E-PRIME For Children With Medical Complexity (E-PRIME)

Enhanced Primary Care Via Telehealth 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Children With Medical Complexity
• Intervention / Treatment: Other: Usual Care and Enhanced Primary Care; Other: Enhanced Primary Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 909
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Savithri Nageswaran, MD; Phone Number: 336-716-6508; Email: snageswa@wakehealth.edu
• Study Contact Backup: Name: Caroline Kimes; Phone Number: 336.716.6014; Email: ckimes@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Savithri Nageswaran, MD; Phone Number: 336-716-6508; Email: snageswa@wakehealth.edu
      • Contact: Sabina Gesell, PhD; Phone Number: 336-713-8738; Email: sgesell@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Delayed Enhanced Primary Care (E-PRIME) Group; Children will receive usual care before receiving E-PRIME 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.; Other Names: Delayed E-PRIME
Experimental: Early Enhanced Primary Care (E-PRIME) Group; Subjects of this arm will receive E-PRIME intervention at the start of enrollment.	Other: 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.; Other Names: E-PRIME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days Outside the Home (DOH)	Number of hospital days + ER visit days + number of in-person appointments / child year	Baseline
Number of Days Outside the Home (DOH)	Number of hospital days + ER visit days + number of in-person appointments / child year	Year 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Emergency Room (ER) visits	Number of ER visits	Year 1
Number of Hospital Days	Number of hospital days/observation period in years	Year 1
Appointment Completion Rate	Proportion of scheduled appointments that were completed	Year 1
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Savithri Nageswaran, MD, Wake Forest University Health Sciences; Principal Investigator: Sabina Gesell, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Telehealth; Collaboration; Providers
• Other Study ID Numbers: IRB00102234; TE-2022C3-30607 (Other Identifier: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No