TelePremie: Telehomecare for Step-down Care Post-NICU Discharge

Study Overview
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Brief Summary
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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.

Official Title
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TelePremie: Telehomecare for Step-down Care Post-NICU Discharge

Conditions
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Anxiety, Self Efficacy

Intervention / Treatment
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* Other: Telehealth virtual appointment


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>No Intervention | |
| Experimental: Telehealth<br>Telehealth virtual appointment | Other: Telehealth virtual appointment<br>* Appointment with NICU clinician via telehealth equipment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The State-Trait Anxiety Inventory |  | Change from Baseline State-Trait Anxiety at 3 months | 
| The Maternal Confidence Questionnaire |  | Change from Baseline self-efficacy at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Intensive Care, Telehealth, Anxiety, Self Efficacy, Parenting/psychology