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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03105713
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : March 18, 2022
Sponsor:
Collaborators:
Helse Vest
Western Norway University of Applied Sciences
University of Bergen
The Research Council of Norway
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Surgery Safety Issues Complication Patient Safety Health Literacy Health Economics Other: Patient Safety Checklist Not Applicable

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 (PG-SGA-SH 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5320 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped Wedge Cluster RCT is considered to align a cross-over design.
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:

Care Providers are masked for patients receiving the intervention and for outcomes.

Outcome sssessors are masked for patients receiving the intervention.
Primary Purpose: Health Services Research
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
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of complications associated with the participants surgery [ Time Frame: Up to 30 days ]
    Total numbers of complications

  2. Number of complications within respiratory system [ Time Frame: Up to 30 days ]
    Number of respiratory complications

  3. Number of complications within cardio-thoracic system [ Time Frame: Up to 30 days ]
    Number of cardio-thoracic complications

  4. Number of infections [ Time Frame: Up to 30 days ]
    Numbers of infections

  5. Number of nervous system complications [ Time Frame: Up to 30 days ]
    Number of nervous system complications

  6. Volume of bleeding associated with operation [ Time Frame: Up to 30 days ]
    Volume of bleedings in mL

  7. Number of embolism associated with the hospital stay [ Time Frame: Up to 30 days ]
    Number of embolies

  8. Number of mechanical implant complications [ Time Frame: Up to 30 days ]
    Number of mechanical implant complications

  9. Number of re-operations [ Time Frame: Up to 30 days ]
    Number of re-operations

  10. Number of re-admissions [ Time Frame: Up to 30 days ]
    Number of re-admissions


Secondary Outcome Measures :
  1. Number of deaths associated with surgery [ Time Frame: Up to 90 days ]
    Total numbers of deaths

  2. Rate of patient scores on Health Literacy Questionaire [ Time Frame: Up to 3 months post discharge ]
    Mean scores of HLQ and EQ5D surveys

  3. Rate of patient scores on EQ5D [ Time Frame: Up to 3 months ]
    Mean scores of EQ5D

  4. Rates of Checklist Implementation Survey scores [ Time Frame: Up to 3 months post discharge ]
    Mean scores on checklist implementation survey


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105713


Contacts
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Contact: Arvid S Haugen, PhD, MSc +4755976850 ext +4755972455 arvid.haugen@helse-bergen.no
Contact: Kristin Harris, MSc +4798486734 kristin.harris@hvl.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Arvid S Haugen, PhD, MSc    +4755976850    arvid.haugen@helse-bergen.no   
Contact: Kristin Harris, MSc    +4798486734    kristin.harris@hvl.no   
Principal Investigator: Kristin Harris, MSc         
Principal Investigator: Arvid S Haugen, PhD         
Sub-Investigator: Eirik Søfteland, PhD         
Sub-Investigator: Asgjerd Moi, PhD         
Sub-Investigator: Anette Storesund, PhD         
Sub-Investigator: Roy M Nilsen, PhD         
Sub-Investigator: Stig Harthug, PhD         
Principal Investigator: Hilde V Wæhle, PhD         
Principal Investigator: Randi M Tangvik, PhD         
Førde Central Hospital Recruiting
Førde, Norway, 6812
Contact: Nils Sletteskog, MD    +4757 83 90 00    nils.sletteskog@helse-foerde.no   
Sponsors and Collaborators
Haukeland University Hospital
Helse Vest
Western Norway University of Applied Sciences
University of Bergen
The Research Council of Norway
Investigators
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Study Director: Hanne Klausen, MD Haukeland University Hospital
More Information
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Additional Information:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 2016/1102
Study protocol in English and other relevant information on this study can be accessed by e-mail to Arvid.Haugen@helse-bergen.no

Publications of Results:

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03105713    
Other Study ID Numbers: REK Vest (2016/1102)
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
Checklist
Patient Checklist
Surgery
Safety
Patient Involvement
 Undernutrition
Implementation
Health literacy
Health economics