USE OF HOME HEALTH SERVICES IN MATERNAL AND INFANT STUDIES

Author(s)

Covington D1, Churchill P1, Hurst N2
1PPD, Wilmington, NC, USA, 2PPD, Morrisville, NC, USA

OBJECTIVES: Maternal and infant studies can be daunting for new mothers especially if blood or specimen samples are required within a few days of birth and throughout the neonatal period.  To facilitate enrollment and retention in these studies, the use of home health nurses have been employed to collect samples in the home rather than requiring mothers and newborns to make site visits.  Our objective is to examine the impact of engaging home health nurses on study enrollment, retention, and protocol compliance. METHODS: We evaluated data from three types of maternal and infant studies including neonatal platelet, placental transfer, and lactation studies.  Global home health agencies were contracted to collect samples from mothers and neonates in the home. In one of the studies, site visits were required initially and the home health approach was implemented later.  We examined enrollment metrics before and after home health services were employed.  In the other studies, the home health model was implemented initially, and we descriptively examined retention and protocol compliance. RESULTS: In the study that initially required site visits, a third of the way into the study, no patients had enrolled.  After the home health model was implemented, 82 patients enrolled which exceeded enrollment targets 4-fold. In the studies where the home health model was implemented initially, enrollment targets were met or are nearing completion.  100% of enrolled subjects have completed study requirements. Additionally, 100% of home visits were completed successfully with 99.5% completed “in window” without issues. Completed CRFs and lab reports were submitted to PIs “in window” per protocol.  Throughout the studies there was no home nurse turn-over. CONCLUSIONS: In this simple descriptive review of three types of maternal and infant studies, the use of home health nurses was successful in facilitating enrollment, retention and specimen/data collection.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PRM188

Topic

Study Approaches

Disease

Pediatrics, Reproductive and Sexual Health

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