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Laryngectomy Education
NCT02601638 · View on ClinicalTrials.gov ↗
Study Summary
Patients undergoing total laryngectomy are at high risk for 30-day unplanned readmission. Many of these readmissions are related to stomal care, and it is thought that the readmissions could be prevented with better patient and caregiver education. The investigators are studying the effect of a comprehensive perioperative education program on 30-day unplanned readmission for patients undergoing total laryngectomy. The comprehensive perioperative education program will include the following additional interventions: -Preoperative visit with the speech pathologist for explanation of laryngectomy physiology, stomal education, and alaryngeal voice rehabilitation. Participants will be expected to undergo this intervention and to attend it with their "laryngectomy coach" (a family member or friend to accompany the patient through the education process), but failure to meet with the speech pathologist will not exclude a patient from the study. * Preoperative education class with a designated ENT laryngectomy nurse for patient and caregiver. The hands-on class introduces the patient and laryngectomy coach to the basics of stomal care. Participants and their "laryngectomy coach" will be expected to attend the preoperative education class * Printed laryngectomy journey guide given to patients at time of study enrollment for patient/caregiver. This journey guide details the preoperative, in-hospital, and post-discharge course and is provided as a reference throughout their journey. * Formalized, nursing administered practical evaluation of minimal competency of laryngectomy care for patient and caregiver/laryngectomy coach. This study will follow patients prospectively from the time of study commencement and then assess changes in patient knowledge before and after the education intervention. It will also compare rate of stomal complications and readmission rates to institutional historical averages to assess improvement in quality care.
Conditions Studied
Interventions
- OTHER Demographics and Health History Questionnaire
- OTHER Pre-Class Laryngectomy Survey
- BEHAVIORAL Counseling session with speech pathologist
- BEHAVIORAL Total Laryngectomy Preoperative Education Class
- OTHER Day of Hospital Discharge Laryngectomy Survey
Study Locations (1)
Missouri
- Washington University School of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02601638
The ClinicalTrials.gov registry entry for NCT02601638 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Total Laryngectomy appearing as the primary indexed condition, and to 5 interventions — of which Demographics and Health History Questionnaire is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02601638 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02601638 about?
NCT02601638 is a clinical study titled "Laryngectomy Education". Patients undergoing total laryngectomy are at high risk for 30-day unplanned readmission. Many of these readmissions are related to stomal care, and it is thought that the readmissions could be prevented with better patient and caregiver education. The investigators are studying the effect of a comp...
What is the current status of trial NCT02601638?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2014-11. Estimated completion is 2016-11.
What conditions does trial NCT02601638 study?
This clinical trial studies the following conditions: Total Laryngectomy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02601638?
The interventions under investigation include: Demographics and Health History Questionnaire (OTHER), Pre-Class Laryngectomy Survey (OTHER), Counseling session with speech pathologist (BEHAVIORAL), Total Laryngectomy Preoperative Education Class (BEHAVIORAL), Day of Hospital Discharge Laryngectomy Survey (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02601638?
This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02601638 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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