Can the SurgInfoBot Improve the Consent Process for Endoscopy? A Randomised Controlled Trial

NCT05159921 | Unknown

• 1 other identifier: REC: 2021-11
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Human-computer interactions or 'Chatbots' have been utilized in a variety of healthcare settings, including the promotion of positive healthcare behaviors, the deliverance of psychological therapy, and the performance of diagnostic tasks. Standard methods of consenting patients for procedures may not always result in patients being fully informed; a 2004 study of patients undergoing screening sigmoidoscopy demonstrated that 39% of surveyed patients could describe no other indication than doctor recommendation for the procedure after undergoing standard consent. his study seeks to investigate the usability of a novel chatbot designed to provide peri-procedural information in two endoscopic procedures - diagnostic oesophagogastroduodenoscopy (OGD) and diagnostic colonoscopy. A novel Chatbot - 'SurgInfoBot' has been developed in order to provide real-time, patient-driven peri-procedural information. This study primarily seeks to assess the effect of SurgInfoBot use on patient satisfaction with the consent process in endoscopy. It will also assess the usability of the chatbot according to the system usability scale and test performance according to the as-yet unvalidated Chatbot Usability Questionnaire (CUX). User engagement will be analyzed objectively using stored metrics. Comparison will be made between perceptions of the SurgInfoBot as an information source and other established patient information sources. The potential impact of the SurgInfoBot on peri-procedural anxiety will also be explored.

Conditions

Gastro-Intestinal Disorder

Keywords

Consent; Chatbot; Endoscopy; Automated conversational agent; Patient education

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  6-point Likert scale from '---' to '+++' - 'Overall, I am satisfied with the information I received before this procedure'

  Immediate (day of procedure)

Secondary Outcomes (4)

• Knowledge

  Immediate (Post- standard consent) and at 6 weeks, (pre-endoscopy procedure)

• Knowledge (subjective)

  Immediate (After provision of standard consent) and at 6 weeks (pre-endoscopy procedure)

• Peri-procedural anxiety

  Immediate (Day of procedure)

• SurgInfoBot Usability

  6 weeks (Pre-procedure)

Study Arms (2)

Standard Consent

NO INTERVENTION

Standard consent procedure: The rationale, risks, benefits, and alternatives for the intended procedure (diagnostic or screening OGD or colonoscopy) will be discussed in the outpatient clinic by a consultant general surgeon (DOK) or members of the surgical team. Patients will be given the opportunity to ask questions. All patients will receive a written information leaflet, which includes contact details for the endoscopy department should patients wish to ask further questions (supplemental data). Those undergoing colonoscopy will receive further instructions along with prescribed colonoscopy 'prep' medication by post. On the day of the procedure, patients are required to sign a standardised consent form.

Standard consent + access to an automated conversational agent (SurgInfoBot)

EXPERIMENTAL

Patients in the SurgInfoBot arm will be consented as above, but will also be granted access to the SurgInfoBot, which they will be invited to use between their outpatient appointment and their endoscopy procedure date. Participants will be provided with an access link and Unique Study Identifier in order to pseudonymise participant data. Participants will be able to access the SurgInfoBot as many times as they wish, and can ask any questions they see fit.

Other: Access to an automated conversational agent (SurgInfoBot)

Interventions

Access to an automated conversational agent (SurgInfoBot) OTHER

See above under arm/group descriptions.

Standard consent + access to an automated conversational agent (SurgInfoBot)

Eligibility Criteria

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

Sponsors & Collaborators

• Tallaght University Hospital: lead
• Royal College of Surgeons, Ireland: collaborator

Study Sites (1)

Tallaght University Hospital

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Dara O Kavanagh, MCh FRCSI

  Tallaght University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dara O Kavanagh, Mch FRCSI

CONTACT

0035314142000; dara.kavanagh@tuh.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Single-blinded. Participants will be aware of which arm they are randomised too (standard consent vs standard consent with automated conversational agent access), while those performing the endoscopy procedure (care providers) will not.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Conultant General and Colorectal Surgeon

Model Details: A single blinded parallel study with 1:1 randomisation.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 16, 2021
• Study Start: November 29, 2021
• Primary Completion: November 1, 2022
• Study Completion: July 1, 2023
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)