Use of a Reproductive Life Planning Tool at the Pediatric Well-Baby Visit With Postpartum Women
Phase: NA
Conditions: Postpartum Period, Contraception Behavior, Women's Health, Primary Health Care
Sponsor: University of Illinois at Chicago

Protocol v3   January 25, 2018 
 Page 1 
 
Research Protocol for  
Use of Reproductive Life Planning Tool At the Pediatric Well-baby Visit                           
with Postpartum Women 
Background 
Unintended pregnancy is a persistent public health challenge in the U.S.  In 2011, 45% 
of the 6.1 million pregnancies were unintended.1  Women who have had a recent 
pregnancy are at increased risk of unintended pregnancy compared to other women of 
reproductive age not using contraception,2 with rates up to 44% in the first postpartum 
(PP) year.3  In addition, adequate birth spacing in the postpartum period is important for 
the health of mother and infant.  Pregnancies with a short interpregnancy interval (within 
18 months of delivery) have been associated with increased risk of preeclampsia, 
preterm birth, and low birth weight.4  Low-income women of color are at increased risk 
of unintended pregnancy and suboptimal birth spacing which in turn increases their risk 
of adverse pregnancy outcomes.5  Improved access to postpartum contraception is 
needed to reduce unintended pregnancies and help women achieve desired birth 
spacing.6,7  While the obstetric postpartum visit has historically provided the opportunity 
for women to receive contraception, many women, particularly low-income women, do 
not attend this visit.8  Uptake of family planning is an ongoing process throughout the 
postpartum period and new approaches are needed to ensure women receive the care 
they need when they desire it.9    
 
Over the last decade, there has been an increased focused on preconception and 
interconception care as an approach to improve women’s and infant’s health.10  The 
growing interest in the continuum of reproductive health care has gained momentum 
and a focus by health professionals on the well-woman primary care visit is likely to 
continue.11 In this context, postpartum care has emerged as the pivotal link between 
prenatal care and well-woman health care.  The fact that a large number of vulnerable 
women, including low-income women and women of color, fail to seek care during the 
postpartum period is a major concern, particularly because they are at higher risk of 
chronic health issues and unintended pregnancy.12,13  On the other hand, women are 
very likely to bring their newborns in for care during this same time period in accordance 
with the well-baby visit (WBV) schedule.14 
 
One recent approach to assist women to reflect on their reproductive health as well as 
contraceptive options to support pregnancy planning, is the integration of a 
Reproductive Life Planning Tool (RLPT) by health care providers into routine practice.15  
To date, reproductive life planning has typically been discussed in the context of a 
woman’s primary care or family planning visit; as such, little is known about the potential 
use of a RLPT as a prompt for referral to care in the context of the WBV, particularly for 
women who may not receive routine postpartum care.16-21  Research has shown that 
pediatric providers are open to referring PP mothers for health care; however, little is 
known about whether those referrals result in care.22  The objective of the proposed 
pilot study is to test an innovative system-level intervention in which postpartum women 
complete a self-administered (RLPT) during their infants’ 2-month WBV, which is 

Protocol v3   January 25, 2018 
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reviewed by the pediatrician and prompts a referral for care as needed.  This feasibility 
study focuses on implementing a systems change to improve the accessibility of well-
woman primary care including reproductive health care for low-income minority 
postpartum women. 
 
Women experience a substantial amount of morbidity during pregnancy which often 
continues into the postpartum (PP) period.23 In turn, women’s PP health status affects 
their lifelong health status as well as their health during a subsequent pregnancy.24  
Receiving appropriate health care during the PP period, and continued care during the 
interconception period, can help to ameliorate these risks and improve health for 
women and children.  While few studies examine women’s utilization of the PP visit, 
estimates for non-attendance vary (11%-40%).8,25-28  Among low-income Medicaid-
insured women in Illinois, fewer than 53.7% received a PP visit in 2013; this is also true 
for the Medicaid population served by the University of Illinois Health system (UIH).29  
 
