Consent in Anaesthesia

NCT06115720 | Unknown DMC

• 2 other identifiers: 30519923SM8319
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Regional Anesthesia; Patient Satisfaction

Keywords

Consent; Patient information; Regional Anaesthesia; General Anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• KAP Questionnaire

  5 - 10 minutes

• Anaesthetic choice

  1 - 2 minutes

Study Arms (2)

Standard video verbal consent process

NO INTERVENTION

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.

Video assisted consent process

EXPERIMENTAL

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

Interventions

Video assisted consent OTHER

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.

Video assisted consent process

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting to pre-operative orthopaedic surgical clinic
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Imperial College London: collaborator

Related Publications (27)

• Woodall NM, Cook TM. National census of airway management techniques used for anaesthesia in the UK: first phase of the Fourth National Audit Project at the Royal College of Anaesthetists. Br J Anaesth. 2011 Feb;106(2):266-71. doi: 10.1093/bja/aeq339. Epub 2010 Dec 4.

  PMID: 21131655 BACKGROUND

• Sury MR, Palmer JH, Cook TM, Pandit JJ. The state of UK anaesthesia: a survey of National Health Service activity in 2013. Br J Anaesth. 2014 Oct;113(4):575-84. doi: 10.1093/bja/aeu292. Epub 2014 Aug 7.

  PMID: 25236896 BACKGROUND

• O'Donnell BD, Ryan H, O'Sullivan O, Iohom G. Ultrasound-guided axillary brachial plexus block with 20 milliliters local anesthetic mixture versus general anesthesia for upper limb trauma surgery: an observer-blinded, prospective, randomized, controlled trial. Anesth Analg. 2009 Jul;109(1):279-83. doi: 10.1213/ane.0b013e3181a3e721.

  PMID: 19535722 BACKGROUND

• Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.

  PMID: 26869374 BACKGROUND

• Mulroy MF, Larkin KL, Batra MS, Hodgson PS, Owens BD. Femoral nerve block with 0.25% or 0.5% bupivacaine improves postoperative analgesia following outpatient arthroscopic anterior cruciate ligament repair. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):24-9. doi: 10.1053/rapm.2001.20773.

  PMID: 11172507 BACKGROUND

• Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.

  PMID: 17543812 BACKGROUND

• Bulka CM, Shotwell MS, Gupta RK, Sandberg WS, Ehrenfeld JM. Regional anesthesia, time to hospital discharge, and in-hospital mortality: a propensity score matched analysis. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):381-6. doi: 10.1097/AAP.0000000000000121.

  PMID: 25025697 BACKGROUND

• Yentis SM, Hartle AJ, Barker IR, Barker P, Bogod DG, Clutton-Brock TH, Ruck Keene A, Leifer S, Naughton A, Plunkett E. AAGBI: Consent for anaesthesia 2017: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2017 Jan;72(1):93-105. doi: 10.1111/anae.13762.

  PMID: 27988961 BACKGROUND

• Winter M, Kam J, Nalavenkata S, Hardy E, Handmer M, Ainsworth H, Lee WG, Louie-Johnsun M. The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial. BJU Int. 2016 Nov;118(5):823-828. doi: 10.1111/bju.13595. Epub 2016 Aug 25.

  PMID: 27440499 BACKGROUND

• Armstrong AW, Alikhan A, Cheng LS, Schupp C, Kurlinkus C, Eisen DB. Portable video media for presenting informed consent and wound care instructions for skin biopsies: a randomized controlled trial. Br J Dermatol. 2010 Nov;163(5):1014-9. doi: 10.1111/j.1365-2133.2010.10067.x.

  PMID: 20977443 BACKGROUND

• Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Epub 2010 Feb 1.

  PMID: 20124283 BACKGROUND

• Mawhinney G, Thakar C, Williamson V, Rothenfluh DA, Reynolds J. Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction. BMJ Open. 2019 Jul 24;9(7):e027712. doi: 10.1136/bmjopen-2018-027712.

  PMID: 31345967 BACKGROUND

• Zhang Y, Ruan X, Tang H, Yang W, Xian Z, Lu M. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017;2017:9593631. doi: 10.1155/2017/9593631. Epub 2017 Jan 16.

  PMID: 28191349 BACKGROUND

• Tipotsch-Maca SM, Varsits RM, Ginzel C, Vecsei-Marlovits PV. Effect of a multimedia-assisted informed consent procedure on the information gain, satisfaction, and anxiety of cataract surgery patients. J Cataract Refract Surg. 2016 Jan;42(1):110-6. doi: 10.1016/j.jcrs.2015.08.019.

