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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if telehealth can enhance care for children with medical complexity (CMC), who have rare diseases affecting multiple organs and require several specialists. The trial will assess whether telehealth can ease life for these children and their caregivers by improving care coordination. Participants will receive either enhanced primary care (E-PRIME) from the start or after a period of usual care. Suitable candidates include children with a chronic condition for over a year, those needing care from at least four specialists, or those relying on medical technology like a feeding tube or ventilator. As an unphased trial, this study presents a unique opportunity to explore innovative care solutions that could significantly improve the quality of life for children and their families.

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 prior data suggests that telehealth is safe for children with medical complexity?

Research has shown that telehealth for primary care is generally safe for children with complex medical needs. Studies have not reported any major safety issues or negative effects from using telehealth to manage their care.

Telehealth enables doctors to monitor and manage care remotely, which is particularly beneficial for children requiring multiple specialists. This approach appears effective, with no major problems reported.

Although specific safety data from clinical studies is lacking, telehealth is widely used and accepted in other areas of medicine, suggesting it is a safe option for children with complex medical needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Enhanced Primary Care (E-PRIME) for children with medical complexity because it offers a proactive and coordinated approach to managing these children's healthcare needs. Unlike usual care, which often involves reactive and fragmented treatment, E-PRIME emphasizes early intervention and personalized care plans tailored to each child's unique medical situation. This comprehensive approach aims to streamline care, reduce hospital visits, and improve overall health outcomes, providing a more integrated and effective healthcare experience for children and their families.

What evidence suggests that Enhanced Primary Care could be effective for children with medical complexity?

This trial will compare two approaches: Early Enhanced Primary Care (E-PRIME) and Delayed Enhanced Primary Care. Studies have shown that telehealth in primary care can be more effective than traditional care for children with complex medical needs. Research comparing these two methods found that telehealth improves access to care, aiding in better management of these needs. Another study found dissatisfaction among families and doctors with traditional care, highlighting the need for improved systems like telehealth. Additionally, telehealth supports organized care coordination, which has improved the care experience for these children. In summary, telehealth in primary care can lead to better management and support for children with complex medical needs. ^{1 2 6 7 8}

Who Is on the Research Team?

Savithri Nageswaran, MD

Principal Investigator

Wake Forest University Health Sciences

Sabina Gesell, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pcori.org pcori.org/research-results/2023/comparing-telehealth-model-primary-care-versus-usual-primary-care-children-complex-medical-conditions

Comparing a Telehealth Model of Primary Care Versus ... This study compares the clinical effectiveness of telehealth-enhanced primary care versus usual care for children with medical complexity (MC).

2. withpower.com withpower.com/trial/phase-children-with-medical-complexity-cmc-5-2024-94454

Enhanced Primary Care for Children With Medical ... A study involving 53 families and 170 primary care physicians revealed significant dissatisfaction with the care of children with medical complexity, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10028546/

Effectiveness of Structured Care Coordination for Children ... This randomized clinical trial uses a waitlist design to assess the effects of a pediatric complex care program on the experiences of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904347/

Enhancing the experience and outcomes of children with ... This realist review aims to understand how optimal experience and outcomes are achieved for CCCN during acute care, in different settings, for whom and why.

5. publications.aap.org publications.aap.org/hospitalpediatrics/article/15/9/701/203073/Implementation-of-an-EHR-Based-Emergency

Implementation of an EHR-Based Emergency Information ... Timely access to concise, accurate clinical information for children with medical complexity (CMC) may improve emergency department (ED) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3387912/

Children With Medical Complexity: An Emerging Population ... Abstract. Children with medical complexity (CMC) have medical fragility and intensive care needs that are not easily met by existing health care models.

7. researchprotocols.org researchprotocols.org/2024/1/e60621

Effectiveness of a Mobile App (Meds@HOME) to Improve ... The research question is, “For children with medical complexity who receive at least one high-risk medication, does use of the Meds@HOME digital ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10794091/

An mHealth Design to Promote Medication Safety in Children ... This study generated design requirements for a tool that may improve medication safety by creating distributed situation awareness within the caregiving ...