Clinical trial NCT04895085: ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort COVID-19 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance
Official title: ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort SARS-CoV-2 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Children With Medical Complexity (CMC)
Keywords: Caregiver
in-person school attendance
In-home COVID testing
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-05-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single site study taking place over 24 months and involving (50) caregivers and their children with medical complexity. Additionally, (20) of these caregivers will be invited to participate in an hour-long, virtual contextual inquiry session.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to learn about the factors parents consider when deciding whether their child will go to school in-person or attend from home. Investigators are also interested in learning whether access to in-home COVID testing is of value to parents and also whether it affects decision-making about returning to school.

This study is being done at UW-Madison in partnership between the Department of Pediatrics and the Department of Industrial and Systems Engineering. A total of 50 caregivers (plus their children with medical complexity) will participate in this study. Additionally, 20 caregivers involved in the study may also be invited to participate in a one-hour, virtual visit in which the caregiver demonstrates and discusses how they perform in-home COVID testing with their child.

The results of the study may help researchers advance their understanding of in-home testing strategies for children with medical complexity.

Detailed description: During the first three months of the study, caregivers will be asked to perform the BinaxNOW Rapid Antigen test on their child twice-weekly. After the first three months of the study, the testing schedule will depend on the statewide (WI) community spread rate. If the rate of spread is above the threshold for higher risk of transmission in schools (defined by the CDC as ≥ 25 new cases per 100,000 population in past 7 days) caregivers will be asked to continue twice-weekly surveillance. If it is below the threshold, caregivers will be offered the option to continue twice-weekly testing or switch to symptomatic-only testing. The study staff will notify caregivers of changes in testing frequency during their weekly communication. Caregivers will be asked to document their testing activities, results, and any possible COVID-19 symptoms on a Parent Testing Log.

If testing produces a negative result, the caregiver will be instructed to document the test result on their testing log. While false negative tests are possible with asymptomatic individuals, there will be no change in standard mitigation measures based on the test results (mandatory masks in school, social distancing, hand hygiene, etc.).

If testing produces a positive result from an asymptomatic individual, the caregiver will be instructed to contact the study team immediately and then obtain a PCR (polymerase chain reaction) test within 48 hours. The study staff will assist the caregiver in making arrangements for this test. In the case of positive tests, children will be restricted from school activities per public health guidelines until the results of the PCR testing are known. If the PCR test returns as a negative result and the child is attending school in-person, they will be allowed to return to school the next day (or if symptomatic, once symptoms resolve). If the PCR returns as positive, the caregiver will be instructed to keep the child at home per public health guidelines. To support families and ensure these steps occur, the study staff will call families daily following positive tests.

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, the caregiver/child must meet the following criteria:

* The caregiver is willing to comply with all study procedures and expects to be available for the duration of the study.
* The caregiver is at least 18 years of age.
* The caregiver is proficient in English.
* The caregiver is self-identified as the primary caregiver (parent, foster parent, legal guardian) of a CMC who is aged 5-16 years at the start of the study and who is enrolled in the Pediatric Complex Care Program (PCCP) at the University of WI-Madison.
* The caregiver is currently providing care on an ongoing basis to their CMC. The child may not be housed in a skilled nursing facility, an acute care or transitional facility, a rehabilitative hospital, a medical group home or in a foster home (unless the primary caregiver for the study is the foster parent).
* The caregiver has access to a web-enabled device (phone, tablet, or computer).
* Caregiver and child are residents of Wisconsin.
* The child attended in-person school pre-pandemic. (Child can currently be attending school in-person, remotely or a hybrid combination).
* The caregiver provides a written informed consent form.

Exclusion Criteria:

* Failure to meet all inclusion criteria.
* The child is hospitalized at the time of enrollment (visit may be rescheduled)
* Children not currently enrolled in public or private school and whose caregiver has no plan to enroll them in the Fall of 2021 (e.g., children currently homeschooling with plans to homeschool in the Fall of 2021 are ineligible).

Primary outcomes:
measure: Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached
timeFrame: Study duration (up to 21 months)
measure: Change in Mean Number of Weekly in Home COVID-19 Tests
timeFrame: Every week up to 21 months
measure: Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests Expected
timeFrame: Study duration (up to 21 months)
measure: Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed
timeFrame: Study duration (up to 21 months)
measure: Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed
timeFrame: Study duration (up to 21 months)
measure: Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing
timeFrame: Study duration (up to 21 months)
measure: Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled Participants
timeFrame: At month 3
measure: Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
timeFrame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Susceptibility: School Takes Precautions
timeFrame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Susceptibility: Likely to Get COVID-19
timeFrame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected
timeFrame: 15 month, 18 month, 21 month, 24 month
measure: Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced
timeFrame: 15 month, 18 month, 21 month, 24 month
measure: Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences
timeFrame: 15 month, 18 month, 21 month, 24 month
measure: Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month
measure: Change in Perceived Benefits to Attend School: Important to Health
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Perceived Benefits to Attend School: In-person Schooling
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Perceived Benefits to Attend School: Therapy Needs
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Perceived Benefits to Attend School: Positive for Family
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Perceived Benefits to Attend School: Positive for Staff
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Perceived Benefits to Attend School: Keep Jobs
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: Number of People
timeFrame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: Proximity
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: PPE
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: Testing
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: Following Recommendations
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: Transportation
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: Wash
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: Close Contact
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Barriers to School Attendance: Masking
timeFrame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
timeFrame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
timeFrame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N
timeFrame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan Coller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: