General information pamphlet plus Consultation meeting for Understanding of Consent in Clinical Research

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
McGovern Medical School at UTHealth Houston, Houston, TX
Understanding of Consent in Clinical Research+1 More
Consultation meeting - Other
Eligibility
Any Age
Female
What conditions do you have?
Select

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.

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Within 1 week of the intervention

Week 1
Neonatal Research Network (NRN) trial consent rate

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care
1 of 2
General information pamphlet plus Consultation meeting
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: General information pamphlet plus Consultation meeting · No Placebo Group · N/A

General information pamphlet plus Consultation meetingExperimental Group · 2 Interventions: Consultation meeting, Pamphlet · Intervention Types: Other, Other
Usual Care
Other
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 1 week of the intervention

Trial Background

Prof. Susan Wootton, Professor
Principal Investigator
The University of Texas Health Science Center, Houston
Closest Location: McGovern Medical School at UTHealth Houston · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Understanding of Consent in Clinical Research
0 CompletedClinical Trials

Eligibility Criteria

Age Any Age · Female Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a mother of an infant who is eligible for the NRN trial.
You are available for an in-person (preference) or phone consultation meeting.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.