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

NCT ID: NCT03554512

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-07-31

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.

Conditions

Anxiety; Self Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care

No Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Telehealth

Telehealth virtual appointment

Group Type: EXPERIMENTAL

Telehealth virtual appointment

Intervention Type: OTHER

Appointment with NICU clinician via telehealth equipment.

Interventions

Telehealth virtual appointment

Appointment with NICU clinician via telehealth equipment.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canada Health Infoway

OTHER

Sponsor Role: collaborator

Horizon Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecil Ojah, MD

Role: PRINCIPAL_INVESTIGATOR

Horizon Health Network

Locations

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Countries

Canada

Other Identifiers

CHSTHCHHN02

Identifier Type: -

Identifier Source: org_study_id