Linking Inter-professional Newborn and Contraception Care (LINCC) Trial - A Novel Approach to Postpartum Contraception Provision at the Well-Baby Visit
Phase: NA
Conditions: Family Planning, Contraception, PostPartum
Sponsor: Rush University Medical Center

Linking Inter-professional Newborn and Contraception Care (LINCC) Trial: A 
Novel Approach to Postpartum Contraception Provision at the Well-Baby Visit
Principal Investigator:
Sadia Haider, MD, MPH
Associate Professor
Vice Chair of Research & Faculty Affairs 
Department of Obstetrics and Gynecology
Rush University Medical Center
1653 W Congress Pkwy, Unit 720, Chicago, IL 60612
Sadia_Haider@rush.edu; 312-942-8793
Co-PI:
Rachel Caskey, MD, MAPP
Associate Professor of Pediatrics and Internal Medicine
Division Chief, Academic Internal Medicine and Geriatrics
University of Illinois at Chicago
840 S. Wood St. MC 856, Chicago, IL 60612
rcaskey@uic.edu; 312-413-1595
Co-Investigators:
Nivedita Mohanty, MD
Chief Research Officer and Director of Evidence Based Practice, AllianceChicago
Pediatrician, Eric Family Health Center
Assistant Professor of Clinical Pediatrics, Northwestern University Feinberg School of 
Medicine
215 W. Ohio Street, 4th Floor, Chicago, IL 60654
nmohanty@alliancechicago.org; 312-504-6569
Kristin Rankin, PhD
Assistant Professor, Division of Epidemiology and Biostatistics
Co-Director, MCH Epidemiology Training Program
University of Illinois at Chicago School of Public Health
1603 W. Taylor St. MC 923, Chicago, IL 60612
krankin@uic.edu; 312-996-4870
Rebecca Campbell, PhD
Assistant Professor, Division of Epidemiology and Biostatistics
University of Illinois at Chicago School of Public Health
1603 W. Taylor St. MC 923, Chicago, IL 60612
rcampb@uic.edu; 312-996-0064
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Consultant:
Rachel Gold, PhD, MPH
Investigator, Kaiser Permanente Northwest Center for Health Research and OCHIN
3800 N. Interstate Avenue, Portland, OR 97227
rachel.gold@kpchr.org; 503-528-3902
Study Location(s):
Seven community health centers (CHCs) - six urban and one rural from 
AllianceChicago’s network
Sponsor: National Institutes of Health (NIH)
Version: v.3
Date: 4/23/2024
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1.0
Project Summary/Abstract
Background: Pregnancies conceived within 18 months of a prior delivery (termed short 
inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health 
outcomes including pre-eclampsia, anemia, and preterm birth.1,2,3-7 Despite these 
negative health consequences, nearly one third of women experience a short IPI, 
highlighting a significant public health problem in the U.S.9 A critical approach to 
preventing short IPIs is to provide postpartum (PP) women with timely access to 
contraception. The current standard clinical practice is to have women return six weeks 
after delivery for a postpartum visit, at which time contraceptive needs are addressed. 
However, many women resume sexual activity prior to six weeks PP, and many women, 
particularly low-income minority women, do not present for this visit. Low rates of 
postpartum contraception uptake leave women vulnerable to an unplanned pregnancy 
and significant negative health consequences. Thus, there is an urgent need for 
alternative approaches to increase timely access to PP contraception to improve 
outcomes for women and children.
Objectives: The study aims to: (1) develop a comprehensive implementation plan to link 
PP contraception and newborn care through co-scheduling visits in community health 
centers (CHC) and (2) use an effectiveness- implementation hybrid design to evaluate 
this novel system-level approach to linking maternal and newborn care at CHCs served 
by our partner organization, AllianceChicago. Lastly, we aim to: (3) assess 
implementation of linked PP contraception and newborn care and report on key barriers 
and facilitators related to successful implementation of the intervention.
Methods: Using a novel approach, we will test a patient-oriented alternative delivery 
system for PP contraception that will fill a gap in our current system resulting in improved 
contraceptive access for women. We will use a cluster randomized cross-sectional 
stepped wedge design to test the novel linked contraception and WBV model’s impact on 
increasing PP contraception uptake in urban and rural CHCs, compared to usual care.
Outcomes: It is expected that the intervention will increase the proportion of women using 
contraception and 2 and 6 months postpartum. Increasing access to timely contraception 
is a promising strategy to help women plan their families and, in turn, reduce the poor 
health sequela associated with short IPI pregnancies. The long-term impact of this study 
is to reduce negative health outcomes among PP women and infants by increasing 
access to patient-oriented PP contraceptive care. Findings may provide evidence 
supporting a paradigm shift for linked PP care and identify important insights to facilitate 
successful implementation of this model of care in CHCs across the nation.  
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Figure 1: Hypothesis—Linking contraception with newborn care will decrease 
unintended pregnancies and improve maternal and child health outcomes
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2.0
Background/Scientific Rationale 
Pregnancies conceived within 18 months of a prior delivery (termed short inter-
pregnancy interval) place mothers and infants at high risk for poor health 
outcomes including pre-eclampsia, anemia, and preterm birth.1,2,3-7 Additionally, among 
women who experience a short IPI, 74.4% report the pregnancy was unintended.8
Despite these negative health consequences, nearly one third of women experience a 
short inter-pregnancy interval, highlighting a significant public health problem in the U.S.9
Consistent contraception use is the most effective way to prevent unintended 
pregnancies.10 Unfortunately, rates of postpartum (PP) contraception use remain low 
leading to high rates of unintended pregnancy and short IPIs.11 Few women receive 
contraception prior to the standard six-week PP visit, and many do not receive 
contraception until after six-weeks PP.11 Among a group of low-income publicly-insured 
women in California (N= 117,664) followed for 18 months PP, only 42% received 
contraception at any time between delivery and 90 days PP, and as few as 13% received 
contraception at their first PP visit.11 Additionally, over a third (36%) of these women had 
a short IPI pregnancy.11 Low rates of PP contraception uptake leave women vulnerable 
to an unplanned pregnancy and significant negative health consequences. Reducing the 
national level of unintended pregnancies is important for women and families, and is an 
important reproductive health goal identified by the United States Department of Health 
and Human Services (DHHS).12 Increasing access to timely PP contraception is a 
promising strategy to help women plan their families and, in turn, reduce the poor health 
sequela associated with short IPI. 
Low-income women are most at-risk for unintended pregnancies and least likely to 
receive timely contraception. More than 19 million U.S. women need publicly supported 
contraceptive services, and of those in need, 5.8 million (30%) are uninsured.10 While 
overall rates of unintended pregnancies have been decreasing since the 1980s, the 
decrease has been primarily among higher-income women. A recent study reported 
significant disparities in unintended pregnancy rates by income, with low- income women 
significantly more likely to experience an unintended pregnancy underscoring the 
importance of testing approaches to meet these women’s contraceptive needs.13
Reproductive health services are limited in many rural areas, contributing to less 
access to health care and poorer maternal and infant health outcomes.14 A 
telephone survey of reproductive age women in Central Pennsylvania in 2004-2005 found 
rurality impacted contraceptive counseling, with women in rural areas significantly less 
likely than urban women to receive counseling related to birth control.15 Sexually active 
women living in rural areas are also less likely to receive reproductive health services 
compared to women in urban areas, with approximately 16.9% and 83.1% receiving 
family planning services in the past 12 months, respectively.14,16 Given this unmet need 
for reproductive health services in rural areas, efforts should also focus on strategies to 
increase access to and provision of contraception for rural women. 
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Community Health Centers (CHCs) serve as a safety net for low income 
underserved urban and rural residents.17 Research has shown that 83% of individuals 
who receive care at CHCs have a form of public insurance or no insurance, while only 
39% of patients who seek care at private physician offices are uninsured or have public 
forms of insurance.18 Overall, CHCs serve an estimated 24% of all low- income women 
of childbearing age in the U.S.19 Despite the varying scope and delivery of family planning 
services across CHCs, virtually all CHCs have reported that they provide at least one 
contraceptive method (99.8%) at one or more clinical sites.19 Most CHCs are adequately 
equipped to provide comprehensive contraception counseling and provision of a broad 
range of contraceptive methods to medically underserved communities. Therefore, CHCs 
serve as an ideal setting for a program intended to reach the women most in need of 
improved contraception services in the PP period. 
The current standard of care is to address women’s PP contraceptive needs at the 
six-week PP visit. However, this model of care is ineffective for many reasons, 
particularly for low-income women. First, many women resume sexual intercourse 
before six-weeks PP and prior to initiation of contraception.20,21 Second, many women do 
not attend the six-week PP visit.22 Prior analyses of Illinois Medicaid data by our team, 
and an analysis of California Medi-Cal data, found PP visit rates to be 56% and 49.4% 
(respectively).22,23 In addition, health disparities exist resulting in African-American 
women and women living in high poverty communities experiencing the lowest rates of 
PP care.22 Third, few women who return for PP care receive contraception at this time 
due to a provider barrier (i.e., inadequate time to address contraception at the visit, less 
skilled providers with lack of knowledge about medically appropriate PP contraception or 
requiring return visit for placement of long-acting methods).11 Fourth, the timing of the six-
week PP visit is based on tradition rather than evidence supporting improved patient 
outcomes.24,25 Finally, efforts to date such as antenatal discussion of the importance of 
the PP visit, use of discharge planners to encourage PP follow-up, and email and text 
reminders have had limited impact on increasing attendance at PP visits or contraception 
use.26,27 This has led to testing alternative strategies to improve uptake of PP 
contraception, such as providing contraception prior to hospital discharge after 
delivery.28,29 Unfortunately, efforts to increase immediate PP contraception provision 
have also faced significant implementation challenges due to lack of knowledge among 
providers of appropriate immediate PP contraception options, financial concerns 
regarding billing and reimbursement, and competing clinical and administrative 
priorities.30 Thus, there is an urgent need for new approaches to improve timely 
access to contraception for PP women. 
A highly promising opportunity to reach PP women is to counsel and provide 
contraception at the newborn care visit. Nearly all mothers routinely bring their infants 
in for newborn care during the first six months of life.31,32 In 2009-2010, 93.2% of women 
reported that their infant had a well-baby visit (WBV) within one week of birth, and in 2011-
2012, 90.9% of U.S. infants attended WBV visits during the first year of life.32 The 
American Academy of Pediatrics recommends normal infants have WBVs at 3-5 days 
post hospital discharge and by one month of age (both of which are prior to the standard 
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PP visit) and four more visits before one year (i.e., two, four, six, and nine months).32
Hence, the newborn care visit is an opportunity to reach more women than are 
reached through the current standard PP visit model of care and there is precedent 
for linking maternal health care to infant care. Addressing maternal health needs 
during a pediatric visit is now standard practice for pediatricians with respect to screening 
for PP depression. Evidence supports findings that PP depression screening is reliable 
and feasible in the pediatric setting, which led to national systematic changes to include 
PP depression screening at the WBV.33 Furthermore, research efforts are beginning to 
study the feasibility of management of PP depression within pediatric care.34 Routine 
infant health care visits represent the most regular contact new mothers have with the 
health care system, making it an ideal venue for implementing timely PP contraception 
care.35
This study will use a novel patient-oriented approach to link (co-schedule) PP 
contraception care with newborn WBV care (Figure 1). Though this model of co-
scheduling care for mothers and newborns may appear intuitive, the current model of 
health care in the U.S. is individual-patient focused. Even in clinical environments where 
care is provided to both mothers and infants (i.e., family medicine clinic), the care is rarely 
coordinated. Continuity of care for families with the same primary care clinician or practice 
has been associated with improved outcomes, including increased use of preventive 
services, better adherence to clinician recommendations, and lower total costs, although 
this model of care has not been well studied in the context of maternal and child care 
delivery.36 Our relatively small system-level change in scheduling practice linking 
maternal contraceptive care with newborn care could have a very large impact on 
women’s receipt of care and contraception. In addition, by offering co-scheduled care to 
all PP women the model explicitly acknowledges the importance of PP care directly to 
new mothers. If successful, the model of care could be implemented broadly in a variety 
of health care settings. This project will contribute to national efforts to improve maternal 
health and decrease unintended pregnancies and short IPI pregnancies specifically 
addressing the Healthy People 2020 goal to decrease unintended pregnancy by ten 
percent.12,37 Finally, results from this project will take the next step in informing the 
science to improve care delivery strategies to provide comprehensive PP care for 
women. 
Based on our findings, we hypothesize that providing PP women contraception care 
linked with newborn care through co-scheduling these visits will increase the 
number of women offered contraception prior to two and six months PP and reduce 
the number of short interval pregnancies. We will use an effectiveness-implementation 
hybrid design guided by two implementation science frameworks (CFIR and RE- AIM) to 
evaluate this novel system-level approach linking maternal and newborn care at 
community health centers served by AllianceChicago, our partner organization. 
AllianceChicago focuses on improving clinical care for vulnerable populations, and has 
significant experience in community-based research. 
The long-term impact of this study is to reduce negative health outcomes among PP 
women and infants by increasing access to patient-oriented PP contraceptive care. 
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Findings may provide evidence supporting a paradigm shift for linked PP care and identify 
important insights to facilitate successful implementation of this model of care in 
community health centers across the nation. 
3.0
Objectives/Aims
Aim 1: Develop a comprehensive implementation plan to link PP contraception and 
newborn care through co-scheduling in community health centers. We will work with 
AllianceChicago to assess community health center fit and readiness. Guided by the 
Consolidated Framework for Implementation Research (CFIR), we will interview 
administrators, staff, providers, and patients from each site with the goal of identifying 
factors that may facilitate or impede the development of an implementation plan for linked 
care.
All study activities for Aim 1 have been completed.
Aim 2: Implement linked PP contraception and newborn care in seven 
geographically diverse community health centers (six urban and one rural) and 
evaluate the effect on provision of PP contraception and rates of short-interval 
pregnancy. We will roll out the intervention across sites with a stepped-wedge, cluster-
randomized design and use AllianceChicago’s common electronic health record to 
evaluate effectiveness by comparing pre- and post-intervention outcomes including clinic-
level provision of all methods of contraception at two and six months PP and clinic-level 
rates of short inter-pregnancy intervals. 
Hypothesis: we hypothesize that providing PP women contraception care linked 
with newborn care through co-scheduling these visits will increase the number of 
women offered contraception prior to two and six months PP and reduce the 
number of short interval pregnancies.
All participating CHC’s have been randomized for the intervention. All sites entered the 
control period April 1, 2021 and the first site will enter the intervention period August 1, 
2021.
Aim 3: Assess implementation of linked PP contraception and newborn care and 
report on key barriers and facilitators related to successful implementation of the 
intervention. A mixed methods approach will be utilized to assess and document the 
implementation process using the RE-AIM (Reach, Effectiveness, Adoption, 
Implementation, and Maintenance) and CFIR frameworks. 
4.0
Study Design Background
Implementation science methods can be used to test the impact of linking maternal 
care with infant care in CHCs and used to enhance the utility of findings. From a 
design standpoint, hybrid trials are increasingly being utilized in implementation research 
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to simultaneously assess the clinical and implementation outcomes resulting from the 
introduction of a clinical intervention in a new context.38 Traditional trial designs that focus 
only on clinical patient outcomes often fail to capture complex details of the 
implementation of the intervention and what factors impact implementation across 
different settings.39 As a result, the public health impact of clinical studies is too often not 
fully realized because evidence is lacking for how interventions can successfully be 
brought to scale or translated to other settings. Hybrid trials can speed the pace of 
translation by generating evidence about both the clinical effectiveness of an 
intervention and factors influencing successful implementation in a given setting. 
Implementation science also provides relevant conceptual and measurement frameworks 
to guide a hybrid trial of clinical outcomes and implementation factors. For instance, the 
Consolidated Framework for Implementation Research (CFIR), which has been used 
to guide the implementation and evaluation of numerous evidence-based health 
programs, synthesizes the concepts of several available models into five inter-related 
domains: intervention characteristics, outer setting, inner setting, characteristics of 
individuals involved, and the process of implementation, with several constructs in each 
domain.40 CFIR accounts for the non-linear process of implementation and incorporates 
consideration of the adaptation that is required for different contexts, making it a useful 
framework for studying the implementation of linked maternal and infant care in CHCs. 
CFIR also describes several constructs particularly relevant to this intervention, a sample 
of which is provided in Table 1 (see approach). 
The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) 
framework is an evaluation and reporting scheme commonly used to examine the 
potential public health impact of an intervention.41 Reach represents the number and 
representativeness of patients who participate out of the eligible patient population. 
