Implementation of a Standardized Tracheostomy Education Discharge Protocol

NCT04741256 | Withdrawn

• 1 other identifier: CASE4320
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Caregiver activation; Caregiver knowledge; Caregiver skills; Caregiver confidence; Tracheostomy

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  At first follow-up (1 week after discharge), an average of 15 minutes

Secondary Outcomes (14)

• Feasibility Questionnaire scores

  At time of surgery, an average of 15 minutes

• Patient Reported Outcomes Measurement Information System (PROMIS) short form scores

  At time of surgery, an average of 15 minutes

• Patient Reported Outcomes Measurement Information System (PROMIS) short form scores

  At discharge (an average of 7 days after surgery), an average of 15 minutes

• Patient Reported Outcomes Measurement Information System (PROMIS) short form scores

  At first follow-up (1 week after discharge), an average of 15 minutes

• Preparedness Caregiver Scale (PCS)

  At discharge (an average of 7 days after surgery), an average of 15 minutes

Study Arms (1)

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.

Behavioral: Education booklet & standardized discharge training

Interventions

Education booklet & standardized discharge training BEHAVIORAL

Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.

Tracheostomy discharge protocol

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Rod Rezaee, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  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: February 2, 2021
• First Posted: February 5, 2021
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)