Implementation of a Standardized Tracheostomy Education Discharge Protocol

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Education booklet & standardized discharge training

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 Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rod Rezaee, MD; Phone Number: 1-800-641-2422; Email: CTUReferral@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
      • Contact: Rod Rezaee, MD; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org
      • Sub-Investigator: Nicole Fowler, MD
      • Principal Investigator: Chelsea Hamill, MD
      • Sub-Investigator: Susan Mazenec, PhD, RN
      • Sub-Investigator: Lauren Sahagian, BSN
      • Sub-Investigator: Kerry-Ann Walker, ARNP
      • Sub-Investigator: Zachary Bennett, MD
      • Sub-Investigator: Mark Frilling, MD
      • Sub-Investigator: Benjamin Johnson, MD
      • Sub-Investigator: Grant Muller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tracheostomy discharge protocol; 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; Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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.	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.	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	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	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	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	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	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	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	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	Post-implementation, 30 days after discharge

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Rod Rezaee, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Tracheostomy; Caregiver activation; Caregiver knowledge; Caregiver skills; Caregiver confidence
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CASE4320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No