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| Name | Class |
|---|---|
| Helse Vest | OTHER |
| Western Norway University of Applied Sciences | OTHER |
| University of Bergen | OTHER |
| The Research Council of Norway |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Controls | No Intervention | Patients do not receive the safety checklist intervention. Care as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Safety Checklist | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Elective surgery.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanne Klausen, MD | Haukeland University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | 5021 | Norway | |||
| Førde Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36973815 | Background | 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. | |
| 31948462 | Result |
| Label | URL |
|---|---|
| The Research Council of Norway's Project Bank description of the PASC project | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 2016/1102 | Study Protocol | View IPD |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2024 | Sep 1, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| OTHER |
Stepped Wedge Cluster RCT is considered to align a cross-over design.
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All participants are masked for the study outcomes. In intervention arm, the participants are not masked for the checklist intervention.
Care Providers are masked for patients receiving the intervention and for outcomes.
Outcome assessors are masked for patients receiving the intervention. Investigators are partially masked for the outcomes across clusters in the intervention phase
Number of re-operations |
| Up to 30 days |
| Number of re-admissions | Number of re-admissions | Up to 30 days |
| 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 |
| Førde |
| 6812 |
| Norway |
| 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. |
| 38625912 | Result | Tangvik 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. |
| 42391984 | Derived | Austarheim 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 Jun 30;151:109756. doi: 10.1016/j.pec.2026.109756. Online ahead of print. |
| 42340942 | Derived | Austarheim 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. |
| 41047253 | Derived | Harris 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. |
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 |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |