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

February 4, 2025 updated by: NHS Lothian

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom
        • Nhs Lothian
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
All patients recruited to the study will undergo a semi-structured questionnaire within 36 hours of admission
Other: Post-operative interview
All patients recruited to the study will undergo a semi-structured interview once they have reached post-operative day 7 or over

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 36 hours of admission
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).
Within 36 hours of admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-operative day 7 to post-operative day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Lothian

Investigators

  • Principal Investigator: Nicholas Clement, MBBS, MD, PhD, FRCS (T&O), Nhs Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC23137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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