Children With Medical ComplexityE-PRIMENCT06216548
E-PRIME For Children With Medical Complexity
A study testing Enhanced Primary Care in people with Children With Medical Complexity, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Children With Medical Complexity
- What is being tested?
- Enhanced Primary Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 909 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than 18 years of age on the date of enrollment (date consented)
- 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 4 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)
Who cannot join
- CMC whose permanent address is outside of the state of North Carolina
- CMC at a long-term care facility
- CMC who are wards of the state, except when the caregiver is a legal guardian and can consent
- CMC whose caregivers do not speak English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Savithri Nageswaran, MD, 336-716-6508, snageswa@wakehealth.edu
Sabina Gesell, PhD, 336-713-8738, sgesell@wakehealth.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Children With Medical Complexity
- Being tested
- Usual Care and Enhanced Primary Care, Enhanced Primary Care
- Keywords
- Collaboration, Providers, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care and Enhanced Primary CareOther
Also called Delayed E-PRIME
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 CareOther
Also called E-PRIME
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.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Enhanced Primary Care (E-PRIME) Group | Active comparator | Children will receive usual care before receiving E-PRIME intervention. Receives: Other: Usual Care and Enhanced Primary Care |
| Early Enhanced Primary Care (E-PRIME) Group | Experimental | Subjects of this arm will receive E-PRIME intervention at the start of enrollment. Receives: Other: Enhanced Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Outside the Home (DOH)
Number of hospital days + ER visit days + number of in-person appointments / child year
Measured: Baseline
Number of Days Outside the Home (DOH)
Number of hospital days + ER visit days + number of in-person appointments / child year
Measured: Year 1
Secondary outcomes (6)
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.
Measured: Year 1
Number of Emergency Room (ER) visits
Number of ER visits
Measured: Year 1
Number of Hospital Days
Number of hospital days/observation period in years
Measured: Year 1
Appointment Completion Rate
Proportion of scheduled appointments that were completed
Measured: 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.
Measured: 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.)
Measured: Month 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start19 Jun 2024
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Medical ComplexityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention participants will complete the Enhanced Primary Care via Telehealth (E-PRIME) intervention for 12 months while Comparison participants will receive usual care for 6 months then complete the E-PRIME intervention for 12 months.
- Masking
- None (open label)
- Enrolment
- 909 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Savithri Nageswaran, MD, Principal investigator, Wake Forest University Health SciencesSabina Gesell, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216548
- Sponsor's protocol ID
- IRB00102234
- Other IDs
- TE-2022C3-30607
- Acronym
- E-PRIME
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Primary Care Via Telehealth for Children With Medical Complexity
- ClinicalTrials.gov ID
- NCT06216548
- Acronym / sponsor ID
- E-PRIME / IRB00102234
- Conditions
- Children With Medical Complexity
- Keywords
- Collaboration, Providers, Telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 909 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention participants will complete the Enhanced Primary Care via Telehealth (E-PRIME) intervention for 12 months while Comparison participants will receive usual care for 6 months then complete the E-PRIME intervention for 12 months.
| Arm | Type | Receives |
|---|---|---|
| Delayed Enhanced Primary Care (E-PRIME) Group | Active comparator | Other: Usual Care and Enhanced Primary CareChildren will receive usual care before receiving E-PRIME intervention. |
| Early Enhanced Primary Care (E-PRIME) Group | Experimental | Other: Enhanced Primary CareSubjects of this arm will receive E-PRIME intervention at the start of enrollment. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Less than 18 years of age on the date of enrollment (date consented)
- 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 4 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)
Key exclusion criteria (4 listed)
- CMC whose permanent address is outside of the state of North Carolina
- CMC at a long-term care facility
- CMC who are wards of the state, except when the caregiver is a legal guardian and can consent
- CMC whose caregivers do not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care and Enhanced Primary CareAlso: Delayed E-PRIMEUsual 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 | Delayed Enhanced Primary Care (E-PRIME) Group |
| Enhanced Primary CareAlso: E-PRIMEThe 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 | Early Enhanced Primary Care (E-PRIME) Group |
Primary outcome
Number of Days Outside the Home (DOH)
Time frame: Baseline
Number of hospital days + ER visit days + number of in-person appointments / child year
Number of Days Outside the Home (DOH)
Time frame: Year 1
Number of hospital days + ER visit days + number of in-person appointments / child year
6 secondary outcomes
Number of Hospitalizations
Time frame: Year 1
Number of Emergency Room (ER) visits
Time frame: Year 1
Number of Hospital Days
Time frame: Year 1
Appointment Completion Rate
Time frame: Year 1
Change in Caregiver Burden scores
Time frame: Month 19
Change in Caregiver Satisfaction with coordination of care scores
Time frame: Month 19
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Savithri Nageswaran, MD principal investigator
Wake Forest University Health Sciences
Sabina Gesell, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Primary Care in people with Children With Medical Complexity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Savithri Nageswaran, MD (336-716-6508, snageswa@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Outside the Home (DOH) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.