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

• ClinicalTrials.gov Identifier: NCT02870413
• Recruitment Status: Completed
• First Posted: August 17, 2016
• Last Update Posted: October 3, 2019
• Sponsor: RAND
• Collaborator: University of Pittsburgh
• Information provided by (Responsible Party): Lori Uscher-Pines, RAND

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Breastfeeding	Behavioral: Telelactation services	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 203 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: The Acceptability, Feasibility, and Impact of Telelactation Among Rural Mothers
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: July 2018
• Actual Study Completion Date: July 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telelactation support; 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; 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 Name: Virtual/remote breastfeeding support
No Intervention: Usual care; Participants in the control arm will receive care as usual.

Outcome Measures

Primary Outcome Measures :

1. Any breastfeeding (yes/no) at 3 months [ Time Frame: Three months ]
2. Exclusive breastfeeding (yes/no) at 3 months [ Time Frame: Three months ]

Secondary Outcome Measures :

1. Breastfeeding satisfaction (self-reported via questionnaire at 3 months postpartum) [ 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."

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 46 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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).

Contacts and Locations

Locations

United States, Virginia

RAND Corporation

Arlington, Virginia, United States, 22202

Sponsors and Collaborators

RAND

University of Pittsburgh

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Uscher-Pines L, Ghosh-Dastidar B, Bogen DL, Ray KN, Demirci JR, Mehrotra A, Kapinos KA. Feasibility and Effectiveness of Telelactation Among Rural Breastfeeding Women. Acad Pediatr. 2020 Jul;20(5):652-659. doi: 10.1016/j.acap.2019.10.008. Epub 2019 Oct 16.

Kapinos K, Kotzias V, Bogen D, Ray K, Demirci J, Rigas MA, Uscher-Pines L. The Use of and Experiences With Telelactation Among Rural Breastfeeding Mothers: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 3;21(9):e13967. doi: 10.2196/13967.

• Responsible Party: Lori Uscher-Pines, Policy Researcher, RAND
• ClinicalTrials.gov Identifier: NCT02870413
• Other Study ID Numbers: 2016-0194-AM03
• First Posted: August 17, 2016
• Last Update Posted: October 3, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Lori Uscher-Pines, RAND:

telehealth