Clinical trial · Interventional
Implementation of a Standardized Tracheostomy Education Discharge Protocol
NCT04741256CI-TRIAL-00098184withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Other (terminated before study began)
Summary
Brief summary (as posted)
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 that allows for caregiver confidence and activation in tracheostomy care for patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education booklet & standardized discharge training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tracheostomy discharge protocol
- description
- 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.
- interventionNames
- Behavioral: Education booklet & standardized discharge training
Primary outcomes (3)
- measure
- Patient-Caregiver Activation Survey scores
- timeFrame
- At time of surgery, an average of 15 minutes
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.