Effectiveness is the impact of the intervention on participant outcomes. Adoption is the 
number and representativeness of eligible staff/settings that agree to deliver the 
intervention out of all eligible staff/settings. Implementation is the fidelity to the 
intervention. Maintenance is the degree to which the intervention is sustained over time. 
RE-AIM provides a useful measurement framework for capturing both clinical and 
implementation outcomes within the same study. Integrating CFIR and RE-AIM within 
a hybrid clinical effectiveness and implementation trial will generate the evidence 
needed to rapidly translate the findings from a clinical trial of linked care maternal 
and infant care to standard practice. 
5.0
Aim 1 Research Design, Methods, and Data Analysis
Aim 1 is to develop a comprehensive implementation plan to link PP contraception and 
newborn care through co-scheduling in community health centers. Our research team 
has demonstrated that, despite favorable patient attitudes towards linked care, delivery 
needs to consider physician, clinic and patient factors, which may influence 
implementation in the CHC setting. To that end and guided by CFIR, Aim 1 will assess 
clinic, staff and patient factors that may affect successful implementation of linked care. 
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A CFIR (Table 1) construct important for successful implementation within the inner 
setting (CHC-level) domain is readiness for implementation.40 We partnered with 
AllianceChicago to engage the CHC sites identified as eligible and introduced the 
intervention to find out which sites are interested in participating in the study. We will 
recruited seven CHCs total (six urban and one rural) from AllianceChicago’s network. 
5.2
Aim 1a: Staff and Clinic Structure Assessment
Participating CHCs were asked to select 4-
6 staff to participate with representation 
from administration, physicians providing 
pediatric or PP services, nurses and 
ancillary staff including schedulers. Key 
informant interviews were conducted 
with selected CHCs by Drs. Caskey and 
Haider and their investigative team to 
identify features of the individual CHCs and 
the overall network that are potential 
barriers and facilitators to implementation 
of 
the 
intervention. 
Semi-structured 
interview guides were developed to ensure 
consistency of qualitative data collected 
while allowing for open-ended responses. 
Questions and prompts were developed to 
solicit 
information 
about 
the 
CFIR 
constructs, which will be closely reviewed 
by both PIs before conducting interviews 
(see Table 1 for a sample of relevant 
constructs). 
5.3
Aim 1b: Patient Assessment
PP women (<9 months PP) who are attending a WBV were asked for voluntary 
participation in an interview by phone. Interviews were conducted by Drs. Caskey and 
Haider and their investigative team with 3 patients per site. Key informant interviews 
were conducted to identify women’s preferences and needs regarding PP contraception 
as well as obtain feedback on the intervention. Semi-structured interview guides were 
developed by the PIs to ensure consistency of qualitative data collected while allowing 
for open-ended responses. Questions and prompts were developed to solicit information 
about the CFIR constructs relevant to patient experience (Table 1). 
5.4
Data Analysis
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All interviews were audio-recorded and transcribed. Qualitative data was coded according 
to CFIR constructs. Emerging themes were identified and categorized as adaptable 
components of the intervention (barriers or facilitators) then compared across the urban 
and rural sites. All interviews were reviewed carefully by both PIs to determine clinically 
relevant aspects particular to ensuring successful implementation development. Themes 
as well as data from the readiness for implementation instrument were used to develop 
an implementation plan for the adapted clinical intervention that includes strategies to 
address potential barriers. 
All study activities for Aim 1a and 1b have been completed.
6.0
Aim 2 Research Design, Methods, and Data Analysis
Aim 2 is to implement linked PP contraception and newborn care in 7 CHCs and evaluate 
the effect on provision of PP contraception and rates of short-interval pregnancy. We 
hypothesize that a linked PP contraception care with newborn care model can be 
implemented successfully in urban and rural CHC settings. PP women offered 
contraceptive care linked with newborn care would be more likely to receive any form of 
contraception at two months PP and by six months PP. Additionally, we hypothesize that 
CHCs will have a lower rate of short IPIs among incoming prenatal patients after 
implementing the linked contraception care with newborn care model compared with their 
rate prior to implementation.
Using a novel approach, we will test a patient-oriented alternative delivery system for PP 
contraception that will fill a gap in our current system resulting in improved contraceptive 
access for women. We will use a cluster randomized cross-sectional stepped wedge 
design to test the novel linked contraception and WBV model’s impact on increasing PP 
contraception uptake in urban and rural CHCs, compared to usual care. We will include 
the 7 CHCs (six urban, one rural) recruited through Aim 1 of this project. 
During the intervention period, staff will capture women during the first WBV (typically 3-
5 days after delivery) and offer to have the next visit co-scheduled for infant and 
contraception care. Current practice at all AllianceChicago CHCs is to ensure all newborn 
infants leave the clinic with the next visit already scheduled. Appointments are scheduled 
during the discharge process at the end of each visit. During the discharge process all 
women 0-6 months postpartum who are established patients will be identified by an 
electronic prompt in the infant’s electronic medical record. The prompt will instruct staff to 
offer the mother a co-scheduled visit for newborn and contraceptive care at the time of 
the next newborn visit.
Those who agree will be co-scheduled and those who are not in need of care, or do not 
wish for co-scheduled care, can decline. Women will be excluded if they had a tubal 
ligation or a long acting reversible contraception planed immediately after delivery. 
Women will be offered this co-scheduling option at each WBV through six months PP. 
Repeat opportunities for co-scheduled care are important as women’s needs and 
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preferences change over time. Prior to initiation of the scheduling change, the PIs with 
Dr. Mohanty and the site clinical champions, will conduct several training sessions of the 
clerical staff, support staff, and clinicians. Training for clinicians will emphasize 
appropriate medical knowledge about PP women’s overall care needs including 
contraception needs. We will brief clinicians on the linked model of care. Training with 
staff will focus on the need for a linked model of care and logistical considerations. 
A key element of the research infrastructure will be AllianceChicago’s uniform electronic 
health record system (EHRS), which is distinguished by the integration of evidence-based 
practice recommendations into the end user interface to provide decision support at the 
point of care. AllianceChicago’s information technology (IT) team will build custom 
templates to match PP women and their infant’s records. They will create a study-specific 
field in the EHR during well-baby visits for infants 0-6 months to prompt and record the 
offering of a co-scheduled appointment for the mother during the discharge process. The 
prompt will be rolled-out consistently among all sites based on the step-wedge design 
(below). 
We will conduct a cluster randomized, cross-sectional stepped wedge study to roll out the 
intervention across sites and assess the change in clinical and implementation outcomes 
from before to after the adapted intervention is introduced into clinics. The cluster, or unit 
of analysis, is the clinic (not individual), which is critical for a system-level intervention. In 
a stepped wedge study, the design is extended so that every cluster provides before and 
after observations and every cluster switches from the control (usual care) to the 
intervention condition (linked care) at regular intervals (“steps”), at different points in time. 
The order in which a cluster switches from control to intervention is randomized. The 
advantages of the stepped wedge design are that it provides a pragmatic and robust 
approach to testing the effectiveness of health service delivery interventions (53). The 
stepped wedge design is pragmatic because the intervention can be rolled out over time. 
Additionally, no individual patient consent is required for this system-level health service 
delivery intervention, and therefore outcomes may be obtained through routinely collected 
de-identified data from the common AllianceChicago EHR. It is a robust design because 
each cluster provides data under both the control and intervention condition and therefore 
may serve as its own control, improving the precision of the study. A limitation of the 
stepped wedge design is the confounding effect of time given that clusters switch over to 
the intervention at different times. To help control for the effect of time, 4 additional 
clusters will be randomized to either the control or the intervention for the entire study 
period, as in a traditional parallel cluster randomized trial.
One urban and one rural CHC site will be randomized to each step occurring at 3-month 
intervals. Each step includes a 3-month transition period when the individual clinics will 
prepare to implement linked care. The design is cross-sectional because outcomes are 
obtained from the subset of patients seen during each time period at each clinic rather 
than following individually recruited patients over time.
6.1
Eligibility
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Eligible participants include women presenting with their infants at one of the 7 chosen 
CHC sites for their first WBV (typically 3-5 days after delivery).
6.1.1 Inclusion Criteria

Women bringing infant for their first WBV at chosen CHC
6.1.2 Exclusion Criteria

PP tubal ligation

Emergency hysterectomy due to life threatening bleeding during the 
delivery
6.1.3 Excluded or Vulnerable Populations
Any males will be excluded from the study because the study outcomes of contraceptive 
method use and pregnancy status are not applicable to males.
6.2
Outcome Variables
Primary outcome:

Receipt of all methods of contraception by two months PP. Using de-
identified patient-level EHRS data for eligible women at each clinic within 
each time interval, we will create a dichotomous variable for receiving any 
contraception by two months PP. We will work with AllianceChicago’s IT 
team to restrict the data pull to eligible women who attended an infant 3-5 
day WBV after the study period began.
Secondary outcome: 

Receipt of all methods of contraception by six months PP. This 
outcome will be calculated similar to the primary outcome with the exception 
of time-period.

Short IPI pregnancies. During the baseline period (control condition) and 
18 months after the introduction of the intervention in each CHC, we will use 
EHRS data to estimate the clinic-level rate of incoming prenatal patients 
presenting with a short IPI. 
6.3
Data Collection
AllianceChicago’s information technology (IT) team will build custom templates to match 
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PP women and their infant’s records. They will create a study-specific field in the EHRS 
during WBV to prompt and record whether a co-scheduled appointment is offered to the 
mother. Similarly, a unique field will be created to record that a PP appointment is co-
scheduled with a WBV appointment. The IT team will build custom reports in their data 
warehouse for the investigators to access and validate data in real-time. Reports will be 
built to pull data (ICD, CPT, and HCPCS codes) from the medical record and billing 
claims. In addition to real-time data, reports will be pulled monthly and reviewed closely 
by Drs. Caskey and Haider and their investigative team. Findings from the reports will be 
used to determine the primary and secondary outcomes. 
6.4
Data Analysis
Drs. Rankin and Campbell, our epidemiology and biostatistics experts will conduct all 
analysis. They will compare the distribution of patient characteristics between the 
unexposed observations from the control period and the exposed observations during the 
intervention period, which are analogous to distributions across arms in a parallel cluster 
randomized trial. Then, they will plot rates of our outcomes over each three- month time 
period, comparing how rates differ from the control period to the intervention period 
overall, within each clinic, and between urban and rural clinics to examine the effects of 
the intervention, time and level of urbanicity on the outcomes. To examine treatment 
effects for our primary and secondary outcomes related to receipt of all methods of 
contraception, we will use a generalized linear mixed model, adjusting for the confounding 
effect of time with the random effect for CHC site and fixed effect for each time interval.53
6.5
Expected Outcomes
Intervention: After the intervention period begins, postpartum women within the selected 
CHC sites will be more likely to receive any contraceptive method by two and six months 
postpartum. We anticipate a minimum absolute increase in contraception use of 15% 
(from 45% to 60%) and a decrease in short IPI pregnancies from approximately 35% to 
20% from before to after the intervention, both of which would have a clinically meaningful 
impact on the population.
Implementation Process: By the end of Aim 2, we expect the intervention will be 
implemented successfully at all sites. However, important clinic-level and system-level 
barriers will be identified at each site. For example, the discharge process likely occurs in 
slightly different ways in each clinic, which may impact who responds to the alert in the 
EHR and the efficiency in which the co-scheduling can be accomplished.
All modifications (i.e. custom fields, prompts) within EHR and scheduling software have 
been built. Participating CHC’s have been randomized for the intervention. All sites 
entered the control period April 1, 2021 and the first site will enter the intervention 
period August 1, 2021.
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7.0
Aim 3 Research Design, Methods, and Data Analysis
Aim 3 is to assess implementation of linked PP contraception and newborn care and 
report on key barriers and facilitators related to successful implementation of the 
intervention. 
7.1
Outcome Variables
We will utilize the RE-AIM framework to evaluate outcomes of the effectiveness-
implementation hybrid trial throughout the trial. Table 3 describes the data collected per 
RE-AIM construct. 
7.2
Data Collection
AllianceChicago’s information technology (IT) team will build custom reports in their data 
warehouse to access and validate data in real-time. Reports will be built to pull data (ICD, 
CPT and HCPCS codes) from the medical record and billing claims; which will be used 
to determine implementation success. Reports will be built to monitor: 1) EHR alert 
consistency; 2) if co-scheduled care is offered; 3) if co-scheduled care is accepted or 
declined by women; 4) among those who accept, if both the co-scheduled appointments 
are completed 
At approximately the midpoint of each site’s intervention period, key informant interviews 
will be conducted with staff, physicians and PP women to assess implementation 
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outcomes such as acceptability, feasibility, and fidelity over time. Semi- structured 
interview guides will be developed around CFIR constructs (similar to Aim 1) to elicit 
information related to barriers and facilitators encountered during the implementation of 
linked care and the RE-AIM implementation outcomes listed in Table 3. Interviews will be 
audio-recorded and transcribed and carefully reviewed by both PIs. If the subject declines 
to have their interview recorded, they will be asked to complete the interview in person 
and notes will be taken in lieu of audio-recording.
7.3
Data Analysis
Reach and implementation outcomes from the EHR will be assessed at the midpoint and 
endpoint of the intervention period for each step. Qualitative data will be coded according 
to CFIR constructs. Data will be coded independently by two coders and then discussed 
to resolve coding discrepancies. Emerging themes will be identified and categorized by 
CFIR construct and/or implementation outcome: acceptability, feasibility, and fidelity. 
Mixed methods will be used to elaborate on quantitative RE-AIM findings with themes 
from qualitative data.56
7.4
Expected Outcomes
We expect to identify important barriers and facilitators as a continuum during the 
implementation 
process 
at 
the 
clinician-level, 
clinic-level 
and 
system-level. 
Understanding those factors could help not only to improve the intervention at the local 
CHCs, but also will could increase understanding of similar interventions in the CHC 
setting. Findings will also result in understanding factors that may differ between urban 
and rural settings. Determining how implementation in CHCs vary over levels of urbanicity 
will be a valuable contribution to the literature. The process and results of this aim will be 
disseminated to contribute to the implementation science literature. 
8.0
Expected Risks/Benefits
Potential risks consist of potential breaches of confidentiality. However, participants will 
be allowed to opt out of the study at any time and to not respond to questions they are 
uncomfortable with, without any penalty. Study records that identify the participant will be 
kept confidential; however there is a risk of loss of confidentiality. Participants will be 
informed of these risks, protections against loss of confidentiality, and their rights to skip 
any question and to withdraw from the study at any time in the consent forms and all 
relevant study documents. We will take the utmost caution to protect the confidentiality of 
responses.
The potential benefits of this research far outweigh the risks. Pregnancies conceived 
within 18 months of a prior delivery (termed short inter-pregnancy interval) place mothers 
and infants at high risk for poor health outcomes including pre-eclampsia, anemia, and 
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preterm birth. Despite these negative health consequences, nearly one third of women 
experience a short inter-pregnancy interval highlighting a significant public health problem 
in the U.S. A critical approach to preventing short inter-pregnancy intervals is to provide 
postpartum women with timely access to contraception. The current standard clinical 
practice is to have women return six weeks after delivery for a PP visit at which time 
contraceptive needs are addressed. However, many women resume sexual activity prior 
to six weeks PP, and many women, particularly low-income minority women do not 
present for this visit. Thus, there is an urgent need for patient-centered approaches to 
improve timely access to PP contraception to improve outcomes for women and children. 
This study has the potential to address these unmet contraceptive needs of postpartum 
women using a patient-centered approach to contraception care. 
