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Clinical Trials/NCT05954676
NCT05954676WithdrawnNot Applicable

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

Washington University School of Medicine0 sites200 target enrollmentStarted: July 17, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
200
Primary Endpoint
30-day readmission

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

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.

Intervention: CareOrbit (Other)

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.

Intervention: CareOrbit (Other)

Outcomes

Primary Outcomes

30-day readmission

Time Frame: At Day 30

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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