HELPix Care Plan for Medical Complexity in Children

Overseen By Alexander F Glick, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Caregiver under 18, Poor vision, Hearing difficulty, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

282 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist parents in caring for children with medical complexity after hospital discharge. It tests the HELPix Care Plan, which includes specialized discharge instructions, against the standard care parents currently receive. The goal is to determine if this plan can reduce the likelihood of children needing to return to the hospital. Families with children who have ongoing health issues in multiple areas and rely on medical equipment, such as feeding tubes or respiratory machines, might be suitable for this study. As an unphased trial, this study provides families an opportunity to contribute to innovative care strategies that could enhance home care for children with complex medical needs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that the HELPix Care Plan is safe for children with medical complexity?

Research has shown that the HELPix Care Plan helps parents manage their children's health after hospital discharge. Although specific safety data for this plan is unavailable, similar methods have improved care organization and medication safety. As this trial does not involve drugs or medical procedures, the risk of physical side effects is lower. Instead, it provides additional support and guidance to families, making the HELPix Care Plan a safe choice for many families seeking to manage complex health needs at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HELPix Care Plan is unique because it focuses on enhancing health literacy through tailored discharge counseling. Unlike standard care, which often involves unstandardized verbal and written instructions, HELPix uses health literacy-informed instructions to ensure families better understand their child's medical needs post-discharge. Researchers are excited about this approach because it aims to empower families with the knowledge to manage complex medical care more effectively, potentially leading to fewer hospital readmissions and better health outcomes for children with complex medical conditions.

What evidence suggests that the HELPix Care Plan is effective for reducing post-hospitalization morbidity in children with medical complexity?

Studies have shown that structured care plans can improve outcomes for children with complex medical needs. Research indicates that organizing and coordinating care better manages these children's needs. Parents report that care planning tools are helpful and simplify caring for their children. Although the strength of the evidence varies, there is moderate confidence that these plans can reduce negative outcomes, such as hospital readmissions. This trial will evaluate the potential effectiveness of the HELPix Care Plan, with some participants receiving this structured intervention and others receiving usual care. ^{1 6 7 8 9}

Who Is on the Research Team?

Alexander F Glick, MD, MS

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for parents or legal guardians who are the primary caregivers of children with complex medical needs, such as chronic conditions in multiple body systems, reliance on technology like respiratory equipment, or serious progressive illnesses. The child must be under 18 years old and discharged home on medication. Caregivers must speak English or Spanish and be willing to participate fully in the study.

Inclusion Criteria

I am the primary caregiver of a child with severe chronic conditions affecting multiple body systems.

I am willing to be assigned to a treatment group by chance.

I am a parent.

Exclusion Criteria

My caregiver is under 18 years old.

Poor visual acuity (<20/50 corrected on Rosenbaum screener for in-person recruitment; by subject report for phone recruitment)

Previously enrolled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Aim 1: Interviews

Parents of CMC and pediatricians are interviewed to understand challenges and facilitators in following discharge instructions.

4 weeks

1 visit (in-person)

Aim 2: Tool Design

A tool is designed to help parents understand and follow discharge instructions, using findings from Aim 1 and extensive testing.

8 weeks

Aim 3: Randomized Controlled Trial

RCT to study the impact of the tool on parent comprehension and adherence to discharge instructions, and post-discharge morbidity.

6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for post-discharge morbidity, including readmissions and emergency department visits.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HELPix Care Plan

Trial Overview The HELPix Care Plan is being tested to see if it helps parents manage their children's care after leaving the hospital. It aims to reduce complications that could lead to readmission by providing better support during this transition period.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

75 participants will be randomized to receive behavioral intervention, consisting of discharge counseling using the health literacy-informed discharge instructions

Group II: Usual Care Active Control 1 Intervention

75 participants will receive standard care, consisting of verbal discharge counseling given by doctors and nurses supplemented by written instructions (all unstandardized).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A study involving 1209 caregivers validated 19 out of 20 new quality measures for assessing care coordination services for children with medical complexity, showing strong positive associations with established validation measures.

Key factors that improved provider ratings included having a knowledgeable and supportive care coordinator and receiving clear, useful written visit summaries, highlighting the importance of effective communication in care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of New Care Coordination Quality Measures for Children with Medical Complexity. Parast, L., Burkhart, Q., Gidengil, C., et al.[2023]

A preliminary list of indicators for undermanaged pain in hospitalized pediatric patients was developed using the Delphi technique, with a consensus of 70% or more on most indicators from experts in pediatric pain management.

The study highlights the need for further refinement and clinical testing of these indicators to effectively identify and address acute pain in children as a significant adverse health care event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Delphi study to identify indicators of poorly managed pain for pediatric postoperative and procedural pain. Twycross, AM., Maclaren Chorney, J., McGrath, PJ., et al.[2021]

The study involved 16 participants, including family caregivers and clinicians, who identified 11 medication safety challenges faced by caregivers of children with medical complexity, highlighting the need for better support in medication management.

Design requirements for a mobile health application were developed to enhance medication safety by improving communication and ensuring timely administration, with plans for future testing to evaluate its effectiveness in reducing medication errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An mHealth design to promote medication safety in children with medical complexity. Jolliff, A., Coller, RJ., Kearney, H., et al.[2023]

A care support project for children with medical complexity improved communication among providers and families by implementing shared care plans and clearly defined team roles.

This collaborative approach helped create specific goals and track tasks, ultimately allowing patients to receive care closer to home and reducing the need for hospital admissions and emergency room visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Step-by-Step Guide to Building a Complex Care Coordination Program in a Small Setting. Sadof, M., Carlin, S., Brandt, S., et al.[2020]

Families with children who have special health care needs require a coordinated medical home that emphasizes teamwork among health care providers to improve care quality and outcomes.

