Hospital-to-Home Transitional Care Interventions (H2H-TCI) Children/Youth With Special Health Care Needs (CYSHCN)

Официальное название

Hospital-to-Home Care Coordination for Children and Youth With Special Health Care Needs

Обзор

Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home Transitional Care Interventions (H2H-TCI) on health service use and parent-reported confidence for hospitalized CYSHCN. Aim 2: Compare the effectiveness of focused and extended dose H2H-TCI among vulnerable CYSHCN subgroups. Hypothesis: Both H2H-TCI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-TCI will better mitigate racial/ethnic outcome disparities than focused H2H-TCI. Aim 3: Evaluate implementation context, processes, and mechanisms via a multi-phase mixed methods study design.

Подробное описание

Primary Aims Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home Transitional Care Interventions (H2H-TCI) on health service use and parent-reported confidence for hospitalized CYSHCN.

Hypothesis: Extended H2H-TCI will be associated with lower acute care use and higher confidence than focused H2H-TCI.

Secondary Aims Aim 2: Compare the effectiveness of focused and extended dose H2H-TCI among vulnerable CYSHCN subgroups.

Hypothesis: Both H2H-TCI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-TCI will better mitigate racial/ethnic outcome disparities than focused H2H-TCI.

Aim 3: Evaluate implementation context, processes, and mechanisms via a multi-phase mixed methods study design.

The study populations consist of adult parent/caregivers' dyad and children/youth with special health care needs. Participants will be randomized to focused dose intervention after discharge or an extended dose intervention. the single dose will receive one phone call from an interventionist post discharge, the extended dose group will receive weekly phone calls for one month from an interventionist.

Analysis of data from the confidence-mediated and vulnerable patient/family characteristics-moderated pathways will address Aims 1 and 2, respectively.

During extraction of data from each site's Electronic Health Record (EHR) data security risks will be mitigated by following established standard operating procedures at Duke and the University of North Carolina (UNC). During preparation of site-based analytical datasets risks will be mitigated by limiting Protected Health Information (PHI) as much as and as early as is practical. All datasets will be stored and reviewed on a secure, cloud-based Protected Analytical and Computing Environment (PACE) at Duke and at UNC in the Secure Research Workspace (SRW).

The investigators will plan to create a Data Safety and Monitoring Board (DSMB) that includes expert clinicians who are not active study team members and are independent of the study sponsor. The DSMB will oversee the safety of volunteers participating in the study as needed.

Вмешательства

• Поведенческое Focused Dose Hospital-to-Home Transitional Care Interventions
  Focused dose H2H-TCIs will consist of a one-time post-discharge phone call completed within 72 hours post-hospital discharge by a clinical interventionist (e.g., nurse care coordinator or care manager). Calls will follow a structured template that provides empirically supported core H2H-TCI functions (follow-up care access, contingency planning, medication review, family education). The interventionist will also conduct a pre-hospital discharge clinical needs assessment with the parent.
• Поведенческое Extended Dose Hospital-to-Home Transitional Care Interventions
  Extended dose H2H-TCIs will include a pre-discharge clinical needs assessment and initial phone call within 72 hours post-discharge, similar to the focused arm. After the initial contact, the dose of the extended H2H-TCI will increase as subjects receive high-intensity support during weekly post-discharge phone contacts through 30 days post-discharge. All contacts in the extended dose arm will be completed by a transition coach interventionist (e.g., nurse care coordinator or care manager) who w

Первичные конечные точки

• 30-day acute care use [Срок оценки: 30 days post-hospital discharge]
• Caregiver confidence [Срок оценки: Baseline, 30 days post-discharge]

Вторичные конечные точки (12)

• 7-day acute care use [Срок оценки: 7-days post-discharge]
• 14-day acute care use [Срок оценки: 14 days post-discharge]
• Readmissions [Срок оценки: 7, 14, 30 days post-discharge]
• Emergency Department (ED) visits [Срок оценки: 7, 14, 30 days post-discharge]
• Outpatient follow-up visit attendance [Срок оценки: 7, 14, 30 days post-discharge]
• Days at home [Срок оценки: 30 and 90 days post-discharge]
• Caregiver strain [Срок оценки: Baseline, 7, 14, 30, and 90-days post-discharge]
• Global health status [Срок оценки: Baseline, 7, 14, 30, and 90-days post-discharge]
• Caregiver mental health-related quality of life (HR-QOL) [Срок оценки: Baseline, 7, 14, 30, and 90-days post-discharge]
• Quality of hospital-to-home care transitions [Срок оценки: 30 days post-discharge]
• Fidelity [Срок оценки: approximately 90 days post-discharge]
• Feasibility Acceptability Appropriateness [Срок оценки: approximately 90 days post-discharge]

Критерии участия

Критерии включения

• For this study, eligible children/youth with special health care needs (CYSHCN) and adult parent/caregiver dyads will be those who meet the following inclusion criteria:

• Child is a CYSHCN, defined as having seen two or more distinct specialty areas for outpatient visits during the 12 months prior to index hospitalization admission date
• Age of hospitalized child is under 18 years old
• Child hospitalized on a general pediatrics inpatient service line at participating site
• Adult parent/caregiver for the child is 18 years or older

Критерии исключения

• Child exclusion criteria:

• Child will be discharged to any location besides home (e.g., long-term care or residential facility, skilled nursing facility, inpatient acute rehabilitation, psychiatric facility)
• Child is a ward of the state or has an ongoing social services investigation
• Child is already receiving transitional care, intensive longitudinal care coordination (e.g., organ/disease-specific clinical program, clinical division within the same institution as the hospital \[e.g., Children's Complex Care Program at UNC; Complex Care Service at Duke\]), and/or longitudinal population health care coordination as part of a bundled alternative payment care model.
• Parent/caregiver exclusion criteria include:

• Age less than 18 years old
• Diminished capacity to provide consent/participate
• Primary language for parent/caregiver is any language besides English or Spanish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• UNC Hospitals — Chapel Hill
• DUHS — Durham

Идентификаторы

NCT: NCT06428175 · Pro00114934

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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