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

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870413
• Other study ID #: 2016-0194-AM03
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: October 2019
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Telelactation services
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.

Locations

Country	Name	City	State
United States	RAND Corporation	Arlington	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
RAND	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any breastfeeding (yes/no) at 3 months		Three months
Primary	Exclusive breastfeeding (yes/no) at 3 months		Three months
Secondary	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