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Remote Enhanced Assessment for Care at Home (REACH)

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University of Pittsburgh

Status

Active, not recruiting

Conditions

Common Childhood Illnesses

Treatments

Other: Remote Enhanced Assessment for Care at Home (REACH) Kit

Study type

Interventional

Funder types

Other

Identifiers

NCT06843564
STUDY24110038

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

6 to 20 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Infants receiving care at study sites presenting for primary care child visit
  • Infants between 6m0d and 20m30d

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Tele-Device Kit Arm
Experimental group
Description:
Families of 6 month old infants will receive tele-device kits that include thermometers, pulse oximeters, and tele-otoscopes and respiratory swab tests, which families will then have the option to use when they schedule telemedicine visits with their usual primary care practice.
Treatment:
Other: Remote Enhanced Assessment for Care at Home (REACH) Kit

Trial contacts and locations

2

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Central trial contact

Kristin Ray, MD, MS

Data sourced from clinicaltrials.gov

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