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OpenTrials
Completed

NCT Number: NCT02601638

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 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.

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Key information

Conditions

Total Laryngectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • planned total laryngectomy at Barnes Jewish Hospital
  • age 18 or older
  • understand spoken or written English language
  • able to provide informed consent.

Exclusion criteria

-none

Treatment and study plan

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

Day of Discharge Practicum

Other

Laryngectomy Education Study Exit Survey

Other

Primary outcomes

  1. Rate of 30-day unplanned readmission

    Time frame: 30 days after hospital discharge (approximately 7 weeks after registration)

    -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.

  2. Rate of postoperative complications

    Time frame: 30 days after hospital discharge (approximately 7 weeks after registration)

    -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.

  3. Change in patient's knowledge about total laryngectomy

    Time frame: 30 days after hospital discharge (approximately 7 weeks after registration)

    -The change in knowledge due to the educational intervention will be measured using a within subject comparison of patient pre- and post-education test scores (e.g. each patient's post-education scores minus preeducation scores).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Effect of Total Laryngectomy Preoperative Education on Postoperative Complications and Unplanned Hospital Readmission

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2015
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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