Implementation of a Standardized Tracheostomy Education Discharge Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Patient-Caregiver Activation Survey scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Education booklet & standardized discharge training (Behavioral)
Outcomes
Primary Outcomes
Patient-Caregiver Activation Survey scores
Time Frame: At first follow-up (1 week after discharge), 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
Patient-Caregiver Activation Survey scores
Time Frame: 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
Patient-Caregiver Activation Survey scores
Time Frame: At discharge (an average of 7 days after 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 Outcomes
- Number of emergency department visits, urgent care or outpatient appointments post-discharge(Post-implementation, 30 days after discharge)
- Feasibility Questionnaire scores(At time of 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)
- Average tracheostomy-related healthcare utilization costs(Post-implementation, 30 days after discharge)
- Nursing survey(Post-implementation, 30 days after discharge)
- Tracheostomy Care Competency Assessment(At first follow-up (1 week after discharge), an average of 15 minutes)
- Preparedness Caregiver Scale (PCS)(At first follow-up (1 week after discharge), an average of 15 minutes)
- Average number of tracheostomy-related phone calls per week post-discharge(Post-implementation, 30 days after discharge)
- 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)
- Preparedness Caregiver Scale (PCS)(At discharge (an average of 7 days after surgery), an average of 15 minutes)
- Tracheostomy Care Competency Assessment(At discharge (an average of 7 days after surgery), an average of 15 minutes)
- Average tracheostomy-related healthcare utilization costs(Pre-implementation (up to 6 months prior to surgery))
- Nursing survey(Pre-implementation (up to 6 months prior to surgery))