Postpartum women are at particularly high risk of unintended pregnancy.3  While some 
women have access to contraception in the hospital after delivery, provision varies and 
typically women do not receive contraception until the 6-week postpartum visit.  
Unfortunately, the timing of the 6-week visit is not based on current evidence about 
women’s sexual activity after pregnancy or the need for timely PP contraception; thus, 
over half of women are at risk for a rapid repeat pregnancy.30  Glazer and colleagues 
found 29% of women were using no contraceptive method at 4-6 months postpartum 
despite the fact they had resumed sexual intercourse and 32% percent of the study 
population were relying on less effective methods.30   
 
In contrast to the PP visit, the Well-Baby Visit (WBV) is highly utilized. In 2011-2012, 
90.9% of U.S. infants received visits during the first year of life.14 Because women are 
more likely to obtain care for their infants, compared to their own PP care, they are likely 
to attend multiple visits in the pediatric setting during the PP period.  In addition, the 
WBV is increasingly acknowledged as a site of care where maternal health issues can 
be addressed.  AAP Bright Futures guidelines for health supervision encourage 
providers to assess maternal well-being as part of routine care of infants.31  This 
approach is particularly salient for the many women who do not attend a routine PP visit 
or who do not select a method of contraception during their PP visit.  While a similar 
model may exist for women who seek care from a family physician who can provide 
care to both the mother and her infant, for most families, adult care is separate from 
pediatric care.  Family physicians provide 17% of primary care visits for children ages 0-
4, while pediatricians provide the remainder.32   
 
To both improve the delivery of interconception care to women of reproductive age and 
to facilitate discussion of contraceptive needs as part of this care, the Centers for 
Disease Control and Prevention (CDC) recommends use of a Reproductive Life Plan 
Tool.10  To date, literature on RLPTs has mostly focused on their use in women-focused 
primary care settings or in family planning settings.16,17,19-21,33  This study seeks to test 
the use of a streamlined self-administered RLPT (attachment) with all PP women 
attending a 2-month WBV with their infant.  Pediatricians will then use the RLPT to 

Protocol v3   January 25, 2018 
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assess women’s need for well-woman primary care, then refer and provide an 
appointment for care for women who desire one. 
 
Specific Aims 
 
Aim I. To determine if introducing a self-administered Reproductive Life Planning Tool 
(RLPT) with postpartum mothers during the 2-month WBV will increase the proportion of 
women receiving a well-woman primary care health visit by 6 months postpartum.  
 
Aim Ia. To determine if introducing a self-administered Reproductive Life Planning Tool 
(RLPT) with postpartum mothers during the 2-month WBV will increase utilization rates 
of contraception by 6 months postpartum. 
 
Aim II: To assess the extent of system adoption as well as patient-, provider-, and 
systems-level barriers and facilitators to integrating a self-administered Reproductive 
Life Planning Tool designed to facilitate referral of postpartum women for primary well-
woman care within the context of a pediatric clinic. 
 
 
Study Design and Intervention 
 
This is a single-site system-level pilot study to measure the impact of a self-
administered RLPT (attachment) during the 2-month WBV on PP women’s subsequent 
receipt of primary health care and contraception, compared to usual care. To facilitate 
women’s uptake of a referral for well-woman primary care, women will be offered the 
opportunity to schedule a visit for herself on the same day as her infant’s next WBV or 
the first available visit if she needs more immediate care. This study will have two 
phases: phase 1 is enrollment of a control or baseline group, followed by a washout 
period; phase 2 is enrollment of the intervention group (intervention).   
 
During phase 2 (intervention), the self-administered RLPT will be implemented in the 
Child and Youth Center (CYC, the general pediatric clinic) and the Primary Care 
Adolescent and Child Clinic (PCAC) at UIH with all PP women bringing infants for the 2-
month WBV. The intervention leverages an existing system designed to screen all PP 
women (through 6-months) for depression.  Currently, when a mother checks-in her 
infant for a visit she is provided an Edinburgh Postpartum Depression Screening tool 
with instructions to complete and return the tool to the infant’s physician during the visit.  
On a daily basis, completed tools are scanned and saved on a secure server (required 
for billing purposes).  This system has been successful for universal PP depression 
screening and referral.  An audit found that in 91% of all WBVs with a child 0-16 wks., 
the infant’s mother was present and eligible to have an Edinburgh tool completed; of 
these, 90% had a completed Edinburgh tool provided to the physician. We will pair the 
RLPT with the Edinburgh tool (back to back on the same piece of paper); women of 2-
month olds will be instructed to complete both sides.  To test the feasibility of this 
approach, we briefly tested locating a general women’s health screening survey on the 
back of the Edinburgh tool.  During the pilot, 37 infants 0-16 wks. of age had a WBV; 
89% of these had a complete Edinburgh. Of those who completed the Edinburgh, 100% 

Protocol v3   January 25, 2018 
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completed the survey on the opposite side, suggesting women are willing to complete 
another brief questionnaire. 
 
During the WBV, physicians will review the information provided by the woman on the 
RLPT about general health, reproductive plans, and use of contraception.  The 
pediatrician will use the RLPT to initiate a brief conversation with mothers about the 
need for a referral for well-woman primary care.  We expect this conversation to take 
less than 3 minutes based on previous studies.22  We will create a referral process to 
the UIH Primary Care Plus clinic (internal medicine) through our electronic medical 
record.  At the close of the WBV, if the mother desires a referral the pediatrician can 
request the referral during the infant’s check-out process.  Research staff will routinely 
review all referral needs and initiate scheduling based on the mother’s preference. 
Women will be asked if they prefer the next available appointment or an appointment 
on the same day as their infant’s next WBV. For women who desire their health care 
visit on the same day as their infant’s next WBV (the 4-month visit), we will schedule 
both visits on the same day.  To the extent possible, the mother’s appointment will be 
earlier the same day (ideally 2 hours before) of the infant’s scheduled visit, to promote 
attendance.  We expect that by offering women the opportunity for a primary care visit 
on the same day as their infants’ next WBV, the likelihood of adherence will be much 
greater than just offering a referral. Among women scheduled for care, if by the date of 
their infant’s next WBV the woman has not attended her visit (she cancels or does not 
show), the research staff will contact her to reschedule, offering either the first available 
appointment or co-scheduling with the infant’s next WBV.    
 
Reproductive Life Planning Tool: We have created a RLPT (in English and Spanish) 
based on detailed feedback from physicians and women regarding how best to 
operationalize a RLPT in the pediatric setting (previous research studies).   
 
Study site:  The CYC and PCAC are comprehensive pediatric clinics; patients can be 
seen by a pediatric faculty member (faculty practice) or by a pediatric resident physician 
with direct supervision by a faculty member.  The clinics serves a predominantly low-
income Medicaid-insured population.   
 
Participant Eligibility: Postpartum women 15-49 years presenting with their infants to 
the CYC or PCAC for a 2-month WBV, and who also receive their own care at UIC 
(needed for chart abstraction purposes), are eligible to participate in the study.  Women 
must be English and Spanish speakers.   
 
Participant Exclusion: Women who are currently pregnant, less than 15 years or older 
than 49 years of age, or do not speak English or Spanish. 
 
Participant Recruitment into the Research Study:  The intervention is planned as a 
system-level intervention, thus, all women whose infants are scheduled for a 2-month 
WBV during the intervention period will have the opportunity to be exposed to the RLPT 
intervention.  On study recruitment days (randomly selected half-days during phase 2), 
women whose infants are scheduled for a 2-month WBV will be approached by a 

Protocol v3   January 25, 2018 
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research assistant (RA) who will screen for eligibility. Recruitment into the study will 
occur before, during or after the WBV, baseline surveys will be  completed during or  
after the WBV to avoid biasing women’s responses on the RLPT, which is administered 
prior to the WBV. If a woman is eligible and interested in participating, she will be 
consented and asked if she has time to complete a baseline survey.  The baseline 
survey will include the domains listed in Table 1.  To the extent possible, the baseline 
survey will be self-administered using a tablet computer linked to the RedCap database.  
A study RA will be available to provide assistance or administer the survey if necessary.  
When possible, the surveys will be completed immediately after the WBV in a private 
room.  We are sensitive to the fact that women may not have the time to stay after the 
WBV, in which case we will request permission to conduct the survey by phone at a 
convenient time.  Our research team has extensive experience recruiting PP 
participants and we have found this to be an effective strategy. Because this is a 
system-level intervention, women who decline participation in the study will still receive 
the intervention but will not participate in any research data collection.  For example, a 
woman who does not agree to participate in the study would still have been given the 
RLPT prior to the infant’s visit and, if desired, she will receive a referral and appointment 
for care though she will not be included in the study. 
 
Though this is a system-level intervention, the intervention is targeting only the 2-month 
WBV, thus we do not expect a RLPT will be offered to a woman more than once.  After 
consent is obtained, the RA will cross-check the participant list using a secure network 
on a tablet device to ensure that the woman is not already enrolled.  Each RLPT will be 
linked to the infant by medical record number and date of birth.  Limited physician 
characteristics (male/female, trainee/faculty) will be recorded; no physician names will 
be collected.  The RLPTs for women who are consented and enrolled in the study will 
remain intact and all data will be collected from the tool and linked to the enrolled 
mother. The RLPTs for women who are not enrolled into the study will be de-identified 
after the Edinburgh tool is scanned by removing and shredding the patient sticker so no 
identifying information remains on the form. This will allow us to calculate clinic-specific 
adoption rates and examine the extent to which provider and system characteristics, 
such as the type of physician (e.g., attending versus resident), demographic 
characteristics of the physician (e.g., sex), and clinic operational factors (e.g., morning 
versus afternoon clinic; day of the week), influences adoption of the intervention (Table 
1).  
 
Consent for Intervention Group:  Informed consent will be obtained for: 1) a baseline 
survey; 2) a phone survey at 6 months PP; and 3) access to a woman’s medical records 
to document receipt of health care services.  Women will be will reimbursed for their 
time with gift cards [$10 at baseline and $10 at 6 months].  The RA will log the 
recruitment process, including number of women approached and if women accepted or 
refused, participation. 
 
Pediatrician Training: Pediatricians (faculty and resident physicians) will all receive a 
1-hour formal training on using the RLPT prior to the start of the study, offered at three 
different times to accommodate physician schedules.  Research staff will touch-base 

Protocol v3   January 25, 2018 
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with pediatricians weekly during the first 4 weeks of the study, and monthly thereafter, to 
answer questions and encourage consistent provider use of the tool.  We will schedule 
a ‘refresher’ training 3 months after the start of the study to reinforce appropriate use of 
the tool.  During the training, physicians will be instructed on how to start a conversation 
with women, what to document on the tool, and how to initiate a referral if needed. 
Physicians are not expected to provide contraceptive counseling to mothers, only to 
engage women in a discussion about their health care needs.  An information sheet 
about the study will be given to all pediatric providers who are trained. 
 
Selection of control group:  The control group will be enrolled during phase 1 (first 4 
months) prior to the introduction of the intervention.  Similar to the intervention group, 
women will be recruited by an RA before, during or after the health care visit and 
screened for eligibility. Informed consent will be obtained for a baseline survey using the 
same procedure as described for the intervention group (same gift card amounts). 
Because we are studying health behaviors, we cannot share the specific aims of the 
study with control group participants as this could bias behavior. The control group 
participants will be told that this is a study monitoring women’s general health care 
experiences at UIH.  After enrollment of the control group, a 6-week washout period 
prior to phase 2 (intervention) will ensure women are not enrolled into both arms of the 
study. 
Sample:  This pilot study will enroll at least 50 women per group. This sample size will 
provide a stable estimate of the intervention’s effect on primary care receipt by 6 
months postpartum for power calculations for a larger, subsequent study of intervention 
effectiveness.  There are approximately 200 deliveries per month at UIH, with 57% 
(114) of these infants having a 2-month WBV at UIH.  For the 4-month period of 
recruitment each for control and intervention groups, we can meet our target enrollment 
of 50 in each group by recruiting women during four of the ten half-day CYC clinics per 
week, assuming a conservative participation rate of 40%. 
 
