Laryngectomy Education

NCT02601638 | Completed

• 1 other identifier: 201411097
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Laryngectomy

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Arm 1

EXPERIMENTAL

* Demographics and Health History Questionnaire (5-10 minutes to complete) * Pre-Class Laryngectomy Survey (5-10 minutes to complete) * Attend a preoperative counseling session with a speech pathologist. It will take 30-60 minutes * Attend the Total Laryngectomy Preoperative Education Class. Participants will attend within 1-2 weeks of providing written consent and prior to their scheduled surgery. The preoperative education class will take one hour. * Complete the Day of Hospital Discharge Laryngectomy Survey at the time of discharge from the hospital (5-10 minutes to complete) * Perform the day of discharge practicum assessing the minimal competency skills for laryngectomy care prior to discharge from the hospital. * Complete the Laryngectomy Education Study Exit survey. Participants will perform an exit survey at the first clinic appointment after 30 days after hospital discharge (15-30 minutes to complete)

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; Other: Day of Discharge Practicum; Other: Laryngectomy Education Study Exit Survey

Interventions

Demographics and Health History Questionnaire OTHER

Arm 1

Pre-Class Laryngectomy Survey OTHER

Arm 1

Counseling session with speech pathologist BEHAVIORAL

Arm 1

Total Laryngectomy Preoperative Education Class BEHAVIORAL

Arm 1

Day of Hospital Discharge Laryngectomy Survey OTHER

Arm 1

Day of Discharge Practicum OTHER

Arm 1

Laryngectomy Education Study Exit Survey OTHER

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Interventions

Demography

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Brian Nussenbaum, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 10, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 13, 2016

Record last verified: 2016-12

Locations

US (1)