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Implementation of a Standardized Tracheostomy Education Discharge Protocol

Case Comprehensive Cancer Center (Case CCC) logo

Case Comprehensive Cancer Center (Case CCC)

Status

Withdrawn

Conditions

Head and Neck Cancer

Treatments

Behavioral: Education booklet & standardized discharge training

Study type

Interventional

Funder types

Other

Identifiers

NCT04741256
CASE4320

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Tracheostomy discharge protocol
Experimental group
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.
Treatment:
Behavioral: Education booklet & standardized discharge training

Trial contacts and locations

1

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Central trial contact

Rod Rezaee, MD

Data sourced from clinicaltrials.gov

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