Expanding Rural Access to Breastfeeding Support Via Telehealth: The Tele-MILC Trial
Condition: Breastfeeding
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Telelactation services
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Virtual/remote breastfeeding support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: telehealth