Parental Perception of COVID-19 Vaccine in Technology Dependent Patients

July 15, 2022 updated by: Northwell Health

Parental Perception of COVID-19 Vaccine in Pediatric Patients With Tracheostomy and Ventilator Dependence

This study involves conducting a telephonic or in person survey regarding parental perception and attitudes about vaccinating the respective "technology dependent" child with the COVID 19 vaccination. "Technology dependent" includes tracheostomy dependence, artificial ventilator dependence and non invasive mechanical ventilation dependence. This population is vulnerable since most patients have underlying lung disease, chronic respiratory failure and require respiratory equipment to assist with breathing. "Technology dependent" patients are particularly vulnerable to respiratory infections and are considered high risk for developing severe COVID 19 illness. Despite this population's high risk for morbidity and mortality from respiratory viral infections, the investigator hypothesize that 50% of the parents are still vaccine hesitant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vaccinating the population is the next step in combating COVID 19 pandemic however there continues to be vaccine hesitancy. Vaccine hesitancy is the indecision of consenting to vaccination (Dosanjh, 2021) and is not a new phenomenon. The most recent example is the reemergence of measles in the United States prior to the COVID 19 pandemic. Anti-vaccine groups have spread messages of conspiracy theories, myths and misperceptions, questions about the speed of vaccine development and long term side effects in the media which also attributes to COVID-19 vaccine hesitancy (Khubcandani et al, 2021).

Children infected with COVID 19 typically have mild symptoms of the disease. Risk factors associated with severe disease are neonatal age group, male gender, lower respiratory tract disease and pre-existing medical conditions. Children who use chronic home mechanical ventilation are considered a high-risk group for developing severe COVID 19 infection (Vasconcello-Castillo et al., 2020). These children have various diagnoses and pathologies such as neuromuscular disease, sleep disorders and chronic lung disease. These patients require continuous use of ventilatory support in the home and are at high risk for respiratory infections and mortality. Most of these patients need advanced nursing care and special respiratory equipment to prevent hospitalization such as manual chest physiotherapy, mechanical ex-sufflator device, chest vest device and increased ventilator support.

Recently the FDA approved of Pfizer's COVID 19 vaccine in ages 12 and older. It is anticipated that by fall 2021 the Pfizer COVID 19 vaccine will be approved by the FDA for children ages 2 and older. Vaccinating children will help decrease transmission of COVID 19, contribute to community immunity and allow kids go back to camps this summer and back to in-person school more safely.

Since the chronic home mechanical ventilation population is at risk for developing severe COVID 19 disease, the investigator would hypothesize that most parents are ready and willing to vaccinate their children. The purpose of this study is to evaluate the parental perception of COVID 19 vaccine in pediatric patients with "technology dependence" and identify the barriers to vaccination.

After surveys are collected and barriers are identified, vaccine counseling will be provided by a provider (nurse practitioner or physician). Vaccine safety, efficacy, side effects will be reviewed with the parents.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health Physician Partners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parents of technology dependent pediatric patients

Description

Inclusion Criteria:

  • Mother or father of child will be interviewed
  • Pediatric patient (age 0-21)
  • "Technology dependent" with one or more of the following: tracheostomy, ventilator use, non-invasive mechanical ventilator use (BiPAP, CPAP, Airvo), diaphragmatic pacing, oxygen

Exclusion Criteria:

  • Other caretakers such as grandparents, aunts, uncles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric Technology Dependent Patients at Cohen Children's Medical Center
Behavioral: COVID 19 vaccine counseling
After surveys are completed, pulmonary provider (nurse practitioner or physician) will provide counseling via phone or in person about the COVID 19 vaccine. Safety, efficacy and side effects will be reviewed.
Pediatric Technology Dependent Patients at Ann & Robert H. Lurie Children's Hospital of Chicago
Behavioral: COVID 19 vaccine counseling
After surveys are completed, pulmonary provider (nurse practitioner or physician) will provide counseling via phone or in person about the COVID 19 vaccine. Safety, efficacy and side effects will be reviewed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of pediatric patient getting COVID 19 vaccine
Time Frame: 6 months after initial survey
6 months after initial survey

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of mothers getting COVID 19 vaccine
Time Frame: 6 months after initial survey
6 months after initial survey
Percentage of fathers getting COVID 19 vaccine
Time Frame: 6 months after initial survey
6 months after initial survey
Percentage of other adults in household getting COVID 19 vaccine
Time Frame: 6 months after initial survey
6 months after initial survey
Percentage of other eligible children in household getting COVID 19 vaccine
Time Frame: 6 months after initial survey
6 months after initial survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Karen Capusan, MSN, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 23, 2021

Primary Completion (ACTUAL)

March 31, 2022

Study Completion (ACTUAL)

March 31, 2022

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (ACTUAL)

October 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-0822

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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