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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Cancer; Head and Neck Neoplasms
• Intervention / Treatment: Other: CareOrbit

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Jason Rich, M.D.; Phone Number: 314-747-3742; Email: richj@wustl.edu
      • Contact: Thomas Barrett, M.D.; Phone Number: 314-448-3321; Email: tfbarrett@wustl.edu
      • Principal Investigator: Jason Rich, M.D.
      • Sub-Investigator: Thomas Barrett, M.D.

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CareOrbit - Patients; Patients will be assigned a username and password to access their CareOrbit account via the internet (caregivers will use the same account information). These patients may designate up to 3 additional individuals who will be participating in the patient's postoperative care to receive the link along with a unique username and password via email. All patients will additionally receive standard pre- and post-operative instructions and care. This will include verbal education by the surgeons at their pre-operative visits. Patient questionnaires will be distributed at the first and second post-operative visits (typically 1-2 weeks after discharge and 3 months after post-operative clinic visit). At 30 days following discharge, the patients' medical records will be reviewed by the study team to assess for the primary or secondary outcomes. Patients will be contacted by telephone to inquire about ED/UC visits outside of the BJC system.	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.
Experimental: CareOrbit - Caregivers; Patients will be assigned a username and password to access their CareOrbit account via the internet (caregivers will use the same account information). These patients may designate up to 3 additional individuals who will be participating in the patient's postoperative care to receive the link along with a unique username and password via email. All patients will additionally receive standard pre- and post-operative instructions and care. This will include verbal education by the surgeons at their pre-operative visits. Patient questionnaires will be distributed at the first and second post-operative visits (typically 1-2 weeks after discharge and 3 months after post-operative clinic visit). At 30 days following discharge, the patients' medical records will be reviewed by the study team to assess for the primary or secondary outcomes. Patients will be contacted by telephone to inquire about ED/UC visits outside of the BJC system.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day readmission	At Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of emergency room/urgent care visits		Through 3 months post-operative
Number of unplanned clinic visits		Through 3 months post-operative
Number of telephone calls/electronic messages to clinic staff		Through 3 months post-operative
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
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: The Foundation for Barnes-Jewish Hospital
• Investigators: Principal Investigator: Jason Rich, M.D., Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Head and neck cancer; CareOrbit; Peri-operative education
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 201909127

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