Head and Neck Cancer
Conditions
Keywords
Caregiver activation, Caregiver knowledge, Caregiver skills, Caregiver confidence, Tracheostomy
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.
Interventions
BEHAVIORALEducation booklet & standardized discharge training
Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Caregiver Activation Survey scores | At time of surgery, an average of 15 minutes | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) short form scores | At time of surgery, an average of 15 minutes | 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 |
| Preparedness Caregiver Scale (PCS) | At discharge (an average of 7 days after surgery), an average of 15 minutes | 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 | At discharge (an average of 7 days after surgery), an average of 15 minutes | 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 |
| Feasibility Questionnaire scores | At time of surgery, an average of 15 minutes | 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. |
| Nursing survey | Pre-implementation (up to 6 months prior to surgery) | 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 | Post-implementation, 30 days after 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-implementation, 30 days after discharge | Post-discharge assessment of feasibility, as measured by average number of tracheostomy-related phone calls per week |
| Average tracheostomy-related healthcare utilization costs | Pre-implementation (up to 6 months prior to surgery) | 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 |
Countries
United States
Outcome results
None listed