None listed
Conditions
Brief summary
Although informed consent for surgical procedures is a well-established practice between the surgeon and patient, if often fails to meet its purpose. The procedure to obtain consent must ensure that the patient understands the nature of his or her condition, the risks and benefits of the proposed treatment, its alternatives and agrees to it voluntarily. In a busy surgical setting including outpatient clinics, emergency departments or private rooms, this process is often time limited. The process can be inadequate and inconsistent, resulting in poorer health outcomes for such patients . Furthermore, patients have varying degrees of cultural backgrounds and educational levels that also influence patient comprehension and understanding. It has been demonstrated that patient comprehension highly correlates with patient care and postoperative complication. The aim of this study is to conduct a randomised controlled trial to determine if video based education delivered through a portable video media (PVM) enabled device improves patient knowledge and satisfaction regarding the consent process for cystoscopy compared with conventional standard verbal consent (SVC). Primary Objective To determine if video based education delivered through a portable video media enabled device improves patient knowledge and satisfaction regarding the consent process for cystoscopy compared with conventional verbal consent. Secondary Objectives To improve the patient education and consent process and provide new ways to communicate risks and benefits of procedures At the start of the trial, participants undergoing an emergency cystoscopy will be randomised in a simple 1:1 randomisation scheme to two study groups Group A: portable video media consent group Group B: standard verbal consent group Randomisation will be performed on appropriate randomisation software. The randomised group allocation sequence will be kept sealed in envelopes until each participant is ready to be randomised. In the video group, surgeons obtained informed consent using an education video. Participants will view this video on a portable video device (iPad). A cross-over will then be performed. At the conclusion of both the SVC and PVM patients will be given the opportunity to ask questions. Main outcome measures are differences in knowledge acquisition and degree of patient satisfaction comparing SVC to PVM consent.
Interventions
This randomised control trial will allocate patients on a 1:1 basis to either video consent or standard verbal consent. Patients will be recruited as those patients presenting in the acute setting through the Emergency Department, requiring a cystoscopy and insertion of ureteric stent, in a public hospital setting.
A crossover will then be performed at 30min.
The video consent will comprise of short video (6.5min) including preoperative information,
1. Indications for cystoscopy and ureteric
This randomised control trial will allocate patients on a 1:1 basis to either video consent or standard verbal consent. Patients will be recruited as those patients presenting in the acute setting through the Emergency Department, requiring a cystoscopy and insertion of ureteric stent, in a public hospital setting. A crossover will then be performed at 30min. The video consent will comprise of short video (6.5min) including preoperative information, 1. Indications for cystoscopy and ureteric stent insertion 2. How the cystoscopy is performed 3. Risks and benefits 4. Post procedure care and follow up The period of recruitment will be 3 months.
Sponsors
Dr Matthew Winter
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Age >18 years Able to read and speak in English (not necessarily as first language) Able to give consent Identified by Urology Registrar as requiring cystoscopy
Exclusion criteria
Age < 18 years Unable to read or speak in English. Unable to give consent
Outcome results
None listed