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NCT Number: NCT06439537

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.

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Key information

Conditions

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

Age range

50 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-structured questionnaire

Other

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

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

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Thematic analysis of narrative contents

    Time frame: Post-operative day 7 to post-operative day 28

    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

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Official study title

Improving Consent In Trauma: Recall (ICIT: Recall) A Multicentre Study of Consent For Hip Fractures

Acronym: ICIT: Recall

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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