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
| Registry | NCT03105713, acronym PASC |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: triple, health services research |
| Enrollment | 8559 (Actual) |
| Sponsor | Haukeland University Hospital (Other); collaborators: Helse Vest, Western Norway University of Applied Sciences, University of Bergen, The Research Council of Norway |
| Conditions | Surgery, Safety Issues, Complication, Patient Safety, Health Literacy, Health Economics |
| Interventions | Patient Safety Checklist (Other) |
| Dates | start 2021-11-01, primary completion 2024-02-29, completion 2024-02-29, first posted 2017-04-10, last updated 2024-09-19 |
| Locations | 2 sites in 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patient Safety Checklist Intervention | Experimental | Other: Patient Safety Checklist | 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) |
| Controls | No intervention | Patients do not receive the safety checklist intervention. Care as usual. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Haukeland University Hospital | Bergen | Norway | |
| Førde Central Hospital | Førde | Norway |