Implementation of a Standardized Tracheostomy Education Discharge Protocol

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT04741256
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-05
• Study Start: 2025-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient-Caregiver Activation Survey scores	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

Secondary Outcome Measures

Name	Time	Method
Feasibility Questionnaire scores	At time of surgery, an average of 15 minutes	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.
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores	At first follow-up (1 week after discharge), an average of 15 minutes	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
Nursing survey	Post-implementation, 30 days after discharge	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
Number of emergency department visits, urgent care or outpatient appointments post-discharge	Post-implementation, 30 days after discharge	Number of emergency department visits, urgent care or outpatient appointments, relating to post-discharge assessment of feasibility and safety of intervention
Tracheostomy Care Competency Assessment	At first follow-up (1 week after discharge), an average of 15 minutes	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
Preparedness Caregiver Scale (PCS)	At first follow-up (1 week after discharge), an average of 15 minutes	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.
Average number of tracheostomy-related phone calls per week post-discharge	Post-implementation, 30 days after discharge	Post-discharge assessment of feasibility, as measured by average number of tracheostomy-related phone calls per week
Average tracheostomy-related healthcare utilization costs	Post-implementation, 30 days after discharge	Average pre and post-implementation tracheostomy-related healthcare utilization costs

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States