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

December 14, 2023 updated by: Susan Wootton, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77006
        • McGovern Medical School at UTHealth Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General information pamphlet plus 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: 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.
Active Comparator: Usual Care
Study participants will not receive the general information pamphlet or consultation.
Other: Usual Care
Study participants will not receive the general information pamphlet or consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal Research Network (NRN) trial consent rate
Time Frame: Within 1 week of the intervention
Within 1 week of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Susan Wootton, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

October 5, 2023

Study Completion (Actual)

October 5, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • QI Project No. 2022-1349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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