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NCT Number: NCT06216548

E-PRIME For Children With Medical Complexity

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.

Recruiting

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The specific aims of this study are to: compare the effectiveness of Enhanced Primary Care via Telehealth (E-PRIME) verses usual care in improving child-level appointment and outcome measures; compare the effectiveness of (E-PRIME) verses usual care in reducing caregiver stress and improving caregiver satisfaction in primary care and care coordination services; evaluate how acceptable, appropriate, and feasible E-PRIME is from the perspective of practice providers and staff, and 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • 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

Treatment and study plan

Usual Care and Enhanced Primary Care

Other

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.

Other names: Delayed E-PRIME

Enhanced Primary Care

Other

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.

Other names: E-PRIME

Primary outcomes

  1. Number of Days Outside the Home (DOH)

    Time frame: Baseline

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

  2. Number of Days Outside the Home (DOH)

    Time frame: Year 1

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

Secondary outcomes

  1. Number of Hospitalizations

    Time frame: Year 1

    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.

  2. Number of Emergency Room (ER) visits

    Time frame: Year 1

    Number of ER visits

  3. Number of Hospital Days

    Time frame: Year 1

    Number of hospital days/observation period in years

  4. Appointment Completion Rate

    Time frame: Year 1

    Proportion of scheduled appointments that were completed

  5. Change in Caregiver Burden scores

    Time frame: Month 19

    Caregiver burden will be measured using the 15-item Impact on Family Scale- Revised which as 15 items and 4 domains - financial, family/social, personal strain, and mastery. Scores will range from 15 to 60. The higher the score the greater the impact.

  6. Change in Caregiver Satisfaction with coordination of care scores

    Time frame: Month 19

    Caregiver satisfaction with coordination of care will be compared between the two groups and measured by the Family Experiences with Coordination of Care survey. Scores will range from 0 to 100 and each item will be measured independently. Higher scores indicate better care (i.e. care plans, coordination, visit summary content, etc.)

Study contacts

Contact information is provided by the study sponsor or research team.

Madeleine Nieto, MPH

CONTACT

[email protected]

336.978.1913

Savithri Nageswaran, MD

CONTACT

[email protected]

336-716-6508

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Enhanced Primary Care Via Telehealth for Children With Medical Complexity

Acronym: E-PRIME

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 22, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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