Head and Neck CancerNCT04741256
Implementation of a Standardized Tracheostomy Education Discharge Protocol
A study testing Education booklet & standardized discharge training in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to identify and establish a safe and effective tracheostomy teaching protocol for caregivers. Results of this study will help in the development of a discharge protocol that allows for caregiver confidence and activation in tracheostomy care for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Education booklet & standardized discharge training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2025to Dec 2025
- 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
- Patient participants:
- Diagnosis of malignancy of the head and neck requiring reconstruction and temporary tracheostomy
- No previous record of tracheostomy
- Has an identified family caregiver who is willing to participate
- Has the tracheostomy in place for at least 10 days after discharge
- Caregiver participants:
- Family member or friend, who is 18 years or older, of an adult patient described above
- Identified by the patient as his/her primary caregiver who is providing daily assistance
Who cannot join
- Patients who do not have a caregiver
- Caregivers who are illiterate.
- Caregivers with previous tracheostomy experience.
- Patients who are decannulated from tracheostomy prior to discharge.
- Patients discharged to a skilled nursing facility at the time of discharge.
- Patients who are tolerating continuous tracheostomy capping at time of discharge
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
The purpose of this study is to identify and establish a safe and effective tracheostomy teaching protocol for caregivers. Results of this study will help in the development of a discharge protocol that allows for caregiver confidence and activation in tracheostomy care for patients.
Read the detailed description
This is a 3-phase, prospective controlled cohort study .
The first "pre-implementation" phase will include assessment of healthcare utilization costs of tracheostomy patients currently and nursing perspective on current caregiver tracheostomy knowledge.
The second "protocol" phase will include assessment of the necessity, acceptability, feasibility, fidelity, safety and effectiveness of a standardized pathway and assessment of the caregiver's activation.
The third "post-implementation" phase will involve assessment of post-implementation tracheostomy-related healthcare utilization costs and nursing perspective on caregiver tracheostomy knowledge.
- Conditions
- Head and Neck Cancer
- Being tested
- Education booklet & standardized discharge training
- Keywords
- Caregiver activation, Caregiver knowledge, Caregiver skills, Caregiver confidence, Tracheostomy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education booklet & standardized discharge trainingBehavioural
Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.
| Study group | Role | What they receive |
|---|---|---|
| Tracheostomy discharge protocol | Experimental | All head and neck cancer patients regardless of participation in the study will receive the standard of care: A copy of a tracheostomy education booklet and standardized discharge training for patients and their caregivers by nursing staff during their inpatient stay.
Research personnel will provide protocol training to the inpatient nurses who are to provide training to caregivers.
Pre-implementation phase: Eligible "patient" participants identified \& healthcare utilization recorded. "Nursing staff" participants complete nursing survey to capture volume of tracheostomy-related questions received.
Protocol-phase: "Caregiver" participants will complete a survey prior to patient tracheostomy, on day of patient discharge, and one week following discharge
Post-implementation phase: "Nursing staff" participants will complete an additional survey similar to the one in the pre-implementation phase. EMR will be reviewed for implementation fidelity. Receives: Behavioral: Education booklet & standardized discharge training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Caregiver Activation Survey scores
Caregiver activation in managing their family members' tracheostomy after implementation of a standardized discharge program as measured by the Patient-Caregiver Activation Survey. This is a validated survey assessing caregiver consisting of 13 questions designed to determined confidence in taking care of their loved one. Scores range from 4 to 52, with higher score indicates higher degree of caregiver activation
Measured: At time of surgery, an average of 15 minutes
Patient-Caregiver Activation Survey scores
Caregiver activation in managing their family members' tracheostomy after implementation of a standardized discharge program as measured by the Patient-Caregiver Activation Survey. This is a validated survey assessing caregiver consisting of 13 questions designed to determined confidence in taking care of their loved one. Scores range from 4 to 52, with higher score indicates higher degree of caregiver activation
Measured: At discharge (an average of 7 days after surgery), an average of 15 minutes
Patient-Caregiver Activation Survey scores
Caregiver activation in managing their family members' tracheostomy after implementation of a standardized discharge program as measured by the Patient-Caregiver Activation Survey. This is a validated survey assessing caregiver consisting of 13 questions designed to determined confidence in taking care of their loved one. Scores range from 4 to 52, with higher score indicates higher degree of caregiver activation
Measured: At first follow-up (1 week after discharge), an average of 15 minutes
Secondary outcomes (14)
Feasibility Questionnaire scores
The feasibility questionnaire evaluates the necessity, acceptability and feasibility of the of the implementation of a standardized discharge program. Questions are related to readiness and willingness to participate in tracheostomy care. It will assess feasibility in attending tracheostomy teaching sessions by nurses and their baseline comfort in tracheostomy care and their enthusiasm in learning tracheostomy care. Questionnaire consists of 12 questions, with scores ranging from 12 to 60, with higher scores indicating higher feasibility of tracheostomy protocol implementation.
