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

Study Overview
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Brief Summary
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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. 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
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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.

Official Title
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The Acceptability, Feasibility, and Impact of Telelactation Among Rural Mothers

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: Telelactation services


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for mothers: ≥ 18 years; Initiated breastfeeding while in the hospital and intend to breastfeed post-discharge Fluent in English Inclusion criteria for infants: Infants must be term or near term (>35 weeks gestational age) Not require a stay in the neonatal intensive care unit Exclusion Criteria: Prisoners, incarcerated individuals, detainees, parolees, probationers will be excluded because there may external circumstances outside of their control that may prevent continuous breastfeeding. 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telelactation support<br>Participants in the experimental group will receive unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 12 weeks post-partum. Services will be available through mobile phone app. | Behavioral: Telelactation services<br>* 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.<br>* Other names: Virtual/remote breastfeeding support;|
| No Intervention: Usual care<br>Participants in the control arm will receive care as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any breastfeeding (yes/no) at 3 months |  | Three months | 
| Exclusive breastfeeding (yes/no) at 3 months |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding satisfaction (self-reported via questionnaire at 3 months postpartum) | 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. | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telehealth