Comparative Effectiveness, Family Engagement, Health Care, Pediatrics, Transitional Care
Conditions
Keywords
Special Needs, Hospital to Home Care, Children and Youth with Special Health Care Needs, Randomized Trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFocused 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.
BEHAVIORALExtended 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 will be formally trained on pillars of the Care Transitions Intervention© (CTI), a multi-faceted H2H-TCI that is the basis for the extended dose arm.
Sponsors
Duke University
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day acute care use | 30 days post-hospital discharge | 30-day, all-cause composite readmission and emergency department (ED) visit rate |
| Caregiver confidence | Baseline, 30 days post-discharge | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day acute care use | 7-days post-discharge | All-cause composite readmission and ED visit rate at 7 days |
| 14-day acute care use | 14 days post-discharge | All-cause composite readmission and ED visit rate at 14 days |
| Readmissions | 7, 14, 30 days post-discharge | All-cause readmission rate at 7, 14, and 30 days |
| Emergency Department (ED) visits | 7, 14, 30 days post-discharge | All-cause ED visits at 7, 14, and 30 days |
| Outpatient follow-up visit attendance | 7, 14, 30 days post-discharge | Completed outpatient visits by clinical area (primary, specialty, allied health) |
| Days at home | 30 and 90 days post-discharge | Annualized days without clinical visits (clinical days without healthcare visits) |
| Caregiver strain | Baseline, 7, 14, 30, and 90-days post-discharge | 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. |
| Global health status | Baseline, 7, 14, 30, and 90-days post-discharge | 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. |
| Caregiver mental health-related quality of life (HR-QOL) | Baseline, 7, 14, 30, and 90-days post-discharge | Change in caregiver-reported mental HR-QOL as scored on the Medical Outcomes Short Form 12 (SF12) survey. |
| Quality of hospital-to-home care transitions | 30 days post-discharge | Pediatric Transition Experience Measure (P-TEM): eight-item, parent-reported measure of overall process and quality of hospital-to-home transitions. |
| Fidelity | approximately 90 days post-discharge | Percentage of intervention core components delivered as planned (goal: ≥80%) |
| Feasibility Acceptability Appropriateness | approximately 90 days post-discharge | Clinical staff and caregiver-reported composite score responses to Feasibility of Implementation, Acceptability of Implementation, and Implementation Appropriateness surveys (4 items each) |
Countries
United States
Contacts
CONTACTJennifer Thomas, MPH
PRINCIPAL_INVESTIGATORDavid Ming, MD
Duke University
Outcome results
None listed