CompletedNot Applicable

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

United States100 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Neonatal Research Network (NRN) trial consent rate

Timeframe: Within 1 week of the intervention

Trial details

NCT IDNCT05541536

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-05

View on ClinicalTrials.gov More Understanding of Consent in Clinical Research trials