Health TrialsbyHealthPanel

E-PRIME For Children With Medical Complexity

ConditionChildren With Medical Complexity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorWake Forest University Health Sciences

About this trial

Children with medical complexity (CMC) have very high needs for health and support services. CMC have very rare diseases that involve multiple organ systems. As a result, all CMC have multiple chronic conditions and need care from many specialists and services. While there are important benefits to the child and family in living at home, the continuing need for complex medical care places a profound burden on caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Less than 18 years of age on the date of enrollment (date consented)

Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months

Complexity of the condition, defined as needing ongoing care with 4 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)

Disqualifiers

CMC whose permanent address is outside of the state of North Carolina

CMC at a long-term care facility

CMC who are wards of the state, except when the caregiver is a legal guardian and can consent

CMC whose caregivers do not speak English or Spanish

Trial design

Design model

Parallel

Treatments tested in this trial

  • Usual Care and Enhanced Primary Care

    Other intervention

    Usual Care: Interdisciplinary complex care teams help coordinate appointments, facilitate communication between the many specialist providers involved in the child's care, support families, assist with practical needs, and are available as a resource (as consultants) for Primary Care Physicians (PCPs) to care for Children with Medical Complexity (CMC). The complex care teams in tertiary care children's hospital is the focus for providing comprehensive care for CMC. Enhanced Primary Care: The E-PRIME team will support the CMC and their caregivers with navigating the patient access portal and how to use the video visit platform for the telehealth visits. The physician or nurse of the E-PRIME team will create clinical summaries about CMC's visit to specialists and hospital and share this health information about CMC with his/her PCP to help the PCP provide care for CMC at home. A team of telehealth experts will help PCPs in using telehealth in their practice.

  • Enhanced Primary Care

    Other intervention

    The intervention has the following components: (A) The staff of the E-PRIME team will support the CMC and their caregivers with navigating the patient access portal and how to use the video visit platform for the telehealth visits. (B) The physician or nurse of the E-PRIME team will create clinical summaries about CMC's visit to specialists and hospital and share this health information about CMC with his/her PCP to help the PCP provide care for CMC at home. (C) A team of telehealth experts will help PCPs in using telehealth in their practice.

Treatment groups

909 Participants
are divided into 2 treatment groups
Group A: Delayed Enhanced Primary Care (E-PRIME) GroupActive comparator 1 intervention
Group B: Early Enhanced Primary Care (E-PRIME) GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Days Outside the Home (DOH)

Number of hospital days + ER visit days + number of in-person appointments / child year

Time frame
Baseline
2

Number of Days Outside the Home (DOH)

Number of hospital days + ER visit days + number of in-person appointments / child year

Time frame
Year 1

Secondary outcomes

1

Number of Hospitalizations

Number of hospitalizations/100-child years in the two groups. Number of hospitalizations during the observation period will be counted and the rate will be calculated as: \[Number of hospitalizations/ observation period in years\]\*100. Planned admissions (i.e. elective surgeries, procedures, treatments, etc.) will be excluded.

Time frame
Year 1
2

Number of Emergency Room (ER) visits

Number of ER visits

Time frame
Year 1
3

Number of Hospital Days

Number of hospital days/observation period in years

Time frame
Year 1
4

Appointment Completion Rate

Proportion of scheduled appointments that were completed

Time frame
Year 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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