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

Study Overview
=================
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.

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

Conditions
-----------------
Implementation of Consent in Clinical Research, Understanding of Consent in Clinical Research

Intervention / Treatment
-----------------
* Other: Consultation meeting
* Other: Pamphlet
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General information pamphlet plus Consultation meeting<br>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<br>* 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.<br>Other: Pamphlet<br>* 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.<br>|
| Active Comparator: Usual Care<br>Study participants will not receive the general information pamphlet or consultation. | Other: Usual Care<br>* Study participants will not receive the general information pamphlet or consultation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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