E-PRIME For Children With Medical Complexity

Children With Medical Complexity Clinical Trial

— E-PRIME  

Official title:

Enhanced Primary Care Via Telehealth for Children With Medical Complexity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216548
• Other study ID #: IRB00102234
• Secondary ID: TE-2022C3-30607
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: April 2028

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Savithri Nageswaran, MD
• Phone: 336-716-6508
• Email: snageswa[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 909
• Est. completion date: April 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Less than 18 years of age

• 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 = 5 sub-specialists/ services OR dependent on = 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)

Exclusion Criteria:

• Children who might turn 18 during the intervention period will be excluded to avoid having to re-consent with adult informed consent form (ICF).

• Children with medical complexity (CMC) who are at a long-term care facility, wards of the state, or whose caregivers do not speak English or Spanish.

Related Conditions & MeSH terms

• Children With Medical Complexity

Intervention

Other:
• Usual Care and Enhanced Primary Care
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
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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days Outside the Home (DOH)	Number of hospital days + ER visit days + number of in-person appointments / child year	Baseline
Primary	Number of Days Outside the Home (DOH)	Number of hospital days + ER visit days + number of in-person appointments / child year	Year 1
Secondary	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.	Year 1
Secondary	Number of Emergency Room (ER) visits	Number of ER visits	Year 1
Secondary	Number of Hospital Days	Number of hospital days/observation period in years	Year 1
Secondary	Appointment Completion Rate	Proportion of scheduled appointments that were completed	Year 1
Secondary	Change in Caregiver Burden scores	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.	Month 19
Secondary	Change in Caregiver Satisfaction with coordination of care scores	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.)	Month 19