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Education Booklet & Standardized Discharge Training for Head and Neck Cancers

N/A

Waitlist Available

Led By Rod Rezaee, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient participants: Diagnosis of malignancy of the head and neck requiring reconstruction and temporary tracheostomy

No previous record of tracheostomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at first follow-up (1 week after discharge), an average of 15 minutes

Awards & highlights

Study Summary

This trial is testing a new tracheostomy teaching protocol to see if it is safe and effective. Results will be used to create a discharge protocol for caregivers to follow when they leave the hospital with a patient who has a tracheostomy.

Who is the study for?

This trial is for adult patients with head and neck cancers who have had a tracheostomy and will keep it for at least 10 days after leaving the hospital. They need a caregiver aged 18+ without prior tracheostomy experience, who can read and is not going to a nursing facility.Check my eligibility

What is being tested?

The study tests an educational booklet & standardized discharge training protocol aimed at improving caregivers' ability to confidently manage tracheostomy care post-discharge from the hospital.See study design

What are the potential side effects?

Since this trial focuses on education rather than medication or surgery, there are no direct medical side effects. However, stress or anxiety may occur as caregivers learn new skills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a cancer diagnosis in my head or neck that needs surgery and a temporary breathing tube.

Select...

I have never had a tracheostomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at first follow-up (1 week after discharge), an average of 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at first follow-up (1 week after discharge), an average of 15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and at first follow-up (1 week after discharge), an average of 15 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-Caregiver Activation Survey scores

Secondary outcome measures

Average number of tracheostomy-related phone calls per week post-discharge

Average tracheostomy-related healthcare utilization costs

Feasibility Questionnaire scores

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tracheostomy discharge protocolExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

453 Previous Clinical Trials

31,794 Total Patients Enrolled

Rod Rezaee, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Media Library

Education booklet & standardized discharge training Clinical Trial Eligibility Overview. Trial Name: NCT04741256 — N/A

Head and Neck Cancers Research Study Groups: Tracheostomy discharge protocol

Head and Neck Cancers Clinical Trial 2023: Education booklet & standardized discharge training Highlights & Side Effects. Trial Name: NCT04741256 — N/A

Education booklet & standardized discharge training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04741256 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial actively looking for participants at the moment?

"As per clinicaltrials.gov, this medical trial has ceased recruitment for the time being as it was last edited on December 2nd 2022 - following its initial posting in April 1st 2023. Though not enrolling participants now, there are other 482 studies actively looking for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implementation of a Standardized Tracheostomy Education Discharge Protocol

2024. "Implementation of a Standardized Tracheostomy Education Discharge Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04741256.