Chatbot on the Prevention of Postoperative Complications

Comparison of Traditional Nurse-led Education and Chatbot on the Prevention of Postoperative Complications After Major Visceral Surgery: a Randomized Controlled Trial

Major visceral surgery encompasses a broad range of operations with a wide variety of procedures that fall under this category. The majority of patients undergoing major visceral surgery often present with cancer and other medical comorbidities and are put at an elevated risk of a large number of medical and surgical postoperative complications

Study Overview

• Status: Not yet recruiting
• Conditions: Visceral Surgery Complications
• Intervention / Treatment: Other: chatbot education

Detailed Description

Complications following major visceral surgery are relatively common and are estimated to occur in 18-23% of patients . The management of complications is challenging for both the elderly patient and the perioperative team, and adds considerably to the cost of care particularly when further interventions involve readmission, unplanned admission to an intensive care unit, interventional radiology and/or an unplanned return to theatre. With the advancement of online patient portals, the use of internet to seek for health information is already a common phenomenon; Chatbot may become a more significant source of information for patients.

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed hamed elzeky, phd; Phone Number: +201040627871; Email: mohamadelzeky@mans.edu.eg
• Study Contact Backup: Name: noha fathy shahine, phd; Phone Number: +201098375398; Email: nohafathy@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 60 years old and above, both sex, scheduled for elective major visceral surgery, able to communicate in the local language, and without any cognitive impairment.

Exclusion Criteria:

• Elderly patients with a history of major psychiatric disorders, patients with a history of previous major visceral surgery, and patients who were unable to provide informed consent will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: traditional nurse-led education
Experimental: chatbot education	Other: chatbot education; elderly patients interacted with Chatbot to discuss general postoperative complication related inquiries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative morbidity	using the postoperative morbidity survey , Patients are assessed for diagnostic features in nine domains (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological, wound and pain). For each of the nine domains morbidity is recorded on the presence or absence of preset criteria and it appears to accurately describe the pattern and prevalence of morbidity in the postoperative setting. I	patient will be evaluated at three time points: 24 hour postoperative; 48 hours postoperative , and 30 days postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
usability of using chatbots	This scale was composed of 16 validated items aimed to assess the personality, onboarding, navigation, understanding, responses, error handling and intelligence of a chatbot.	4 weeks postoperatively
Geriatric anxiety	questionnaire comprising 30 items, called the GAS was created to evaluate, screen for, and quantify the intensity of anxiety symptoms in older persons	will be measured at three time points: 90 to 120 minutes before the preoperative consultation (baseline ); after 7 days postoperative, and after 30 days postoperative
quality of life	This short version of the SF-36 tool consists of 12 items and eight scales: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and perceived mental health (MH).	will be measured at two time points : at baseline (preoperative ) and after 30 days postoperative

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 0637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No