Hip Fractures Clinical Trial
— ICIT: RecallOfficial title:
Improving Consent In Trauma: Recall (ICIT: Recall) A Multicentre Study of Consent For Hip Fractures
NCT number | NCT06439537 |
Other study ID # | AC23137 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2024 |
Est. completion date | September 2024 |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 50 Years to 110 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Scotland |
Lead Sponsor | Collaborator |
---|---|
NHS Lothian |
United Kingdom,
Bhangu 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. — View Citation
Herrera-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. — View Citation
Howard 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. — View Citation
Kalisvaart 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. — View Citation
Probert 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. — View Citation
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. — View Citation
Thiruchandran 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. — View Citation
Zalmay 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incapacity | Proportion of individuals admitted with hip fractures that do not have capacity to consent. The measurement tool will be the 4AT. | Within 36 hours of admission | |
Primary | 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). | Within 36 hours of admission | |
Secondary | 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 | Post-operative day 7 to post-operative day 28 |
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