Education Booklet & Standardized Discharge Training for Head and Neck Cancers

Overseen By Rod Rezaee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: No caregiver, Illiterate, Previous tracheostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to develop a safe and effective method for teaching caregivers to manage tracheostomies (a tube in the neck to assist with breathing) for patients with head and neck cancers. An education booklet and standardized training will ensure caregivers feel confident and prepared when patients return home. The trial is suitable for patients with head and neck cancer who have recently undergone tracheostomies, lack prior tracheostomy experience, and have a family member or friend willing to assist them daily. As an unphased trial, this study provides patients the opportunity to contribute to enhancing caregiver education and support.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this tracheostomy teaching protocol is safe for caregivers?

Research has shown that using an educational booklet along with standard training for tracheostomy care is safe for both caregivers and patients. This method helps caregivers learn to care for someone with a tracheostomy, a procedure that creates an opening in the neck to aid breathing.

No negative effects have been reported from this educational approach. Studies have found that better training and resources increase caregivers' confidence and preparedness, which is crucial for patient safety and recovery. This training does not involve medication or physical treatment, so it poses no direct health risks.

Overall, this type of caregiver education focuses on building knowledge and confidence, essential for effective tracheostomy care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve the discharge process for patients with head and neck cancers by using an education booklet and standardized training. Unlike current methods, which may vary in content and delivery, this approach ensures consistent information is given to both patients and caregivers, potentially reducing confusion and anxiety during recovery. By standardizing the training and measuring its impact, the trial hopes to find out how better education can lead to improved patient outcomes and reduced healthcare utilization, such as fewer post-discharge complications or questions for healthcare providers.

What evidence suggests that this tracheostomy teaching protocol is effective for caregiver confidence and activation?

Research has shown that educational booklets and clear discharge instructions can greatly increase confidence in managing a tracheostomy for both patients and their caregivers. In this trial, participants will receive a tracheostomy education booklet and standardized discharge training. Studies have found that picture-based handouts enhance understanding and boost confidence in managing tracheostomies. A consistent education process also improves knowledge and confidence among healthcare providers, leading to better patient care. These findings suggest that clear, organized educational materials significantly aid caregivers in managing tracheostomy care at home. ^{2 3 6 7 8}

Who Is on the Research Team?

Rod Rezaee, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult patients with head and neck cancers who have had a tracheostomy and will keep it for at least 10 days after leaving the hospital. They need a caregiver aged 18+ without prior tracheostomy experience, who can read and is not going to a nursing facility.

Inclusion Criteria

I am over 18 and care for someone eligible for this trial.

My tracheostomy has been in place for at least 10 days after I left the hospital.

I am the main person helping with daily needs.

Exclusion Criteria

Patients who do not have a caregiver

My tracheostomy tube has been removed before leaving the hospital.

Caregivers who are illiterate.

Timeline for a Trial Participant

Pre-implementation

Assessment of healthcare utilization costs and nursing perspective on current caregiver tracheostomy knowledge

4 weeks

1 visit (in-person)

Protocol

Assessment of the necessity, acceptability, feasibility, fidelity, safety, and effectiveness of a standardized pathway and caregiver activation

4 weeks

3 visits (in-person), 1 visit (virtual)

Post-implementation

Assessment of post-implementation tracheostomy-related healthcare utilization costs and nursing perspective on caregiver tracheostomy knowledge

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after implementation

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Education booklet & standardized discharge training

Trial Overview The study tests an educational booklet & standardized discharge training protocol aimed at improving caregivers' ability to confidently manage tracheostomy care post-discharge from the hospital.

How Is the Trial Designed?

Group I: Tracheostomy discharge protocol Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

The Multimode Comprehensive Tailored Information Package (MCTIP) significantly improved cancer knowledge and satisfaction among 96 Head and Neck cancer patients compared to standard care, with results showing higher levels of knowledge and satisfaction at all evaluation points (p<0.001).

This study highlights the importance of providing tailored information to meet patients' needs, suggesting that personalized information services can enhance the overall experience and understanding of cancer treatment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do multimedia based information services increase knowledge and satisfaction in head and neck cancer patients? D'Souza, V., Blouin, E., Zeitouni, A., et al.[2017]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

A total of 602 head and neck cancer survivors provided patient-reported outcomes through an Internet-based survivorship care plan program, highlighting the effectiveness of this approach in gathering valuable data.

The most common treatment-related toxicities reported were difficulty swallowing (61.5%) and changes in skin color/texture (49.7%), indicating that these issues, along with fatigue, are significant concerns that need to be addressed in survivorship care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. Peach, MS., Trifiletti, DM., Vachani, C., et al.[2022]

This ongoing randomized trial involves 150 head-and-neck cancer patients and aims to improve adherence to prophylactic swallowing exercises (PSE) by comparing three different delivery methods: home exercises, home exercises with app counseling, and face-to-face therapy with a speech pathologist.

The study will evaluate the impact of these adherence-improving measures on patients' swallowing function and quality of life, highlighting the importance of maximizing adherence to enhance the effectiveness of PSE after (chemo)radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial). Baudelet, M., Van den Steen, L., Duprez, F., et al.[2020]

Implementing a comprehensive clinical care pathway for 55 patients undergoing major head and neck surgery significantly reduced pulmonary complications by 32.5% and shortened hospital stays by an average of 7.4 days.

The care pathway was found to be safe, with no increase in flap reoperation rates, suggesting it is an effective strategy for improving postoperative outcomes in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of pulmonary complications and hospital length of stay with a clinical care pathway after head and neck reconstruction. Yeung, JK., Dautremont, JF., Harrop, AR., et al.[2022]

Citations

1. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/270017

Implementation of a Standardized Tracheostomy Education ... 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 ...

2. ovid.com ovid.com/journals/cnur/pdf/10.1097/ncc.0000000000001237~effectiveness-of-pictorial-education-handout-on-tracheostomy

Effectiveness of Pictorial Education Handout on ... Conclusions: Pictorial patient education handouts were effective tools for improving patients' and family caregivers' confidence in tracheostomy care, and it is ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25041983/

Effectiveness of a standardized education process ... - PubMed Conclusions: A standardized education module for tracheostomy care teaching resulted in significant increases in provider knowledge and confidence.

4. researchgate.net researchgate.net/publication/369883344_Effectiveness_of_Pictorial_Education_Handout_on_Tracheostomy_Care_Self-efficacy_in_Patients_With_Head_and_Neck_Cancer_and_Family_Caregivers_A_Pilot_Quasi-Experimental_Study

(PDF) Effectiveness of Pictorial Education Handout on ... We recruited a total of 39 participants, including 22 patients with head and neck cancer-related tracheostomy and 17 family caregivers in 2021.

5. trachjournal.scholasticahq.com trachjournal.scholasticahq.com/article/129226-addressing-education-and-care-gaps-in-tracheostomy-management-insights-from-a-multi-stakeholder-global-survey

Insights from a Multi-Stakeholder Global Survey - Tracheostomy Effectiveness of Pictorial Education Handout on Tracheostomy Care Self-efficacy in Patients With Head and Neck Cancer and Family Caregivers: A Pilot Quasi ...

6. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-9-2021-d8e47

Education Booklet & Standardized Discharge Training for Head ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110650/

Experiences and Educational Needs of Hospital Staff ... Objective: To assess the experience and educational needs of hospital staff who care for pediatric patients with tracheostomies.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10635432/

Tracheostomy care quality improvement in low- and middle ... Tracheostomy is a lifesaving, essential procedure performed for airway obstruction in the case of head and neck cancers, prolonged ventilator ...