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Improving the Informed Consent Process for Elective Surgery using an Informed Consent Curriculum

Among patients about to have elective surgery, can standardised operation-specific instructional tools improve knowledge more than current informed consent practices

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001190897
Enrollment
200
Registered
2012-11-13
Start date
2005-02-02
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Currently all patients about to undergo elective surgery in common law countries are required to give their informed consent to proceed. However, the literature suggests that many participants are not well informed when they give their consent. The aim of this study is to assess baseline knoweldge of elective procedures. The secondary aim is to see if baseline knowledge can then be improved through the use of an operation-specific instructional tool

Interventions

Validated Standardised Operation-Specific Instructional Tool Both tools (Total Hip Replacement and Operative Laparoscopy) are multimedia based, linear in format, and require about 15 minutes to view on a computer. They require simple user interaction (mouse click) to progress through, and allow users to review previously received information, but not to skip forward. Participants only view the tool relevant to their surgery once during the trial. The timing of the use of these tools was not regu

Validated Standardised Operation-Specific Instructional Tool Both tools (Total Hip Replacement and Operative Laparoscopy) are multimedia based, linear in format, and require about 15 minutes to view on a computer. They require simple user interaction (mouse click) to progress through, and allow users to review previously received information, but not to skip forward. Participants only view the tool relevant to their surgery once during the trial. The timing of the use of these tools was not regulated during the trial. Participants were recruited in surgeons rooms, outpatient clinics, and pre-admission clinics, and the information was delivered when participants were available.

Sponsors

Dr Damian Claydon-Platt
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Awaiting total hip replacement surgery or an operative laparoscopy for investigation of pelvic pain

Exclusion criteria

Non-English Speaking

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026