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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05954676
Collaborator
The Foundation for Barnes-Jewish Hospital (Other)
100
1
1
15.5
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CareOrbit
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effects of Online Peri-operative Education Program for Patients Undergoing Major Head & Neck Surgery
Anticipated Study Start Date :
Jul 17, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CareOrbit

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.

Outcome Measures

Primary Outcome Measures

  1. 30-day readmission [At Day 30]

Secondary Outcome Measures

  1. Number of emergency room/urgent care visits [Through 3 months post-operative]

  2. Number of unplanned clinic visits [Through 3 months post-operative]

  3. Number of telephone calls/electronic messages to clinic staff [Through 3 months post-operative]

  4. Satisfaction of education [At pre-operative visit, 2 weeks post-operative, and 3 months post-operative]

    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.

  5. Preparedness for head and neck surgery and post-operative care [At pre-operative visit, 2 weeks post-operative, and 3 months post-operative]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jason Rich, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05954676
Other Study ID Numbers:
  • 201909127
First Posted:
Jul 20, 2023
Last Update Posted:
Jul 20, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2023