Chronic Disease ManagementNCT06993129
A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity
A study testing Emergency Care Action Plan in people with Chronic Disease Management and Infants Health, run by University of Vermont at 4 sites in United States.
Trial summary
Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Chronic Disease Management, Infants Health, Emergency
- What is being tested?
- Emergency Care Action Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Apr 2026to 1 Jun 2031
- 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 0 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0 to 6 months
- Admitted to the University of Vermont Medical Center, Cincinnati Children's Hospital, Children's Hospital of Philadelphia, or Colorado Children's Hospital Neonatal Intensive Care Unit (NICU),
- Meets or is expected to meet Children with Medical Complexity status as determined by the treating NICU clinician and defined as "children with multiple significant chronic health problems including multiple organ systems, which result in functional limitations, high health care needs or utilization, and often require need for, or use of, medical technology."
- Has three or more documented complex chronic conditions (CCCs)
Who cannot join
- Does not have a caregiver participant who agrees to their participation in the study to complete follow-up surveys
- Does not intend to use the hospital or affiliated sites of which they were recruited from for care during the one-year trial period
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Roz King, MSN, RN contact
United States4 sites
Colorado Children's Hospital
Aurora, Colorado, 80045
Sandra Spencer, MD, 720-777-1234, sandra.spencer@childrenscolorado.org
University of Vermont Medical Center
Burlington, Vermont, 05401
Christian Pulcini, MD, MEd, MPH, 802-324-8368, christian.pulcini@uvm.edu
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, 45229
Lauren Riney, DO, 513-636-4293, lauren.riney@cchmc.org
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 05482
Joseph Zorc, MD, MSCE, (215) 590-1000, zorc@email.chop.edu
About this study
Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. The PI and team propose to adapt and put into place an emergency care action plan (ECAP) for IMC across four US hospitals, working directly with medical providers and families in each setting. After the tool is made available to providers and families, the PI and team will measure if the ECAP tool helps decrease the number of hospitalizations (primary research outcome) for IMC, as well as if the ECAP is feasible, acceptable, and useable for those using the ECAP over a one-year period.
Read the detailed description
The project goal is to optimize and implement an emergency care action plan (ECAP) developed previously by the PI and team (through an NIH K23 award) to improve emergency care for infants with medical complexity, a particularly challenging subset of CMC with high utilization and unique challenges in the acute care setting. Dr. Pulcini and team will conduct a hybrid type I effectiveness-implementation randomized trial of the ECAP at four sites (Children's Hospital Colorado, Cincinnati Children's Hospital Medical Center, Children's Hospital of Philadelphia, and the University of Vermont), measuring both health care outcomes/effectiveness (primary endpoint: number of hospitalizations) and implementation (endpoints include acceptability, feasibility, and useability). Dr. Pulcini and team will also measure key secondary health service measures (ex. ED visits, caregiver stress and self-efficacy) and monitor facilitators and barriers to implementation throughout the trial at each site.
- Conditions
- Chronic Disease Management, Infants Health, Emergency, Utilization, Health Care, Caregiver Stress
- Being tested
- Emergency Care Action Plan
- Keywords
- Children with Medical Complexity, Hybrid Implementation Trial, Health Service Utilization
- Medical subject headings
- Emergencies, Patient Acceptance of Health Care, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Care Action PlanOther
An Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in a patient's electronic health record for access by providers in an emergency. Patients/families will have digital access to the ECAP and be given a paper copy. The patient's care team and caregiver(s) (parent/legal guardian) will collaborate to create an individualized ECAP containing the following content: caregiver contact information, patient summary, anticipated emergency presentations with suggested management, problem list (emergency relevant only), medication list, technology dependence, baseline important physical exam findings, baseline vital signs, allergies, advance directive information, contact information for established care providers, and other important information.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Care Action Plan | Experimental | An Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in the electronic health record. Receives: Other: Emergency Care Action Plan |
| Standard Care | No intervention | The current standard of care does not include emergency care planning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
Dichotomous variable for hospitalization vs. no hospitalization (yes/no)
Measured: Day 0 (NICU discharge) to Month 12
Secondary outcomes (4)
Number of ED Visits
Number of ED visits
Measured: Day 0 (NICU discharge) to Month 12
Usability
Will assess usability using an adaption of the System Usability Scale (SUS) and qualitative assessment of implementation barriers and facilitators (for intervention group only).
Measured: Day 0 (NICU discharge) to Month 12
Acceptability
Will assess acceptability using an adaptation of the Theoretical Framework of Acceptability (TFA), including the following constructs: affective attitude, burden, intervention coherence, self-efficacy, and opportunity costs. Qualitative assessment of implementation barriers and facilitators (for intervention group only) will also elicit perspectives of acceptability.
Measured: Day 0 (NICU discharge) to Month 12
Feasibility of Intervention
Will assess feasibility using an adaptation of the Feasibility of Intervention Measure (FIM), as well as a qualitative assessment of implementation barriers and facilitators (for intervention group only).
Measured: Day 0 (NICU discharge) to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Disease ManagementStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Pulcini, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993129
- Sponsor's protocol ID
- FP00005878
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article after de-identification will be shared (text, tables, figures and appendices).
