Clinical trial NCT04741256: Implementation of a Standardized Tracheostomy Education Discharge Protocol
Official title: Implementation of a Standardized Tracheostomy Education Discharge Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Caregiver activation
Caregiver knowledge
Caregiver skills
Caregiver confidence
Tracheostomy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 75
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-Caregiver Activation Survey scores
timeFrame: At time of surgery, an average of 15 minutes
measure: Patient-Caregiver Activation Survey scores
timeFrame: At discharge (an average of 7 days after surgery), an average of 15 minutes
measure: Patient-Caregiver Activation Survey scores
timeFrame: At first follow-up (1 week after discharge), an average of 15 minutes
Secondary outcomes:
measure: Feasibility Questionnaire scores
timeFrame: At time of surgery, an average of 15 minutes
measure: Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
timeFrame: At time of surgery, an average of 15 minutes
measure: Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
timeFrame: At discharge (an average of 7 days after surgery), an average of 15 minutes
measure: Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
timeFrame: At first follow-up (1 week after discharge), an average of 15 minutes
measure: Preparedness Caregiver Scale (PCS)
timeFrame: At discharge (an average of 7 days after surgery), an average of 15 minutes
measure: Preparedness Caregiver Scale (PCS)
timeFrame: At first follow-up (1 week after discharge), an average of 15 minutes
measure: Tracheostomy Care Competency Assessment
timeFrame: At discharge (an average of 7 days after surgery), an average of 15 minutes
measure: Tracheostomy Care Competency Assessment
timeFrame: At first follow-up (1 week after discharge), an average of 15 minutes
measure: Average tracheostomy-related healthcare utilization costs
timeFrame: Pre-implementation (up to 6 months prior to surgery)
measure: Average tracheostomy-related healthcare utilization costs
timeFrame: Post-implementation, 30 days after discharge
measure: Nursing survey
timeFrame: Pre-implementation (up to 6 months prior to surgery)
measure: Nursing survey
timeFrame: Post-implementation, 30 days after discharge
measure: Number of emergency department visits, urgent care or outpatient appointments post-discharge
timeFrame: Post-implementation, 30 days after discharge
measure: Average number of tracheostomy-related phone calls per week post-discharge
timeFrame: Post-implementation, 30 days after discharge
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Rod Rezaee, MD
role: PRINCIPAL_INVESTIGATOR
References: