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OpenTrials
Completed

NCT Number: NCT05541536

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

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McGovern Medical School at UTHealth Houston

Houston, Texas, 77006, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consultation meeting

Other

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.

Pamphlet

Other

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.

Usual Care

Other

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

Primary outcomes

  1. Neonatal Research Network (NRN) trial consent rate

    Time frame: Within 1 week of the intervention

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2022
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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