Expanding Rural Access to Breastfeeding Support Via Telehealth: The Tele-MILC Trial



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 46
Updated:3/29/2019
Start Date:October 2016
End Date:July 2018

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The investigators will conduct a randomized controlled trial (RCT) to generate data on the
impact of direct-to-consumer "telelactation" (virtual breastfeeding support) services.
Postpartum mothers age 18 and older who have initiated breastfeeding will be recruited at a
critical access hospital without access to IBCLCs in rural Pennsylvania and randomized into
two study arms: 1) outpatient telelactation services via video calls on personal devices or
2) usual care. Data on breastfeeding duration and exclusivity, as well as perceptions and
satisfaction with breastfeeding, will be captured via surveys and in-depth interviews and
compared across groups.

Increasing breastfeeding rates is an ongoing public health priority because of the health and
economic benefits for infants, mothers, and communities. Professional lactation support,
specifically by International Board Certified Lactation Consultants (IBCLCs), increases
breastfeeding duration and exclusivity. Rural and underserved mothers have lower
breastfeeding rates, and limited access to professional lactation support may contribute to
this disparity. As such, the Surgeon General identifies increasing access to IBCLCs as a
policy priority. Virtual "telelactation" consults that use two-way video have the potential
to increase access to IBCLC services in rural settings that lack them. Several companies have
begun to offer telelactation through a direct-to-consumer (DTC) model, where patients
initiate video calls with providers using their personal devices including mobile phones,
tablets, and laptops. While four studies with small samples explored the use of antiquated
videoconferencing technology (i.e., that required dedicated equipment) for lactation support,
no research has studied DTC telelactation or linked telelactation with breastfeeding
outcomes. To address this evidence gap, the investigators will conduct a randomized
controlled trial (RCT) to generate data on the impact of DTC telelactation services.
Postpartum mothers age 18 and older who have initiated breastfeeding will be recruited at a
critical access hospital without access to IBCLCs in rural Pennsylvania and randomized into
two study arms: 1) outpatient telelactation services via video calls on personal devices or
2) usual care. Data on breastfeeding duration and exclusivity, as well as perceptions and
satisfaction with breastfeeding, will be captured via surveys and in-depth interviews and
compared across groups. This study will be the first experimental evaluation of telelactation
and the first ever evaluation of DTC telelactation services. The results will inform policy
debates about reimbursement and regulation of DTC telehealth services and the strengths and
limitations of this model of healthcare delivery as applied to breastfeeding. It also has the
potential to promote breastfeeding, one of the most widely recommended health behaviors among
underserved families, and improve children's health in rural settings.

Inclusion Criteria for mothers:

1. ≥ 18 years;

2. Initiated breastfeeding while in the hospital and intend to breastfeed post-discharge

3. Fluent in English

Inclusion criteria for infants:

1. Infants must be term or near term (>35 weeks gestational age)

2. Not require a stay in the neonatal intensive care unit

Exclusion Criteria:

1. Prisoners, incarcerated individuals, detainees, parolees, probationers will be
excluded because there may external circumstances outside of their control that may
prevent continuous breastfeeding.

2. Mothers and infants will be excluded if they have maternal, fetal, or neonatal
conditions or complications with the potential to physiologically compromise
breastfeeding or milk supply (e.g., infant cardiac defects, post-partum infant
ventilator dependence), and or contraindications to breastfeeding as specified by the
American Academy of Pediatrics (e.g., HIV+ status).
We found this trial at
1
site
1200 South Hayes Street
Arlington, Virginia 22202
Phone: 703-413-1100
?
mi
from
Arlington, VA
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