The key informant interviews will allow us to effectively develop and implement a linked 
postpartum and newborn care in CHCs and in turn, compare clinic-level provision of all 
methods of contraception and clinic- level rates of short inter-pregnancy intervals. The 
intervention and assessments will allow us to understand how well this intervention works 
and provide critical feedback in a real-world setting. The possible risks (i.e. potential 
confidentiality breaches) are outweighed by the new knowledge gained regarding how to 
implement this patient-centered model intervention in both urban and rural CHC settings. 
We have adequate safeguards to protect against these risks and will alert the RUMC IRB 
of any problems. 
9.0
Data Collection and Management Procedures
We will collect qualitative and quantitative data from participants via audio-recorded and 
transcribed key informant interviews administered via laptop computer, telephone, and/or 
paper-and-pencil evaluations. Additionally, clinic-level EHR data will be collected pre- and 
post-implementation of the intervention. 
Subjects will be assigned a study ID during the course of the study. All data collected will 
use the participant’s study number in place of identified information. Participant 
information will be de-identified and will not be linked to any specific subject. The consent 
forms will be the only remaining link to the subjects. They will be available only to the IRB-
approved research team. Given reliance agreement between collaborating institutions, 
consent forms for the subjects will be securely stored in a locked filing cabinet in a locked 
office within a PI’s institution (i.e. Rush University Medical Center [RUMC], University of 
Illinois at Chicago [UIC]). All data will be stored on a secure, password- protected 
computer accessible only to the study team. 
A reliance request on behalf of UIC and AllianceChicago was approved in July 2021. This 
reliance agreement is being submitted to RUMC’s Institutional Review Board (IRB) and 
once approved, the RUMC’s IRB will be the IRB of Record. Additionally, data from this 
study will be shared between collaborating sites (i.e., RUMC, UIC, AllianceChicago). A 
confidentiality agreements are in place and a data sharing agreement will be submitted 
and approved prior to any data being shared between sites.
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10.0
Quality Control and Quality Assurance
Analysis of each phase will help to ensure adherence to the protocol as well as informing 
the next phase of the research project.  The co-investigators are all responsible for 
ensuring the quality of the data and how the analysis will inform the next phase of the 
research study.
11.0
Data and Safety Monitoring
The PIs and Co-Is are responsible for monitoring the data, assuring protocol compliance, 
and conducting safety reviews regularly. The research staff will oversee day-to-day 
compliance. This protocol presents minimal risks to the subjects and adverse events or 
other problems are not anticipated. The PIs, Co-Is, and research staff will be responsible 
for monitoring the data, assuring protocol compliance, and conducting safety reviews at 
regular intervals, which must be conducted at a minimum of every 6 months (including 
when re-approval of the protocol is sought). During the review process, the PIs, Co-Is and 
research staff will evaluate whether the study should continue unchanged, require 
modification/amendment, or to close enrollment. The PIs, Co-Is, IRB, and research staff 
will ensure that any deviations from the protocol or safety concerns are reported 
according to institutional guidelines. Data and study risk will be assessed throughout the 
study. 
12.0
Regulatory Requirements
12.1
Informed Consent
A qualified member of the study team will conduct eligibility screening to ensure 
participant eligibility. Eligible participants will be consented and enrolled. Recruitment will 
take place at the participating CHC sites. The informed consent process will inform the 
participant that participation in the study is completely voluntary. 
12.2
Subject Confidentiality
Confidentiality will be maintained by following the data collection and management plans 
described previously in the protocol.  Additionally, we will provide each participant with a 
study ID number that will be used to code all collected data. Participant information will 
be de-identified and will not be linked to any specific subject. Only key research personnel 
will have access to all collected data. All identifiers will be destroyed upon completion of 
the study.    
12.3
Unanticipated Problems
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Any unanticipated problems experienced by study personnel will be reported to the PI 
and co-PI.  The PI and co-PI will then report any problems to the IRB, and National 
Institutes of Health, as necessary. 
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Improving Health by Linking Postpartum and Well-Baby Visits:
Administrative Supplement to LINCC Trial
Project Summary/Abstract
Severe maternal morbidity (SMM) and maternal mortality (MM) remain a public health 
crisis in the United States despite efforts to improve maternal health. Most pregnancy-
related deaths in the U.S. occur in the postpartum (PP) period, thus, timely access to high 
quality comprehensive care during the transition period from prenatal to PP period is 
critical to reduce SMM and MM. 
High quality longitudinal health care improves outcomes for women before, during and 
after pregnancy; and decreases morbidity and mortality related to pregnancy. The 
“Linking Inter-professional Newborn and Contraception Care (LINCC) Trial” was funded 
in 2019 to test a novel, patient-centered approach to providing contraception care, in 
conjunction with an infant’s well baby visit (WBV), for PP women. The LINCC trial aims 
to remove barriers to accessing PP care by co-scheduling the PP contraception visit with 
WBVs. The LINCC trial provides an ideal foundation upon which to develop a reproducible 
model to identify women at risk for MM and SMM, and link them into care, among a 
national sample of predominantly low-income women receiving care at Community Health 
Centers (CHCs). 
The specific aims of this study are to: (1) build a population-health interface to identify 
pregnant and PP women at risk for SMM or MM using standard clinical health data from 
electronic medical records and (2) Validate the registry (i.e., LINK MOMS) using data from 
CHCs across the country. Lastly, we aim to: (3) design an implementation plan for the 
LINK MOMS registry in CHCs across the country. 
Increasing access to timely comprehensive care is a promising strategy to prevent 
pregnancy-related morbidity and mortality. The long-term impact of this study is to reduce 
adverse health outcomes among PP women by increasing access to patient-oriented care 
before, during, and after pregnancy. Findings may provide evidence supporting a 
paradigm shift for linked PP care and identify important insights to facilitate successful 
implementation of this registry in health care systems across the nation.
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Background/Scientific Rationale 
Maternal Morbidity and Mortality in the United States: Severe maternal morbidity 
(SMM) and maternal mortality (MM) in the U.S. remains a public health crisis despite 
efforts to improve maternal health. Given most pregnancy-related deaths in the U.S. occur 
in the postpartum (PP) period[1], a critical preventive measure to SMM and MM is timely 
access to quality health care during the transition between the prenatal period to one year 
PP.
Importance of Continuum of Care for PP Women: Standard clinical practice, i.e. a 
single PP visit approximately six weeks after delivery, fails to provide adequate care for 
women, particularly for those at risk for SMM or MM. Indeed, many women, particularly 
low-income minority women, do not present for the traditional PP visit [3]. In fact, prior 
analyses of Illinois Medicaid data by our team, and an analysis of California Medi-Cal 
data, found PP visit rates to be 56% and 49.4% (respectively) [4, 5]. Because the majority 
of maternal deaths occur between 6-weeks to 12-months after delivery, the need for a 
continuum of care that extends beyond the traditional 6-week period is essential to 
improve outcomes for new mothers [6]. In May 2019, The American College of 
Obstetricians and Gynecologists’ (ACOG) reported that PP care should be an on-going 
process with the timing of visits scheduled to address woman’s individual needs, including 
recovery from birth, newborn care, psychosocial and sexual well-being, contraception, 
chronic disease management, and transition to ongoing well-woman care[7]. 
Unfortunately, this proposed continuum of PP care has not yet been adopted broadly 
across the U.S.
Disparities in Access to Quality Maternity Care: Access to quality maternity care is a 
critical component of positive maternal health outcomes, especially within the PP period 
as most complications occur within this period. However, research has indicated that 
access to reproductive health care and health insurance continues to be a barrier for 
women [8]. Although disparities in the rates of uninsured have narrowed among some 
populations [9], gaps do remain, particularly for low-income and minority women [10]. For 
