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

Primary Purpose

Head and Neck Cancer, Head and Neck Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CareOrbit
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Head and neck cancer, CareOrbit, Peri-operative education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CareOrbit - Patients

CareOrbit - Caregivers

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

30-day readmission

Secondary Outcome Measures

Number of emergency room/urgent care visits
Number of unplanned clinic visits
Number of telephone calls/electronic messages to clinic staff
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.
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.

Full Information

First Posted
July 10, 2023
Last Updated
September 8, 2023
Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05954676
Brief Title
Online Peri-operative Education Program for Patients Undergoing Major Head & Neck Surgery
Official Title
Effects of Online Peri-operative Education Program for Patients Undergoing Major Head & Neck Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Neoplasms
Keywords
Head and neck cancer, CareOrbit, Peri-operative education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CareOrbit - Patients
Arm Type
Experimental
Arm Description
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.
Arm Title
CareOrbit - Caregivers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CareOrbit
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-day readmission
Time Frame
At Day 30
Secondary Outcome Measure Information:
Title
Number of emergency room/urgent care visits
Time Frame
Through 3 months post-operative
Title
Number of unplanned clinic visits
Time Frame
Through 3 months post-operative
Title
Number of telephone calls/electronic messages to clinic staff
Time Frame
Through 3 months post-operative
Title
Satisfaction of education
Description
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.
Time Frame
At pre-operative visit, 2 weeks post-operative, and 3 months post-operative
Title
Preparedness for head and neck surgery and post-operative care
Description
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.
Time Frame
At pre-operative visit, 2 weeks post-operative, and 3 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Rich, M.D.
Phone
314-747-3742
Email
richj@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Barrett, M.D.
Phone
314-448-3321
Email
tfbarrett@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Rich, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Rich, M.D.
Phone
314-747-3742
Email
richj@wustl.edu
First Name & Middle Initial & Last Name & Degree
Thomas Barrett, M.D.
Phone
314-448-3321
Email
tfbarrett@wustl.edu
First Name & Middle Initial & Last Name & Degree
Jason Rich, M.D.
First Name & Middle Initial & Last Name & Degree
Thomas Barrett, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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