Overview

This trial is active, not recruiting.

Conditions heart defects, congenital, hypoplastic left heart syndrome, single ventricle defect, stress, psychological
Treatment early palliative care team consultation
Sponsor University of Michigan
Start date April 2013
End date October 2015
Trial size 40 participants
Trial identifier NCT02462434, HUM00072957

Summary

This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates born with single ventricle physiology. Half of the participants will receive early palliative care team consultation, while the other half will receive usual care (no or late palliative care intervention). The investigators hypothesize maternal stress, anxiety, and depression will be lower in the palliative care intervention group compared with the control group, and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Early pediatric palliative care team consultation for single ventricle patients will occur in this group following birth but prior to the first stage palliative surgery.
early palliative care team consultation
The palliative care team will evaluate the patient and family with the following core palliative care goals in mind: evaluating maternal understanding of their child's diagnosis and eliciting maternal concerns regarding their child's physical symptoms, identifying maternal social support systems and additional life stressors, identifying maternal expectations and hopes for their child's medical care, and assessing maternal fears surrounding their child's diagnosis and medical treatments. Palliative care team support and resources will then be provided in areas of necessity identified for the family. Palliative care team follow up will then be determined based on the level of need identified for each individual study participant.
(No Intervention)
Usual care for single ventricle patients will be provided with palliative care team consultation occurring at any point (if it is determined the child and family would benefit from palliative care consultation) during the child's neonatal hospital stay.

Primary Outcomes

Measure
Change in maternal State-Trait Anxiety Index scores
time frame: Up to 4 weeks
Change in maternal Beck Depression Index II scores
time frame: Up to 4 weeks
Change in maternal Brief Cope Inventory survey scores
time frame: Up to 4 weeks
Change in maternal PedsQL Family Impact Module survey scores
time frame: Up to 4 weeks

Secondary Outcomes

Measure
Length of neonate's intensive care unit (ICU) stay in days
time frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Length of neonate's total hospital stay in days
time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Mothers pregnant with fetuses with single ventricle physiology who are planned to undergo staged single ventricle palliative surgery with the first surgery occurring in the neonatal period. Exclusion Criteria: - Mothers with neonates born at a gestational age of less than 32 weeks requiring admission and management in the Neonatal Intensive Care Unit. - Mothers with neonates diagnosed with major non-cardiac congenital anomalies requiring additional surgical management beyond cardiac surgery in the neonatal period. - Non-English-speaking mothers who are unable to adequately comprehend and respond to survey questions administered as part of this study.

Additional Information

Official title Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology Requiring Neonatal Surgery
Principal investigator Hayley S Hancock, MD
Description Mothers of children with congenital heart disease are at increased risk of psychological morbidity including stress, anxiety, and depression. In particular, mothers of patients with single ventricle physiology who require neonatal surgery, face a great deal of stress related to the risk of serious complications including neonatal death. Previous studies have suggested that providing emotional psychosocial support may modify the development of significant psychosocial problems in parents of children with congenital heart disease. The pediatric palliative care team specializes in multiple elements of psychological and spiritual care for families of such children. The purpose of this pilot study is to evaluate maternal psychological distress and to examine the potential impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates born with single ventricle physiology. Mothers will complete four questionnaires measuring anxiety, depression, and quality of life/family functioning at a prenatal follow up visit and again prior to neonatal surgical hospital stay discharge (or at 30 days). Infants will be randomly assigned (by date of birth) to receive early palliative care team consultation or usual care (no or late palliative care intervention). The investigators hypothesize maternal stress, anxiety, and depression will be lower in the palliative care intervention group compared with the control group, and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Michigan.