Enhanced Primary Care for Children With Medical Complexity

(E-PRIME Trial)

Overseen By Madeleine Nieto, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Outside North Carolina, Long-term care, Wards, Language, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

909 Participants Needed

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. ^{1 2 3 4 5}

What 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. ^{1 2 4 6 7}

Research Team

Savithri Nageswaran, MD

Principal Investigator

Wake Forest University Health Sciences

Sabina Gesell, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility 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

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

Treatment Details

Interventions

• Enhanced Primary Care
• Usual Care and Enhanced Primary Care

Trial Overview 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.

Participant Groups

Group I: Early Enhanced Primary Care (E-PRIME) Group Experimental Treatment 1 Intervention

Subjects of this arm will receive E-PRIME intervention at the start of enrollment.

Group II: Delayed Enhanced Primary Care (E-PRIME) Group Active Control 1 Intervention

Children will receive usual care before receiving E-PRIME intervention.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

A study involving 53 families and 170 primary care physicians revealed significant dissatisfaction with the care of children with medical complexity, highlighting a lack of coordination between primary care and hospital services, with 73.6% of families reporting this issue.

Primary care physicians expressed a need for better training and experience in managing complex medical cases, with 96.5% feeling inadequately trained and 80.5% noting poor communication with hospitals, indicating a critical need for improved education and resources in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current situation of children with medical complexity: An experience between primary and hospital care]. Monroy Tapiador, MÁ., Climent Alcalá, FJ., Rodríguez Alonso, A., et al.[2021]

Coordinating care for children with complex medical needs requires strong relationships and effective communication between families and healthcare providers.

Partnerships with specialized complex care programs can enhance the overall care experience for these children and their families, making it more manageable within busy primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Maya: A Family, Pediatrician, and Complex Care Partnership. Owens, H., Hansen, SP., Lee, KJ.[2021]

The electronic referral and consultation system at Boston Children's Hospital significantly improved communication between primary care providers and specialists, with 89% of PCPs reporting better communication and 92% feeling they could provide superior patient care.

The system led to faster specialist response times and reduced wait times for appointments from 48 to 34 days, while improving completion rates of specialty visits from 58% to 70%, although it did not change the overall volume of referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Care: Using an Electronic Consult Form to Facilitate Primary Care Provider-Specialty Care Coordination. Rea, CJ., Wenren, LM., Tran, KD., et al.[2019]

Community primary care providers (PCPs) identified significant barriers to caring for children with medical complexity, including issues like polypharmacy, multiple organ system involvement, and the challenges posed by rare diagnoses, which affect their ability to provide effective care.

To enhance care coordination, PCPs emphasized the need for more time with patients and families, improved communication with specialists, and the use of summative action plans, highlighting these as key facilitators for better managing the complexities of care for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Children with Medical Complexity: Perspectives of Primary Care Providers. Foster, CC., Mangione-Smith, R., Simon, TD.[2018]

In a study of 1591 children with special health care needs, low-quality family-centered care was linked to significantly higher rates of nonurgent emergency department visits, indicating that better family engagement in care could reduce unnecessary healthcare use.

For privately insured children, low-quality family-centeredness was also associated with increased hospitalizations, suggesting that improving the quality of family-centered care is crucial for preventing avoidable health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between quality of primary care and health care use among children with special health care needs. Raphael, JL., Mei, M., Brousseau, DC., et al.[2020]

A total of 11 Entrustable Professional Activities (EPAs) were developed for pediatricians caring for children with medical complexity (CMC), outlining essential knowledge, skills, and attitudes needed for competency.

The EPAs were fully aligned with the Accreditation Council for Graduate Medical Education milestones, ensuring that they meet established educational standards and were refined based on feedback from diverse stakeholders, including clinicians and family leaders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multistakeholder Approach to the Development of Entrustable Professional Activities in Complex Care. Huth, K., Henry, D., Cribb Fabersunne, C., et al.[2022]

A point-of-care screening algorithm was successfully implemented to identify children with medical complexity (CMC) among hospitalized patients, categorizing 2187 inpatients into three groups based on their health care needs.

Children identified as CMC had significantly more complex chronic conditions and higher hospital resource use compared to those with special health care needs or previously healthy children, indicating they are a key group that could benefit from enhanced care coordination services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Complexity Screening Algorithm to Identify Children With Medical Complexity. Parente, V., Parnell, L., Childers, J., et al.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Current situation of children with medical complexity: An experience between primary and hospital care]. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Caring for Maya: A Family, Pediatrician, and Complex Care Partnership. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Shared Care: Using an Electronic Consult Form to Facilitate Primary Care Provider-Specialty Care Coordination. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Caring for Children with Medical Complexity: Perspectives of Primary Care Providers. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Associations between quality of primary care and health care use among children with special health care needs. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Multistakeholder Approach to the Development of Entrustable Professional Activities in Complex Care. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Point-of-Care Complexity Screening Algorithm to Identify Children With Medical Complexity. [2022]