RAND Corporation
Arlington, Virginia, 22202, United States
NCT Number: NCT02870413
The investigators will conduct a randomized controlled trial (RCT) to generate data on the impact of direct-to-consumer "telelactation" (virtual breastfeeding support) services. We will explore the feasibility, acceptability, and impact of these 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.
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Notify Me18 year–46 year
Female
Interventional
Not applicable
Arlington, Virginia, 22202, United States
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 feasibility, acceptability, and 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 and with telelactation services, 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for mothers:
Inclusion criteria
for infants:
Exclusion criteria
Mothers will get unlimited access (for a three month period) to video calls with lactation consultants who are available 24/7. Mothers can use the service as demanded.
Other names: Virtual/remote breastfeeding support
Time frame: Three months
Time frame: Three months
Time frame: Three months
Survey question which captures extent of satisfaction with the experience of breastfeeding. Question reads: How satisfied do you feel about the experience of breastfeeding your baby over the past three months? (Very unsatisfied, somewhat unsatisfied, neither unsatisfied nor satisfied, somewhat satisfied, very satisfied). We will create a binary variable (satisfied vs. unsatisfied) based on this response, with those reporting "somewhat satisfied" or "very satisfied" defined as "satisfied."
RAND
Other
The Acceptability, Feasibility, and Impact of Telelactation Among Rural Mothers
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