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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 is a NA study of Total Laryngectomy that has completed, run by Washington University School of Medicine. The registered enrollment target is 55 participants. The trial reports 1 study location across 1 state.

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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.

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

FieldValue
Enrollment Target 55 participants
Start Date 2014-11
Est. Completion 2016-11
Phase NA

What the Registry Record Tells You About NCT02601638

The ClinicalTrials.gov registry entry for NCT02601638 describes a study currently listed as completed, categorized as NA. 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 1,502 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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