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

Primary Purpose

Gastro-Intestinal Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Access to an automated conversational agent (SurgInfoBot)
Sponsored by
Tallaght University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastro-Intestinal Disorder focused on measuring Consent, Chatbot, Endoscopy, Automated conversational agent, Patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients undergoing elective diagnostic or screening colonoscopy or Oesophagogastroduodenoscopy (OGD) are eligible for inclusion, provided they are aged 18 or over and have capacity to consent to participate in this trial.

Exclusion Criteria:

  • Patients undergoing sigmoidoscopy procedures will not be included, as the SurgInfoBot does not contain specific information regarding sigmoidoscopy. Patients undergoing planned procedures beyond those required for diagnostics (such as biopsy, campylobacter-like organism testing or polyp retrieval) are not eligible for inclusion; this includes patients undergoing endoscopic stenting, endoscopic mucosal resection (EMR), planned endoscopic laser ablation, or other interventional procedures. Patients undergoing emergency or inpatient endoscopy are not eligible for inclusion. This trial does not exclude patients who dio not speak English as their first language, though patients requiring an interpreter are not eligible for inclusion.

Sites / Locations

  • Tallaght University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Consent

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Knowledge
a 5 item questionnaire using both open and multiple choice questions
Knowledge (subjective)
Perceived knowledge will also be assessed using a six-point Likert scale, based on participant responses to the statement: "I feel well informed about the planned procedure" from '- - -' to '+ + +'
Peri-procedural anxiety
Peri-procedural anxiety will be recorded on the day of the procedure using the State-Trait Anxiety Inventory for adults
SurgInfoBot Usability
SurgInfoBot usability will be recorded using the validated ChatBot Usability Questionnaire developed by Holmes et al. (2019), a usability scale specifically designed for evaluating chatbots in healthcare.

