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Comparing information for consent for cardiology procedures given by a video, or by a doctor, to see if this improves patient understanding of a procedure.

A randomised controlled trial comparing video-assisted medical consent with traditional doctor-patient informed consent for procedures in cardiology to assess patient knowledge and satisfaction

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001969257
Enrollment
152
Registered
2018-12-05
Start date
2020-03-02
Completion date
2020-11-16
Last updated
2019-12-10

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

Conditions

None listed

Brief summary

Informed medical consent is often poorly done; it can be time consuming, there is no clear standard between different medical practitioners, and overwhelmingly, the literature provides support for standardised animations or video consent. Video animations have been shown to improve patient comprehension, take the same amount of time, or can even save time and in most cases there is an improvement in patient satisfaction and comprehension. Videos have been successfully used to consent for colonoscopy, knee arthroscopy, laparoscopic urological procedures, cataract surgery, intravenous fluorescent angiography, vascular procedures, coronary angiography, cardiac electrophysiology, urogynaecological surgery as well as for clinical trials. There are no studies evaluating video informed consent for cardiology procedures in Australia. Given the literature shows improvements in patient understanding and satisfaction, it is anticipated that the video informed consent will lead to enhanced clinical practice, including enhanced knowledge retention by patients, improved patient and physician satisfaction, improved recall of the procedure, as well as saving minutes per consultation. We aim to compare traditional doctor-patient informed consent to a video animation when consenting for cardiology procedures such as a coronary angiogram. We propose that the video consent will be superior to traditional doctor patient consent – patients will have better retention of information, comprehension and understanding and higher satisfaction.

Interventions

Patients will receive video-assisted consent or usual care when informed consent is undertaken for cardiology procedures. Arm 1 (video-assisted consent) Arm 2 (usual care) The intervention is one short video animation (approximately 5 minutes) that discusses the risks, benefits and alternatives of the cardiology procedure, and will be watched on a computer or tablet computer in the doctor's clinic or hospital. The animations are narrated by a voiceover artist from a script constructed by cardio

Patients will receive video-assisted consent or usual care when informed consent is undertaken for cardiology procedures. Arm 1 (video-assisted consent) Arm 2 (usual care) The intervention is one short video animation (approximately 5 minutes) that discusses the risks, benefits and alternatives of the cardiology procedure, and will be watched on a computer or tablet computer in the doctor's clinic or hospital. The animations are narrated by a voiceover artist from a script constructed by cardiology specialists. These videos have been designed specifically for the study. The animation will be watched by the patient and a research assistant will supervise to ensure that the video is watched in its entirety by the patient. All participants will be offered the opportunity to ask questions after the video has been watched or after the doctor has undertaken informed consent. Only one video is watched by the participant, and only one video is available for the procedure.

Sponsors

Consentic
Lead SponsorCommercial sector/Industry

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

Patients aged greater than 18 years of age, who are undergoing a cardiology procedure, and who are able to provide informed medical consent will be invited to participate in the study.

Exclusion criteria

Patients with visual impairment, hearing impairment, or who come from a non-English speaking background without a command of English, or do not have the capacity to consent will be excluded from participation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026