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

NCT05954676 | Withdrawn

• 1 other identifier: 201909127
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Head and Neck Cancer; Head and Neck Neoplasms

Keywords

Head and neck cancer; CareOrbit; Peri-operative education

Outcome Measures

Primary Outcomes (1)

• 30-day readmission

  At Day 30

Secondary Outcomes (5)

• 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

  At pre-operative visit, 2 weeks post-operative, and 3 months post-operative

• Preparedness for head and neck surgery and post-operative care

  At pre-operative visit, 2 weeks post-operative, and 3 months post-operative

Study Arms (2)

CareOrbit - Patients

EXPERIMENTAL

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 - Caregivers

EXPERIMENTAL

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

Interventions

CareOrbit OTHER

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.

CareOrbit - Caregivers; CareOrbit - Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Have had or are undergoing free flap surgery and/or total laryngetomy
• Have internet access
• English speaking

You may not qualify if:

• Younger than 18 years of age
• No internet access
• Non-English speaking

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jason Rich, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 20, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share