Novel Approach To Improving Lactation Support With Mobile Health Technology
Condition: Breastfeeding; Feeding Behavior
Study type: Interventional

Summary: 
      This is a randomized trial of use of a mobile health tool (EpxBreastfeeding) aimed at
      improving breastfeeding adherence and duration among recent mothers who self identify as
      motivated to breastfeed. As a result of text communication and expedited coaching through
      common breastfeeding challenges, the investigators expect more mothers in the study arm will
      continue breastfeeding through the first 6 months after giving birth.
    

Detailed description: 
      Immediately following delivery, mothers are given the task of learning to care for a newborn,
      coping with rapid hormone changes, and in many cases, learning to breastfeed, all with
      minimal contact with their obstetric provider. Traditionally, women are not seen by their
      obstetrician until 6 weeks postpartum, increasing the likelihood that they will switch to
      formula feeding despite a clear antenatal intent to breastfeed.

      Data suggests that exclusive breastfeeding for the first six months of life is associated
      with lower rates of respiratory and ear infections in babies with fewer required
      hospitalizations, due to the protective effect of maternal antibodies in breast milk. Fewer
      children go on to develop asthma and allergies. Additionally, adolescents who were breastfed
      demonstrate higher intelligence quotient (IQ) averages that their peers who were not. The
      benefits of breastfeeding for mothers include healthy weight loss and protection against
      ovarian and breast cancer, as well as psychological wellness through maternal-infant bonding.
      The World Health Organization (WHO) has published extensive data to support recommendations
      for exclusive breastfeeding in the first 6-month period. Exclusive breastfeeding is defined
      as the infant's only source of nutrition being human breast milk (along with vitamins,
      minerals, and medications). While the WHO and the American Congress of Obstetricians and
      Gynecologists (ACOG) recommend 6 months of exclusive breastfeeding, data published by the
      Centers for Disease Control (CDC) in 2016 show that only 81.1% of mothers ever try
      breastfeeding, only 44.4% exclusively breastfeed through 3 months, and only 22.3% exclusively
      breastfeed over 6 months. In Missouri, the CDC's report card data shows that 85.4% of mothers
      ever breastfed, and rates of exclusive breastfeeding were 49.7% and 24.7% at 3 and 6 months
      respectively. At the investigators' local hospital, a recent chart review as part of the
      Barnes Jewish Hospital's Baby Friendly designation process demonstrated that only 45% of
      mothers who received prenatal care at the Center for Advanced Medicine (CAM) or the Center
      for Outpatient Health (COH) were exclusively breastfeeding at 6 weeks postpartum (unpublished
      data). In order to reach the Healthy People 2020 goals of 42.6% breastfeeding at 3 months and
      60.6% at 6 months, it is important to identify modifiable barriers to optimal breastfeeding
      practices and create innovative solutions to address them.

      One of these barriers is access to lactation support. Mothers frequently have difficulty
      becoming familiar with the process of breastfeeding during the immediate postpartum period.
      "Difficulty latching" or "inadequate milk production" are the most common causes of concern,
      driving mothers to supplement with or switch to milk formula products. Once efforts to
      breastfeed cease, mammary milk production slows and cannot be restarted. Mothers who have
      started formula feeds at time of discharge from the hospital are five times more likely to
      stop breastfeeding completely in the first week. The ACOG strongly supports breastfeeding,
      recognizing it as a public health priority, and has promoted the implementation of clinical
      resources in hospital systems nationwide. Many hospitals employ dedicated professionals
      trained in breastfeeding (lactation consultants and obstetric and postpartum nurses trained
      specifically in lactation support) to counsel and assist mothers, and the use of lactation
      consultants has been shown to significantly increase breastfeeding rates. Unfortunately,
      trends show that after mothers and infants are discharged from the hospital, they lose
      connection with these providers. The lack of support is one of many factors that may lead to
      cessation of exclusive breastfeeding.

