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NCT02601638 · ClinicalTrials.gov registry record · NA
Laryngectomy Education
A NA study of Total Laryngectomy, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT02601638: Completed NA study of Total Laryngectomy, sponsored by Washington University School of Medicine.
NCT02601638 is a NA study of Total Laryngectomy that has completed, run by Washington University School of Medicine. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601638, a NA study of Total Laryngectomy, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
-Calculate and report the rates of readmission for the patients undergoing the comprehensive laryngectomy education and compare to the rates of unplanned readmission and postoperative complications from historical cohorts at our institution.
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 |
What the finished NCT02601638 record still lists
NCT02601638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
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.
NCT02601638 reports a single indexed study location in Missouri.
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.
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).
Who is sponsoring clinical trial NCT02601638?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02601638's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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