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

The University of Texas System (UT)

Status: Completed

Conditions: Implementation of Consent in Clinical Research; Understanding of Consent in Clinical Research

Treatments: Other: Usual Care; Other: Consultation meeting; Other: Pamphlet

Study type: Interventional

Funder types: Other

Identifiers

NCT05541536

QI Project No. 2022-1349

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

General information pamphlet plus Consultation meeting

Experimental group

Description:

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.

Treatment:

Other: Pamphlet

Other: Consultation meeting

Usual Care

Active Comparator group

Description:

Study participants will not receive the general information pamphlet or consultation.

Treatment:

Other: Usual Care