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

Surgery Clinical Trial

— PASC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03105713
• Other study ID #: REK Vest (2016/1102)
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: Haukeland University Hospital
• Contact: Arvid S Haugen, PhD, MSc
• Phone: +4755976850
• Email: arvid.haugen[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5320
• Est. completion date: December 30, 2025
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Health Economics
• Health Literacy
• Patient Safety
• Safety Issues
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Førde Central Hospital	Førde

Sponsors (5)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Vest, The Research Council of Norway, University of Bergen, Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications associated with the participants surgery	Total numbers of complications	Up to 30 days
Primary	Number of complications within respiratory system	Number of respiratory complications	Up to 30 days
Primary	Number of complications within cardio-thoracic system	Number of cardio-thoracic complications	Up to 30 days
Primary	Number of infections	Numbers of infections	Up to 30 days
Primary	Number of nervous system complications	Number of nervous system complications	Up to 30 days
Primary	Volume of bleeding associated with operation	Volume of bleedings in mL	Up to 30 days
Primary	Number of embolism associated with the hospital stay	Number of embolies	Up to 30 days
Primary	Number of mechanical implant complications	Number of mechanical implant complications	Up to 30 days
Primary	Number of re-operations	Number of re-operations	Up to 30 days
Primary	Number of re-admissions	Number of re-admissions	Up to 30 days
Secondary	Number of deaths associated with surgery	Total numbers of deaths	Up to 90 days
Secondary	Rate of patient scores on Health Literacy Questionaire	Mean scores of HLQ and EQ5D surveys	Up to 3 months post discharge
Secondary	Rate of patient scores on EQ5D	Mean scores of EQ5D	Up to 3 months
Secondary	Rates of Checklist Implementation Survey scores	Mean scores on checklist implementation survey	Up to 3 months post discharge

External Links

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