The Impact of Patient Safety Incidents on Patients' Quality of Life

Completed

• Conditions: Hip Fractures; Knee Fracture
• Interventions: Procedure: Surgery for hip and knee replacement

• Registration Number: NCT05464771
• Lead Sponsor: Imperial College London

Brief Summary

This study estimates the impact of patient safety events on QoL in elective surgery patients using a secondary data set

Detailed Description

Background: The burden of patient safety incidents (PSIs) is often characterised by their impact on mortality, morbidity and treatment costs. Few studies have attempted to estimate the impact of PSIs on patients' health-related quality of life (HRQoL) and the studies that have made such estimates primarily focus on a narrow set of incidents. The aim of this paper is to estimate the impact of PSIs on HRQoL of patients undergoing elective surgery in England.

Materials and Methods: A unique linked longitudinal data set consisting of Patient Reported Outcome Measures (PROMS) for patients with hip and knee replacements linked to Hospital Episode Statistics (HES) collected between 2013/14 and 2016/17 is examined. Patients with any of nine US Agency for Healthcare Research and Quality (AHRQ) PSI indicators are identified. HRQoL is measured using the general EuroQol five dimensions questionnaire (EQ-5D) before and after surgery. Exploiting the longitudinal structure of the data, exact matching combined with difference in differences to estimate the impact of experiencing a PSI on HRQoL and its individual dimensions, comparing HRQoL improvements after surgery in similar patients with and without a PSI.

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395346

Inclusion Criteria

• no

Exclusion Criteria

• Patients for which health related quality of life is not observed both before and after surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients experiencing adverse event while in hospital	Surgery for hip and knee replacement	Patients that have experienced a patient safety incident according to the Patient Safety Indicators (PSIs) developed by the U.S. Agency for Healthcare Research and Quality (AHRQ)

Primary Outcome Measures

Name	Time	Method
EuroQual - 5 Dimensions (EQ5D)	2013-17	quality of life

Trial Locations

Locations (1)

Acute Trusts in England; 🇬🇧 Multiple Locations, United Kingdom