MedTrace Logo

ICIT: Recall A Multicentre Study of Consent For Hip Fractures

NCT06439537 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-02-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • NHS Lothian

    lead OTHER_GOV

Principal Investigators

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

Eligibility

Min Age
50 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439537 on ClinicalTrials.gov