SurgeryPASCNCT03105713
Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery
A study testing Patient Safety Checklist in people with Surgery and Safety Issues, run by Haukeland University Hospital at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Safety Issues, Complication
- What is being tested?
- Patient Safety Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,559 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Nov 2021to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Must be cognitive able to use the checklist.
- Age under 18 years.
- Non-surgical procedures.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, 5021
Førde Central Hospital
Førde, 6812
About this study
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
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.
Read the 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.
- Conditions
- Surgery, Safety Issues, Complication, Patient Safety, Health Literacy, Health Economics
- Being tested
- Patient Safety Checklist
- Keywords
- Checklist, Patient Checklist, Surgery, Safety, Patient Involvement, Undernutrition, Implementation, Health literacy, Health economics
- Medical subject headings
- Patient Participation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Safety ChecklistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Safety Checklist Intervention | Experimental | 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) Receives: Other: Patient Safety Checklist |
| Controls | No intervention | Patients do not receive the safety checklist intervention. Care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications associated with the participants surgery
Total numbers of complications
Measured: Up to 30 days
Number of complications within respiratory system
Number of respiratory complications
Measured: Up to 30 days
Number of complications within cardio-thoracic system
Number of cardio-thoracic complications
Measured: Up to 30 days
Number of infections
Numbers of infections
Measured: Up to 30 days
Number of nervous system complications
Number of nervous system complications
Measured: Up to 30 days
Volume of bleeding associated with operation
Volume of bleedings in mL
Measured: Up to 30 days
Number of embolism associated with the hospital stay
Number of embolies
Measured: Up to 30 days
Number of mechanical implant complications
Number of mechanical implant complications
Measured: Up to 30 days
Number of re-operations
Number of re-operations
Measured: Up to 30 days
Number of re-admissions
Number of re-admissions
Measured: Up to 30 days
Secondary outcomes (4)
Number of deaths associated with surgery
Total numbers of deaths
Measured: Up to 90 days
Rate of patient scores on Health Literacy Questionaire
Mean scores of HLQ and EQ5D surveys
Measured: Up to 3 months post discharge
Rate of patient scores on EQ5D
Mean scores of EQ5D
Measured: Up to 3 months
Rates of Checklist Implementation Survey scores
Mean scores on checklist implementation survey
Measured: Up to 3 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Nov 2021
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped Wedge Cluster RCT is considered to align a cross-over design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8,559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest, Western Norway University of Applied Sciences, University of Bergen, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Hanne Klausen, MD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105713
- Sponsor's protocol ID
- REK Vest (2016/1102)
- Acronym
- PASC
- Status last verified
- Sep 2024
- First submitted
- 20 Mar 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36973815Harris 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.
PubMed 31948462Tangvik 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.
PubMed 38625912Austarheim AKS, Waehle HV, Harris K, Haugen AS. Exploring surgical patients' health literacy following the use of a patient safety checklist - A qualitative study. Patient Educ Couns. 2026 Oct;151:109756. doi: 10.1016/j.pec.2026.109756. Epub 2026 Jun 30.
PubMed 42391984Austarheim AKS, Harris K, Waehle HV, Storesund A, Tangvik RJ, Haugen AS. Effect of a patient-driven perioperative intervention on health literacy: A stepped-wedge cluster randomised sub-study. PLoS One. 2026 Jun 24;21(6):e0352245. doi: 10.1371/journal.pone.0352245. eCollection 2026.
PubMed 42340942Harris 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.
PubMed 41047253
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03105713
- Acronym / sponsor ID
- PASC / REK Vest (2016/1102)
- Conditions
- Surgery, Safety Issues, Complication, Patient Safety, Health Literacy, Health Economics
- Keywords
- Checklist, Patient Checklist, Surgery, Safety, Patient Involvement, Undernutrition, Implementation, Health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,559 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Vest, Western Norway University of Applied Sciences, University of Bergen, The Research Council of Norway
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster RCT is considered to align a cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Patient Safety Checklist Intervention | Experimental | Other: Patient Safety ChecklistThe 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 intervention | –Patients do not receive the safety checklist intervention. Care as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Must be cognitive able to use the checklist.
- Age under 18 years.
- Non-surgical procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Safety ChecklistThe 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. | Other | Patient Safety Checklist Intervention |
Primary outcome
Number of complications associated with the participants surgery
Time frame: Up to 30 days
Total numbers of complications
Number of complications within respiratory system
Time frame: Up to 30 days
Number of respiratory complications
Number of complications within cardio-thoracic system
Time frame: Up to 30 days
Number of cardio-thoracic complications
Number of infections
Time frame: Up to 30 days
Numbers of infections
Number of nervous system complications
Time frame: Up to 30 days
Number of nervous system complications
Volume of bleeding associated with operation
Time frame: Up to 30 days
Volume of bleedings in mL
Number of embolism associated with the hospital stay
Time frame: Up to 30 days
Number of embolies
Number of mechanical implant complications
Time frame: Up to 30 days
Number of mechanical implant complications
Number of re-operations
Time frame: Up to 30 days
Number of re-operations
Number of re-admissions
Time frame: Up to 30 days
Number of re-admissions
4 secondary outcomes
Number of deaths associated with surgery
Time frame: Up to 90 days
Rate of patient scores on Health Literacy Questionaire
Time frame: Up to 3 months post discharge
Rate of patient scores on EQ5D
Time frame: Up to 3 months
Rates of Checklist Implementation Survey scores
Time frame: Up to 3 months post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 36973815Harris 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.
- Results publication: PubMed 31948462Harris 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.
- Results publication: PubMed 38625912Tangvik 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.
- Derived from this study: PubMed 42391984Austarheim AKS, Waehle HV, Harris K, Haugen AS. Exploring surgical patients' health literacy following the use of a patient safety checklist - A qualitative study. Patient Educ Couns. 2026 Oct;151:109756. doi: 10.1016/j.pec.2026.109756. Epub 2026 Jun 30.
- Derived from this study: PubMed 42340942Austarheim AKS, Harris K, Waehle HV, Storesund A, Tangvik RJ, Haugen AS. Effect of a patient-driven perioperative intervention on health literacy: A stepped-wedge cluster randomised sub-study. PLoS One. 2026 Jun 24;21(6):e0352245. doi: 10.1371/journal.pone.0352245. eCollection 2026.
- Derived from this study: PubMed 41047253Harris 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.
- The Research Council of Norway's Project Bank description of the PASC projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Klausen, MD study director
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Safety Checklist in people with Surgery and Safety Issues, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complications associated with the participants surgery (time frame: Up to 30 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105713, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.