Status:

WITHDRAWN

Implementation of a Standardized Tracheostomy Education Discharge Protocol

Lead Sponsor:

Case Comprehensive Cancer Center

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to identify and establish a safe and effective tracheostomy teaching protocol for caregivers. Results of this study will help in the development of a discharge protocol th...

Detailed Description

This is a 3-phase, prospective controlled cohort study . The first "pre-implementation" phase will include assessment of healthcare utilization costs of tracheostomy patients currently and nursing pe...

Eligibility Criteria

Inclusion

  • Patient participants:
  • Diagnosis of malignancy of the head and neck requiring reconstruction and temporary tracheostomy
  • No previous record of tracheostomy
  • Has an identified family caregiver who is willing to participate
  • Has the tracheostomy in place for at least 10 days after discharge
  • Caregiver participants:
  • Family member or friend, who is 18 years or older, of an adult patient described above
  • Identified by the patient as his/her primary caregiver who is providing daily assistance

Exclusion

  • Patients who do not have a caregiver
  • Caregivers who are illiterate.
  • Caregivers with previous tracheostomy experience.
  • Patients who are decannulated from tracheostomy prior to discharge.
  • Patients discharged to a skilled nursing facility at the time of discharge.
  • Patients who are tolerating continuous tracheostomy capping at time of discharge

Key Trial Info

Start Date :

July 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2025

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04741256

Start Date

July 1 2025

End Date

December 1 2025

Last Update

December 2 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44106

Implementation of a Standardized Tracheostomy Education Discharge Protocol | DecenTrialz