Consent in Anaesthesia

Study Overview
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Brief Summary
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DESIGN: Prospective randomised-controlled trial AIM: To determine whether presenting both techniques of general anaesthesia and regional anaesthesia in an unbiased manner, with video media, aids the anaesthetic consent process, compared to standard verbal consent alone. OUTCOME MEASURES Primary outcome: - Participants' satisfaction regarding the anaesthetic consent process Secondary outcomes: Knowledge, attitudes and practices towards anaesthesia Participants' choice of anaesthetic technique POPULATION: General adult population (>18yrs), males and females DURATION: 2 years

Detailed Description
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The main aim of this study is to determine if presenting both anaesthetic techniques of general anaesthesia (GA) and regional anaesthesia (RA) to a participant in an unbiased manner, with video media, affects the participants' satisfaction, knowledge of, and attitudes towards anaesthesia. The investigators hypothesise that using video media will improve participants' satisfaction with the anaesthetic consent process, thereby resulting in better quality informed consent. Participant's knowledge retention, attitudes and practices towards GA and RA, measured by an knowledge, attitudes and practices (KAP) questionnaire based on the consent process. Participant's stated preference for anaesthetic technique (i.e. General or Regional). Several studies have shown that video-based patient education have led to better patient comprehension and satisfaction as well as reduced patient anxiety during the consent process compared to verbal consent. Examples The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial showed that 80.7% of patients preferred portable video media (PVM) and 19.3% preferred standard video consent (SVC). PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia, showed that preoperative multimedia information reduces the anxiety of patients undergoing surgery under regional anaesthesia. This type of information is easily delivered and can benefit many patients. Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction concluded: Introduction of a video consent tool was found to be a positive adjunct to traditional consenting methods. Patient-clinician consent dialogue can now be documented. A randomised controlled study to further evaluate the effects of video consent on patients' retention of information, preoperative and postoperative anxiety, patient reported outcome measures as well as length of stay may be beneficial. During the Covid pandemic, with the need for social distancing, this is particularly useful and allows for involvement of family support for decision making by allowing sufficient time for informed consent to be made. The aim of this study is to determine if the use of video assisted consent during the anaesthetic consent process, for both GA and RA, affects the participants' satisfaction, knowledge of, and attitudes towards, anaesthesia. The investigators hypothesise that using video media will improve participant knowledge, understanding and satisfaction of the anaesthetic consent process, thereby resulting in better quality informed consent.

Official Title
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CIA: Consent in Anaesthesia, Prospective Randomised-controlled Trial

Conditions
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Regional Anesthesia, Patient Satisfaction

Intervention / Treatment
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* Other: Video assisted consent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting to pre-operative orthopaedic surgical clinic Informed consent Exclusion Criteria: Patients <18 years or vulnerable groups Inability to communicate in English or language difficulty that requires an interpreter Severe vision or hearing loss if lack of other communication channels Private patients Prisoners Patients who reside outside the United Kingdom (home address) Opt-out patients on General Practitioner register

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Recruited participants, randomised to one of two groups. Control group: standard video verbal consent process for GA and RA for orthopaedic surgery. This verbal communication will be pre-recorded and shown to the participant. Intervention group: Same pre-recorded standard verbal consent, additionally recorded video of the anaesthetic process for both GA and RA.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard video verbal consent process<br>The control group will undergo the standard video verbal consent process for both GA and RA for orthopaedic surgery. This will be delivered using a standardised video script that will be generated from existing certified material. | |
| Experimental: Video assisted consent process<br>The intervention group will also be shown the same pre-recorded standard verbal consent, but following this will additionally be shown a specifically recorded video of the anaesthetic process for both GA and RA. | Other: Video assisted consent<br>* The intervention group will also be shown the same pre-recorded standard verbal consent, but following this will additionally be shown a specifically recorded video of the anaesthetic process for both GA and RA. This video will aim to communicate the same information as that found in the traditional verbal consent, using an actor undergoing an anaesthetic to provide context.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction CSQ-8 | Client Satisfaction Questionnaire is a questionnaire measuring satisfaction. Response options differ from item to item, but all are based on a four-point scale. Examples include: How satisfied are you with the amount of help you have received? (which response options: 1 = Quite dissatisfied, 2 = Indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied; and, Have the services you received helped you to deal more effectively with your problems? (Which has the response options: 4 = Yes, they helped a great deal, 3 = Yes, they helped somewhat, 2 = No, they didn't help, 1 = No, they seemed to make things worse. with an overall score is produced by summing all item responses. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction. | 5 -10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KAP Questionnaire | Knowledge, attitudes and practices towards anaesthesia. Response options differ from item to item, but all are based on a five-point scale. Examples include: How afraid are you of a sore throat? (which response options: 1 = Very unafraid, 2 = Unafraid, 3 = Neither afraid or unafraid, 4 = Afraid, 5 = Very Afraid; and, Having permanent nerve damage (Which has the response options: 1 = Very unafraid, 2 = Unafraid, 3 = Neither afraid or unafraid, 4 = Afraid, 5 = Very Afraid; with an overall score is produced by summing all item responses. Higher values indicating a higher level of being afaid. | 5 - 10 minutes | 
| Anaesthetic choice | Participants' preferred choice choice of anaesthetic technique: General or Regional tick box | 1 - 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Consent, Patient information, Regional Anaesthesia, General Anaesthesia