Measured: At time of surgery, an average of 15 minutes
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Safety, as measured by the PROMIS scores - 7-item questionnaire that assess self-reported anxiety in the family caregiver. A higher score correlates with a higher level of anxiety. Scores range from 7 to 25, with higher scores indicating a greater severity of anxiety
Measured: At time of surgery, an average of 15 minutes
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Safety, as measured by the PROMIS scores - 7-item questionnaire that assess self-reported anxiety in the family caregiver. A higher score correlates with a higher level of anxiety. A higher score correlates with a higher level of anxiety. Scores range from 7 to 25, with higher scores indicating a greater severity of anxiety
Measured: At discharge (an average of 7 days after surgery), an average of 15 minutes
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Safety, as measured by the PROMIS scores - 7-item questionnaire that assess self-reported anxiety in the family caregiver. A higher score correlates with a higher level of anxiety. A higher score correlates with a higher level of anxiety. Scores range from 7 to 25, with higher scores indicating a greater severity of anxiety
Measured: At first follow-up (1 week after discharge), an average of 15 minutes
Preparedness Caregiver Scale (PCS)
PCS scores - Response categories correspond to the level of preparedness. Scale consists of 9 questions, with scores ranging from 0 to 4 with high score indicating the more prepared the caregiver feels for caregiving.
Measured: At discharge (an average of 7 days after surgery), an average of 15 minutes
Preparedness Caregiver Scale (PCS)
PCS scores - Response categories correspond to the level of preparedness. Scale consists of 9 questions, with scores ranging from 0 to 4 with high score indicating the more prepared the caregiver feels for caregiving.
Measured: At first follow-up (1 week after discharge), an average of 15 minutes
Tracheostomy Care Competency Assessment
Effectiveness will be measured with the tracheostomy care competency assessment. This survey will be an individual's subjective assessment of his or her knowledge of tracheostomy care. A 5-point Likert scale will be used from 1 "strongly disagree" to 5 "strongly agree" and assess different aspects of tracheostomy care outlined during their tracheostomy teaching provided by nurses. This assessment includes 12 questions with scores ranging from from 12 to 60 with higher scores indicating higher competency.
Results form pre-implementation to post-implementation will be compared using a paired t-test or McNemar tes
Measured: At discharge (an average of 7 days after surgery), an average of 15 minutes
Tracheostomy Care Competency Assessment
Effectiveness will be measured with the tracheostomy care competency assessment. This survey will be an individual's subjective assessment of his or her knowledge of tracheostomy care. A 5-point Likert scale will be used from 1 "strongly disagree" to 5 "strongly agree" and assess different aspects of tracheostomy care outlined during their tracheostomy teaching provided by nurses. This assessment includes 12 questions with scores ranging from from 12 to 60 with higher scores indicating higher competency.
