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

NCT05541536 | Completed

• 1 other identifier: QI Project No. 2022-1349
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Neonatal Research Network (NRN) trial consent rate

  Within 1 week of the intervention

Study Arms (2)

General information pamphlet plus Consultation meeting

EXPERIMENTAL

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; Other: Pamphlet

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Consultation meeting 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.

General information pamphlet plus Consultation meeting

Pamphlet 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.

General information pamphlet plus Consultation meeting

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mother already approached by clinical research coordinator (CRC) for NRN trial

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

McGovern Medical School at UTHealth Houston

Houston, Texas, 77006, United States

Location

Study Officials

• Susan Wootton, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 15, 2022
• Study Start: September 1, 2022
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)