Implementing a practice-based care-coordination model, which includes clear definitions, frameworks, and competencies, is essential for enhancing health outcomes and professional satisfaction in delivering care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice-based care coordination: a medical home essential. McAllister, JW., Presler, E., Cooley, WC.[2007]

Children with medical complexity require extensive health services and are high resource utilizers, highlighting the need for optimized care within their medical home and neighborhood.

Strategies aimed at improving care delivery can lead to significant benefits, such as reducing unplanned hospital admissions and emergency department visits, while also enhancing patient and family experiences and lowering out-of-pocket costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognition and Management of Medical Complexity. Kuo, DZ., Houtrow, AJ.[2019]

A new inpatient care model for children with medical complexity at a children's hospital improved care coordination by integrating a multidisciplinary team, including pharmacists, dieticians, and social workers, which was positively received by families and providers.

The model included structured processes like medication reconciliation and care coordination rounds, suggesting that similar approaches could enhance care in other hospitals, although further research is needed to assess its impact on patient health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a New Care Model for Hospitalized Children With Medical Complexity. White, CM., Thomson, JE., Statile, AM., et al.[2020]

Care plans for children with medical complexity (CMC) are viewed as valuable tools by both parents and healthcare providers, as they centralize care and improve communication between families and providers.

A standardized, family-centered care plan template that addresses both medical and social needs is recommended to enhance care coordination and strengthen relationships in the care of CMC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the usefulness of comprehensive care plans for children with medical complexity (CMC): a qualitative study. Adams, S., Cohen, E., Mahant, S., et al.[2021]

This study developed a systematic method to evaluate 1915(c) Medicaid waivers for children with medical complexity, analyzing 142 waivers across 45 states, which is a first in this area.

The analysis revealed significant variability in how waivers defined eligibility, transition plans, and wait lists, indicating a need for standardized approaches to improve service provision for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Publicly Funded Home and Community-Based Care for Children With Medical Complexity: Protocol for the Analysis of Medicaid Waiver Applications. Keim-Malpass, J., Letzkus, LC., Constantoulakis, L.[2020]

In a study involving 195 pediatric patients over 33 months, clinical pharmacists identified and intervened in 65 medication-related issues, with a remarkable 95% acceptance rate from pediatricians, highlighting their crucial role in enhancing medication safety.

Following pharmacist counseling, parents' understanding of medication increased by 28%, and their concerns about drug administration and side effects significantly decreased by 67% and 49%, respectively, demonstrating the effectiveness of pharmacist involvement in patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pharmacist medication review for paediatric patients: an observational study. Solano, M., Jeannin, M., Anxionnat, R., et al.[2022]

A quality improvement initiative targeting children with neurologic impairment and feeding tubes led to an 18% reduction in hospital admissions and a 31.9% decrease in average length of stay over a 4-year period, significantly lowering inpatient costs by nearly $11.8 million.

The initiative also resulted in an 8.2% increase in the percentage of children maintaining healthy weight ranges, demonstrating that coordinated care can enhance health outcomes while reducing healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Population Intervention to Improve Outcomes in Children With Medical Complexity. Noritz, G., Madden, M., Roldan, D., et al.[2019]

Children with medical complexity (CMC) face unique challenges due to their severe health conditions and high care needs, which are not adequately addressed by current healthcare models.

The article proposes a definitional framework for CMC that highlights their significant service needs and suggests a research agenda to improve care and evaluate outcomes from multiple perspectives, including those of the child and family.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with medical complexity: an emerging population for clinical and research initiatives. Cohen, E., Kuo, DZ., Agrawal, R., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-3-2021-9e421

HELPix Care Plan for Medical Complexity in Children The HELPix Care Plan treatment is supported by research showing that care coordination and structured care plans improve outcomes for children with medical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10028546/

Effectiveness of Structured Care Coordination for Children ... We found improvement in perceived utility of care planning tools in those receiving the CCKO intervention compared with those waiting to receive ...

3. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-13-10

Exploring the usefulness of comprehensive care plans for ... The purpose of this qualitative study was to understand the usefulness and desired content of comprehensive care plans by exploring the perceptions of parents ...

4. aap.org aap.org/en/patient-care/children-with-medical-complexity/?srsltid=AfmBOoruIseABkexEBA3T2ZZAALAC_to83mn7e4fZxWTWOjs66Va2H-s

Children with Medical Complexity Discover guidance and resources to support pediatricians and health care teams caring for children with medical complexity.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38813833/

Comprehensive care programmes for children with medical ... Overall, the certainty of the evidence for the effectiveness of comprehensive care for CMC ranged from low to moderate across outcomes and the …

6. nda.nih.gov nda.nih.gov/study.html?id=393

Study - NIMH Data Archive We also identified a rare risk locus for ASD and language delay at chromosomal region 2q24 (implicating NR4A2) and another lower-penetrance locus involving ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3387912/

Children With Medical Complexity: An Emerging Population ... This “catastrophic” category comprised only 0.4% of the children but was responsible for 11% of health care charges and 24% of all pediatric hospital charges.

8. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/cloud-care-feasibility-study-cloud-based-care-plans-children-medical-complexity

A Feasibility Study of Cloud-Based Care Plans for Children ... The use of a cloud-based, multidisciplinary care plan for children with medical complexity is feasible to implement and may improve care coordination for ...

9. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(21)00264-3/fulltext

Hypothermia for moderate or severe neonatal ... In summary, the HELIX trial data suggest that therapeutic hypothermia alongside optimal tertiary neonatal intensive care do not reduce brain ...