instance, while an average of 13% of adult women in the U.S. are uninsured, the 
percentages are greater for Black (15%), Latina (24%), and low-income women 
(26%)[10]. In addition, uninsured women use fewer preventative services (e.g., 
mammograms, well-woman visits) and are more likely to delay care due to cost [11]. Thus, 
increasing prevalence of chronic disease risk factors [12], coupled with inadequate care 
due to cost or delays, puts low-income and minority women at an high risk for adverse 
maternal health outcomes.
Other key factors contributing to poor access to care include geographic disparities (e.g., 
distance to care, transportation needs) [6, 13]. Compared to those living in urban areas, 
women living in rural areas experience disparities in obstetric care access and outcomes 
[14]. In fact, maternal and infant mortality rates in most rural areas of the U.S. are 
measurably higher than those in large metropolitan areas [15]. Furthermore, research 
suggests that risk factors for related chronic diseases such as diabetes, high cholesterol, 
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and cardiovascular disease are becoming more prevalent in women of reproductive age 
[12], with the burden of these conditions disproportionality falling on women in rural or 
low-income communities [16]. Given more than 18 million women of reproductive age live 
in rural counties of the U.S., and nearly half a million women give birth each year in rural 
hospitals [17, 18], ensuring access to maternity care for all women has the potential to 
reduce preventable maternal mortality and morbidity across the U.S. and improve 
maternal outcomes overall.
Community Health Centers (CHCs) serve as a safety net for underserved urban and 
rural residents [19]. Research has shown that 83% of individuals who receive care at 
CHCs have a form of public insurance or no insurance, while only 39% of patients who 
seek care at private physician offices are uninsured or have public forms of insurance 
[20] Overall, CHCs serve an estimated 24% of all low-income women of childbearing age 
in the U.S. [24]. Therefore, CHCs can serve as an ideal setting to identify women at risk 
for poor pregnancy-related outcomes.
Optimize Linkage to Continued Care – Leveraging the “Linking Inter-professional 
Newborn and Contraception Care (LINCC)” Trial: A crucial approach to preventing 
pregnancy-related morbidity and mortality is to provide women-centered approaches to 
improve timely access to comprehensive care before, during and after pregnancy. The 
LINCC Trial was funded in 2019 to test a novel, woman-centered approach to providing 
contraception in conjunction with an infant’s well baby visit (WBV) to PP women. This 
intervention aims to remove barriers to accessing PP care by co-scheduling the PP care 
with WBVs. The LINCC model allows women greater opportunity to receive timely PP 
contraception, space pregnancies, and decrease the risk of a rapid repeat pregnancy 
within a short inter-pregnancy interval which is associated with poor maternal and infant 
outcomes. The LINCC Trial provides an ideal platform for a larger paradigm shift in PP 
care: ensuring a continuum of care throughout the pregnancy and interception period. 
Comprehensive women’s health care, including PP care, preventive care, chronic disease 
management and mental health care, is desperately needed to address rising SMM and 
MM, especially among underserved vulnerable women. By leveraging our existing 
community partnership with AllianceChicago as well as our clinical champions at 
participating CHCs engaged in the ongoing LINCC Trial, we will build a population-health 
approach to identify women at highest risk for maternal morbidity and mortality.
Impact of the Research: Most pregnancy-related deaths in the U.S. occur in the PP 
period [1], however the traditional model for PP care is inadequate in identifying women 
at risk for SMM and MM; and inadequate in addressing maternal health needs in the inter-
conception period [3]. The fragmentation of the current healthcare system leads to 
inadequate linkage between health care services, specifically for women at highest risk 
for adverse health outcomes [21, 22]. Early identification of women who are at risk for 
SMM or MM will lead to earlier management of chronic conditions and prevention of 
pregnancy-related complications.
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Study Design Background
The “Improving Health by Linking Postpartum and Well-Baby Visits (LINCC Trial)” was 
funded in 2019 to test a novel, patient-centered approach to providing contraception care, 
in conjunction with an infant’s well baby visit (WBV), for postpartum (PP) women. The 
impetus for the LINCC Trial was to improve outcomes for women at greatest risk for poor 
pregnancy-related outcomes: low-income and minority women. The LINCC Trial is 
reducing barriers to receipt of PP contraception care by linking women’s care with 
newborn care. The LINCC model allows women greater opportunity to receive timely PP 
contraception, space pregnancies, and decrease the risk of a rapid repeat pregnancy 
within a short interpregnancy interval which is associated with poor maternal and infant 
outcomes. Thus, the LINCC Trial is an ideal foundation upon which to further develop a 
reproducible model to identify pregnant and postpartum women at risk for severe 
maternal morbidity (SMM) and maternal mortality (MM) among a national sample of 
federally qualified health centers and respond to the goals of the administrative 
supplement.
The specific aims of this study are to:
1) Build a population-health interface to identify pregnant and PP women at risk for 
severe maternal morbidity or mortality using standard clinical health data from 
electronic health records and create a LINK MOMS registry;
2) Validate the LINK MOMS registry using data from Community Health Centers 
(CHCs) across the country;
3) Design an implementation plan for the LINK MOMS registry in CHCs across the 
country. This supplement aims to bridge the gap in care during a critical time, the 
PP period, by identifying women at increased risk of SMM and MM.
The LINCC Trial provides an ideal platform for a larger paradigm shift in PP care: ensuring 
a continuum of care throughout the pregnancy and interception period. By leveraging our 
existing community partnership with AllianceChicago, as well as our clinical champions 
engaged in at participating CHCs, from the ongoing LINCC Trial, we will build a 
population-health approach to identify women at highest risk for maternal morbidity and 
mortality with the long-term goal of providing improved linkage to care.
The following text will outline the study activities for Aims 1, 2, and 3 of this Administrative 
Supplement. 
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Aim 1: Build a population-health interface to identify pregnant and PP women at 
risk for severe maternal morbidity or mortality using standard clinical health data 
from electronic health records (EHR).
In partnership with AllianceChicago, we will use Health Catalyst’s Population Builder™ to 
build a registry to identify pregnant and PP women at risk for SMM or MM. Though many 
women do not receive timely or adequate PP care, nearly all women receive at least some 
medical care during pregnancy [23]. We hypothesize that medical record data, even if 
limited, can be used for early identification of women at highest risk for SMM and MM and 
will result in earlier intervention and improved health outcomes.
Health Catalyst Population Builder™ is a tool designed to interface with large datasets, 
including medical records, to develop robust registries based on pre-specified criteria. 
Importantly, Population Builder™ is end-user friendly through the use of visually-oriented 
data, a drag-and-drop interface, rapid identification of desired populations and flexibility 
to be used in many domains (clinical, financial, and geographic). Nontechnical individuals 
can easily learn to use the tool, which allows for rapid access to desired data by clinical 
staff.
Population Builder™ can interface with standard EHR data and create populations based 
on defined criteria. We will build a registry, LINK MOMS, to identify pregnant and PP 
women at risk for SMM or MM. To ensure accurate identification of women at risk, our 
team will convene subject matter experts (SMEs) from AllianceChicago, and affiliated 
CHCs, to refine the data used to build the LINK MOMS registry. LINK MOMS will include 
a combination of International Classification of Diseases, Tenth Revision (ICD-10) codes, 
Common Procedural Technology (CPT) codes, lab results, demographics, and clinic visit 
data. For example, we anticipate using CPT codes to identify women who are pregnant 
or PP; well established ICD-10 codes to identify women at risk for SMM or MM 
(gestational diabetes, hypertension, depression, substance use, etc.) or women who have 
SMM [24]; and identifiers of social determinants of health (housing instability, financial 
limitations, violence, etc.). 
Focus Group Sessions
Approximately 15 subject matter experts (SMEs) from the collaborating LINCC Trial 
sites will be convened twice to participate in two focus group sessions:
1. First to provide guidance on potential data to include in the registry; 
2. And second to review the registry build.
Inclusion Criteria

English-speaking staff member at AllianceChicago or affiliated CHC 
collaborating on the LINCC Trial

Ages 18 and above
Exclusion Criteria

Not a staff member at AllianceChicago or affiliated CHC
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
Under 18 years old
Subject enrollment:
Subject matter experts from AllianceChicago and affiliated Community Health Centers 
(CHC) of any age were recruited to refine the data used to build the LINK MOMS registry. 
Dr. Mohanty will coordinate with the CHC’s and facilitate recruitment of eligible 
participants for the two focus groups. The RUMC and UIC study team will then conduct 
these focus groups. Trained research assistants from RUMC and UIC will consent SMEs 
prior to participating in the focus groups. Those interested and eligible will complete an 
oral informed consent form and be enrolled in the study. All participants will have their 
participation and all risks and benefits to participation explained to them.
Data Collection and Management Procedures
We will collect data from participants via audio-recorded and transcribed focus group 
sessions administered virtually. All focus group session data will be stored on a secure, 
password- protected computer accessible only to the study team.
Focus group subjects will be assigned a study ID during the course of the study. All data 
collected will use the participant’s study number in place of identified information. 
Participant information will be de-identified and will not be linked to any specific subject. 
The consent forms will be the only remaining link to the subjects. They will be available 
only to the research team. Consent forms for the subjects will be securely stored in a 
locked filing cabinet in a locked RUMC office. All data will be stored on a secure, 
password- protected computer accessible only to the study team. 
Both focus group sessions will take place virtually over the Zoom platform and be audio-
recorded and transcribed. Qualitative data will be coded independently by two coders and 
then discussed to resolve coding discrepancies. Emerging themes will be identified and 
categorized as components of the registry. All sessions will be reviewed carefully by the 
PIs to determine clinically relevant aspects particular to ensuring successful registry 
development. 

Each focus group session is expected to take approximately 1 hour

Each participant will receive $100 gift card after participating in each session 
for a total of $200. (Per benchmark standard for clinicians [hourly rate = $100])
Retrospective Chart Review
In addition, once the LINK MOMS metrics are defined and built; the registry will be tested 
nationally using 32 CHCs affiliated with AllianceChicago. During the test phase the 
registry will be limited to electronic health record (EHR) data from 2017-2019. This time 
frame allows for the validation process to include review of care after delivery. This 
retrospective chart review will be conducted to test the registry. Data will be collected on 
all pregnant or postpartum women attending the 32 CHCs affiliated with AllianceChicago. 
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The chart will be reviewed to ensure the registry is accurately identifying women at risk 
of adverse health outcomes during pregnancy and the postpartum period.
Retrospective Chart Review Criteria
Approximately 1000 charts will be included in the retrospective chart review period from 
2017-2019.
Inclusion Criteria

Pregnant or postpartum women of reproductive age attending an appointment 
at an AllianceChicago affiliated CHC between 2017-2019.
Exclusion Criteria

Pregnant or postpartum women of reproductive age attending an appointment 
at a health clinic not affiliated with AllianceChicago

Pregnant or postpartum women of reproductive age attending an appointment 
at an AllianceChicago affiliated CHC outside of the 2017-2019 date range
Data Collection and Management Procedures
The AllianceChicago study team and SMEs will test the LINK MOMS registry using data 
from CHCs within AllianceChicago's network. Data from this retrospective chart review 
process will be securely stored at AllianceChicago Office. The RUMC and UIC teams will 
oversee the testing process and provide insight where applicable. De-identified data may 
be shared between sights for this aim of the study.
A reliance request on behalf of AllianceChicago and UIC has been approved and is being 
submitted via amendment to RUMC’s IRB for final approval. Once approved, the RUMC 
IRB will be the IRB of Record. Additionally, de-identified data from this study will be shared 
between collaborating sites (i.e., RUMC, UIC, AllianceChicago). Confidentiality 
agreements and a data sharing agreement will be submitted and approved prior to any 
data being shared between sites.
The first focus group session for Aim 1 has been completed. The second focus group 
will be conducted in Fall 2021. The variables and metrics for the registry are currently 
being defined and built by the study team. The registry is on track to be built and ready 
for testing and validation in September 2021.
Aim 2: Validate the LINK MOMS registry using data from CHCs across the 
country.
To ensure the registry accurately identifies women at risk for SMM and MM, 
AllianceChicago SMEs in conjunction with SMEs across a sub-set of clinical sites will 
validate the national LINK MOMS registry through a manual review of patient-level EHR 
data (i.e., retrospective chart review). A random sample of 15% of women from the LINK 
MOMS registry will be pulled for validation. The validation process will include a manual 
review of each patient’s chart and discussion with treating clinicians if appropriate. The 
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chart review will include all clinical data 2017-2019, which will include the timeframe 
during and after pregnancy. A structured chart abstraction tool will be used to standardize 
the review process; and each abstraction will result in one of three outcomes: Appropriate, 
Inappropriate, Unknown. Our team will meet with the validation team weekly during the 
validation process to review findings and refine the validation methodology as needed.
Retrospective Chart Review Criteria
Approximately 15% of the 1000 charts (Aim 1) will be included in the retrospective chart 
review period from 2017-2019.
Inclusion Criteria

Pregnant or postpartum women of reproductive age attending an appointment 
at an AllianceChicago affiliated CHC between 2017-2019.
Exclusion Criteria

Pregnant or postpartum women of reproductive age attending an appointment 
at a health clinic not affiliated with AllianceChicago

Pregnant or postpartum women of reproductive age attending an appointment 
at an AllianceChicago affiliated CHC outside of the 2017-2019 date range.
Data Collection Analysis
The chart abstraction process will include documentation of details supporting the final 
outcome (Appropriate, Inappropriate, Unknown). For example, the registry identifies a 
chart with a one-time use of ICD-10 code 013.9 (gestational hypertension). However, 
upon chart review the documented blood pressure measurements were found to be 
normal during pregnancy. Thus, the team concludes the use of the code was likely an 
error and the chart is labelled as an inappropriate identification of risk. Similarly, the team 
may find conflicting data in the EHR and the chart is labelled as an unknown identification 
of risk. 
All charts found to be unknown or inappropriate will be reviewed by the validation team 
and PIs (Haider, Caskey) and the group will reach consensus on the final determination 
(Appropriate, Inappropriate or Unknown). If needed, the team will engage the woman’s 
care providers to accrue additional information. All findings will be compiled and used to 
continually refine the LINK MOMS registry. An example of such a registry refinement 
process would be if the team determines, based on the chart abstraction, that certain ICD 
codes need to be documented more than once for the chart to be pulled into the registry.  
The AllianceChicago study team and SMEs will validate the LINK MOMS registry using 
data from CHCs within AllianceChicago's network. Data from this retrospective chart 
review and validation process will be securely stored at AllianceChicago Office. The 
RUMC and UIC team will oversee the validation process and provide insight where 
applicable. De-identified data may be shared between sights for this aim of the study.
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Aim 3: Design an implementation plan for the LINK MOMS registry in CHCs across 
the country.
Key Informant Interviews
Through in-depth key-informant interviews, we will use the guidance from women and 
women’s health providers to develop a strategy for how best to incorporate LINK MOMS 
data into practice. 
Inclusion Criteria