Results form pre-implementation to post-implementation will be compared using a paired t-test or McNemar tes
Measured: At first follow-up (1 week after discharge), an average of 15 minutes
Average tracheostomy-related healthcare utilization costs
Effectiveness will be measured with the tracheostomy care competency assessment. This survey will be an individual's subjective assessment of his or her knowledge of tracheostomy care. A 5-point Likert scale will be used from 1 "strongly disagree" to 5 "strongly agree" and assess different aspects of tracheostomy care outlined during their tracheostomy teaching provided by nurses. This assessment includes 12 questions with scores ranging from from 12 to 60 with higher scores indicating higher competency.
Results form pre-implementation to post-implementation will be compared using a paired t-test or McNemar tes
Measured: Pre-implementation (up to 6 months prior to surgery)
Average tracheostomy-related healthcare utilization costs
Average pre and post-implementation tracheostomy-related healthcare utilization costs
Measured: Post-implementation, 30 days after discharge
Nursing survey
Effectiveness will be measured with the Nursing Survey scores. This is an 11 question survey designed to capture the amount of phone calls nurses receive regarding tracheostomy related questions over the last 6 months.
Results form pre-implementation to post-implementation will be compared using a paired t-test or McNemar tes
Measured: Pre-implementation (up to 6 months prior to surgery)
Nursing survey
Effectiveness will be measured with the Nursing Survey scores. This is an 11 question survey designed to capture the amount of phone calls nurses receive regarding tracheostomy related questions over the last 6 months.
Results form pre-implementation to post-implementation will be compared using a paired t-test or McNemar tes
Measured: Post-implementation, 30 days after discharge
Number of emergency department visits, urgent care or outpatient appointments post-discharge
Number of emergency department visits, urgent care or outpatient appointments, relating to post-discharge assessment of feasibility and safety of intervention
Measured: Post-implementation, 30 days after discharge
Average number of tracheostomy-related phone calls per week post-discharge
Post-discharge assessment of feasibility, as measured by average number of tracheostomy-related phone calls per week
Measured: Post-implementation, 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Other (terminated before study began)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rod Rezaee, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741256
- Sponsor's protocol ID
- CASE4320
- Status last verified
- Nov 2025
- First submitted
- 2 Feb 2021
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Insignia Health provides rights to the Patient-Caregiver survey. As part of the agreement for access to the survey, they request that at the conclusion of the study we share the entire de-identified dataset. These will not be published by them or shared with another party
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Standardized Tracheostomy Education Discharge Protocol
- ClinicalTrials.gov ID
- NCT04741256
- Acronym / sponsor ID
- CASE4320
- Conditions
- Head and Neck Cancer
- Keywords
- Caregiver activation, Caregiver knowledge, Caregiver skills, Caregiver confidence, Tracheostomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other (terminated before study began)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Feb 2021 (actual)
- 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.
The purpose of this study is to identify and establish a safe and effective tracheostomy teaching protocol for caregivers. Results of this study will help in the development of a discharge protocol that allows for caregiver confidence and activation in tracheostomy care for patients.
Detailed description
This is a 3-phase, prospective controlled cohort study .
The first "pre-implementation" phase will include assessment of healthcare utilization costs of tracheostomy patients currently and nursing perspective on current caregiver tracheostomy knowledge.
The second "protocol" phase will include assessment of the necessity, acceptability, feasibility, fidelity, safety and effectiveness of a standardized pathway and assessment of the caregiver's activation.
The third "post-implementation" phase will involve assessment of post-implementation tracheostomy-related healthcare utilization costs and nursing perspective on caregiver tracheostomy knowledge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracheostomy discharge protocol | Experimental | Behavioral: Education booklet & standardized discharge trainingAll head and neck cancer patients regardless of participation in the study will receive the standard of care: A copy of a tracheostomy education booklet and standardized discharge training for patients and their caregivers by nursing staff during their inpatient stay. Research personnel will provide protocol training to the inpatient nurses who are to provide training to caregivers. Pre-implementation phase: Eligible "patient" participants identified \& healthcare utilization recorded. "Nursing staff" participants complete nursing survey to capture volume of tracheostomy-related questions received. Protocol-phase: "Caregiver" participants will complete a survey prior to patient tracheostomy, on day of patient discharge, and one week following discharge Post-implementation phase: "Nursing staff" participants will complete an additional survey similar to the one in the pre-implementation phase. EMR will be reviewed for implementation fidelity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of malignancy of the head and neck requiring reconstruction and temporary tracheostomy
- No previous record of tracheostomy
- Has an identified family caregiver who is willing to participate
- Has the tracheostomy in place for at least 10 days after discharge
- Family member or friend, who is 18 years or older, of an adult patient described above
Key exclusion criteria (6 listed)
- Patients who do not have a caregiver
- Caregivers who are illiterate.
