Telelactation Among

Rural Breastfeeding
Mothers
Results from the Tele-MILC RCT
Lori Uscher-Pines
April 5, 2019
OVERVIEW
 U.S. children born in 2012
Any breastfeeding Exclusive breastfeeding
100%
80%
60%
40%
20%
0%
0 1 2 3 4 5 6 7 8 9 10 11 12

Child’s age (months)

SOURCE: National Immunization Study 3
“Oh that’s okay, I
have received too
much
breastfeeding
support already,”
International Board-Certified
Lactation Consultants
Health care professionals who specialize in
the clinical management of breastfeeding

Although they are proven to help,

many communities lack IBCLCs
Telelactation is a
potential solution,
but research is
limited
A new telelactation model has emerged…

But there has been no research on the impact of these services

and whether they are feasible and acceptable to breastfeeding mothers
 Interactive
instructional/
support video
calls through
patient’s
personal
device
Breastfeeding mother Lactation consultant

Unscheduled, on-demand assistance

Advantages Available 24/7, including from home
Inexpensive

Requires wifi or data network access and computer literacy

Disadvantages Consultants cannot provide hands-on assistance
 STUDY
AIMS

Breastfeeding mother Lactation consultant

The Tele-MILC trial evaluated the feasibility, acceptability,

and impact of telelactation via personal devices on
breastfeeding duration and exclusivity among rural women.
METHODS
 Randomized
controlled trial

Recruitment:
October 2016–
May 2018 in a
critical access
hospital in PA
 Randomized Inclusion
controlled trial criteria

Recruitment: Postpartum women:

October 2016– >18 years
May 2018 in a Valid email
critical access
Spoke English
hospital in PA
Gestational age >35
weeks
Initiated BF and
planned to continue
 Randomized Inclusion Exclusion
controlled trial criteria criteria

Recruitment: Postpartum women: Multiple infants

October 2016– >18 years Separation from
May 2018 in a Valid email infant
critical access
Spoke English Condition where
hospital in PA
Gestational age >35 BF contraindicated
weeks
Initiated BF and
planned to continue
 Randomized Inclusion Exclusion Mothers tracked
controlled trial criteria criteria for 12 weeks

Recruitment: Postpartum women: Multiple infants Surveyed at

October 2016– >18 years Separation from baseline, 4, and 12
May 2018 in a Valid email infant weeks
critical access
Spoke English Condition where $25 in incentives
hospital in PA
Gestational age >35 BF contraindicated for each assessment
weeks
Initiated BF and
planned to continue
 Tele-MILC process at recruitment hospital
Intervention Intervention follow-up

Use of and satisfaction

with video calls

Random assignment Online survey 2, 4, and 12 weeks

Online survey at enrollment post-discharge

Assessed for eligibility

Control
Control
Excluded (not eligible) follow-up
 The intervention

Download the PACIFY app Unlimited, on-demand access to video

and enter coupon code calls with IBCLCs
Self-reported primary outcomes
• Any breastfeeding at 12 weeks (yes/no)
• Exclusive breastfeeding (infant fed only Feasibility measures
(telelactation participants)
breastmilk) at 12 weeks (yes/no)
• Use of telelactation (any
use, number of visits)
• Satisfaction with advice
Self-reported secondary outcome received via telelactation
• Breastfeeding satisfaction during the video calls
period of breastfeeding (satisfied vs.
not satisfied)
Assessment of whether randomization
achieved balance across arms
(t-test and chi-squared tests)

Linear regression ANALYSIS

• Intent-to-treat approach that estimates the effect of
treatment on those randomized to receive it
• Instrumental variable approach that estimates the
effect of treatment on the treated
• All models adjust for exclusive breastfeeding in the
hospital
• Underpowered study
Regression models
• with and without adjustment for exclusive
breastfeeding in the hospital SENSITIVITY
Alternative regression models ANALYSIS
• Tested within the IV approach using probit model

Survival analyses
• Time to breastfeeding cessation

Comparable results
for all tests
RESULTS
 Consort diagram

Enrollment Allocation Follow-up Analysis

Allocated to Lost to Analyzed (n=94)

intervention follow-up No participants excluded
(n=102) (n=8) from analysis
Assessed for
Randomized
eligibility
(n=203)
(n=313) Lost to
Allocated to Analyzed (n=93)
control follow-up No participants excluded
from analysis
Excluded (n=110) (n=101) (n=8)
• Did not meet inclusion criteria (n=89)
• Declined to participate (n=19)
• Other reasons, not screened (n=2)
 Participant characteristics at enrollment
Education Race/ethnicity
High school diploma or less Married Non-Hispanic, white

47% 43% 53% 57% 96% 97%

Planned to work during

baby’s first year Owned a smartphone
Telelactation
Control 52% 59% 97% 95%
 Participant characteristics at enrollment
Annual household income
Telelactation 18% 13% 10% 16% 22% 11%

Control 14% 10% 16% 14% 15% 19%

$0–$14,999 $15,000–$24,999 $25,000–$39,999 $40,000–$54,999 $55,000–$79,999

$80,000+

Insurance during pregnancy

Telelactation 48% 48% 4%

Control 43% 51% 4%

Private Public Uninsured

 Participant characteristics (pre-pregnancy)
Maternal health
100% Telelactation Control
90%
80%
70%
60%
50%
40%
30%
20%
10%
0% Smoked during last 3
months
Smoked
of pregnancy Diabetes Hypertension Obese (BMI ≥ 30) Depression or anxiety
 Participant characteristics at enrollment
Childbirth and labor
100% Telelactation Control
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Cesarean section Primiparous Gestationalage
Gestational age> Infantbirthweight
Infant birthweight< Prior breastfeeding
>37
37weeks
weeks <2,500g
2,500g experience
 Participant characteristics at enrollment
Planned to breastfeed Planned to breastfeed
at least 3 months at least 6 months

Breastfeeding
intentions and 100% 96% 93% 90%
initial patterns
Breastfed in first hour Breastfed exclusively
after birth in hospital
Telelactation
Control 79% 87% 71% 86%
 Experiences with the intervention

50%
of telelactation
arm participants
Breastfeeding mother reported Lactation consultant
participating in
one or more video
Vendor EMR data showed that
calls with an IBCLC
33% of participants engaged in
during the study
substantive discussion about a
period*
breastfeeding challenge

* Includes demonstration calls in which they briefly spoke to an IBCLC to learn how to use the application
Among users who received substantive support…

83 total 3+ calls
29%
calls 1 call
45%
completed
2 calls
26%
Characteristics of Telelactation Users and Non-users
Childbirth and breastfeeding

Users Non-users

87% 86% 84% 86% 81%

62% 65%
52% 55% 52%
44%
39%
 Characteristics of telelactation users and non-users
Other maternal characteristics

Users Non-users
97% 97%

65% 68%
52% 46% 55%
45% 49% 46% 41% 35%

e ce ce r s
n n n ty ek om
ho ur
a ra 1 s we m
tp s su in e
ar n n 12 it m
sm ei ci rk by -
ed va
t
bl
i
wo i rst
n Pr
i u to ng F
Ow
P ki
n ed o r
Working by
an W
Pl 12 weeks
Reasons for Not Using Telelactation
(among non-users)

26%

11%
8% 7%
 Call Characteristics (n = 83)
1–4 5–8 9–12 13+
<7 days weeks weeks weeks weeks
Age of 45% 25% 13% 7% 12%
infant

8 AM–12 PM 12 PM–4 PM 4 PM–8 PM 8 PM–8 AM

Time 28% 35% 27% 11%
of call

Weekdays, 8 AM–6 PM
Calls during
business 59%
hours
 Topics Discussed during Call (n=83)
0% 5% 10% 15% 20% 25% 30% 35%
Breast pain, soreness, infection
Use of nipple shields
Latch/positioning
Milk supply/production
Breast pump use
Infant condition/health
Infant weight/enough milk
Return to work
Issues discussed similar to
Mother's health/medications hotline calls, with exception
Mother's dietary restrictions of nipple shield use
Infant uninterested in eating
 User Experiences Were Overwhelmingly Positive

87% 91% 78%

reported that the were satisfied did not report any

app was helpful with the help they technical
received difficulties

Recommendations for improvement:

• Add text or audio-only visits
• Allow user to request a particular IBCLC
• Connect users with peers
• Automatically schedule monthly visits
 % breastfeeding at 12 weeks
(by model)
Treatment Control
Difference = 3% Difference = 5%
Exclusive breastfeeding
Difference = 11%
Difference = 5%

71% 68% 73% 68%

51% 56%
46% 45%

ITT IV ITT IV
 Breastfeeding satisfaction
Telelactation participants were less likely to report satisfaction with their breastfeeding
experience, but differences were not statistically significant

73% (lactation arm participants) 67%

78% (control participants) 78%

ITT IV

(5% difference, p=0.41) (11% difference, p=0.41)

DISCUSSION
Study had high participation rates, little
attrition, and 50% of intervention women
had a video call

• Suggests the feasibility

and acceptability of
telelactation
• However, we did not
see statistically
significant
improvements in
primary outcomes
 Observations
Telelactation has higher
uptake than other telehealth
interventions
• A population of
mothers committed to
breastfeeding
• App introduced by
trusted providers, and
test calls were
encouraged
Future models should
consider how to
deliver support
services that require
less activation by
mothers.
The study was underpowered and included one site with
predominantly white mothers in Pennsylvania.
 1st
Breastfeeding mother Lactation consultant

First experimental evaluation of

two-way video for breastfeeding support
First evaluation of direct-to-consumer
telelactation services 43
 Conclusions

• We documented robust
usage and positive
experiences with
telelactation in an
underserved population
• Services feasible and likely
to improve access and
convenience
Telelactation may improve
breastfeeding rates, but a
larger study is needed
(e.g., with higher-risk populations,
longer tracking, first-time mothers)
Acknowledgments
Thanks to
Kandice Kapinos,
Ateev Mehrotra,
Bonnie Ghosh-Dastidar,
Virginia Kotzias,
Debra Bogen,
Kristin Ray,
Jill Demirci,
Mary Ann Rigas,
Laura Stokes
Additional Slides
Standard Intent-to-Treat (ITT) Analysis for RCT
Intervention Intervention follow-up

ITT: Compare women

Random
across two groups at
assignment
follow-up

Control
Control
follow-up
Some Will Not “Take-up” or Use the “Treatment”
Intervention follow-up
Intervention
Use
app
Use instrumental
variables technique
Do not use to “adjust” for this
Random app in our comparison
assignment across groups

Without this
adjustment,
treatment “effect”
may look smaller
than it actually is
Control
Control
follow-up
 How the Instrumental Variables Model Works
From this model, you
Randomization get a predicted
Stage 1 App Use
(instrument) probability of app use
for each mom,

Breastfeeding
Stage 2 ^
𝐴𝑝𝑝 𝑢𝑠𝑒 outcomes:
duration,
satisfaction
Qualitative Interviews in First 6 Months of Study

Telephone interviews with Telephone interviews with mothers

high-volume IBCLCs identified who were offered telelactation
by app vendor (n=7) services at 5 weeks postpartum
(n=17)
 Characteristics of Mothers We Interviewed

Participant characteristics
• Median age: 25 (SD = 5.3 years)
• Majority white, married, high school–educated,
multiparous, with prior breastfeeding experience
• Receiving Medicare or Medicaid
39 mothers
enrolled in telelactation
portion at time of interviews

17 mothers All initiated

breastfeeding in
interviewed hospital and planned
to continue
 Characteristics of IBCLCs We Interviewed

• Professional backgrounds included dietetics, nursing, case management, childbirth

education, public health program coordination, WIC counseling
• All had prior experience providing telephone-based lactation counseling
• All had provided telelactation services for 1+ years at interview
• Years since IBCLC certification range: 4–20 (median: 7 years)
IBCLCs
 Characteristics of Telelactation Visits
I used [the app] mostly
Women reported visits most often in the first at night, because it was
two weeks postpartum quiet while my son was
• Wide range of issues (cluster feeds, latch, pain, pump operation) sleeping.
• All times of the day, when a mother had a quiet time and space
• Would use again for any breastfeeding issue (teeth, transitions to bottle)

Just really questions

that I think any mom who can
Google stuff should already
know. IBCLCs made distinctions between
rural and metropolitan calls
I’m going back • Rural mothers: crisis, basic info, comprehensive
to work. I have a assistance
private office. • Urban mothers: seeking reassurance, affirmation
 Positive Attributes of Telelactation
IBCLC quality and experience Ease of use
Empathetic, patient, professional, On-demand access to support on
consistent, clear mother’s personal device

[My IBCLC] was a good

listener. She was caring. She
It’s right there. It’s
cared what I had to say, too. . . .
so easy to click on
It was an actual two-sided
it and just do it.
conversation.
 Positive attributes of telelactation
Video enhances experience
Convenient, efficient, facilitated trust, visuals
Especially with the post-partum mom
who’s tired [it’s difficult].
I mean, it’s so amazing to be able to
say, . . . “See that suck? That’s a suck
where [baby] is getting milk.” Or,
“See that suck? That’s where she’s
telling you she’s done with that.”
IBCLC
Fills a void
Bridge between in-person visits, timely
support in areas with limited providers,
providers get education too
I like sitting in on [app
breastfeeding consults] because
I, as a nurse, feel like I’m
getting feedback too.
RN
 Impact of Telelactation:
Encouragement to Keep Going

Obviously, there was nothing like

this app [when I had my first child]. I probably would have ended up
If they had this a couple years ago, I waiting. I would have kept my
probably would have breastfed him questions and waited until the
longer—if I had someone I could call pediatrician’s visit, even though
right at home. they’re not lactation consultants.

But I was able to get my questions

answered before that, and then I
didn’t have to spend time during
[the doctor] visit to talk about that
stuff. I was able to focus on other
things.
 Barriers and Reasons for App Non-use
Barriers to telelactation
• Getting up the nerve to call (Potential solution: Offer text and audio/phone visits in addition to video
visits)
• Continuity of care (Potential solution: Allow IBCLCs to see previous provider’s notes; allow mothers to
request same IBCLC)
• Getting the app to work (affected a small subgroup): dropped calls, poor connection/signal/coverage

I know some people feel
uncomfortable with video
chatting. . . . I wasn’t too positive
on video chatting somebody I
didn’t quite exactly know.
Reasons for not using the app
• Convenient access to in-person support that the mother
preferred
• Limited need for professional breastfeeding support
(e.g., previous breastfeeding experience, lack of
challenges)
• Competing demands that deprioritized breastfeeding
concerns
 Conclusions

Feasibility and utility of telelactation services

• Telelactation for rural mothers is feasible and acceptable
• Easy to use
• Fills a void
• Rural mothers: crisis, basic info, comprehensive assistance
• Potentially more useful for first-time mothers
• “Digital divide” not a major issue