Implementation of a Standardized Tracheostomy Education Discharge Protocol

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementation of a Standardized Tracheostomy Education Discharge Protocol

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Education booklet & standardized discharge training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tracheostomy discharge protocol<br>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<br>* Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver knowledge, Caregiver skills, Caregiver confidence, Tracheostomy, Caregiver activation