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

Sponsor

Haukeland University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03105713

Collaborator

Helse Vest (Other), Western Norway University of Applied Sciences (Other), University of Bergen (Other), The Research Council of Norway (Other)

5,320

Enrollment

Locations

Arms

Anticipated Duration (Months)

2660

Patients Per Site

57.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Safety Issues Complication Patient Safety Health Literacy Health Economics	Other: Patient Safety Checklist	N/A

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 (PG-SGA-SH 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

Study Type:

Interventional

Anticipated Enrollment :

5320 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Stepped Wedge Cluster RCT is considered to align a cross-over design.Stepped Wedge Cluster RCT is considered to align a cross-over design.

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

Care Providers are masked for patients receiving the intervention and for outcomes. Outcome sssessors are masked for patients receiving the intervention.

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient Safety Checklist Intervention 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 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.
No Intervention: Controls Patients do not receive the safety checklist intervention. Care as usual.

Arm

Intervention/Treatment

Experimental: Patient Safety Checklist Intervention

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

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.

No Intervention: Controls

Patients do not receive the safety checklist intervention. Care as usual.

Outcome Measures

Primary Outcome Measures

Number of complications associated with the participants surgery [Up to 30 days]
Total numbers of complications
Number of complications within respiratory system [Up to 30 days]
Number of respiratory complications
Number of complications within cardio-thoracic system [Up to 30 days]
Number of cardio-thoracic complications
Number of infections [Up to 30 days]
Numbers of infections
Number of nervous system complications [Up to 30 days]
Number of nervous system complications
Volume of bleeding associated with operation [Up to 30 days]
Volume of bleedings in mL
Number of embolism associated with the hospital stay [Up to 30 days]
Number of embolies
Number of mechanical implant complications [Up to 30 days]
Number of mechanical implant complications
Number of re-operations [Up to 30 days]
Number of re-operations
Number of re-admissions [Up to 30 days]
Number of re-admissions

Secondary Outcome Measures

Number of deaths associated with surgery [Up to 90 days]
Total numbers of deaths
Rate of patient scores on Health Literacy Questionaire [Up to 3 months post discharge]
Mean scores of HLQ and EQ5D surveys
Rate of patient scores on EQ5D [Up to 3 months]
Mean scores of EQ5D
Rates of Checklist Implementation Survey scores [Up to 3 months post discharge]
Mean scores on checklist implementation survey