Laryngectomy Education

Total Laryngectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601638
• Other study ID #: 201411097
• Status: Completed
• Phase: N/A
• First received: November 9, 2015
• Last updated: December 12, 2016
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Postoperative Complications
• Total Laryngectomy

Intervention

Other:
• Demographics and Health History Questionnaire

• Pre-Class Laryngectomy Survey

Behavioral:
• Counseling session with speech pathologist

• Total Laryngectomy Preoperative Education Class

Other:
• Day of Hospital Discharge Laryngectomy Survey

• Day of Discharge Practicum

• Laryngectomy Education Study Exit Survey

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of 30-day unplanned readmission	-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.	30 days after hospital discharge (approximately 7 weeks after registration)	No
Primary	Rate of postoperative complications	-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.	30 days after hospital discharge (approximately 7 weeks after registration)	Yes
Primary	Change in patient's knowledge about total laryngectomy	-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).	30 days after hospital discharge (approximately 7 weeks after registration)	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine