Clinical trial NCT06843564: Remote Enhanced Assessment for Care at Home (REACH)
Official title: Enhanced Primary Care Telemedicine at Home: a Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Common Childhood Illnesses
Keywords: Telemedicine
Telehealth
Pediatric
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this single arm pilot clinical trial is to test the feasibility and acceptability of providing families of infants with kits of tele-peripheral devices to use during telemedicine visits with their usual primary care practice.

The main question it aims to answer are:

- the feasibility of providing families of infants with a kit to tele-peripheral devices to use during at-home, same-day live-interactive primary care telemedicine visits.

Participants will receive a kit with tele-peripheral devices which they will have the option to use during telemedicine visits with their primary care practice. Participants will be asked to consent to electronic record review and to complete surveys about their experiences receiving care.

Detailed description: The investigators will prospectively enroll 100 children (6 month 0 days to 8 months 30 days) in this one-arm pilot feasibility study. Enrolled participants will receive kits including pulse oximeters, thermometers, and tele-otoscopes as well as respiratory viral swab tests and will complete a test call with study team members to confirm ability to connect and use the devices.

After enrollment, families will continue to seek care based on their own preferences and primary care clinic guidance, but will have the ability to provide additional information to their primary care clinicians when primary care telemedicine visits occur.

The investigators will ask families to complete online surveys at 0, 30, and 180 days, and the investigators will perform chart reviews to capture visits (telemedicine and in-person to primary care, urgent care, and emergency department) and antibiotic receipt.

Eligibility criteria: Inclusion Criteria:

* Infants receiving care at study sites presenting for 6 mo well child visit
* Infants between 6m0d and 8m30d

Exclusion Criteria:

* Caregiver not able to consent in English or Spanish
* Child has chronic condition (prematurity \<33 weeks, congenital anomaly)
* Child is ward of the state
* Family lacks device and/or wifi plan to be able to participate in telemedicine visits

Primary outcomes:
measure: Retention
timeFrame: From enrollment to survey completed 6 months after enrollment, up to 18 months
Secondary outcomes:
measure: Recruitment
timeFrame: Day approached for recruitment, up to one year
measure: Caregiver Satisfaction
timeFrame: From enrollment to survey completed 6 months after enrollment, up to 18 months
measure: Kit utilization
timeFrame: From enrollment to survey completed 6 months after enrollment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh Primary Care Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Community Pediatrics - Castle Shannon
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kristin Ray, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: