Hip FracturesICIT: RecallNCT06439537
ICIT: Recall A Multicentre Study of Consent For Hip Fractures
An observational study of Hip Fractures and Hip Injuries, run by NHS Lothian at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 110 years
- Conditions the study is for
- Hip Fractures, Hip Injuries
- What is being tested?
- Semi-structured questionnaire and Post-operative interview
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Dec 2023to 31 Dec 2024
- 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 50 to 110 years
- All sexes
- Adult, Older adult
Study population: Participants listed for hip fracture surgery, after sustaining a hip fracture surgery under the care of participating surgeons at the Royal Infirmary of Edinburgh. Approximately 100 participants will be included in this prospective cohort study recruited through consecutive sampling.
Who may be able to join
- Inpatient on trauma and orthopaedic wards
- Is candidate for a hip fracture operation
- Able to provide informed consent
- Able to participate in a conversation (without the use of a translator)
Who cannot join
- Deemed to be too unwell or medically unstable to participate
- Under Adult With Incapacity Act or other detaining orders
- Patients scoring a 4AT score of 4 or more
- Unable to provide consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
NHS Lothian
Edinburgh
About this study
Official title: Improving Consent In Trauma: Recall (ICIT: Recall) A Multicentre Study of Consent For Hip Fractures
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.
Read the 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 patient's 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 patient's 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.
- Conditions
- Hip Fractures, Hip Injuries
- Being tested
- Semi-structured questionnaire, Post-operative interview
- Keywords
- hip fracture, consent, incapacity
- Medical subject headings
- Hip Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured questionnaireOther
All patients recruited to the study will undergo a semi-structured questionnaire within 36 hours of admission
Post-operative interviewOther
All patients recruited to the study will undergo a semi-structured interview once they have reached post-operative day 7 or over
| Study group | Role | What they receive |
|---|---|---|
| Single-group for all hip fracture patients | Single-group cohort for all hip fracture patients who are candidates for an operation Receives: Other: Semi-structured questionnaire; Other: Post-operative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incapacity
Proportion of individuals admitted with hip fractures that do not have capacity to consent. The measurement tool will be the 4AT.
Measured: Within 36 hours of admission
Retention of complications
Proportion of complications discussed initially in consenting individuals that were still retained by the time of interview (within 36 hours of admission).
Measured: Within 36 hours of admission
Secondary outcomes (1)
Thematic analysis of narrative contents
The personal experience of giving consent for hip fracture operations through semi-structured questionnaires. The measurement tool is a thematic analysis using a qualitative coding framework, whereas the unit of measure is the frequency and prevalence of themes
Measured: Post-operative day 7 to post-operative day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 Dec 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nicholas Clement, MBBS, MD, PhD, FRCS (T&O), Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439537
- Sponsor's protocol ID
- AC23137
- Acronym
- ICIT: Recall
- Status last verified
- Feb 2025
- First submitted
- 6 May 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ring J, Talbot C, Cross C, Hinduja K. NHSLA litigation in hip fractures: Lessons learnt from NHSLA data. Injury. 2017 Aug;48(8):1853-1857. doi: 10.1016/j.injury.2017.06.009. Epub 2017 Jun 19.
PubMed 28648408Herrera-Perez M, Gonzalez-Martin D, Sanz EJ, Pais-Brito JL. Ethical Dilemmas with Regard to Elderly Patients with Hip Fracture: The Problem of Nonagenarians and Centenarians. J Clin Med. 2022 Mar 27;11(7):1851. doi: 10.3390/jcm11071851.
PubMed 35407459Zalmay P, Collis J, Wilson H. Patients Lacking the Capacity to Consent to Hip Fracture Surgery May Be Undergoing Major Operations Without Their Next of Kin Being Involved in Best-Interests Decisions: A Quality Improvement Report. Cureus. 2021 Dec 10;13(12):e20322. doi: 10.7759/cureus.20322. eCollection 2021 Dec.
PubMed 35028219Kalisvaart KJ, Vreeswijk R, de Jonghe JF, van der Ploeg T, van Gool WA, Eikelenboom P. Risk factors and prediction of postoperative delirium in elderly hip-surgery patients: implementation and validation of a medical risk factor model. J Am Geriatr Soc. 2006 May;54(5):817-22. doi: 10.1111/j.1532-5415.2006.00704.x.
PubMed 16696749Thiruchandran G, McKean AR, Rudran B, Imam MA, Yeong K, Hassan A. Improving consent in patients undergoing surgery for fractured neck of femur. Br J Hosp Med (Lond). 2018 May 2;79(5):284-287. doi: 10.12968/hmed.2018.79.5.284.
PubMed 29727232Probert N, Malik AA, Lovell ME. Surgery for fractured neck of femur - are patients adequately consented? Ann R Coll Surg Engl. 2007 Jan;89(1):66-9. doi: 10.1308/003588407X160846.
PubMed 17316526Bhangu A, Hood E, Datta A, Mangaleshkar S. Is informed consent effective in trauma patients? J Med Ethics. 2008 Nov;34(11):780-2. doi: 10.1136/jme.2008.024471.
PubMed 18974409Howard A, Webster J, Quinton N, Giannoudis PV. 'Hobson's choice': a qualitative study of consent in acute surgery. BMJ Open. 2020 Oct 8;10(10):e037657. doi: 10.1136/bmjopen-2020-037657.
PubMed 33033090
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Consent In Trauma: Recall (ICIT: Recall) A Multicentre Study of Consent For Hip Fractures
- ClinicalTrials.gov ID
- NCT06439537
- Acronym / sponsor ID
- ICIT: Recall / AC23137
- Conditions
- Hip Fractures, Hip Injuries
- Keywords
- hip fracture, consent, incapacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Jun 2024 (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.
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.
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 patient's 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 patient's 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-group for all hip fracture patients | – | Other: Semi-structured questionnaire, Other: Post-operative interviewSingle-group cohort for all hip fracture patients who are candidates for an operation |
Who may qualify
- Ages
- 50 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants listed for hip fracture surgery, after sustaining a hip fracture surgery under the care of participating surgeons at the Royal Infirmary of Edinburgh. Approximately 100 participants will be included in this prospective cohort study recruited through consecutive sampling.
Key inclusion criteria (4 listed)
- Inpatient on trauma and orthopaedic wards
- Is candidate for a hip fracture operation
- Able to provide informed consent
- Able to participate in a conversation (without the use of a translator)
Key exclusion criteria (4 listed)
- Deemed to be too unwell or medically unstable to participate
- Under Adult With Incapacity Act or other detaining orders
- Patients scoring a 4AT score of 4 or more
- Unable to provide consent
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 |
|---|---|---|
| Semi-structured questionnaireAll patients recruited to the study will undergo a semi-structured questionnaire within 36 hours of admission | Other | Single-group for all hip fracture patients |
| Post-operative interviewAll patients recruited to the study will undergo a semi-structured interview once they have reached post-operative day 7 or over | Other | Single-group for all hip fracture patients |
Primary outcome
Incapacity
Time frame: Within 36 hours of admission
Proportion of individuals admitted with hip fractures that do not have capacity to consent. The measurement tool will be the 4AT.
Retention of complications
Time frame: Within 36 hours of admission
Proportion of complications discussed initially in consenting individuals that were still retained by the time of interview (within 36 hours of admission).
1 secondary outcome
Thematic analysis of narrative contents
Time frame: Post-operative day 7 to post-operative day 28
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 5 Feb 2025.
- Background: PubMed 28648408Ring J, Talbot C, Cross C, Hinduja K. NHSLA litigation in hip fractures: Lessons learnt from NHSLA data. Injury. 2017 Aug;48(8):1853-1857. doi: 10.1016/j.injury.2017.06.009. Epub 2017 Jun 19.
- Background: PubMed 35407459Herrera-Perez M, Gonzalez-Martin D, Sanz EJ, Pais-Brito JL. Ethical Dilemmas with Regard to Elderly Patients with Hip Fracture: The Problem of Nonagenarians and Centenarians. J Clin Med. 2022 Mar 27;11(7):1851. doi: 10.3390/jcm11071851.
- Background: PubMed 35028219Zalmay P, Collis J, Wilson H. Patients Lacking the Capacity to Consent to Hip Fracture Surgery May Be Undergoing Major Operations Without Their Next of Kin Being Involved in Best-Interests Decisions: A Quality Improvement Report. Cureus. 2021 Dec 10;13(12):e20322. doi: 10.7759/cureus.20322. eCollection 2021 Dec.
- Background: PubMed 16696749Kalisvaart KJ, Vreeswijk R, de Jonghe JF, van der Ploeg T, van Gool WA, Eikelenboom P. Risk factors and prediction of postoperative delirium in elderly hip-surgery patients: implementation and validation of a medical risk factor model. J Am Geriatr Soc. 2006 May;54(5):817-22. doi: 10.1111/j.1532-5415.2006.00704.x.
- Background: PubMed 29727232Thiruchandran G, McKean AR, Rudran B, Imam MA, Yeong K, Hassan A. Improving consent in patients undergoing surgery for fractured neck of femur. Br J Hosp Med (Lond). 2018 May 2;79(5):284-287. doi: 10.12968/hmed.2018.79.5.284.
- Background: PubMed 17316526Probert N, Malik AA, Lovell ME. Surgery for fractured neck of femur - are patients adequately consented? Ann R Coll Surg Engl. 2007 Jan;89(1):66-9. doi: 10.1308/003588407X160846.
- Background: PubMed 18974409Bhangu A, Hood E, Datta A, Mangaleshkar S. Is informed consent effective in trauma patients? J Med Ethics. 2008 Nov;34(11):780-2. doi: 10.1136/jme.2008.024471.
- Background: PubMed 33033090Howard A, Webster J, Quinton N, Giannoudis PV. 'Hobson's choice': a qualitative study of consent in acute surgery. BMJ Open. 2020 Oct 8;10(10):e037657. doi: 10.1136/bmjopen-2020-037657.
- Individual participant dataSharing planned: No
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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.
Nicholas Clement, MBBS, MD, PhD, FRCS (T&O) principal investigator
NHS Lothian
2 sites 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 Hip Injuries, run by NHS Lothian at 2 sites 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 4 inclusion and 4 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incapacity (time frame: Within 36 hours of admission). The study lists 2 primary outcomes in all. 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 NCT06439537, which also lists 8 linked publications.
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 5 Feb 2025.