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Emergency Care Plans for Infants With Medical Complexity (ECAP Trial)

N/A

Waitlist Available

Led By Christian D Pulcini, MD, MEd, MPH

Research Sponsored by University of Vermont

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 0 to 6 months

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 (nicu discharge) to month 12, assessed at quarterly intervals (month 3, 6, 9, 12)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to measure the impact of using an Emergency Care Action Plan (ECAP) for infants leaving the Neonatal Intensive Care Unit (NICU). The ECAP is a tool to help

Who is the study for?

This trial is for infants with complex medical needs who have been discharged from the Neonatal Intensive Care Unit (NICU). It aims to help caregivers and providers manage emergencies by using a tool called an Emergency Care Action Plan.

What is being tested?

The study tests if having an Emergency Care Action Plan (ECAP) in a child's Electronic Health Record helps reduce hospital stays and emergency visits. The ECAP's usage, acceptance, and long-term adoption are also evaluated.

What are the potential side effects?

There are no direct side effects associated with the use of an Emergency care action plan as it is not a medication or procedure but rather a management tool designed to improve emergency care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 6 months old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 (nicu discharge) to month 12, assessed at quarterly intervals (month 3, 6, 9, 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 (nicu discharge) to month 12, assessed at quarterly intervals (month 3, 6, 9, 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 (nicu discharge) to month 12, assessed at quarterly intervals (month 3, 6, 9, 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inpatient hospitalization

Secondary study objectives

Avoidance of ED visits

Caregiver self-efficacy

Caregiver stress

+3 more

Other study objectives

Cost

Implementation outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Emergency Care Action PlanExperimental Treatment1 Intervention

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.

Group II: Standard CareActive Control1 Intervention

The current standard of care does not include emergency care planning.

0 / 1Eligibility criteria met