ICIT: Recall A Multicentre Study of Consent For Hip Fractures

NCT06439537 | Completed

• 1 other identifier: AC23137
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Fractures; Hip Injuries

Keywords

hip fracture; consent; incapacity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Thematic analysis of narrative contents

  Post-operative day 7 to post-operative day 28

Study Arms (1)

Single-group for all hip fracture patients

Single-group cohort for all hip fracture patients who are candidates for an operation

Other: Semi-structured questionnaire; Other: Post-operative interview

Interventions

Semi-structured questionnaire OTHER

All patients recruited to the study will undergo a semi-structured questionnaire within 36 hours of admission

Single-group for all hip fracture patients

Post-operative interview OTHER

All patients recruited to the study will undergo a semi-structured interview once they have reached post-operative day 7 or over

Single-group for all hip fracture patients

Eligibility Criteria

• Age: 50 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (2)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

NHS Lothian

Edinburgh, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 28648408 BACKGROUND

• 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.

  PMID: 35407459 BACKGROUND

• 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.

  PMID: 35028219 BACKGROUND

• 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.

  PMID: 16696749 BACKGROUND

• 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.

  PMID: 29727232 BACKGROUND

• 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.

  PMID: 17316526 BACKGROUND

• 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.

  PMID: 18974409 BACKGROUND

• 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.

  PMID: 33033090 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Hip Injuries

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Nicholas Clement, MBBS, MD, PhD, FRCS (T&O)

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 3, 2024
• Study Start: December 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)