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NCT05464771 Clinical Trial

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

Hip Fractures Clinical Trial

Official title:
The Impact of Patient Safety Incidents on Patients' Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05464771
Other study ID # 123
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date December 1, 2021

Study information
Verified date July 2022
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 395346
Est. completion date December 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - no Exclusion Criteria: - Patients for which health related quality of life is not observed both before and after surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgery for hip and knee replacement
Elective inpatient surgery for hip and knee replacement

Locations
Country Name City State
United Kingdom Acute Trusts in England Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary EuroQual - 5 Dimensions (EQ5D) quality of life 2013-17
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