Anxiety Depression, Cardiac Arrest, Family Support
Conditions
Brief summary
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.
Interventions
OTHEREducation Intervention
Caregivers will receive education modules at multiple time points during their children's post cardiac arrest recovery trajectory
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 17 Years
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
1\) Parent or legal guardian is not the child's caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 3 months post enrollment | Proportion of enrolled caregivers who complete the study requirements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Screen as Measured by the Patient Health Questionnaire-4 | Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported. | The Patient Health Questionnaire-4 (PHQ-4) is used to quickly assess and measure symptoms of anxiety. Possible scores range from 0 to 6, where a score of 3 or greater is considered a positive screen. |
| Anxiety Screen as Measured by the Patient Health Questionnaire-4 | Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported. | The Patient Health Questionnaire-4 (PHQ-4) is used to quickly assess and measure symptoms of anxiety. Possible scores range from 0 to 6, where a score of 3 or greater is considered a positive screen. |
| Presence and Severity of Post Traumatic Stress Disorder Symptoms as Measured by the Posttraumatic Stress Disorder Checklist (PCL-5) | Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported. | The Post Traumatic Stress Disorder Checklist (PCL-5) is used to assess the presence and severity of post traumatic stress disorder symptoms. Possible scores range from 0 to 80, with higher scores indicating greater symptom severity. |
| Uncertainty regarding a child's medical diagnosis, treatment, or health condition as measured by Parents' Perception of Uncertainty Scale (PPUS) | Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported. | The Parents' Perception Uncertainty in Illness Scale (PPUS) is used to measure a parent's uncertainty surrounding their child's medical diagnosis, treatment, or health condition. Possible scores range from 32 to 160, with higher scores indicating a higher level of uncertainty. |
Countries
United States
Contacts
CONTACTElizabeth Herrup, MD
Outcome results
None listed