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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual Care | Active Comparator | Study participants will not receive the general information pamphlet or consultation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Research Network (NRN) trial consent rate | Within 1 week of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Wootton, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGovern Medical School at UTHealth Houston | Houston | Texas | 77006 | United States |
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| 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. |
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| Usual Care | Other | Study participants will not receive the general information pamphlet or consultation. |
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