Full Information

First Posted
November 24, 2021
Last Updated
December 15, 2021
Sponsor
Tallaght University Hospital
Collaborators
Royal College of Surgeons, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT05159921
Brief Title
Can the SurgInfoBot Improve the Consent Process for Endoscopy? A Randomised Controlled Trial
Official Title
Can an Automated Conversational Agent (the SurgInfoBot) Improve the Consent Process for Patients Undergoing Endoscopy? A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tallaght University Hospital
Collaborators
Royal College of Surgeons, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Introduction 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. The growth of the internet has enabled greater access to information regarding healthcare interventions, the truth and value of which cannot always be verified. The use of Chatbots - online programs which attempt to replicate person to person interactions - in providing healthcare information has been successfully employed by prior studies. Recent studies have investigated the role of chatbots in providing information in the post-operative period, across orthopaedic surgery, vascular surgery and urology. The value of such human-computer interactions in providing pre-procedural information is less well explored. 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. Only 19% of patients mentioned bleeding and perforation as possible complications. This 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. Methods Trial design This randomised controlled trial will be reported according to the CONsolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. A single blinded parallel study with 1:1 randomisation will be performed. This study will be conducted at Tallaght University Hospital (Dublin, Ireland). Participants All patients undergoing diagnostic or screening colonoscopy or Oesophagogastroduodenoscopy (OGD) will be eligible for inclusion, provided they are aged 18 or over and have capacity to consent to participate in this trial. Patients undergoing sigmoidoscopy procedures will not be included, as the SurgInfoBot does not contain specific information regarding sigmoidoscopy. Patients undergoing planned procedures beyond those required for diagnostics (such as biopsy, campylobacter-like organism testing or polyp retrieval) will not be eligible for inclusion; this includes patients undergoing endoscopic stenting, endoscopic mucosal resection (EMR), planned endoscopic laser ablation, or other interventional procedures. Patients undergoing emergency or inpatient endoscopy will not be eligible for inclusion. This trial did not exclude patients who did not speak English as their first language, though patients requiring an interpreter will not be eligible for inclusion. Patients were recruited from an academic teaching hospital in West Dublin. Eligible patients will be attending outpatient appointments with a single colorectal and general surgeon (DO K). All endoscopy procedures will be performed in the same recruiting institution. Interventions Participants will be randomised to receive either standard consent, or standard consent with SurgInfoBot access. The standard consent procedure is as follows: The rationale, risks, benefits, and alternatives for the intended procedure (diagnostic or screening OGD or colonoscopy) are discussed in the outpatient clinic by a consultant general surgeon (DOK) or members of the surgical team. Patients are given the opportunity to ask questions. All patients receive a written information leaflet, which includes contact details for the endoscopy department should patients wish to ask further questions. Those undergoing colonoscopy 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. Patients in the SurgInfoBot arm will be consented as above, but will also 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 can access the SurgInfoBot as many times as they wish, and could ask any questions they see fit. The 'SurgInfoBot' is a fully automated conversational agent, built as a web page that can be accessed via computer or smartphone. The SurgInfoBot was developed within the department of Surgical Affairs, Royal College of Surgeons in Ireland, using the Microsoft Chatbot Framework (Microsoft Corporation, 2019) and hosted by the Azure cloud system (Microsoft corporation, 2019). It is a command-based chatbot which relies on a database of questions and replies to answer user queries. A question bank with associated answers was developed initially by two general surgery residents (BM, CT) using national freely-available online resources where available, and high quality peer-reviewed articles where no national resources addressed the topic of concern. Content was verified for accuracy by a consultant colorectal/ general surgeon (DO K). An iterative process of content generation, usability testing, modification and re-testing was undertaken with healthy volunteers, in order to populate the SurgInfoBot's knowledge database and ensure adequate usability prior to patient use. Randomisation Randomisation will be performed using an online randomisation system (https://www.sealedenvelope.com/simple-randomiser/v1/lists) . After undergoing standard endoscopy consenting procedures as above, patients will be asked to consent to take part in this research study. Recruited patients will then be allocated the next available unique study identifier, randomly allocating patients to receive standard further consent information (printed information leaflet) or access to the SurgInfoBot (printed information leaflet and access instructions for the SurgInfoBot online interface). Both groups of patients will also receive a link (via e-mail) to the survey of baseline demographics which will completed before access to the SurgInfoBot is granted. Patients in the SurgInfoBot access arm will also receive an e-mail with their access details. Baseline data Baseline demographic information will be recorded. This includes participant gender, age, first language (English or other), level of educational attainment and electronic health literacy as measured using the eHEALS (eHealth Literacy Scale) score. Primary Outcome Measure and Determination of Sample Size: Patient satisfaction with the pre-procedural information received will be recorded using a 6-point Likert scale from '- - -' to '+ + +' using the following statement: "Overall, I am satisfied with the information I received before this procedure. This study was powered to detect a 0.5 point increase in satisfaction, based on a mean and standard deviation derived from a previous study utilising this scale by Huber et al. 201213, with a power of 80% and alpha of 0.05. Thirty-one participants were therefore required for recruitment in each group. Based on an anticipated drop-out rate of 20%, we aimed to recruit 70 patients in total (35 in each group). Secondary Outcome Measures: Knowledge: Knowledge was assessed using a 5 item questionnaire using both open and multiple choice questions; participants were asked to identify the procedure they were having performed name the indication for having this procedure performed, identify the nature of sedation given, identify the risks of the procedure, and identify the alternatives of having the procedure performed. Items and responses were reviewed by a general surgery resident (CT) and colorectal/ general surgeon (DOK) for content validity. Knowledge questionnaires were administered immediately after standard consent was provided, and on the day of the procedure. Perceived knowledge was also assessed using a six-point Likert scale, based on participant responses to the statement: "I feel well informed about the planned procedure" from '- - -' to '+ + +' Anxiety Peri-procedural anxiety was recorded on the day of the procedure using the State-Trait Anxiety Inventory for adults14 SurgInfoBot usability SurgInfoBot usability was recorded using the validated ChatBot Usability Questionnaire developed by Holmes et al. (2019)15, a usability scale specifically designed for evaluating chatbots in healthcare. Statistical Analysis Categorical data will be presented as both absolute and relative frequencies, continuous data by mean and standard deviation. Comparisons between groups will be made using the Chi-Square test and t-tests. An effect size will be calculated for the primary outcome measure (Overall Satisfaction scores) - 95% confidence intervals will also be reported. Multivariate logistic regression will be used to identify predictors of complete satisfaction (defined as an overall satisfaction score of +++). All tests will be two-tailed, with p<0.05 considered statistically significant. All analyses will be performed with SPSS software (IBM, USA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Intestinal Disorder
Keywords
Consent, Chatbot, Endoscopy, Automated conversational agent, Patient education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single blinded parallel study with 1:1 randomisation.
Masking
Care Provider
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Consent
Arm Type
No Intervention
Arm Description
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.
Arm Title
Standard consent + access to an automated conversational agent (SurgInfoBot)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Access to an automated conversational agent (SurgInfoBot)
Intervention Description
See above under arm/group descriptions.
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
6-point Likert scale from '---' to '+++' - 'Overall, I am satisfied with the information I received before this procedure'
Time Frame
Immediate (day of procedure)
Secondary Outcome Measure Information:
Title
Knowledge
Description
a 5 item questionnaire using both open and multiple choice questions
Time Frame
Immediate (Post- standard consent) and at 6 weeks, (pre-endoscopy procedure)
Title
Knowledge (subjective)
Description
Perceived knowledge will also be assessed using a six-point Likert scale, based on participant responses to the statement: "I feel well informed about the planned procedure" from '- - -' to '+ + +'
Time Frame
Immediate (After provision of standard consent) and at 6 weeks (pre-endoscopy procedure)
Title
Peri-procedural anxiety
Description
Peri-procedural anxiety will be recorded on the day of the procedure using the State-Trait Anxiety Inventory for adults
Time Frame
Immediate (Day of procedure)
Title
SurgInfoBot Usability
Description
SurgInfoBot usability will be recorded using the validated ChatBot Usability Questionnaire developed by Holmes et al. (2019), a usability scale specifically designed for evaluating chatbots in healthcare.
Time Frame
6 weeks (Pre-procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients undergoing elective diagnostic or screening colonoscopy or Oesophagogastroduodenoscopy (OGD) are eligible for inclusion, provided they are aged 18 or over and have capacity to consent to participate in this trial. Exclusion Criteria: Patients undergoing sigmoidoscopy procedures will not be included, as the SurgInfoBot does not contain specific information regarding sigmoidoscopy. Patients undergoing planned procedures beyond those required for diagnostics (such as biopsy, campylobacter-like organism testing or polyp retrieval) are not eligible for inclusion; this includes patients undergoing endoscopic stenting, endoscopic mucosal resection (EMR), planned endoscopic laser ablation, or other interventional procedures. Patients undergoing emergency or inpatient endoscopy are not eligible for inclusion. This trial does not exclude patients who dio not speak English as their first language, though patients requiring an interpreter are not eligible for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dara O Kavanagh, Mch FRCSI
Phone
0035314142000
Ext
2211
Email
dara.kavanagh@tuh.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dara O Kavanagh, MCh FRCSI
Organizational Affiliation
Tallaght University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tallaght University Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dara O Kavanagh, MCh FRCSI
Phone
0035314142000
Ext
2211
Email
dara.kavanagh@tuh.ie

12. IPD Sharing Statement

Plan to Share IPD
No

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

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