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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Complication, Surgery, Safety Issues, Patient Safety, Health Literacy, Health Economics

Intervention / Treatment
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* Other: Patient Safety Checklist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped Wedge Cluster RCT is considered to align a cross-over design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Safety Checklist Intervention<br>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<br>* 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.<br>|
| No Intervention: Controls<br>Patients do not receive the safety checklist intervention. Care as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Number of re-operations | Up to 30 days | 
| Number of re-admissions | Number of re-admissions | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Checklist, Patient Checklist, Surgery, Safety, Patient Involvement, Undernutrition, Implementation, Health literacy, Health economics