NCT05541536

Facilitating Learning Health Care (LHC) and Neonatal Research: Effects of a Brief Introductory Discussion Between a Neonatologist and the Parents of Eligible Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The primary purpose of this pilot quality improvement study is to assess the impact of a brief introductory discussion about Learning Health Care (LHC) and clinical research between a neonatologist and the mothers (and the fathers, if present) of infants eligible for trials of the Neonatal Research Network (NRN) before they are approached for consent by clinical research coordinator (CRC) approach for NRN trial). Mothers will also be given a general information pamphlet addressing the same topic.

Conditions

• Understanding of Consent in Clinical Research
• Implementation of Consent in Clinical Research

Interventions

Type	Name	Description
OTHER	Consultation meeting	Study team member will approach mothers \< 24 hrs (up to 5 min prior) of CRC approach for NRN trial. During the consultation meeting (5 minutes), the study team member will review the pamphlet and answer any questions. Visits will ideally occur in person. If the mother is not at bedside, 1 attempt will be made to reach the mother by phone in which case the pamphlet will be forwarded by mail.
OTHER	Pamphlet	Study team member will distribute pamphlet to beside nurse to give to mother. The pamphlet provides information about Learning Health Care (LHC) and clinical research.
OTHER	Usual Care	Study participants will not receive the general information pamphlet or consultation.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2022-09-15
• Last updated: 2023-12-15

Locations

1 site across 1 country: United States