Publications
Pulcini CD, Broder-Fingert S, Callas P, Dayan PS, Drath B, Gravel-Pucillo C, Kuo DZ, Lamberson M, Mistry RD, Palaza A, Stevens M, Yeager J, Stapleton RD. Human-Centered Design to Create an Emergency Care Action Plan for Children With Medical Complexity. Pediatrics. 2025 Feb 12:e2024069125. doi: 10.1542/peds.2024-069125. Online ahead of print.
PubMed 39933576
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity
- ClinicalTrials.gov ID
- NCT06993129
- Acronym / sponsor ID
- FP00005878
- Conditions
- Chronic Disease Management, Infants Health, Emergency, Utilization, Health Care, Caregiver Stress
- Keywords
- Children with Medical Complexity, Hybrid Implementation Trial, Health Service Utilization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 28 May 2025 (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.
Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. The PI and team propose to adapt and put into place an emergency care action plan (ECAP) for IMC across four US hospitals, working directly with medical providers and families in each setting. After the tool is made available to providers and families, the PI and team will measure if the ECAP tool helps decrease the number of hospitalizations (primary research outcome) for IMC, as well as if the ECAP is feasible, acceptable, and useable for those using the ECAP over a one-year period.
Detailed description
The project goal is to optimize and implement an emergency care action plan (ECAP) developed previously by the PI and team (through an NIH K23 award) to improve emergency care for infants with medical complexity, a particularly challenging subset of CMC with high utilization and unique challenges in the acute care setting. Dr. Pulcini and team will conduct a hybrid type I effectiveness-implementation randomized trial of the ECAP at four sites (Children's Hospital Colorado, Cincinnati Children's Hospital Medical Center, Children's Hospital of Philadelphia, and the University of Vermont), measuring both health care outcomes/effectiveness (primary endpoint: number of hospitalizations) and implementation (endpoints include acceptability, feasibility, and useability). Dr. Pulcini and team will also measure key secondary health service measures (ex. ED visits, caregiver stress and self-efficacy) and monitor facilitators and barriers to implementation throughout the trial at each site.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Care Action Plan | Experimental | Other: Emergency Care Action PlanAn Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in the electronic health record. |
| Standard Care | No intervention | –The current standard of care does not include emergency care planning. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 0 to 6 months
- Admitted to the University of Vermont Medical Center, Cincinnati Children's Hospital, Children's Hospital of Philadelphia, or Colorado Children's Hospital Neonatal Intensive Care Unit (NICU),
- Meets or is expected to meet Children with Medical Complexity status as determined by the treating NICU clinician and defined as "children with multiple significant chronic health problems including multiple organ systems, which result in functional limitations, high health care needs or utilization, and often require need for, or use of, medical technology."
- Has three or more documented complex chronic conditions (CCCs)
Key exclusion criteria (2 listed)
- Does not have a caregiver participant who agrees to their participation in the study to complete follow-up surveys
- Does not intend to use the hospital or affiliated sites of which they were recruited from for care during the one-year trial period
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 |
|---|---|---|
| Emergency Care Action PlanAn Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in a patient's electronic health record for access by providers in an emergency. Patients/families will have digital access to the ECAP and be given a paper copy. The patient's care team and caregiver(s) (parent/legal guardian) will collaborate to create an individualized ECAP containing the following content: caregiver contact information, patient summary, anticipated emergency presentations with suggested management, problem list (emergency relevant only), medication list, technology dependence, baseline important physical exam findings, baseline vital signs, allergies, advance directive information, contact information for established care providers, and other important information. | Other | Emergency Care Action Plan |
Primary outcome
Hospitalization
Time frame: Day 0 (NICU discharge) to Month 12
Dichotomous variable for hospitalization vs. no hospitalization (yes/no)
4 secondary outcomes
Number of ED Visits
Time frame: Day 0 (NICU discharge) to Month 12
Usability
Time frame: Day 0 (NICU discharge) to Month 12
Acceptability
Time frame: Day 0 (NICU discharge) to Month 12
Feasibility of Intervention
Time frame: Day 0 (NICU discharge) to Month 12
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 6 Jun 2025.
- Background: PubMed 39933576Pulcini CD, Broder-Fingert S, Callas P, Dayan PS, Drath B, Gravel-Pucillo C, Kuo DZ, Lamberson M, Mistry RD, Palaza A, Stevens M, Yeager J, Stapleton RD. Human-Centered Design to Create an Emergency Care Action Plan for Children With Medical Complexity. Pediatrics. 2025 Feb 12:e2024069125. doi: 10.1542/peds.2024-069125. Online ahead of print.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article after de-identification will be shared (text, tables, figures and appendices).
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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.
Roz King, MSN, RN contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Care Action Plan in people with Chronic Disease Management and Infants Health, run by University of Vermont at 4 sites 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Christian D Pulcini, MD, MEd, MPH ((802) 847-2434, christian.pulcini@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization (time frame: Day 0 (NICU discharge) to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06993129, which also lists 1 linked publication.
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 6 Jun 2025.