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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8559 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-02-29

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.

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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.

Conditions

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Surgery Safety Issues Complication Patient Safety Health Literacy Health Economics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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

Study Groups

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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)

Group Type EXPERIMENTAL

Patient Safety Checklist

Intervention Type 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.

Controls

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hanne Klausen, MD

Role: STUDY_DIRECTOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Førde Central Hospital

Førde, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND

PMID: 36973815 (View on PubMed)

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.

Reference Type RESULT

PMID: 31948462 (View on PubMed)

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.

Reference Type RESULT

PMID: 38625912 (View on PubMed)

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.

Reference Type DERIVED

PMID: 41047253 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Study Documents

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Document Type: Study Protocol

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 [email protected]

View Document