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

Not Applicable

Completed

• Conditions: Understanding of Consent in Clinical Research; Implementation of Consent in Clinical Research
• Interventions: Other: Usual Care; Other: Consultation meeting; Other: Pamphlet

• Registration Number: NCT05541536
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-31
• Study Start: 2022-09-01
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-15
• Primary Completion: 2023-10-05
• Study Completion: 2023-10-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Mothers of infants eligible for Neonatal Research Network (NRN) trial (antenatal or postnatal)
• English or Spanish speaking
• Available for in-person (preference) or phone consultation meeting
• Mother not already approached for NRN trial

Exclusion Criteria

• Mother already approached by clinical research coordinator (CRC) for NRN trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Study participants will not receive the general information pamphlet or consultation.
General information pamphlet plus Consultation meeting	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.
General information pamphlet plus Consultation meeting	Pamphlet	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.

Primary Outcome Measures

Name	Time	Method
Neonatal Research Network (NRN) trial consent rate	Within 1 week of the intervention

Trial Locations

Locations (1)

McGovern Medical School at UTHealth Houston; 🇺🇸 Houston, Texas, United States