Can an Automated Conversational Agent (the SurgInfoBot) Improve the Consent Process for Patients Undergoing Endoscopy? A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Consent
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)
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.
干预措施: Access to an automated conversational agent (SurgInfoBot) (Other)
结局指标
主要结局
Patient Satisfaction
时间窗: Immediate (day of procedure)
6-point Likert scale from '---' to '+++' - 'Overall, I am satisfied with the information I received before this procedure'
次要结局
- Peri-procedural anxiety(Immediate (Day of procedure))
- Knowledge(Immediate (Post- standard consent) and at 6 weeks, (pre-endoscopy procedure))
- SurgInfoBot Usability(6 weeks (Pre-procedure))
- Knowledge (subjective)(Immediate (After provision of standard consent) and at 6 weeks (pre-endoscopy procedure))
研究者
Dara Kavanagh
Conultant General and Colorectal Surgeon
Tallaght University Hospital