Clinical trial NCT04867395: A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Official title: A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children With Medical Complexity (CMC)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-04-30
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study will take place in 3 phases at 2 sites: Bellevue Hospital Center (BHC) and Hassenfeld Children's Hospital (HCH). Parents of CMC with a prior or current admission will be recruited at these two sites, as well as pediatricians who care for these children in the inpatient setting for the following 3 aims:

* In Aim 1, parents of CMC and pediatricians will be interviewed to understand their views on what makes it challenging, and what can make it easier, for parents to understand and follow the instructions they get from the hospital about how to take care of their CMC after leaving the hospital. The study team will also ask pediatricians what may make it difficult to provide relevant education to families.
* In Aim 2, a tool will be designed to make it easier for parents to understand and follow the discharge instructions for their CMC. The study team will use structure of existing tool, findings from Aim 1, and extensive interviews and testing of the tool with parents and pediatricians as the new tool is designed.
* In Aim 3, a randomized controlled trial (RCT) will be conducted to study the impact of the tool on parent comprehension and adherence (or how well they can follow) their child's discharge instructions, as well as its impact on post-discharge morbidity (such as readmissions and emergency department visits). Parents will be randomized to either receive usual hospital care and instructions or the intervention/tool (in addition to the usual care and instructions). The study team will also ask parents who receive the intervention about its usability.

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.

Primary outcomes:
measure: Parent Comprehension of Discharge Instructions
timeFrame: Visit 2 (Day 0-1)
measure: Parent Adherence to Discharge Instructions
timeFrame: Visits 3-4 (Days 1-45)
measure: Number of CMC with any type of post-discharge morbidity
timeFrame: Visit 4 (Day 30-45)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alexander F Glick, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: