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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety; Self Efficacy
• Intervention / Treatment: Other: Telehealth virtual appointment

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; No Intervention
Experimental: Telehealth; Telehealth virtual appointment	Other: Telehealth virtual appointment; Appointment with NICU clinician via telehealth equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Horizon Health Network
• Collaborators: Canada Health Infoway
• Investigators: Principal Investigator: Cecil Ojah, MD, Horizon Health Network

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Anxiety; Telehealth; Self Efficacy; Neonatal Intensive Care; Parenting/psychology
• Other Study ID Numbers: CHSTHCHHN02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No