Patients: Pregnant or postpartum (delivery within last 12 months) women 
(ages 18 and above) receiving care at an affiliated CHC in AllianceChicago 
network

Providers: English or Spanish-speaking women’s health provider at affiliated 
CHC (ages 18 and above)
Exclusion Criteria

Patient: Not a pregnant or postpartum women receiving care at an affiliated 
CHC in AllianceChicago’s network (under 18 years old)

Providers: Not a women’s health provider at affiliated CHC in 
AllianceChicago’s network (under 18 years old)
Subject enrollment:
The key informant interviews will be conducted by a member of our research team using 
a semi-structured interview guide to ensure consistency of data collection while allowing 
for open-ended responses. Questions and prompts will be developed to solicit 
information; which will be closely reviewed by the PIs before conducting interviews. 
Participation will be voluntary.

Patient: The study team will coordinate with the CHC’s to facilitate recruitment of 
eligible participants for the key informant interviews. Staff at each CHC will hand 
out study flyers to recruit patients. Interested patients will reach out to the study 
team using the contact information on the flyers. A trained research assistant will 
determine eligibility and coordinate a time with the patient to participate in the 
interview by phone. The research assistant will consent eligible patients prior to 
participating in the interview. Those interested and eligible will complete an oral 
informed consent form and be enrolled in the study. All participants will have their 
participation and all risks and benefits to participation explained to them.

Providers: The study team will coordinate with the CHC’s and facilitate 
recruitment of eligible participants for the key informant interviews. A trained 
research assistant will determine eligibility and coordinate a time with the providers 
to participate in the interview by phone. The research assistant will consent eligible 
providers prior to participating in the interview. Those interested and eligible will 
complete an oral informed consent form and be enrolled in the study. All 
participants will have their participation and all risks and benefits to participation 
explained to them.
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
Each interview (patient and provider) is expected to take approximately 30 
minutes.

Each patient participant will receive $25 gift card after participating in one 
interview.

Each provider participant will receive $50 gift card after participating in one 
interview (Per benchmark standard for clinicians [hourly rate = $100]).
Women’s Voices: We will recruit 10 women who are pregnant or PP (delivery within last 
12 months) to participate in an interview by phone. Interviews will focus on women’s 
preferences and needs regarding care, feedback on the LINK MOMS registry, 
suggestions for how the registry should be used to identify and link women to needed 
care, and concerns regarding privacy.
Provider’s Voices: We will recruit 10 women’s health providers who provide pregnancy 
and/or PP care. We aim to recruit a variety of providers with varying backgrounds and 
perspectives (OB/GYN, Family Medicine, Nurse Midwife and Internal Medicine). 
Interviews will focus on clinician’s preferences regarding how registry data is utilized in 
clinical practice, barriers and facilitators to utilization of LINK MOMS and any resource 
considerations. 
Aim 3a: Evaluate usability of LINK MOMS registry 
Survey 
A qualified study team member will disseminate a survey via REDCap to evaluate the 
usability and usefulness of the LINK MOMS registry. The 8-question deidentified survey 
will be sent to the 20 emails of health providers who currently use the registry. 
Data Analysis
Data analysis: All interviews will be audio-recorded and transcribed. Data will be coded 
independently by two coders and then discussed to resolve coding discrepancies. 
Emerging themes will be identified and categorized as important considerations for an 
implementation plan for the LINK MOMS registry. All interviews will be reviewed carefully 
by both PIs to determine relevant aspects particular to ensuring successful 
implementation development.
Data Collection and Management Procedures
We will collect qualitative and quantitative data from participants via audio-recorded and 
transcribed key informant interviews administered virtually. 
Interview subjects will be assigned a study ID during the course of the study. All data 
collected will use the participant’s study number in place of identified information. 
Participant information will be de-identified and will not be linked to any specific subject. 
The consent forms will be the only remaining link to the subjects. They will be available 
only to the research team. Consent forms for the subjects will be securely stored in a 
locked filing cabinet in a locked RUMC office. All data will be stored on a secure, 
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password- protected computer accessible only to the study team.
Clinic-level EHR data collected retrospectively as part of the testing process in Aim 1 and 
validation process in Aim 2 will be stored securely at AllianceChicago Office. 
A reliance request on behalf of UIC and AllianceChicago was approved in July 2021. This 
reliance agreement is being submitted to RUMC’s Institutional Review Board (IRB) and 
once approved, the RUMC’s IRB will be the IRB of Record. Additionally, de-identified data 
from this study will be shared between collaborating sites (i.e., RUMC, UIC, 
AllianceChicago). Confidentiality agreements are in place and a data sharing agreement 
will be submitted and approved prior to any data being shared between sites.
Quality Control and Quality Assurance
Analysis of each phase will help to ensure adherence to the protocol as well as informing 
the next phase of the research project. The co-investigators are all responsible for 
ensuring the quality of the data and how the analysis will inform the next phase of the 
research study.
Data and Safety Monitoring
The PIs and Co-I are responsible for monitoring the data, assuring protocol compliance, 
and conducting safety reviews regularly. The research staff will oversee day-to-day 
compliance. This protocol presents minimal risks to the subjects and adverse events or 
other problems are not anticipated. The PIs, Co-I, and research staff will be responsible 
for monitoring the data, assuring protocol compliance, and conducting safety reviews at 
regular intervals, which must be conducted at a minimum of every 6 months (including 
when re-approval of the protocol is sought). During the review process, the PIs, Co-Is and 
research staff will evaluate whether the study should continue unchanged, require 
modification/amendment, or to close enrollment. The PIs, Co-I, IRB, and research staff 
will ensure that any deviations from the protocol or safety concerns are reported 
according to institutional guidelines. Data and study risk will be assessed throughout the 
study. 
Informed Consent
Focus group sessions (Aim 1): A qualified member of the study team will conduct eligibility 
screening to ensure participant eligibility in focus group sessions. Eligible participants will 
be complete oral consent over the phone and be enrolled. Recruitment will take place at 
AllianceChicago and participating CHC sites. The oral informed consent process will 
inform the participant that participation in the study is completely voluntary. 
Retrospective chart review (Aim 1 and 2): The study team is requesting a waiver of 
consent process and consent documentation for the retrospective chart reviews in Aims 
1 and 2.
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Key informant interviews (Aim 3): A qualified member of the study team will conduct 
eligibility screening to ensure participant is eligible to participate in the key informant 
interview. Eligible participants (providers and patients) will complete oral consent over the 
phone and be enrolled. Recruitment will take place at AllianceChicago and participating 
CHC sites. The oral informed consent process will inform the participant that participation 
in the study is completely voluntary. 
Survey (Aim 3a): No identified data will be obtained. Therefore, a Waiver of Documented 
Consent will be submitted. 
Subject Confidentiality
Confidentiality will be maintained by following the data collection and management plans 
described previously in the protocol.  Additionally, we will provide each participant with a 
study ID number that will be used to code all collected data. Participant information will 
be de-identified and will not be linked to any specific subject. Only key research personnel 
will have access to all collected data. All identifiers will be destroyed upon completion of 
the study.    
Unanticipated Problems
Any unanticipated problems experienced by study personnel will be reported to the PIs.  
The PIs will then report any problems to the IRB, and National Institutes of Health, as 
necessary.
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ORA: 21062201-IRB01   Date IRB Approved: 4/5/2024   Amendment Date: 4/26/2024