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

September 10, 2024 updated by: Haukeland University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8559

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital
      • Førde, Norway, 6812
        • Førde Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of complications associated with the participants surgery
Time Frame: Up to 30 days
Total numbers of complications
Up to 30 days
Number of complications within respiratory system
Time Frame: Up to 30 days
Number of respiratory complications
Up to 30 days
Number of complications within cardio-thoracic system
Time Frame: Up to 30 days
Number of cardio-thoracic complications
Up to 30 days
Number of infections
Time Frame: Up to 30 days
Numbers of infections
Up to 30 days
Number of nervous system complications
Time Frame: Up to 30 days
Number of nervous system complications
Up to 30 days
Volume of bleeding associated with operation
Time Frame: Up to 30 days
Volume of bleedings in mL
Up to 30 days
Number of embolism associated with the hospital stay
Time Frame: Up to 30 days
Number of embolies
Up to 30 days
Number of mechanical implant complications
Time Frame: Up to 30 days
Number of mechanical implant complications
Up to 30 days
Number of re-operations
Time Frame: Up to 30 days
Number of re-operations
Up to 30 days
Number of re-admissions
Time Frame: Up to 30 days
Number of re-admissions
Up to 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of deaths associated with surgery
Time Frame: Up to 90 days
Total numbers of deaths
Up to 90 days
Rate of patient scores on Health Literacy Questionaire
Time Frame: Up to 3 months post discharge
Mean scores of HLQ and EQ5D surveys
Up to 3 months post discharge
Rate of patient scores on EQ5D
Time Frame: Up to 3 months
Mean scores of EQ5D
Up to 3 months
Rates of Checklist Implementation Survey scores
Time Frame: Up to 3 months post discharge
Mean scores on checklist implementation survey
Up to 3 months post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haukeland University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bergen
The Research Council of Norway
Helse Vest
Western Norway University of Applied Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hanne Klausen, MD, Haukeland University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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 version 2.1 is up-loaded in ClinicalTrials.gov along with the SAP. English version of the trial and other relevant information on this study can be accessed by e-mail to arvid.steinar.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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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