## Protocol Section
### Identification Module
**NCT ID:** NCT06428175

**Acronym:** H2H-CYSHCN

**Brief Title:** Hospital-to Home Care Care Transition Interventions (H2H-CTI) Children/Youth With Special Health Care Needs (CYSHCN)

**Official Title:** Hospital-to-Home Care Transition Intervention (H2H-CTI) for Children and Youth With Special Health Care Needs (CYSHCN)

#### Organization Study ID Info
**ID:** Pro00114934
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2028-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Duke University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

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

**Detailed Description:** Primary Aims Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home care transition interventions (H2H-CTI) on health service use and parent-reported confidence for hospitalized CYSHCN.

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

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

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

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.

### Conditions Module

**Conditions:**

- Health Care

- Pediatrics

- Transitional Care

- Comparative Effectiveness

- Family Engagement

**Keywords:**

- Special Needs

- Hospital to Home Care

- Children and Youth with Special Health Care Needs

- Randomized Trial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 480

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Focused Dose Hospital-to-Home Care Transition Intervention

**Label:** Focused Dose Hospital-to-Home Care Transition Intervention

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Behavioral: Extended Dose Hospital-to-Home Care Transition Intervention

**Label:** Extended Dose Hospital-to-Home Care Transition Intervention

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Focused Dose Hospital-to-Home Care Transition Intervention

**Description:** Focused dose H2H-CTIs 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-CTI 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.

**Name:** Focused Dose Hospital-to-Home Care Transition Intervention

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Extended Dose Hospital-to-Home Care Transition Intervention

**Description:** Extended dose H2H-CTIs 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-CTI 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 will be formally trained on pillars of the Care Transitions Intervention© (CTI), a multi-faceted H2H-CTI that is the basis for the extended dose arm.

**Name:** Extended Dose Hospital-to-Home Care Transition Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 30-day, all-cause composite readmission and emergency department (ED) visit rate

**Measure:** 30-day acute care use

**Time Frame:** 30 days post-hospital discharge

**Description:** Change in caregiver-reported confidence that their child can avoid hospitalization within the next one month (1=not confident; 10=fully confident; \<5 is low confidence)

**Measure:** Caregiver confidence

**Time Frame:** Baseline, 30 days post-discharge

#### Secondary Outcomes

**Description:** All-cause composite readmission and ED visit rate at 7 days

**Measure:** 7-day acute care use

**Time Frame:** 7-days post-discharge

**Description:** All-cause composite readmission and ED visit rate at 14 days

**Measure:** 14-day acute care use

**Time Frame:** 14 days post-discharge

**Description:** All-cause readmission rate at 7, 14, and 30 days

**Measure:** Readmissions

**Time Frame:** 7, 14, 30 days post-discharge

**Description:** All-cause ED visits at 7, 14, and 30 days

**Measure:** Emergency Department (ED) visits

**Time Frame:** 7, 14, 30 days post-discharge

**Description:** Completed outpatient visits by clinical area (primary, specialty, allied health)

**Measure:** Outpatient follow-up visit attendance

**Time Frame:** 7, 14, 30 days post-discharge

**Description:** Annualized days without clinical visits (clinical days without healthcare visits)

**Measure:** Days at home

**Time Frame:** 30 and 90 days post-discharge

**Description:** Change in caregiver-reported strain (measured by scores on seven-item Caregiver Strain Questionnaire Short Form 7, CGSQ-SF7 survey), where a higher score indicates a higher level of caregiver strain.

**Measure:** Caregiver strain

**Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge

**Description:** Change in caregiver-reporter PROMIS global health status survey. PROMIS assessments are scored on a T-score metric. High scores mean more of the concept being measured. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population.

**Measure:** Global health status

**Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge

**Description:** Change in caregiver-reported mental HR-QOL as scored on the Medical Outcomes Short Form 12 (SF12) survey.

**Measure:** Caregiver mental health-related quality of life (HR-QOL)

**Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge

**Description:** Pediatric Transition Experience Measure (P-TEM): eight-item, parent-reported measure of overall process and quality of hospital-to-home transitions.

**Measure:** Quality of hospital-to-home care transitions

**Time Frame:** 30 days post-discharge

**Description:** Percentage of intervention core components delivered as planned (goal: ≥80%)

**Measure:** Fidelity

**Time Frame:** approximately 90 days post-discharge

**Description:** Clinical staff and caregiver-reported composite score responses to Feasibility of Implementation, Acceptability of Implementation, and Implementation Appropriateness surveys (4 items each)

**Measure:** Feasibility Acceptability Appropriateness

**Time Frame:** approximately 90 days post-discharge

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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:

  1. 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
  2. Age of hospitalized child is under 18 years old
  3. Child hospitalized on a general pediatrics inpatient service line at participating site
  4. Adult parent/caregiver for the child is 18 years or older

Exclusion Criteria:

* Child exclusion criteria:

  1. 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)
  2. Child is a ward of the state or has an ongoing social services investigation
* Parent/caregiver exclusion criteria include:

  1. Age less than 18 years old
  2. Diminished capacity to provide consent/participate
  3. Primary language for parent/caregiver is any language besides English

**Maximum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shannon.widman@duke.edu

**Name:** Shannon A Widman

**Phone:** 919-681-7252

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Duke University

**Name:** David Ming, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
