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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

Study 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
902 Previous Clinical Trials
320,804 Total Patients Enrolled
Susan Wootton, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this research endeavor?

"Indeed, clinicaltrials.gov reports that this trial is open for enrollment and was initially posted on September 1st 2022 with the most recent update dating back to September 14th of the same year. 50 individuals need to be recruited from a single medical centre in order for the study to reach completion."

Answered by AI

Are there any vacant positions in this clinical trial available for people to join?

"Affirmative. The clinical trial posted on the 9th of September 2022 is recruiting patients, and was last updated two weeks later."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
McGovern Medical School at UTHealth Houston
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~39 spots leftby Apr 2025