Remote Enhanced Assessment for Care At Home (REACH)

Not Applicable

Not yet recruiting

• Conditions: Common Childhood Illnesses

• Registration Number: NCT06843564
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-27
• Study Start: 2025-03
• Primary Completion: 2026-09
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Retention	From enrollment to survey completed 6 months after enrollment, up to 18 months	Percent who complete 6 months survey

Secondary Outcome Measures

Name	Time	Method
Recruitment	Day approached for recruitment, up to one year	Percent of individuals approached who consent
Kit utilization	From enrollment to survey completed 6 months after enrollment	Number of primary care telemedicine visits where kit devices are and are not used, assessed through both survey and through chart review.
Caregiver Satisfaction	From enrollment to survey completed 6 months after enrollment, up to 18 months	Caregiver satisfaction with care using the tele-device kit as reported at 6 month survey. Satisfaction will be assessed a single Likert scale survey item, ranging from 0 to 4, with higher scores indicating greater satisfaction with care.

Trial Locations

Locations (2)

UPMC Children's Hospital of Pittsburgh Primary Care Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Children's Community Pediatrics - Castle Shannon; 🇺🇸 Pittsburgh, Pennsylvania, United States