Clinical trial NCT03105713: Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Safety Issues
Complication
Patient Safety
Health Literacy
Health Economics
Keywords: Checklist
Patient Checklist
Surgery
Safety
Patient Involvement
Undernutrition
Implementation
Health literacy
Health economics
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Vest
name: Western Norway University of Applied Sciences
name: University of Bergen
name: The Research Council of Norway
First posted: 2017-04-10
Enrollment: 8559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped Wedge Cluster RCT is considered to align a cross-over design.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of complications associated with the participants surgery
timeFrame: Up to 30 days
measure: Number of complications within respiratory system
timeFrame: Up to 30 days
measure: Number of complications within cardio-thoracic system
timeFrame: Up to 30 days
measure: Number of infections
timeFrame: Up to 30 days
measure: Number of nervous system complications
timeFrame: Up to 30 days
measure: Volume of bleeding associated with operation
timeFrame: Up to 30 days
measure: Number of embolism associated with the hospital stay
timeFrame: Up to 30 days
measure: Number of mechanical implant complications
timeFrame: Up to 30 days
measure: Number of re-operations
timeFrame: Up to 30 days
measure: Number of re-admissions
timeFrame: Up to 30 days
Secondary outcomes:
measure: Number of deaths associated with surgery
timeFrame: Up to 90 days
measure: Rate of patient scores on Health Literacy Questionaire
timeFrame: Up to 3 months post discharge
measure: Rate of patient scores on EQ5D
timeFrame: Up to 3 months
measure: Rates of Checklist Implementation Survey scores
timeFrame: Up to 3 months post discharge
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Førde
country: Norway
facility: Førde Central Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Hanne Klausen, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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: 10.1186/s12913-020-4888-1.
citation: 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.