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Recruiting NCT04867395

NCT04867395 A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity

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Clinical Trial Summary
NCT ID NCT04867395
Status Recruiting
Phase
Sponsor NYU Langone Health
Condition Children With Medical Complexity (CMC)
Study Type INTERVENTIONAL
Enrollment 282 participants
Start Date 2021-07-23
Primary Completion 2027-03-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
HELPix Care Plan

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 282 participants in total. It began in 2021-07-23 with a primary completion date of 2027-03-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The overarching objective of this study is to make it easier for parents of children with medical complexity (CMC) to take care of their children after discharge home from the hospital and reduce the chance of post-hospitalization morbidity (meaning bad outcomes such as readmissions) after discharge. CMC, or those with multiple chronic conditions, progressive conditions, or technology dependence, are at high risk for post-hospitalization morbidity.

Eligibility Criteria

Inclusion Criteria: Parents * English or Spanish-speaking * Parent or legal guardian and primary caregiver of child who has medical complexity (defined by significant chronic conditions in ≥2 body systems, progressive conditions associated with decreased life expectancy, dependence on technology for \>6 months \[e.g., respiratory equipment, central lines, feeding tubes\], or progressive/metastatic malignancies) who was admitted to the acute or intensive care units * The individual's child is ≤18 years old * The individual's child was discharged home or is expected be discharged home on ≥1 daily medication. * Willingness to be randomized to intervention group * Willingness and ability to participate in study procedures Exclusion Criteria: Parents * Caregiver \<18 years old * Poor visual acuity (\<20/50 corrected on Rosenbaum screener for in-person recruitment; by subject report for phone recruitment) * Self-reported hearing difficulty * Previously enrolled.

Contact & Investigator

Central Contact

Alexander F Glick, MD, MS

✉ alexander.glick@nyulangone.org

📞 212-263-8198

Principal Investigator

Alexander F Glick, MD, MS

PRINCIPAL INVESTIGATOR

NYU Langone Health

Frequently Asked Questions

Who can join the NCT04867395 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Children With Medical Complexity (CMC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04867395 currently recruiting?

Yes, NCT04867395 is actively recruiting participants. Contact the research team at alexander.glick@nyulangone.org for enrollment information.

Where is the NCT04867395 trial being conducted?

This trial is being conducted at New York, United States.

Who is sponsoring the NCT04867395 clinical trial?

NCT04867395 is sponsored by NYU Langone Health. The principal investigator is Alexander F Glick, MD, MS at NYU Langone Health. The trial plans to enroll 282 participants.

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