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

NCT05541536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-12-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Susan Wootton, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-10-05
Completion
2023-10-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05541536 on ClinicalTrials.gov