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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the HELPix Care Plan treatment 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 complexity. These approaches help reduce hospital admissions and emergency room visits, improve communication among healthcare providers, and enhance the overall quality of care for children and their families. ^{1 2 3 4 5}

Is the HELPix Care Plan safe for children with medical complexity?

The available research does not provide specific safety data for the HELPix Care Plan, but it focuses on improving care coordination and medication safety for children with medical complexity, which may indirectly support safer care. ^{1 6 7 8 9}

How is the HELPix Care Plan treatment different from other treatments for children with medical complexity?

The HELPix Care Plan is unique because it focuses on creating a comprehensive care plan with clearly defined roles for care teams, improving communication, and setting specific goals to support children with medical complexity. This approach helps keep children in their local medical homes and reduces the need for hospital visits, unlike traditional treatments that may not offer such coordinated care. ^{1 8 10 11 12}

What is the purpose of this trial?

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.

Research Team

Alexander F Glick, MD, MS

Principal Investigator

NYU Langone Health

Eligibility Criteria

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)

I have trouble hearing.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Step-by-Step Guide to Building a Complex Care Coordination Program in a Small Setting. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Practice-based care coordination: a medical home essential. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Recognition and Management of Medical Complexity. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Development of a New Care Model for Hospitalized Children With Medical Complexity. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A Population Intervention to Improve Outcomes in Children With Medical Complexity. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Impact of pharmacist medication review for paediatric patients: an observational study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Delphi study to identify indicators of poorly managed pain for pediatric postoperative and procedural pain. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Exploring the usefulness of comprehensive care plans for children with medical complexity (CMC): a qualitative study. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

An mHealth design to promote medication safety in children with medical complexity. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Children with medical complexity: an emerging population for clinical and research initiatives. [2022]

11. Canada 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. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Validation of New Care Coordination Quality Measures for Children with Medical Complexity. [2023]