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Consultation meeting for Informed Consent

N/A
Waitlist Available
Led By Susan Wootton, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 week of the intervention
Awards & highlights

Summary

This trial will study whether a brief discussion about Learning Healthcare (LHC) and clinical research from a neonatologist, as well as a general information pamphlet, will impact a mother's (and father's, if present) decision to consent to an NRN trial.

Eligible Conditions
  • Informed Consent

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 week of the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 week of the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neonatal Research Network (NRN) trial consent rate

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: General information pamphlet plus Consultation meetingExperimental Treatment2 Interventions
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.
Group II: Usual CareActive Control1 Intervention
Study participants will not receive the general information pamphlet or consultation.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
919 Previous Clinical Trials
324,941 Total Patients Enrolled
Susan Wootton, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
~35 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
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