CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Semi-structured questionnaire +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06439537
NCT06439537N/ACompleted

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

NHS Lothian·observational·Posted Jun 3, 2024·Updated Feb 5, 2025

In Brief

An observational study evaluating Semi-structured questionnaire and Post-operative interview for Hip Fractures and Hip Injuries. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJun 3, 2024
Enrollment StartDec 15, 2023
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 2.1 years ago

Interventions

Semi-structured questionnaireother

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

Post-operative interviewother

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