MedDataX Logo

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

NCT ID: NCT05541536

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Consultation meeting

Intervention Type OTHER

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.

Pamphlet

Intervention Type OTHER

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.

Usual Care

Study participants will not receive the general information pamphlet or consultation.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Study participants will not receive the general information pamphlet or consultation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Usual Care

Study participants will not receive the general information pamphlet or consultation.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susan Wootton

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Wootton, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McGovern Medical School at UTHealth Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QI Project No. 2022-1349

Identifier Type: -

Identifier Source: org_study_id