Removing Surrogates Uncertainty to Reduce Fear and Anxiety After Cardiac Events - Kids
Purpose
This pilot randomized controlled trial (RCT) will test the feasibility and acceptability of the informational intervention program, Heartsight, to reduce caregivers' uncertainty experienced throughout their child's illness trajectory after cardiac arrest. The investigator aims to enroll up to 30 caregivers of pediatric cardiac arrest patients to (Aim 1a) pilot recruitment and randomization (2:1) procedures, and (Aim 1b) estimate retention rate at 3 months and assess engagement and utilization metrics for frequency of access and time spent on each module of the informational packages. The investigator also aims to evaluate the association of the intervention with efficacy outcomes in an exploratory manner in preparation for a larger trial, including (Aim2a) a preliminary estimate of the association of intervention with the surrogate's uncertainty levels at 3 months post-discharge, and (Aim 2b) a preliminary estimate of the association of intervention with the surrogate's anxiety, depression, and post-traumatic stress symptoms at 3 months post-discharge.
Conditions
- Cardiac Arrest
- Anxiety Depression
- Family Support
Eligibility
- Eligible Ages
- Between 0 Days and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Caregiver 1. Caregiver of a child <17.5 years of age who had at least a 2 minute cardiac arrest, is expected to be discharged within 30 days, and to survive at least 3 months post-discharge from hospital. 2. English speaking Child 1. <17.5 years of age 2. Have had a cardiac arrest lasting more than 2 minutes within the past 7 days and have not yet been discharged from pediatric intensive care unit (PICU) or cardiac intensive care unit (CICU)
Exclusion Criteria
- ) Parent or legal guardian is not the child's caregiver
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Intervention |
Caregivers will receive cardiac arrest education intervention called Heartsight |
|
|
No Intervention Usual Care |
Patients and caregivers will receive usual care |
|
Recruiting Locations
Philadelphia, Pennsylvania 19104
More Details
- Status
- Recruiting
- Sponsor
- Children's Hospital of Philadelphia