  PMID: 26948785 BACKGROUND

• Batuyong ED, Jowett AJ, Wickramasinghe N, Beischer AD. Using multimedia to enhance the consent process for bunion correction surgery. ANZ J Surg. 2014 Apr;84(4):249-54. doi: 10.1111/ans.12534.

  PMID: 24812709 BACKGROUND

• Rossi MJ, Guttmann D, MacLennan MJ, Lubowitz JH. Video informed consent improves knee arthroscopy patient comprehension. Arthroscopy. 2005 Jun;21(6):739-43. doi: 10.1016/j.arthro.2005.02.015.

  PMID: 15944633 BACKGROUND

• Eggers C, Obliers R, Koerfer A, Thomas W, Koehle K, Hoelscher AH, Bollschweiler E. A multimedia tool for the informed consent of patients prior to gastric banding. Obesity (Silver Spring). 2007 Nov;15(11):2866-73. doi: 10.1038/oby.2007.340.

  PMID: 18070779 BACKGROUND

• Bowers N, Eisenberg E, Montbriand J, Jaskolka J, Roche-Nagle G. Using a multimedia presentation to improve patient understanding and satisfaction with informed consent for minimally invasive vascular procedures. Surgeon. 2017 Feb;15(1):7-11. doi: 10.1016/j.surge.2015.09.001. Epub 2015 Oct 14.

  PMID: 26464072 BACKGROUND

• Celik EC, Ekinci M, Ciftci B, Golboyu BE, Kilinc OO. Influence of visual information on consent for invasive procedures in intensive care unit. Niger J Clin Pract. 2018 May;21(5):609-613. doi: 10.4103/njcp.njcp_437_16.

  PMID: 29735862 BACKGROUND

• Groves ND, Humphreys HW, Williams AJ, Jones A. Effect of informational internet web pages on patients' decision-making: randomised controlled trial regarding choice of spinal or general anaesthesia for orthopaedic surgery. Anaesthesia. 2010 Mar;65(3):277-82. doi: 10.1111/j.1365-2044.2009.06211.x.

  PMID: 20336817 BACKGROUND

• Elkassabany NM, Abraham D, Huang S, Kase B, Pio F, Hume E, Israelite C, Liu J. Patient education and anesthesia choice for total knee arthroplasty. Patient Educ Couns. 2017 Sep;100(9):1709-1713. doi: 10.1016/j.pec.2017.04.014. Epub 2017 Apr 29.

  PMID: 28487116 BACKGROUND

• Zarnegar R, Brown MR, Henley M, Tidman V, Pathmanathan A. Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery. J R Soc Med. 2015 Nov;108(11):451-6. doi: 10.1177/0141076815604494. Epub 2015 Oct 2.

  PMID: 26432814 BACKGROUND

• Salzwedel C, Petersen C, Blanc I, Koch U, Goetz AE, Schuster M. The effect of detailed, video-assisted anesthesia risk education on patient anxiety and the duration of the preanesthetic interview: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):202-9, table of contents. doi: 10.1213/01.ane.0000287665.96156.72.

  PMID: 18165579 BACKGROUND

• Mihalj M, Carrel T, Gregoric ID, Andereggen L, Zinn PO, Doll D, Stueber F, Gabriel RA, Urman RD, Luedi MM. Telemedicine for preoperative assessment during a COVID-19 pandemic: Recommendations for clinical care. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):345-351. doi: 10.1016/j.bpa.2020.05.001. Epub 2020 May 14.

  PMID: 32711839 BACKGROUND

• Kickbusch IS. Health literacy: addressing the health and education divide. Health Promot Int. 2001 Sep;16(3):289-97. doi: 10.1093/heapro/16.3.289.

  PMID: 11509466 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Rowlands G, Khazaezadeh N, Oteng-Ntim E, Seed P, Barr S, Weiss BD. Development and validation of a measure of health literacy in the UK: the newest vital sign. BMC Public Health. 2013 Feb 7;13:116. doi: 10.1186/1471-2458-13-116.

  PMID: 23391329 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Boyne Bellew

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

• Christopher Mullington

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boyne Bellew

CONTACT

+44(0)203 312 1248; boyne.bellew@nhs.net

Sam Haddad

CONTACT

+44(0)203 312 1248; sam.haddad@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors are blinded to which arm the participants are allocated when analysing the data.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 3, 2023
• Study Start: November 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share