Total LaryngectomyNCT02601638
Laryngectomy Education
A study testing Demographics and Health History Questionnaire, Pre-Class Laryngectomy Survey and Counseling session with speech pathologist in people with Total Laryngectomy, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Laryngectomy
- What is being tested?
- Demographics and Health History Questionnaire, Pre-Class Laryngectomy Survey and Counseling session with speech pathologist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned total laryngectomy at Barnes Jewish Hospital
- age 18 or older
- understand spoken or written English language
- able to provide informed consent.
Who cannot join
- -none
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effect of Total Laryngectomy Preoperative Education on Postoperative Complications and Unplanned Hospital Readmission
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:
Read more
-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
- Being tested
- Demographics and Health History Questionnaire, Pre-Class Laryngectomy Survey, Counseling session with speech pathologist, Total Laryngectomy Preoperative Education Class, Day of Hospital Discharge Laryngectomy Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographics and Health History QuestionnaireOther
Pre-Class Laryngectomy SurveyOther
Counseling session with speech pathologistBehavioural
Total Laryngectomy Preoperative Education ClassBehavioural
Day of Hospital Discharge Laryngectomy SurveyOther
Day of Discharge PracticumOther
Laryngectomy Education Study Exit SurveyOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 30 days after hospital discharge (approximately 7 weeks after registration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total LaryngectomyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Nussenbaum, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601638
- Sponsor's protocol ID
- 201411097
- Status last verified
- Dec 2016
- First submitted
- 9 Nov 2015
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Laryngectomy Preoperative Education on Postoperative Complications and Unplanned Hospital Readmission
- ClinicalTrials.gov ID
- NCT02601638
- Acronym / sponsor ID
- 201411097
- Conditions
- Total Laryngectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | 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* 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- planned total laryngectomy at Barnes Jewish Hospital
- age 18 or older
- understand spoken or written English language
- able to provide informed consent.
Key exclusion criteria (1 listed)
- -none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demographics and Health History Questionnaire | Other | Arm 1 |
| Pre-Class Laryngectomy Survey | Other | Arm 1 |
| Counseling session with speech pathologist | Behavioural | Arm 1 |
| Total Laryngectomy Preoperative Education Class | Behavioural | 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 |
Primary outcome
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)
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Study Title: Oncological and Functional Results After Total Laryngectomy and Pharyngolaryngectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Nussenbaum, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demographics and Health History Questionnaire, Pre-Class Laryngectomy Survey and Counseling session with speech pathologist in people with Total Laryngectomy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of 30-day unplanned readmission (time frame: 30 days after hospital discharge (approximately 7 weeks after registration)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.