Enhanced Primary Care for Children With Medical Complexity
(E-PRIME Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Outside North Carolina, Long-term care, Wards, Language, others
No Placebo Group
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Enhanced Primary Care for children with medical complexity?
Research highlights that effective care for children with medical complexity involves strong relationships, structured information-sharing, and partnerships with complex care programs, which can improve care outcomes. Additionally, using electronic systems to coordinate between primary care and specialists can enhance communication and care quality.
12345What makes the Enhanced Primary Care treatment unique for children with medical complexity?
Enhanced Primary Care for children with medical complexity focuses on improving care coordination and building strong relationships between families, primary care providers, and complex care programs. This approach is unique because it emphasizes structured information-sharing and partnerships to address the robust needs of these children, which is not typically the focus of usual care.
12467Eligibility Criteria
This trial is for children with complex medical needs involving multiple chronic conditions and organ systems. They require care from various specialists and have high support needs. The study aims to help caregivers by testing if telehealth can ease the burden of coordinating care among different providers.Inclusion Criteria
I am under 18 years old.
Complexity of the condition, defined as needing ongoing care with ≥ 5 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)
Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months
Exclusion Criteria
I am a child with complex medical needs, either in long-term care, under state care, or with non-English/Spanish speaking caregivers.
I am over 18 and won't need to change consent forms during the study.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Early Enhanced Primary Care (E-PRIME) Intervention
Subjects receive E-PRIME intervention at the start of enrollment
19 months
Telehealth visits as needed
Delayed Enhanced Primary Care (E-PRIME) Intervention
Children receive usual care before receiving E-PRIME intervention
19 months
Telehealth visits as needed
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is examining whether enhanced primary care that includes telehealth services can improve treatment, monitoring, and management for these children compared to usual care. It seeks to determine if this approach reduces caregiver stress and improves coordination between healthcare providers.
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Enhanced Primary Care (E-PRIME) GroupExperimental Treatment1 Intervention
Subjects of this arm will receive E-PRIME intervention at the start of enrollment.
Group II: Delayed Enhanced Primary Care (E-PRIME) GroupActive Control1 Intervention
Children will receive usual care before receiving E-PRIME intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health SciencesWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
[Current situation of children with medical complexity: An experience between primary and hospital care]. [2021]To analyze the assessment of the care of children with medical complexity (CMC) in Primary Care (PC), from the point of view of their doctors and their families.
Caring for Maya: A Family, Pediatrician, and Complex Care Partnership. [2021]Coordinating care to meet the robust needs of children with medical complexity and their families is challenging, especially in the setting of a busy primary care practice. This article describes the experience of one family and pediatrician and highlights specific factors, such as a focus on building relationships, meaningful and structured information-sharing, and partnership with a complex care program, that can positively affect care. [Pediatr Ann. 2020;49(11):e486-e490.].
Shared Care: Using an Electronic Consult Form to Facilitate Primary Care Provider-Specialty Care Coordination. [2019]The quality of children's health is compromised by poor care coordination between primary care providers (PCPs) and specialists. Our objective was to determine how an electronic consultation and referral system impacts referral patterns and PCP-specialist communication.
Caring for Children with Medical Complexity: Perspectives of Primary Care Providers. [2018]To describe typical care experiences and key barriers and facilitators to caring for children with medical complexity (CMC) from the perspective of community primary care providers (PCPs).
Associations between quality of primary care and health care use among children with special health care needs. [2020]To determine whether parent-reported quality of primary care was associated with subsequent health care use for children with special health care needs.
A Multistakeholder Approach to the Development of Entrustable Professional Activities in Complex Care. [2022]Care of children with medical complexity (CMC) involves unique knowledge, skills, and attitudes. Previous work has identified curricular priorities in complex care for pediatricians yet there are no established competency frameworks to guide curriculum development. We aimed to develop and appraise Entrustable Professional Activities (EPAs) for the care of CMC with multistakeholder involvement.
Point-of-Care Complexity Screening Algorithm to Identify Children With Medical Complexity. [2022]For pediatric complex care programs to target enhanced care coordination services to the highest-risk patients, it is critical to accurately identify children with medical complexity (CMC); however, no gold standard definition exists. The aim of this study is to describe a point-of-care screening algorithm to identify CMC with high health care use, a group that may benefit the most from improved care coordination.