Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439537
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-06
Brief Title:
ICIT Recall A Multicentre Study of Consent For Hip Fractures
Sponsor:
NHS Lothian
Organization:
NHS Lothian
Study Overview
Official Title:
Improving Consent In Trauma Recall ICIT Recall A Multicentre Study of Consent For Hip Fractures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICIT Recall
Brief Summary:
Hip fractures are a major cause litigation in patients undergoing trauma surgery Common causes of litigation in hip operations are alleged incompetent surgery and development of pressure sources both of which are associated with poor quality of consent One aspect of poor consent is patients not being able to retain information discussed with them prior to their operation There are many factors attributed to this including pain in the acute setting administration of sedating medications and the high rate of delirium in this patient cohort However even in individuals deemed to have capacity during the consent process studies have shown that many were unable to explain what type of surgery they had or express knowledge of the potential complications Importantly the hip fracture patient demographic is very different from patients undergoing a planned procedure in that they have had an acute injury following physical trauma tend to be older and medically frailer Research into the recall of patients undergoing gynaecological or abdominal surgeries further corroborate patients poor recall of potential complications in the acute setting
Patients with hip fractures face a range of risks some of which can result in a substantial mortality rate regardless of whether surgery is performed The list of complications includes infections in the hip joint and wound development of pressure sores occurrence of pulmonary embolism PE and deep vein thrombosis DVT myocardial infarction urinary tract infection pneumonia and potential procedural failures As such the ability of patients to remember the discussed complications is critical to their well-being and overall quality of life and remains an unmet clinical need
Patients with hip fractures face a range of risks some of which can result in a substantial mortality rate regardless of whether surgery is performed The list of complications includes infections in the hip joint and wound development of pressure sores occurrence of pulmonary embolism PE and deep vein thrombosis DVT myocardial infarction urinary tract infection pneumonia and potential procedural failures As such the ability of patients to remember the discussed complications is critical to their well-being and overall quality of life and remains an unmet clinical need
Detailed Description:
Improving Consent In Trauma Recall ICIT Recall will be a multicentre quality improvement project within the NHS clinical care setting The aim of this study is to assess hip fracture patients ability retain information regarding their injury proposed operation potential complications and alternatives following obtaining formal written consent To that end the project is intended to be a multicentre study with interviews across a range of different health boards The investigators also wish to listen to individual patients experience of the surgical consent process through a follow-up interview once it has been over one week since their operation Part 1 the structured face-to-face questionnaire was established to identify the extent of the problem and what patients find memorable or overlooked about the consent process Part 2 the interview was designed to obtain qualitative data on what patients find important and to allow the participants to tell their story The overarching objective of this project is to empower patients so that they are more involved and have a greater understanding of the operation that they have consented to This includes simple measures such as providing a patient information leaflet or improving communication with the patient or close family members during their consent process Sometimes poor retention of information is unavoidable due to the significant pain and stress patients are under and for this reason our aim is to improve the quality of consent for major procedures like hip operations
As part of the project the investigators also wish to engage with and capture patient-cantered experiences through a further interview The investigators aim to like to capture their experience of the consent process entirely from the patients perspective Patient stories are a powerful tool to promote culture change in patient care Unlike surveys patient stories allow a seamless flow of thoughts and feelings that can provide insight into their journey to recovery Here the aim is to highlight the importance of good communication and an overall clear consent process in promoting wellbeing This aspect of care tends to be overlooked Addressing this issue is particularly important in delivering compassionate care within the NHS
As part of the project the investigators also wish to engage with and capture patient-cantered experiences through a further interview The investigators aim to like to capture their experience of the consent process entirely from the patients perspective Patient stories are a powerful tool to promote culture change in patient care Unlike surveys patient stories allow a seamless flow of thoughts and feelings that can provide insight into their journey to recovery Here the aim is to highlight the importance of good communication and an overall clear consent process in promoting wellbeing This aspect of care tends to be overlooked Addressing this issue is particularly important in delivering compassionate care within the NHS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None