Implementation of a Standardized Tracheostomy Education Discharge Protocol
NCT ID: NCT04741256
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-07-31
2025-12-31
Brief Summary
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Detailed Description
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The first "pre-implementation" phase will include assessment of healthcare utilization costs of tracheostomy patients currently and nursing perspective on current caregiver tracheostomy knowledge.
The second "protocol" phase will include assessment of the necessity, acceptability, feasibility, fidelity, safety and effectiveness of a standardized pathway and assessment of the caregiver's activation.
The third "post-implementation" phase will involve assessment of post-implementation tracheostomy-related healthcare utilization costs and nursing perspective on caregiver tracheostomy knowledge.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Tracheostomy discharge protocol
All head and neck cancer patients regardless of participation in the study will receive the standard of care: A copy of a tracheostomy education booklet and standardized discharge training for patients and their caregivers by nursing staff during their inpatient stay.
Research personnel will provide protocol training to the inpatient nurses who are to provide training to caregivers.
Pre-implementation phase: Eligible "patient" participants identified \& healthcare utilization recorded. "Nursing staff" participants complete nursing survey to capture volume of tracheostomy-related questions received.
Protocol-phase: "Caregiver" participants will complete a survey prior to patient tracheostomy, on day of patient discharge, and one week following discharge
Post-implementation phase: "Nursing staff" participants will complete an additional survey similar to the one in the pre-implementation phase. EMR will be reviewed for implementation fidelity.
Education booklet & standardized discharge training
Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.
Interventions
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Education booklet & standardized discharge training
Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Rod Rezaee, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Locations
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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE4320
Identifier Type: -
Identifier Source: org_study_id
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