Back to resultsImplementation of a Standardized Tracheostomy Education Discharge Protocol
Primary Purpose
Head and Neck Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education booklet & standardized discharge training
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Caregiver activation, Caregiver knowledge, Caregiver skills, Caregiver confidence, Tracheostomy
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
Sites / Locations
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tracheostomy discharge protocol
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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.
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
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
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
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.
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.
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
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
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
Average tracheostomy-related healthcare utilization costs
Average pre and post-implementation tracheostomy-related healthcare utilization costs
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
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
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
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
Full Information
NCT ID
NCT04741256
First Posted
February 2, 2021
Last Updated
May 15, 2023
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04741256
Brief Title
Implementation of a Standardized Tracheostomy Education Discharge Protocol
Official Title
Implementation of a Standardized Tracheostomy Education Discharge Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Caregiver activation, Caregiver knowledge, Caregiver skills, Caregiver confidence, Tracheostomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tracheostomy discharge protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education booklet & standardized discharge training
Intervention Description
Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.
Primary Outcome Measure Information:
Title
Patient-Caregiver Activation Survey scores
Description
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
Time Frame
At time of surgery, an average of 15 minutes
Title
Patient-Caregiver Activation Survey scores
Description
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
Time Frame
At discharge (an average of 7 days after surgery), an average of 15 minutes
Title
Patient-Caregiver Activation Survey scores
Description
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
Time Frame
At first follow-up (1 week after discharge), an average of 15 minutes
Secondary Outcome Measure Information:
Title
Feasibility Questionnaire scores
Description
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.
Time Frame
At time of surgery, an average of 15 minutes
Title
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Description
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
Time Frame
At time of surgery, an average of 15 minutes
Title
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Description
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
Time Frame
At discharge (an average of 7 days after surgery), an average of 15 minutes
Title
Patient Reported Outcomes Measurement Information System (PROMIS) short form scores
Description
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
Time Frame
At first follow-up (1 week after discharge), an average of 15 minutes
Title
Preparedness Caregiver Scale (PCS)
Description
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.
Time Frame
At discharge (an average of 7 days after surgery), an average of 15 minutes
Title
Preparedness Caregiver Scale (PCS)
Description
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.
Time Frame
At first follow-up (1 week after discharge), an average of 15 minutes
Title
Tracheostomy Care Competency Assessment
Description
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
Time Frame
At discharge (an average of 7 days after surgery), an average of 15 minutes
Title
Tracheostomy Care Competency Assessment
Description
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
Time Frame
At first follow-up (1 week after discharge), an average of 15 minutes
Title
Average tracheostomy-related healthcare utilization costs
Description
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
Time Frame
Pre-implementation (up to 6 months prior to surgery)
Title
Average tracheostomy-related healthcare utilization costs
Description
Average pre and post-implementation tracheostomy-related healthcare utilization costs
Time Frame
Post-implementation, 30 days after discharge
Title
Nursing survey
Description
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
Time Frame
Pre-implementation (up to 6 months prior to surgery)
Title
Nursing survey
Description
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
Time Frame
Post-implementation, 30 days after discharge
Title
Number of emergency department visits, urgent care or outpatient appointments post-discharge
Description
Number of emergency department visits, urgent care or outpatient appointments, relating to post-discharge assessment of feasibility and safety of intervention
Time Frame
Post-implementation, 30 days after discharge
Title
Average number of tracheostomy-related phone calls per week post-discharge
Description
Post-discharge assessment of feasibility, as measured by average number of tracheostomy-related phone calls per week
Time Frame
Post-implementation, 30 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rod Rezaee, MD
Phone
1-800-641-2422
Email
CTUReferral@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rod Rezaee, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rod Rezaee, MD
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Nicole Fowler, MD
First Name & Middle Initial & Last Name & Degree
Chelsea Hamill, MD
First Name & Middle Initial & Last Name & Degree
Susan Mazenec, PhD, RN
First Name & Middle Initial & Last Name & Degree
Lauren Sahagian, BSN
First Name & Middle Initial & Last Name & Degree
Kerry-Ann Walker, ARNP
First Name & Middle Initial & Last Name & Degree
Zachary Bennett, MD
First Name & Middle Initial & Last Name & Degree
Mark Frilling, MD
First Name & Middle Initial & Last Name & Degree
Benjamin Johnson, MD
First Name & Middle Initial & Last Name & Degree
Grant Muller, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Implementation of a Standardized Tracheostomy Education Discharge Protocol
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