Online Peri-operative Education Program for Patients Undergoing Major Head & Neck Surgery

Head and Neck Cancer Clinical Trial

Official title:

Effects of Online Peri-operative Education Program for Patients Undergoing Major Head & Neck Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954676
• Other study ID #: 201909127
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: September 2023
• Source: Washington University School of Medicine
• Contact: Jason Rich, M.D.
• Phone: 314-747-3742
• Email: richj[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase of the project will evaluate the utility and efficacy of a personalized online patient education platform developed from efforts in Phase 1 in 1) increasing patients' and caregivers' pre- and post-operative preparedness and satisfaction, and 2) reducing readmission, ED/Urgent care/unplanned clinic visits and telephone calls to clinic staff.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Have had or are undergoing free flap surgery and/or total laryngetomy

• Have internet access

• English speaking

Exclusion Criteria:

• Younger than 18 years of age

• No internet access

• Non-English speaking

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• CareOrbit
CareOrbit is a third-party organization that provides a HIPAA-compliant, patient-centered digital engagement platform that helps create, organize, and update content to educate and serve the patient and caregivers through their entire treatment journey.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day readmission		At Day 30
Secondary	Number of emergency room/urgent care visits		Through 3 months post-operative
Secondary	Number of unplanned clinic visits		Through 3 months post-operative
Secondary	Number of telephone calls/electronic messages to clinic staff		Through 3 months post-operative
Secondary	Satisfaction of education	Participants will complete a survey asking satisfaction of the educational material. Answers range from 1=excellent to 5=poor. A higher score indicates a higher level of satisfaction.	At pre-operative visit, 2 weeks post-operative, and 3 months post-operative
Secondary	Preparedness for head and neck surgery and post-operative care	Participants will complete a survey asking satisfaction of the educational material. Answers range from 1=excellent to 5=poor. A higher score indicates a higher level of preparedness.	At pre-operative visit, 2 weeks post-operative, and 3 months post-operative