 
Table 1   Study Variable Table 
 
Variable 
Specific 
Aim  
Level of 
Measurement 
Time of 
Collection 
Tool 
Variable 
Type 
Demographic Data  
I  
Women  
Enrollment 
Baseline 
survey 
Covariate 
Physician 
Characteristics 
  Male/Female,  
  Trainee/Faculty 
II 
Physicians 
Enrollment 
Medical 
record 
schedule 
Covariate  
Clinical Operations 
  Visit time and day of 
week 
II 
Health 
System  
Enrollment 
Medical 
record 
schedule 
Covariate 
Health and Family Planning 
Women’s general health 
status 
I 
Women 
Enrollment  Baseline 
Survey 
Covariate 

Protocol v3   January 25, 2018 
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Women’s general health 
behaviors (smoking, 
alcohol, nutrition and 
exercise) 
I 
Women 
Enrollment  Baseline 
Survey 
Covariate 
Plans for future 
pregnancy 
I 
Women 
Enrollment 
RLPT 
Covariate 
Current contraception  
type and use 
I 
Women 
Enrollment  RLPT 
Covariate 
Pregnancy status 
I 
Women 
6 months 
postpartum 
Phone 
survey and 
Chart 
review 
Dependent 
Referral to primary care 
I 
Women 
Enrollment 
RLPT 
Dependent 
Receipt of primary care 
visit 
I 
Women 
6 months 
postpartum 
Phone 
survey and 
Chart 
review 
Dependent 
Use contraception, 
duration and method 
I 
Women  
6 months 
postpartum 
Phone 
survey and 
Chart 
review 
Dependent 
Feasibility, Acceptability, and Adoption of RLPT 
Ease of use, comfort 
and satisfaction with tool 
II 
Physician 
Year 2 
Focus 
groups 
Acceptabilit
y 
Ease of use, comfort 
and satisfaction with tool 
II  
Women 
Enrollment 
Baseline 
survey 
Acceptabilit
y 
Women’s need and 
desire for referral 
I and II  
Women 
Enrollment 
RLPT 
Acceptabilit
y 
Women’s barriers and 
facilitators 
II  
Women 
6 months 
postpartum 
Phone 
survey and 
Chart 
review 
Feasibility 
Physician barriers and 
facilitators  
II 
Physician 
Completion 
of study 
Focus 
groups 
Feasibility 
Completion rate for grey 
box on RLPT form 
II 
Health 
System 
Enrollment 
RLPT 
completion 
rate by 
women 
and 
physicians 
Adoption 
  
Data Sources and Collection 
   
Surveys of Women: All participants will complete a baseline survey (English and 
Spanish) at the time of enrollment in the study (during or after the WBV) and will receive 

Protocol v3   January 25, 2018 
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a phone call at 6 months PP for the follow-up survey (survey and interview questions 
domains listed in Table 1).  During the baseline survey, in addition to demographic 
information, women will be asked about their general health status and health 
behaviors, and current contraception type and use.  Those in intervention arm will be 
asked about their experience completing the RLPT during the WBV, referral to well-
woman primary care (if applicable).  For the follow-up survey we will try to reach each 
participant as close to 6 months as possible, but no later than 9 months PP.  Structured 
phone interviews with women will include questions from the following domains: 1) use 
of health care services; 2) use and type(s) of contraception; and 3) known pregnancy 
status. The intervention group interviews will also include experience completing the 
RLPT during the WBV; and, the process of getting care (for those who chose to do so) 
(SA II).  To verify RLPT exposure at the individual level, the RLPT tool will be linked to 
the mother using the patient sticker placed on the tool. 
 
Medical Records:  Medical records will be reviewed at baseline and at 6 months PP to 
determine receipt of health care services and contraception.  We recognize that some 
women may receive additional health care outside the UIC system; for this group, we 
will not be able to confirm medical visits outside the UIC system.   
 
