Hip FracturesNCT05464771
The Impact of Patient Safety Incidents on Patients' Quality of Life
An observational study of Hip Fractures and Knee Fracture, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study estimates the impact of patient safety events on QoL in elective surgery patients using a secondary data set Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures, Knee Fracture
- What is being tested?
- Surgery for hip and knee replacement
- Type of treatment
- Surgery or procedure
- How many people
- 395,346 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2018to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The data available for our study was collected between 2013 and 2017. The patient safety incidents studied are relatively rare, and in order to yield enough observations to reliably estimate the impact of different incidents, the sample is limited to patients undergoing hip or knee replacements because these have more observations than do varicose veins and groin hernia. There are 267,477 and 288,967 observations for patients undergoing hip replacement and knee replacement respectively. Furthermore, the sample is limited to patients with observations of health status both before and after surgery.
Who may be able to join
- no
Who cannot join
- Patients for which health related quality of life is not observed both before and after surgery.
Trial locations and contacts
1 site in 1 country.
About this study
This study estimates the impact of patient safety events on QoL in elective surgery patients using a secondary data set
Read the 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.
- Conditions
- Hip Fractures, Knee Fracture
- Being tested
- Surgery for hip and knee replacement
- Medical subject headings
- Hip Fractures, Knee Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for hip and knee replacementProcedure or surgery
Elective inpatient surgery for hip and knee replacement
| Study group | Role | What they receive |
|---|---|---|
| Patients experiencing adverse event while in hospital | 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) Receives: Procedure: Surgery for hip and knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQual - 5 Dimensions (EQ5D)
quality of life
Measured: 2013-17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Dec 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 395,346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464771
- Sponsor's protocol ID
- 123
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xiao M, Kristensen SR, Marti J, Mossialos E. The impact of patient safety incidents during hip and knee replacements on patients' health related quality of life: a before and after study using longitudinal data linked to patient-reported outcome measures. Int J Surg. 2023 May 1;109(5):1085-1093. doi: 10.1097/JS9.0000000000000275.
PubMed 37026831
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Patient Safety Incidents on Patients' Quality of Life
- ClinicalTrials.gov ID
- NCT05464771
- Acronym / sponsor ID
- 123
- Conditions
- Hip Fractures, Knee Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395,346 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients experiencing adverse event while in hospital | – | Procedure: Surgery for hip and knee replacementPatients 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) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The data available for our study was collected between 2013 and 2017. The patient safety incidents studied are relatively rare, and in order to yield enough observations to reliably estimate the impact of different incidents, the sample is limited to patients undergoing hip or knee replacements because these have more observations than do varicose veins and groin hernia. There are 267,477 and 288,967 observations for patients undergoing hip replacement and knee replacement respectively. Furthermore, the sample is limited to patients with observations of health status both before and after surgery.
Key inclusion criteria (1 listed)
- no
Key exclusion criteria (1 listed)
- Patients for which health related quality of life is not observed both before and after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for hip and knee replacementElective inpatient surgery for hip and knee replacement | Procedure or surgery | Patients experiencing adverse event while in hospital |
Primary outcome
EuroQual - 5 Dimensions (EQ5D)
Time frame: 2013-17
quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 37026831Xiao M, Kristensen SR, Marti J, Mossialos E. The impact of patient safety incidents during hip and knee replacements on patients' health related quality of life: a before and after study using longitudinal data linked to patient-reported outcome measures. Int J Surg. 2023 May 1;109(5):1085-1093. doi: 10.1097/JS9.0000000000000275.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Knee Fracture, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQual - 5 Dimensions (EQ5D) (time frame: 2013-17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.