Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery (PASC)

Development and Implementation of Surgical Safety Checklists for Patients to Use Before Admission, Before Discharge and After Discharge (PASC) - a Stepped Wedge Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Complication; Safety Issues; Health Literacy; Patient Safety; Health Economics
• Intervention / Treatment: Other: Patient Safety Checklist

Detailed Description

The PASC consist of measures that enable patients to optimize their own health prior to surgery and for discharge from hospital. The checklist addresses risk areas as pre-operative information and preparations, post-operative information, and post-operative plans and follow-up. Pre-operative risk areas are contact information, medication safety, health status, optimizing health and nutritional status, dental status, comprehend critical information, preparation two weeks before surgery, communication with surgical ward, and discharge planning. Post-operative risk areas are prevention of complications, medication safety, activity restriction, and pain relief.

The checklist has been developed in cooperation with patients, patients' representatives, surgeons, general practitioners, ward doctors, nurses, pharmacists, clinical nutritionists, safety officers, hospital managers, information technology experts and the researchers. The intervention include paper and electronically versions of the checklist. Of eligible surgical wards, seven were randomly selected based on power calculation. All the invited wards agreed to participate. Surgical patients from these wards, in two Norwegian hospitals, will be invited to participate in the trial. Based on data from a validation and feasibility study of PASC, the power analysis suggest to include 38 patients per month (on average), per cluster over 20 months, as the lowest number of participants to detect a 5% (33.3% relative risk reduction). An intra-cluster-correlation at 0.05, and type I and type II error at 0.05 and 0.20, respectively, were assumed.

The outcomes of this study are primarily patient outcomes (morbidity and mortality). The study further assess outcomes on nutritional status (MST form), implementation (acceptability, appropriateness and feasibility survey), health economic (EQ-5D-3L) data, and health literacy (HLQ), from surveys and forms.

Based on power calculation, 350 questionnaires will be distributed in each arm of the trial (baseline and internvention).

Focus group interviews with content analysis will be applied to assess patients and health care personnel's experiences with patients' use of PASC.

• Study Type: Interventional
• Enrollment (Estimated): 5320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Harris, PhD; Phone Number: +4798486734; Email: kristin.harris@hvl.no
• Study Contact Backup: Name: Arvid S Haugen, PhD, MSc; Phone Number: +4755972455 +4755976850; Email: arvid.haugen@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Principal Investigator: Kristin Harris, PhD
    • Sub-Investigator: Andy Healey, PhD
    • Sub-Investigator: Nick Sevdalis, PhD
    • Contact: Arvid S Haugen, PhD, MSc; Phone Number: +4755976850; Email: arvid.haugen@helse-bergen.no
    • Contact: Kristin Harris, MSc; Phone Number: +4798486734; Email: kristin.harris@hvl.no
    • Principal Investigator: Arvid S Haugen, PhD
    • Sub-Investigator: Eirik Søfteland, PhD
    • Sub-Investigator: Anette Storesund, PhD
    • Sub-Investigator: Stig Harthug, PhD
    • Principal Investigator: Hilde V Wæhle, PhD
    • Principal Investigator: Randi M Tangvik, PhD
  • Førde, Norway, 6812
    • Recruiting
    • Førde Central Hospital
    • Contact: Nils Sletteskog, MD; Phone Number: +4757 83 90 00; Email: nils.sletteskog@helse-foerde.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Elective surgery.

• Age over 18 years.
• Able to use Norwegian language.
• Patients must have had surgery 2-4 weeks before inclusion for the focus group interviews.

Exclusion Criteria:

• Must be cognitive able to use the checklist.
• Age under 18 years.
• Non-surgical procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Safety Checklist Intervention; The 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)	Other: Patient Safety Checklist; 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.
No Intervention: Controls; Patients do not receive the safety checklist intervention. Care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of deaths associated with surgery	Total numbers of deaths	Up to 90 days
Rate of patient scores on Health Literacy Questionaire	Mean scores of HLQ and EQ5D surveys	Up to 3 months post discharge
Rate of patient scores on EQ5D	Mean scores of EQ5D	Up to 3 months
Rates of Checklist Implementation Survey scores	Mean scores on checklist implementation survey	Up to 3 months post discharge

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen; The Research Council of Norway; Helse Vest; Western Norway University of Applied Sciences
• Investigators: Study Director: Hanne Klausen, MD, Haukeland University Hospital

Publications and helpful links

General Publications

• Harris 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.
• 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.

Helpful Links

• The Research Council of Norway's Project Bank description of the PASC project

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Implementation; Surgery; Health economics; Health literacy; Undernutrition; Checklist; Patient Involvement; Patient Checklist
• Other Study ID Numbers: REK Vest (2016/1102)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Study Data/Documents

1. Study Protocol
   Information identifier: 2016/1102
   Information comments: Study protocol in English and other relevant information on this study can be accessed by e-mail to Arvid.Haugen@helse-bergen.no

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No