Focus Groups with Providers: We will conduct two in-depth qualitative focus groups 
with physicians (residents and faculty) after the intervention is complete during study 
year 2.  The focus group guide will include questions from the following domains: 1) 
Experience implementing the RLPT; and, 2) barriers and facilitators to implementation 
of RLPT (SA II).  In addition, study investigators will keep a running log of barriers and 
facilitators experienced throughout the intervention implementation period. 
 
Data Management  
 
All survey data will be directly entered into REDcap web-based data capture screens 
that will be programmed and tested prior to the study. Data will be imported to SAS for 
analysis. Variables (Table 1) will be merged across time point by study ID and cleaned 
and recoded.  Focus groups will be recorded, transcribed, and uploaded to DeDoose 
qualitative analysis software.  Completion of the Grey Box (physician section of the tool) 
will be a measure of provider “adoption” of the intervention; completion rates will be 
tracked by comparing completed forms with completed clinic visits for 2-month WBVs.  
Completed clinic visit data are available in our existing medical record scheduling 
system.   
 
Analysis 
 
Specific Aim I and Ia: Baseline characteristics will be assessed for equivalency across 
groups using chi-square tests for categorical and t-tests for continuous variables. 
Unbalanced characteristics will be adjusted for in further analyses. The primary 
outcome, receipt of primary care services for women by 6 months PP (SA I) will be 
ascertained both by self-report during the 6-month phone interview and by medical 
record review, in order to minimize missing data. Evidence of a visit from either source 

Protocol v3   January 25, 2018 
 Page 9 
 
will be counted as receipt.  Utilization, type and duration of contraception (SA Ia) by 6 
months PP will be assessed similarly.  An intent-to-treat analysis will be performed for 
SA I and Ia.  A crude relative risk (RR) and risk difference (RD) will be calculated with 
95% confidence intervals to estimate the effect of the intervention on primary outcomes.  
If adjustment is needed for covariates, RRs and RDs will be estimated using the 
average marginal predictions from a fitted logistic regression model with the following 
form:41 
 
logit(y) = β0 + β1x1 + β2x2 + …+ βkxk , where: 
y = 
SA 1: Woman’s primary care visit by 6 months (1 = Yes/0 = No) 
SA 1a: Use of contraception at 6 months (1 = Yes/0 = No) 
x1 = 
RLPT Intervention (1 = Intervention/0 = Control) 
x2 – xk = 
Unbalanced covariates  
 
Specific Aim II: Patient and physician facilitators, barriers and satisfaction data will be 
gathered from the RLPT, surveys, and focus groups.  System adoption will be defined 
as the number of completed RLPT forms clinic-wide during the intervention (for 
enrollees and non-enrollees) divided by the total number of eligible visits during that 
time period, which will be ascertained through the clinic’s scheduling database.  
Adoption will be compared across provider (e.g., status) and clinic operation factors 
(e.g., day of week) using chi-square tests. Adoption statistics will be shared with 
providers prior to focus groups, allowing them to elaborate on these findings.  
Qualitative focus group data from providers will be coded according to domains and 
analyzed for emergent themes related to feasibility and acceptability. Women’s 
perceptions of feasibility and acceptability will be derived through the survey data and 
will be analyzed by other key covariates.  
 
Although the findings of this study will reflect the experiences of low-income women at 
one large medical center in Chicago, they are likely to be relevant to the experiences of 
many low-income women.  While a hospital outpatient clinic is a unique health care 
setting, the experience of having a pediatrician discuss new mothers’ health needs and 
refer them for their own care is likely to be similar across pediatric practices. This study 
will add to the emerging literature related to a dual care focus for mother and infant. If 
this intervention is successful, it will provide evidence of the feasibility of introducing a 
system-level intervention related to women’s health into pediatric practice.  This 
information can inform changes in payment and policy to support the ability of 
pediatricians to discuss women’s health needs and facilitate referral with mothers at 
their infants’ WBV, with the ultimate goal of increasing women’s use of primary care and 
PP contraception, preventing rapid repeat and unintended pregnancies, and ultimately 
decreasing adverse pregnancy outcomes.       
 
 
 
 

Protocol v3   January 25, 2018 
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