patient reported data as outcome measures. A consortium of all relevant stakeholders and users participate: two hospitals with seven surgical clusters, patient representatives, representatives of general practitioners, and interdisciplinary in-hospital professionals. The 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable surgery
Started Nov 2021
Typical duration for not_applicable surgery
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedSeptember 19, 2024
September 1, 2024
2.3 years
March 20, 2017
September 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Number of complications associated with the participants surgery
Total numbers of complications
Up to 30 days
Number of complications within respiratory system
Number of respiratory complications
Up to 30 days
Number of complications within cardio-thoracic system
Number of cardio-thoracic complications
Up to 30 days
Number of infections
Numbers of infections
Up to 30 days
Number of nervous system complications
Number of nervous system complications
Up to 30 days
Volume of bleeding associated with operation
Volume of bleedings in mL
Up to 30 days
Number of embolism associated with the hospital stay
Number of embolies
Up to 30 days
Number of mechanical implant complications
Number of mechanical implant complications
Up to 30 days
Number of re-operations
Number of re-operations
Up to 30 days
Number of re-admissions
Number of re-admissions
Up to 30 days
Secondary Outcomes (4)
Number of deaths associated with surgery
Up to 90 days
Rate of patient scores on Health Literacy Questionaire
Up to 3 months post discharge
Rate of patient scores on EQ5D
Up to 3 months
Rates of Checklist Implementation Survey scores
Up to 3 months post discharge
Study Arms (2)
Patient Safety Checklist Intervention
EXPERIMENTALThe intervention to be administered is a patient safety checklist (two parts) for patients to be performed on paper or electronically: a) before admission to hospital, and b) under hospital stay (discharge)
Controls
NO INTERVENTIONPatients do not receive the safety checklist intervention. Care as usual.
Interventions
The intervention is developed, validated and to be implemented in seven surgical clusters in two hospitals, in a stepped wedge cluster randomized controlled trial of the PASC for patients to use.
Eligibility Criteria
You may qualify if:
- Elective surgery.
- Age over 18 years.
- Able to use Norwegian language.
You may not qualify if:
- Must be cognitive able to use the checklist.
- Age under 18 years.
- Non-surgical procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haukeland University Hospitallead
- Helse Vestcollaborator
- Western Norway University of Applied Sciencescollaborator
- University of Bergencollaborator
- The Research Council of Norwaycollaborator
Study Sites (2)
Haukeland University Hospital
Bergen, 5021, Norway
Førde Central Hospital
Førde, 6812, Norway
Related Publications (4)
Harris K, Softeland E, Moi AL, Harthug S, Ravnoy M, Storesund A, Jurmy E, Skeie E, Waehle HV, Sevdalis N, Haugen AS. Feasibility of implementing a surgical patient safety checklist: prospective cross-sectional evaluation. Pilot Feasibility Stud. 2023 Mar 27;9(1):52. doi: 10.1186/s40814-023-01277-3.
PMID: 36973815BACKGROUNDHarris K, Softeland E, Moi AL, Harthug S, Storesund A, Jesuthasan S, Sevdalis N, Haugen AS. Patients' and healthcare workers' recommendations for a surgical patient safety checklist - a qualitative study. BMC Health Serv Res. 2020 Jan 16;20(1):43. doi: 10.1186/s12913-020-4888-1.
PMID: 31948462RESULTTangvik RJ, Skeie E, Haugen AS, Harthug S, Harris K. Is self-screening for 'at risk of malnutrition' feasible in a home setting? PLoS One. 2024 Apr 16;19(4):e0299305. doi: 10.1371/journal.pone.0299305. eCollection 2024.
PMID: 38625912RESULTHarris K, Waehle HV, Storesund A, Harthug S, Tangvik RJ, Monsen Lukcova D, Havik W, Humberset A, Stavang E, Hagerup K, Teigland Tepstad A, Sandsbakk Austarheim AK, Healey A, Sevdalis N, Haugen AS. Surgical patients' experiences with the Patients' Safety Checklist (PASC): a qualitative interview study. BMJ Open. 2025 Oct 5;15(10):e105554. doi: 10.1136/bmjopen-2025-105554.
PMID: 41047253DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hanne Klausen, MD
Haukeland University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- All participants are masked for the study outcomes. In intervention arm, the participants are not masked for the checklist intervention. Care Providers are masked for patients receiving the intervention and for outcomes. Outcome assessors are masked for patients receiving the intervention. Investigators are partially masked for the outcomes across clusters in the intervention phase
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2017
First Posted
April 10, 2017
Study Start
November 1, 2021
Primary Completion
February 29, 2024
Study Completion
February 29, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share
REKVest has decided that data which are anonymous, where it directly or indirectly is not possible to identify individuals, could be shared with other scientists or scientific journals.