- Caregivers with previous tracheostomy experience.
- Patients who are decannulated from tracheostomy prior to discharge.
- Patients discharged to a skilled nursing facility at the time of discharge.
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 |
|---|---|---|
| Education booklet & standardized discharge trainingTracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet. | Behavioural | Tracheostomy discharge protocol |
Primary outcome
Patient-Caregiver Activation Survey scores
Time frame: At time of surgery, an average of 15 minutes
Caregiver activation in managing their family members' tracheostomy after implementation of a standardized discharge program as measured by the Patient-Caregiver Activation Survey. This is a validated survey assessing caregiver consisting of 13 questions designed to determined confidence in taking care of their loved one. Scores range from 4 to 52, with higher score indicates higher degree of caregiver activation
Patient-Caregiver Activation Survey scores
Time frame: At discharge (an average of 7 days after surgery), an average of 15 minutes
Caregiver activation in managing their family members' tracheostomy after implementation of a standardized discharge program as measured by the Patient-Caregiver Activation Survey. This is a validated survey assessing caregiver consisting of 13 questions designed to determined confidence in taking care of their loved one. Scores range from 4 to 52, with higher score indicates higher degree of caregiver activation
Patient-Caregiver Activation Survey scores
Time frame: At first follow-up (1 week after discharge), an average of 15 minutes
Caregiver activation in managing their family members' tracheostomy after implementation of a standardized discharge program as measured by the Patient-Caregiver Activation Survey. This is a validated survey assessing caregiver consisting of 13 questions designed to determined confidence in taking care of their loved one. Scores range from 4 to 52, with higher score indicates higher degree of caregiver activation
14 secondary outcomes
Feasibility Questionnaire scores
Time frame: At time of surgery, an average of 15 minutes
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Time frame: At time of surgery, an average of 15 minutes
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Time frame: At discharge (an average of 7 days after surgery), an average of 15 minutes
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Time frame: At first follow-up (1 week after discharge), an average of 15 minutes
Preparedness Caregiver Scale (PCS)
Time frame: At discharge (an average of 7 days after surgery), an average of 15 minutes
Preparedness Caregiver Scale (PCS)
Time frame: At first follow-up (1 week after discharge), an average of 15 minutes
Tracheostomy Care Competency Assessment
Time frame: At discharge (an average of 7 days after surgery), an average of 15 minutes
Tracheostomy Care Competency Assessment
Time frame: At first follow-up (1 week after discharge), an average of 15 minutes
Average tracheostomy-related healthcare utilization costs
Time frame: Pre-implementation (up to 6 months prior to surgery)
Average tracheostomy-related healthcare utilization costs
Time frame: Post-implementation, 30 days after discharge
Nursing survey
Time frame: Pre-implementation (up to 6 months prior to surgery)
Nursing survey
Time frame: Post-implementation, 30 days after discharge
Number of emergency department visits, urgent care or outpatient appointments post-discharge
Time frame: Post-implementation, 30 days after discharge
Average number of tracheostomy-related phone calls per week post-discharge
Time frame: Post-implementation, 30 days after discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. Insignia Health provides rights to the Patient-Caregiver survey. As part of the agreement for access to the survey, they request that at the conclusion of the study we share the entire de-identified dataset. These will not be published by them or shared with another party
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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.
Rod Rezaee, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education booklet & standardized discharge training in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center 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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 2 Dec 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient-Caregiver Activation Survey scores (time frame: At time of surgery, an average of 15 minutes). 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 2 Dec 2025.