      In typical postpartum practice, patients return to their obstetrics provider for a visit at 6
      weeks. This is inadequate for addressing breastfeeding concerns, as it occurs too late to
      promote a return to a breastfeeding. Proactive outreach in busy obstetrics practices is
      expensive, time-consuming and inefficient due to challenges with identifying and targeting
      resources to mothers who are most in need of a help achieving their breastfeeding goals.
      Postpartum visits are, by default, included in a patient's global obstetric package and
      providers are in many cases unable to bill separately for lactation support visits, which can
      make it harder for mothers and providers to address issues earlier postpartum. Ideally, an
      approach to improving patient/provider communication in the 2 postpartum weeks when most
      breastfeeding challenges arise would provide support out of the office setting, with follow
      up through 6 months. The system must ideally be low cost, low tech, and efficient enough to
      be implemented widely. Short message service (SMS) texting interventions mark a novel entry
      point to the healthcare field and enable targeting to patients across the socioeconomic
      spectrum. Every cell phone is equipped for SMS texting. This form of communication also
      allows the patient to respond to prompt messages, thereby reducing the burden on patients to
      initiate communication.

      Breastfeeding improves maternal and infant health. Most expert bodies recommend at least 6
      months of exclusive breastfeeding. Unfortunately, breastfeeding can be difficult to start and
      sustain due to a variety of mostly treatable factors; many mothers are currently left to
      navigate these difficulties on their own. The investigators hypothesize that close and
      individualized assistance will increase the rates of exclusive breastfeeding. To achieve
      this, a novel, automated, two-way text messaging platform has been developed. This system
      offers encouragement and education but perhaps more importantly, it collects and categorizes
      feedback from each mother to identify those that may benefit from personalized follow-up by a
      trained professional. This system was developed by a team of students and healthcare
      professionals. The investigators propose implementing it in obstetrics clinics at BJH, and
      will study its impact through quantitative measures and feedback. If successful, this
      proposal will create a scalable technological solution to improve breastfeeding adherence.

      Hypothesis:

      An automated bidirectional communication tool (EpxBreastfeeding) to monitor nursing status
      and assess for common problems related to breastfeeding will improve provider awareness and
      expedite personal follow-up with patients identified as at risk of stopping breastfeeding,
      and will improve breastfeeding adherence over time compared to controls.

      Specific Aims:

        1. Determine if exclusive breastfeeding duration can be improved by using an automated
           bidirectional communication tool compared to standard of care through six months
           postpartum.

        2. Compare time-to-event incidence reporting and subsequent provider response time to
           duration of breastfeeding status (intervention cohort only).

        3. Collect subjective data from mothers receiving the intervention, as well as ancillary
           professionals who are designated for notification and follow-up to consider the
           feasibility and acceptance of an automated bidirectional mHealth lactation support
           intervention in the clinical setting.
    

Intervention name(s): EpxBreastfeeding; Baby book survey
Intervention type(s): Other; Other
Intervention description(s): We developed an algorithm using the Epharmix platform, an automated toll-free phone and text message-based system that can programmatically query patients via their personal phones and subsequently collect response data, allowing clinically-relevant responses to trigger alerts to designated healthcare providers. The intervention for breastfeeding, hereafter referred to as EpxBreastfeeding, was built using significant clinical and patient input to only ask the most clinically-relevant questions for breastfeeding in a multiple-choice manner, such as "In the past [x] days, have you fed your baby 1) breast milk only, 2) breast milk and formula or 3) formula only?". These communications elicit patient-reports of breastfeeding at intervals of interest for the provider, which is, on average, every 2 days in the first three weeks postpartum and every 5 days subsequently. All data is filtered by clinician-designed algorithms to stratify patients into categories.; We developed a "baby book" template that will be given to mothers allowing them to make note of dates related to their child's development during the first year. Examples include: When was baby's first appointment with his/her pediatrician? When did you add formula into baby's feeding? When did you start feeding baby only formula? When did you introduce solid food into baby's diet? When did baby first smile? When did you start reading to baby? What was the first book you read to baby? Whe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: mobile health (mHealth); electronic health (eHealth); breastfeeding; infant nutrition; text messaging intervention