A randomised controlled trial comparing video-assisted informed medical consent to traditional doctor patient consent for Mohs micrographic surgery.

A comparison of video assisted medical consent compared to traditional doctor-patient consent for medical procedures.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000647134

Acronym

N/A

Enrollment

102

Registered

2019-05-01

Start date

2019-03-11

Completion date

2019-11-04

Last updated

2023-07-18

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

Conditions

None listed

Brief summary

The purpose of the study is to compare a new way of undertaking informed medical consent, that being with the aid of a video, to the regular way a doctor would tell you about the procedure (which is usually a conversation between the doctor and yourself). Who is it for? You may be eligible for this study if you are aged 18 or over and are attending Royal North Shore Hospital or The Skin Hospital (Darlinghurst) for Mohs micrographic surgery. Study details Participants will be randomised by chance into two groups. One group will first watch a 6 minute video about the procedure before talking with their doctor to address any questions. The other group will only talk with their doctor (usual practice). As part of this study, all participants will complete a number of questionnaires before and after the consent process. It is hoped this research will show improved patient comprehension of the risks and benefits of the procedure, enhance patient satisfaction with the consent process, lower anxiety levels and save time.

Interventions

Participants will watch a 6 minute video describing Mohs micrographic surgery, including the method, risks, benefits, alternatives and aftercare. Following this, they will then see their doctor to address any personal questions or concerns, however, the procedure will not be explained to them again. Adherence will be ensured through direct observation of the participants by the study personnel.

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

Inclusion criteria

Patients attending the Mohs micrographic surgery clinic at Royal North Shore Hospital or The Skin Hospital who will be consented for Mohs micrographic surgery.

Exclusion criteria

Those who are not able to provide informed medical consent for themselves. Also those who have a visual or hearing impairment.

Outcome results