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Implementation of a Standardized Tracheostomy Education Discharge Protocol

  • Time Stamp: October 30, 2023 8:00 PM
  • Source Node: 253199

Studies

Study First Submitted Date 2021-02-02
Study First Posted Date 2021-02-05
Last Update Posted Date 2023-05-16
Start Month Year October 2023
Primary Completion Month Year July 1, 2024
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-16

Detailed Descriptions

Sequence: 20606197
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.

Facilities

Sequence: 198923672
Name University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
City Cleveland
State Ohio
Zip 44106
Country United States

Facility Contacts

Sequence: 27981180
Facility Id 198923672
Contact Type primary
Name Rod Rezaee, MD
Email CTUReferral@UHhospitals.org
Phone 800-641-2422

Facility Investigators

Sequence: 18254451 Sequence: 18254452 Sequence: 18254453 Sequence: 18254454 Sequence: 18254455 Sequence: 18254456 Sequence: 18254457 Sequence: 18254458 Sequence: 18254459
Facility Id 198923672 Facility Id 198923672 Facility Id 198923672 Facility Id 198923672 Facility Id 198923672 Facility Id 198923672 Facility Id 198923672 Facility Id 198923672 Facility Id 198923672
Role Sub-Investigator Role Principal Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator
Name Nicole Fowler, MD Name Chelsea Hamill, MD Name Susan Mazenec, PhD, RN Name Lauren Sahagian, BSN Name Kerry-Ann Walker, ARNP Name Zachary Bennett, MD Name Mark Frilling, MD Name Benjamin Johnson, MD Name Grant Muller, MD

Conditions

Sequence: 51876276
Name Head and Neck Cancer
Downcase Name head and neck cancer

Id Information

Sequence: 39924390
Id Source org_study_id
Id Value CASE4320

Countries

Sequence: 42319095
Name United States
Removed False

Design Groups

Sequence: 55297546
Group Type Experimental
Title Tracheostomy discharge protocol
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.

Interventions

Sequence: 52194622
Intervention Type Behavioral
Name Education booklet & standardized discharge training
Description Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.

Keywords

Sequence: 79391940 Sequence: 79391941 Sequence: 79391942 Sequence: 79391943 Sequence: 79391944
Name Caregiver activation Name Caregiver knowledge Name Caregiver skills Name Caregiver confidence Name Tracheostomy
Downcase Name caregiver activation Downcase Name caregiver knowledge Downcase Name caregiver skills Downcase Name caregiver confidence Downcase Name tracheostomy

Design Outcomes

Sequence: 176402078 Sequence: 176402079 Sequence: 176402080 Sequence: 176402081 Sequence: 176402082 Sequence: 176402083 Sequence: 176402084 Sequence: 176402085 Sequence: 176402086 Sequence: 176402087 Sequence: 176402088 Sequence: 176402089 Sequence: 176402090 Sequence: 176402091 Sequence: 176402092 Sequence: 176402093 Sequence: 176402094
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Patient-Caregiver Activation Survey scores Measure Patient-Caregiver Activation Survey scores Measure Patient-Caregiver Activation Survey scores Measure Feasibility Questionnaire scores Measure Patient Reported Outcomes Measurement Information System (PROMIS) short form scores Measure Patient Reported Outcomes Measurement Information System (PROMIS) short form scores Measure Patient Reported Outcomes Measurement Information System (PROMIS) short form scores Measure Preparedness Caregiver Scale (PCS) Measure Preparedness Caregiver Scale (PCS) Measure Tracheostomy Care Competency Assessment Measure Tracheostomy Care Competency Assessment Measure Average tracheostomy-related healthcare utilization costs Measure Average tracheostomy-related healthcare utilization costs Measure Nursing survey Measure Nursing survey Measure Number of emergency department visits, urgent care or outpatient appointments post-discharge Measure Average number of tracheostomy-related phone calls per week post-discharge
Time Frame At time of surgery, an average of 15 minutes Time Frame At discharge (an average of 7 days after surgery), an average of 15 minutes Time Frame At first follow-up (1 week after discharge), an average of 15 minutes Time Frame At time of surgery, an average of 15 minutes Time Frame At time of surgery, an average of 15 minutes Time Frame At discharge (an average of 7 days after surgery), an average of 15 minutes Time Frame At first follow-up (1 week after discharge), an average of 15 minutes Time Frame At discharge (an average of 7 days after surgery), an average of 15 minutes Time Frame At first follow-up (1 week after discharge), an average of 15 minutes Time Frame At discharge (an average of 7 days after surgery), an average of 15 minutes Time Frame At first follow-up (1 week after discharge), an average of 15 minutes Time Frame Pre-implementation (up to 6 months prior to surgery) Time Frame Post-implementation, 30 days after discharge Time Frame Pre-implementation (up to 6 months prior to surgery) Time Frame Post-implementation, 30 days after discharge Time Frame Post-implementation, 30 days after discharge Time Frame Post-implementation, 30 days after discharge
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 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 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 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. 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 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 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 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. 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. 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 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 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 Description Average pre and post-implementation tracheostomy-related healthcare utilization costs 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 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 Description Number of emergency department visits, urgent care or outpatient appointments, relating to post-discharge assessment of feasibility and safety of intervention Description Post-discharge assessment of feasibility, as measured by average number of tracheostomy-related phone calls per week

Browse Conditions

Sequence: 192293713 Sequence: 192293714 Sequence: 192293715
Mesh Term Head and Neck Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms
Downcase Mesh Term head and neck neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48043624
Agency Class OTHER
Lead Or Collaborator lead
Name Case Comprehensive Cancer Center

Overall Officials

Sequence: 29112167
Role Principal Investigator
Name Rod Rezaee, MD
Affiliation University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Central Contacts

Sequence: 11946942
Contact Type primary
Name Rod Rezaee, MD
Phone 1-800-641-2422
Email CTUReferral@UHhospitals.org
Role Contact

Design Group Interventions

Sequence: 67790748
Design Group Id 55297546
Intervention Id 52194622

Eligibilities

Sequence: 30591420
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253878493
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 14

Designs

Sequence: 30339140
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28716234
Responsible Party Type Sponsor
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