Clinical trial NCT03554512: TelePremie: Telehomecare for Step-down Care Post-NICU Discharge
Official title: TelePremie: Telehomecare for Step-down Care Post-NICU Discharge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Self Efficacy
Keywords: Neonatal Intensive Care
Telehealth
Anxiety
Self Efficacy
Parenting/psychology
Lead sponsor: Horizon Health Network
Sponsor class: OTHER
Collaborators: name: Canada Health Infoway
First posted: 2018-06-13
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Telehealth is a means of providing care from a distance, at the convenience of the patient. This study will be testing the addition of Telehealth visits (TH) to the standard of care (SOC) following discharge from the neonatal intensive care unit (NICU). This study will be used to determine whether Telehealth appointments post-NICU discharge can improve the experiences of parents in caring for their infant and reduce the number of health care visits they have with their infant within three months post-NICU discharge.

Participants in this study will be randomly assigned to two groups. One group will receive the standard of care, which means they will have an appointment in place with a primary care provider, pediatrician or return visit to the NICU post discharge. The second group will have the standard of care described above and two Telehealth visits within the first week at home with their infant.

The study will explore the experiences of parents of NICU infants following their discharge from NICU, both those receiving standard of care (SOC) and the Telehealth monitoring intervention. Participants will be required to complete surveys online at 5 time periods: when parents decide to be part of the study, prior to discharge from NICU, 1 day after discharge, 2 days following the primary care provider visit and at 3 months following discharge from NICU. The questionnaires used will measure parental anxiety levels and parental confidence. The number of infant visits to the primary care provider, pediatrician, emergency department and NICU will also be collected at three months post-NICU discharge.

A subset of participants (from both SOC and TH groups) will further participate in semi-structured interviews about their experiences in the NICU and caring for their children after discharge. NICU clinicians who consent will participate in semi-structured interviews about their experiences with the Telehealth intervention.

The cost-effectiveness of the Telehealth intervention will be analysed in comparison to SOC.


Eligibility criteria: Inclusion Criteria:

* Parent-infant pairs admitted to neonatal intensive care unit where study is conducted.
* Parent has internet access.
* Parent has literacy level such that they are comfortable reading and filling out surveys.
* Infant is likely to survive.

Exclusion Criteria:

* Infant discharged to foster care.
* Infant transferred or discharged within 3 days of admission to neonatal intensive care unit.

Primary outcomes:
measure: The State-Trait Anxiety Inventory
timeFrame: Change from Baseline State-Trait Anxiety at 3 months
measure: The Maternal Confidence Questionnaire
timeFrame: Change from Baseline self-efficacy at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
Study officials:
affiliation: Horizon Health Network
name: Cecil Ojah, MD
role: PRINCIPAL_INVESTIGATOR
References: