A randomised trial of detailed written consent compared to standard verbal consent in adults with routine orthopaedic trauma

Not Applicable

Completed

• Conditions: Orthopaedic trauma; Surgery - Other surgery; Public Health - Health promotion/education

• Registration Number: ACTRN12621000852853
• Lead Sponsor: A/Prof Sam Adie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-01
• Study Completion: 2021-10-03
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

The inclusion criteria for this study is: (i) 18 years of age or above; (ii) patients with confirmed distal radius, ankle, femoral shaft, tibial shaft (lower limb long bone fracture), distal femur or proximal tibia fractures; (iii) able to speak and read the English language; (iv) capacity to make health care decisions independently; and (v) willing to participate in the trial.

Exclusion Criteria

Patients will be deemed ineligible if they are: (i) medically diagnosed with cognitive impairment, including dementia; (ii) have limited literacy; (iii) poor or no understanding of the trial; (iv) in a critical medical condition; (v) require very urgent surgery (prioritised within 8 hours of presentation) vi) return to theatre for a surgical site infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified