Clinical trial NCT02601638: Laryngectomy Education
Official title: Effect of Total Laryngectomy Preoperative Education on Postoperative Complications and Unplanned Hospital Readmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Laryngectomy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of 30-day unplanned readmission
timeFrame: 30 days after hospital discharge (approximately 7 weeks after registration)
measure: Rate of postoperative complications
timeFrame: 30 days after hospital discharge (approximately 7 weeks after registration)
measure: Change in patient's knowledge about total laryngectomy
timeFrame: 30 days after hospital discharge (approximately 7 weeks after registration)
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Brian Nussenbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References: