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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-Device Kit Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Enhanced Assessment for Care at Home (REACH) Kit | Other | 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. Note that the investigators are not studying the devices themselves; the investigators are instead studying health care use and experiences when these devices are made available. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Percent who complete 6 months survey | From enrollment to survey completed 6 months after enrollment, up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Percent of individuals approached who consent | Day approached for recruitment, up to one year |
| Caregiver Satisfaction | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Ray, MD, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh Primary Care Center | Pittsburgh | Pennsylvania | 15213 | United States | ||
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| ID | Term |
|---|---|
| D020794 | Receptor Protein-Tyrosine Kinases |
| ID | Term |
|---|---|
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
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|
| From enrollment to survey completed 6 months after enrollment, up to 18 months |
| Kit utilization | Number of primary care telemedicine visits where kit devices are and are not used, assessed through both survey and through chart review. | From enrollment to survey completed 6 months after enrollment |
| UPMC Children's Community Pediatrics - Castle Shannon |
| Pittsburgh |
| Pennsylvania |
| 15234 |
| United States |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |