Minding the Gap: Improving Women's Health Through Coordinated Postpartum Planning
Phase: NA
Conditions: Maternal Death, Maternal Morbidity
Sponsor: Emory University

Study Protocol 
 
 
 Minding the gap: improving women’s health through coordinated 
postpartum planning 
 
 
Protocol Date: December 4, 2024 
 
 
NCT05430815 

Protocol Title: Minding the gap: improving women’s health through coordinated postpartum 
planning 
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Protocol Version: Version 14, 4_Dec_2024
PROTOCOL TITLE: Minding the gap: improving women’s health through coordinated 
postpartum planning
PRINCIPAL INVESTIGATOR: 
Anne Dunlop, MD, MPH
Professor, Department of Gynecology and Obstetrics
 
VERSION: 14 (4-DEC-2024)  
Revision #
Version 
Date
Summary of Changes
1
10/1/2020
Updated and added in methods and timing of follow-up for 
control group participants, for survey reminders and re-
engagement purposes. 
2
11/16/2020
Added additional information to be abstracted from the 
electronic medical record prior to qualitative interviews 
(Aim 1). 
3
12/18/2020
Added a Community Advisory Board component; included 
FaceTime and Google Duo as alternate modalities for 
conducting in-depth interviews; changed incentive for in-
depth interview from $25 to $50 and increased interview 
duration from 60 minutes to 90 minutes; corrected an 
inconsistency in the protocol (incorrectly stated that verbal 
consent would be used for the in-depth interviews)
4
10/21/2021
Added a pilot phase for the RCT and EPIC SmartForm
5
5/11/2022
Changed the language to reflect study coordinator instead 
of nurse coordinator. Updated subject compensation to 
reflect enrollment and study visits. Added additional 
information on randomization methods. Removed assent 
process and will use Under 18 ICF instead for consent. 
Added in-person option for revoking authorization and 
replaced with an email option. 
6
07/11/2022
Clarified how participants will be contacted for survey 

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Protocol Version: Version 14, 4_Dec_2024
reminders and remote visit scheduling. 
Removed 2-month control group outreach for re-
engagement. 
7
10/03/2022
Added that postpartum planning visits can occur during 
any type of prenatal care visit (fetal monitoring, 
ultrasound, routine) or an inpatient antenatal 
hospitalization.
Expanded the modalities through which recruitment can 
occur, adding phone contact prior to or following prenatal 
care visits for eligible patients and early contact (at 18-19 
weeks) for patients who will become eligible at 20 weeks.
Changed the details of the delivery hospitalization visit to 
allow the visit to be completed prior to delivery, if needed.
8
02/20/2023
Added the option for the delivery admission visit to be 
conducted via phone for participants with a Covid + 
diagnosis during their delivery hospitalization.
9
03/14/2023
Added pre-pregnancy obesity as an eligible diagnosis for 
RCT enrollment
10
05/03/2023
Added the option to obtain electronic consent, via 
REDCap, during phone recruitment for RCT enrollment
11
08/08/2023
Updated Principal Investigator and updated page info for 
Table of Contents section
12
11/16/2023
Updated details for blinding, abstraction, and blinded 
review of internal and external postpartum visits; Added 
phone visit for completion of delivery admission visit for 
intervention participants delivering outside of Grady 
hospital; updated table of contents page info
13
12/4/2024
Updated additional funding source (AMETHIST@PENN) 
that supports more detailed analysis of already collected 
data (for implementation assessment). Updated analysis 
section to reflect more detailed analysis of data for 

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Protocol Version: Version 14, 4_Dec_2024
FUNDING SOURCE: National Institutes of Health; AMETHIST@PENN Pilot Grant 
Table of Contents
1.
Study Summary....................................................................................................................4-5
2.
Objectives................................................................................................................................5
3.
Background ..........................................................................................................................6-7
4.
Study Endpoints ......................................................................................................................7
5.
Study Intervention/Investigational Agent...............................................................................9
6.
Procedures Involved...........................................................................................................9-12
7.
Data and Specimen Banking..................................................................................................14
8.
Sharing of Results with Participants......................................................................................14
9.
Study Timelines................................................................................................................14-14
10. Inclusion and Exclusion Criteria .......................................................................................15-15
11. Vulnerable Populations....................................................................................................16-16
12. Local Number of Participants................................................................................................17
13. Recruitment Methods......................................................................................................17-18
14. Withdrawal of Participants....................................................................................................19
15. Risks to Participants.........................................................................................................19-19
16. Potential Benefits to Participants..........................................................................................20
17. Data Management and Confidentiality............................................................................20-21
18. Provisions to Monitor the Data to Ensure the Safety of Participants ..............................23-23
19. Provisions to Protect the Privacy Interests of Participants..............................................25-24
20. Economic Burden to Participants..........................................................................................25
21. Consent Process...............................................................................................................25-26
22. Setting ...................................................................................................................................28
implementation assessment in relation to primary and 
secondary outcomes. 

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23. Resources Available .........................................................................................................28-27
24. References .......................................................................................................................29-29
1. Study Summary
Study Title
Minding the gap: improving women’s health through 
coordinated postpartum planning
Study Design
Sequential mixed methods design. Aim 1 will involve 
in-depth interviews; Aim 2 is a pragmatic randomized 
trial. The RCT Pilot will include medical record review 
and abstraction only. 
Primary Objective
To develop and evaluate a culturally tailored, 
comprehensive postpartum care system for pregnant 
women who deliver at Grady Memorial Hospital and 
are at increased risk for SMM due to cardiovascular 
risk factors.
Secondary Objective(s)
Research 
Intervention(s)/Interactions
Comprehensive postpartum care system vs standard 
of care
Study Population
Aim 1: Women who attended prenatal care and 
delivered a live-born infant at Grady Memorial 
Hospital for a pregnancy complicated by chronic 
diabetes, chronic hypertension, gestational diabetes, 
or hypertensive disorder of pregnancy.
Aim 2: Women who received 1 or more prenatal care 
visits in at Grady Memorial Hospital, intend to deliver 
at Grady, have a documented diagnosis of chronic 
diabetes, chronic hypertension, pre-pregnancy 
obesity, gestational diabetes, or hypertensive disorder 
of pregnancy (gestational hypertension or 
preeclampsia).
RCT Pilot: Medical records of pregnant patients who 
would be eligible for Aim 2 (enrolled in prenatal care 
with eligible diagnosis)
Sample Size
Aim 1: Up to 30 women

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Aim 2: 320 women
RCT Pilot: Up to 10
Study Duration for 
individual participants
Aim 1: 30 minutes
Aim 2: Approximately 20 months (enrolled during 
prenatal care and followed 14 months after delivery)
RCT Pilot: NA (no participant interaction)
Study Specific 
Abbreviations/ Definitions 
EMR, electronic medical record; HDP, hypertensive 
disorders of pregnancy
Funding Source (if any)
National Institutes of Health; AMETHIST@PENN Pilot 
Grant
2. Objectives
The purpose of the study is to design, implement, and evaluate a holistic postpartum 
women’s health care system within Grady Memorial Hospital for women who have 
cardiovascular risk factors for SMM including chronic hypertension, chronic diabetes, 
pre-pregnancy obesity, gestational diabetes, or a hypertensive disorder of pregnancy 
(HDP, includes gestational hypertension or preeclampsia). We will use a sequential 
mixed methods design.  First, we will conduct in-depth interviews with women who 
have given birth in the prior year to characterize barriers and facilitators to accessing 
postpartum care. The information from these interviews will be used to inform the 
design of a postpartum care system. Next, we will conduct a pragmatic randomized trial 
to test the effectiveness of the system on postpartum care engagement (versus 
standard of care).
Aim 1:  Conduct in-depth interviews with women who gave birth at Grady in the 
previous year to better understand barriers (individual, social, structural) to accessing 
and engaging in postpartum care.
Aim 2: Conduct a pragmatic randomized trial with 320 high-risk pregnant women who 
will receive either the enhanced postpartum system or standard of care. We will 
collect and analyze qualitative and quantitative data on process and outcome measures 
including adherence with recommended care visits and screenings, contraception 
initiation and use, use of medications for chronic conditions, and participant opinions 
about the system of care through 12 months postpartum. We hypothesize that women 
in the postpartum care system arm will have better rates of care engagement, 
utilization, and satisfaction compared with the control arm. 

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RCT Pilot: To design and test data collection instruments and processes for the 
randomized trial (Aim 2) using electronic medical record data from potentially eligible 
patients. 
3. Background
The US maternal mortality ratio is the highest among developed nations at 26.4 
maternal deaths per 100,000 livebirths.1 Among the states, Georgia has the second 
highest maternal mortality (66.3 per 100,000), with a 60% higher rate for black vs white 
women (95.6 vs 59.7 per 100,000).2 Nearly 100 times more common than maternal 
mortality is severe maternal morbidity (SMM), defined as unexpected outcomes of labor 
and delivery that result in short- and long-term deleterious health consequences. 
Maternal mortality and SMM are highest among women who are black, publicly insured 
or uninsured, and deliver in safety-net hospitals.3,4 In Georgia, 66% of maternal deaths 
occur to women insured by Medicaid at delivery and the majority of deaths and SMM 
occur postpartum, a time during which healthcare visits are poorly attended and 
oftentimes inaccessible.5 The Georgia Maternal Mortality Review Committee concluded 
that two-thirds of maternal deaths are preventable, with chronic health conditions, 
obesity, delays in accessing and fragmentation of care as key contributors.5 As solutions, 
it recommends improved prenatal and postpartum follow-up and case management, 
control of chronic health conditions, and extension of Medicaid coverage beyond 60 
days postpartum.
While the postpartum period represents a crucial window of opportunity for promoting 
women’s current and future health, up to 40% of US women do not attend postpartum visits,6,7 
due to structural barriers (e.g., lack of insurance, transportation or childcare),8,9 social barriers 
(e.g., medical mistrust and poor patient-provider relationships),10,11 or low perceived utility of 
postpartum care.12-14 Moreover, the lowest rates of postpartum care utilization are 
concentrated among women with the highest rates of pregnancy complications and chronic 
conditions (e.g., women who are uninsured or Medicaid-insured, low-income, and non-Hispanic 
black).15.16 Timely and adequate use of postpartum care is especially important for women with 
diabetes, hypertensive disease, or pre-pregnancy obesity as these conditions are associated 
with increased risk for postpartum morbidity and mortality and cardiovascular disease later in 
life.17 
We plan to conduct an intervention study to assess the effect of a woman-centered, 
comprehensive postpartum care system on postpartum visit attendance and follow-up care 
among medically underserved women with chronic diabetes, chronic hypertension, pre-
pregnancy obesity, gestational diabetes, or hypertensive disorder of pregnancy (HDP). Because 

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implementing and sustaining a comprehensive postpartum care system in a health disparities 
population requires a thorough understanding of patient preferences regarding the structural 
and process elements of care, methods of provider-patient communication, and strategies for 
addressing social and contextual barriers to care,18,19 we will use in-depth interviews to inform 
the intervention design and then assess health outcomes and satisfaction. The intervention will 
include the integration of a postpartum care planning tool in the electronic medical record 
(EPIC) and separate REDCap data collection instruments. In order to finalize intervention 
protocols and data collection forms, we will pilot the instruments using medical record data 
from patients not enrolled in the trial prior to beginning the trial. 
4. Study Endpoints 
Aim 1: The study endpoint for Aim 1 is completion of the in-depth interview, which will 
be used to inform the design of the intervention tested in Aim 2. 
Aim 2: The primary outcome for the randomized trial is attendance at the postpartum 
visit (between 4-12 weeks), as engaging women in care is critical to addressing needs 
and reducing SMM risk. Secondary outcomes include receipt of recommended early 
postpartum screenings for diabetes and hypertension (e.g., glucose testing or blood 
pressure checks), contraceptive initiation and use, use of medication for chronic 
conditions, pregnancy complications (including SMM), hospital readmissions, mental 
health status, perceived risks for SMM and cardiovascular disease, plans and use of care, 
and satisfaction with care (Table 1).  Secondary outcomes will be assessed at 2 time 
points – 12 weeks after delivery and 14 months after delivery (to allow for 
approximately 12 months of follow-up after attending the 4–12-week postpartum visit). 
RCT Pilot: Once study instruments are finalized, all entered data will be deleted. 
Table 1. Study outcomes and timing of assessment
12-week survey
14-month survey
Postpartum visit attendance (primary outcome)
Receipt of recommended testing
Contraceptive use
Medication use
Pregnancy complications
Hospital readmissions
Perceived risks (SMM, CVD)
Plans for primary & specialty care
Mental health 
Satisfaction with postpartum care 
Contraceptive use
Medication use
Pregnancy complications
Hospital readmissions
Perceived risks (CVD)
Use of primary & specialty care
Mental health 
Self-rated health

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5. Study Intervention/Investigational Agent
Aim 1: No intervention strategies will be delivered or evaluated as part of Aim 1, and the usual 
standard of obstetrical or other clinical care will not be altered in any way for women who 
participate in this research study.  
Aim 2: Women who choose to participate in the pragmatic trial will be randomized to the 
control or intervention arm using minimization, a covariate-adaptive randomization method to 
achieve balance in the proportion of participants with each of the diagnoses (chronic diabetes, 
chronic hypertension, pre-pregnancy obesity, gestational diabetes, and/or HDP) across the two 
study arms. The intervention will consist of a comprehensive postpartum care system that 
integrates American College of Obstetrician and Gynecologist’s (ACOG) postpartum care 
guidelines17 together with American College of Cardiology and American Heart Association 
(ACC/AHA) guidelines20 for the prevention of cardiovascular disease in women and patient 
preferences for care coordination and communication (from Aim 1). The system will consist of: 
1) a tailored postpartum care plan that is collaboratively developed with patient and provider 
input and addresses both social and medical needs; 2) an electronic medical record (EMR) 
based tool for documenting the plan and monitoring postpartum care; and 3) a postpartum 
follow-up phone call at 1 week postpartum. To provide continuity of care for women in the 
intervention group and to prevent spillover effects for women in the standard care group, a 
trained, dedicated healthcare professional located in the OB/GYN clinic will deliver the 
postpartum intervention.
RCT Pilot: No intervention strategies will be delivered. 
6. Procedures Involved
Aim 1: A member of the research team will contact eligible women by phone using contact 
information given in the electronic medical record and, if interested, schedule a time for a 
remote in-depth interview conducted via phone, Zoom, FaceTime, or Google Duo (per 
participant preference) The research team member will attempt to reach a participant up to 3 
times, leaving a voicemail if unavailable. Prior to the interview, a member of the research team 
will abstract information on the postpartum visit, pregnancy, and delivery characteristics from 
the medical record using a standardized abstraction form. Prior to performing the qualitative 
interviews over the telephone, the research team member will obtain written consent using 
REDCap. We will use interview guides, and women will be asked to participate only once. We 
do not anticipate that informants will be stressed from this study, nor will they be deceived. 
The purpose of this study is to learn more about patient preferences for postpartum care.
All interviews will be audio-recorded with the consent of the patients and transcribed verbatim. 
Once transcribed and checked, audio-recordings will be deleted. Transcripts will not be linked 

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to participant name’s or identifying information. However, we will retain information on 
participant age, diagnosis, postpartum visit attendance, and parity for analytic purposes.
Aim 2:
Control: If randomized to the control study arm, participants will receive usual care, which 
includes regular prenatal care visits and discussions on infant feeding plans and contraception 
at provider discretion. In usual care, participants will schedule a 4–12-week postpartum visit 
during their delivery hospitalization. If signed up for the service, participants will receive a 
Grady initiated text message reminder for their scheduled postpartum visit. In addition, all 
patients with a HDP are automatically scheduled to receive a mobile integrated health home 
visit for a blood pressure check 7-10 days after delivery.  We will provide outreach to the 
control and intervention participants at 12 months after delivery, to re-engage them and 
remind them about the 14-month survey.  
Figure 1. Postpartum care system and data collection schematic
Intervention: If randomized to the intervention arm, participants will receive usual care (as 
described above) plus the postpartum planning intervention (Figure 1). Postpartum Planning 
study visits will occur during prenatal care visits including fetal monitoring visits, ultrasound 
visits and other care visits prior to delivery, including any antenatal hospitalizations. During 
study visits the participants will engage in a 30–45-minute visit with the study coordinator to 
create a tailored postpartum plan, and if the patient is hospitalized prior to delivery, 
postpartum planning visits may be held, and modules completed during the hospitalization.
The plan is intended to: 1) document all recommended postpartum screenings and follow-up in 
the Epic EMR system (via a postpartum planning Epic SmartForm) and 2) actively engage 
women in their care, thereby reinforcing the importance of postpartum follow-up and the 
transition to primary care. The plan will include, at minimum, recommended postpartum check-

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ups and evidence-based screenings based on risk factors derived from both ACOG and 
ACC/AHA guidelines (e.g., 1-week blood pressure check for those with HDP), participant 
preferences for breastfeeding and contraception, tailored referrals for postpartum visits and 
supports (e.g., providers in the women’s zip code, transportation vouchers), and contact 
information for the patient’s postpartum care team (OB/GYN, primary care provider, any 
specialty care provider, patient’s partner, or other social support network). The planning 
discussions will be guided by 20 topic-specific modules and will be tailored to address specific 
risk conditions (e.g., hypertension) as appropriate. Table 2 depicts the topics covered in the 
postpartum care planning modules. Each module consists of a structured discussion, supported 
by a short (1-2 page) information sheet on the topic, of which participants will receive both 
physical and electronic copies (see patient education modules 1-20).
Receipt of the educational modules will be documented in REDCap (see REDCap data collection 
instruments). The study coordinators will be responsible for conducting all planning discussions, 
providing continuity of care, and creating the postpartum care plan. At each prenatal visit, the 
study coordinator and participant will complete the postpartum planning modules, and the 
postpartum plan will be documented and updated (if needed) in the participant’s EMR. The 
plan will also be made available to participants via MyChart (a secure patient portal through 
Epic that gives patients online access to their medical record), allowing them to review it from 
their phone or home computer. For participants without an active MyChart account, the plan 
will be printed and provided to them. During the participant’s delivery hospitalization, a study 
coordinator will visit the participant to finalize the postpartum plan and provide a printed copy 
of the plan for the participant to take home and review. For participants with a Covid + 
diagnosis during the delivery hospitalization, the delivery admission visit will be conducted via 
phone.  If an intervention participant delivers outside of Grady hospital, the delivery admission 
visit will be conducted via phone. Within 1 week of discharge, the study coordinator will call the 
Table 2. Postpartum care plan module topics
Care team
Postpartum visit
Pregnancy complications
Immunizations
Postpartum problems
Mental health
Sexual health and function
Reproductive life planning
STIs
Healthy relationships
Maternal support team
Returning to work
Tobacco use
Substance use
Healthy weight
Food security and housing
Infant feeding
Chronic disease and specialty care
Heart disease prevention
Transition to primary care

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participant to check in and address any postpartum concerns. The intervention ends at the time 
of the 1-week check-in phone call.  
Follow-up (Intervention and Control): After the first week postpartum, all participants, 
whether in the control or intervention arm, are treated the same. Consistent with standard care 
protocols at Grady, intervention participants with a HDP will have a mobile integrated health 
visit with blood pressure check at 7-10 days postpartum.  Consistent with ACOG guidelines,17 all 
participants will be encouraged to attend a comprehensive visit between 4-12 weeks 
postpartum, which will include a full assessment of physical, social, and psychological well-
being, including chronic condition surveillance and management, and a plan to transition to 
primary and specialty care as needed.
Data collection
For women in both the control and intervention arms of the study, we will collect research data 
using REDCap surveys, remote survey follow-up, and abstraction of the medical record. 
12-week and 14-month survey: A REDCap link for the 12-week and 14-month surveys in English 
or Spanish, according to the participant’s primary language, will be sent to the participant’s 
email on file to collect supplemental information on primary and secondary outcomes and 
patient experiences. Participants will be asked to complete the surveys on their own, using 
either their phone or a computer. The study coordinator will then conduct a remote follow-up 
session with each participant via phone, Zoom, Facetime, or Google Duo to review and discuss 
the surveys, including any missing responses. Each survey and remote follow-up session will last 
20-30 minutes. The week prior to each survey, a research team member will contact the 
participant to provide a reminder about the upcoming survey, schedule the remote visit to 
review survey responses and send the survey link. The research team member will offer 
participants the option to reschedule the remote follow-up session for a time that is more 
convenient. If we cannot reach a participant by phone, we will try each contact method at three 
different times (e.g., daytime, evening, weekend), leaving messages as appropriate. In addition, 
we will check the Grady EMR for any updates to patient contact information that were 
ascertained through clinical encounters during the follow-up period, and we will ask 
participants to confirm their preferred contact information upon completing the 12-week 
survey. For participants who report health care encounters that are not documented in the 
Grady EMR (including the Care Everywhere function in Epic), we will ask where they received 
care, and ask for permission to request medical records from that location; this may require 
participant signing additional consent form specific to the facility where they received health 
care. 
The 12-week survey will measure depressive symptoms21 and functional social support22, 
perceptions of risk for SMM or cardiovascular disease23 and need for preventative measures, 

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plans and actions for well-woman, primary and/or specialty care, and implementation 
outcomes, including opinions of and satisfaction with postpartum care and the planning 
process. The 14-month survey will assess well-woman, primary and specialty care use, 
contraceptive use, perceived cardiovascular risks, mental well-being (depression21 and social 
support22), and self-rated health.25 (See the 12-week survey and 14-month survey documents 
for more information.) The survey will also validate EMR information on hospital readmission, 
SMM, and medication adherence. 
To promote retention of participants over the 14-month follow-up period, we will ask 
participants to provide at least three ways to contact them (e.g., email addresses, own phone 
number, or phone number of a partner or family member). Upon completing the 12-week 
survey, the research team will confirm the preferred contact information for the 14-month 
survey. 
Medical chart review will be used to ascertain health care utilization (postpartum visit, primary 
care or specialty care utilization, hospital admissions), diagnoses, and medical prescriptions in 
the 12 months postpartum. A standardized medical abstraction form will be used by research 
team members who have trained in data abstraction from the medical record. If additional 
medical records are available from care obtained outside of Grady, that information will also be 
reviewed and abstracted.  The primary outcome of interest (4–12-week postpartum visit 
attendance) will be identified using data from the medical record. Information on all outpatient 
visits occurring between delivery discharge and 12 weeks postpartum will be abstracted and 
blinded for review. Two independent physicians will review the blinded information and 
determine whether the visit meets the criteria for a comprehensive postpartum visit. ER and 
urgent care visits external to Grady that fall within the 4 – 12-week postpartum period and 
through 14 months postpartum will be abstracted but not blinded for review by the blinded 
reviewers. Information for these visit types occurring within Grady Health System during these 
time periods will be obtained from the “GOGO” data warehouse (IRB00103211). Mobile 
integrated health visits, triage visits, and nurse visits occurring during these time periods will not 
be abstracted or blinded. 
Questionnaires and medical chart review will involve collection of identifiable information as 
names, medical record numbers, telephone numbers, and dates are required for the follow-up 
of the individuals at subsequent study visits and for ascertainment of outcomes via the EMR.  
RCT Pilot: EMR review will be used to create, design, and finalize the Epic and REDCap data 
collection instruments. By piloting the form via medical records, we will ensure efficient and 
feasible data collection processes during the intervention. 

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7. Data and Specimen Banking 
Aim 1: All interviews will be transcribed verbatim. Audio-recordings and transcripts will be 
housed in password protected computer systems secured by Emory University. The transcripts 
will be cleaned and identified prior to analysis. A transcript key will be maintained that links the 
informant to their de-identified file and audio-recording. Deidentified transcripts will be stored 
on REDCap and OneDrive, both of which are compliant with Emory University’s HIPAA security 
policies and procedures.
Aim 2: All study data will be kept on a password-protected Emory OneDrive folder or REDCap 
database, accessible only to a limited number of research team members. No one will have 
access to the data or the identifying information other than the Investigators or their designee. 
All data entry will be done on password-protected and encrypted tablet computers with 
REDCap software, which allows for the transfer of data to the Emory server over the internet in 
a HIPAA-compliant, encrypted manner. Upon study completion, de-identified study data will be 
kept in HIPPA-compliant databases until they are fully analyzed and are no longer needed.
RCT Pilot: All data entry for the pilot will be done on password-protected and encrypted tablet 
computers with REDCap software, which allows for the transfer of data to the Emory server 
over the internet in a HIPAA-compliant, encrypted manner. First, we will test a paper version of 
the postpartum care plan to inform the design of the Epic EMR tool (SmartForm). Once the 
SmartForm has been developed and deployed in Epic, we will also use patient records to test its 
functionality prior to the start of the RCT. 
8. Sharing of Results with Participants
Once the study results are publicly disseminated, we will inform the study participants 
via text, email, or telephone, depending on their preferred means of contact.  Aim 2 
participants with an active account will be able to view the postpartum plan via 
MyChart. For participants without an active MyChart account, the postpartum plan will 
be printed for them. We will work with the Community Advisory Board for this study to 
disseminate results broadly to the communities served by Grady. 
9. Study Timelines
Aim 1: Each in-depth interview is expected to last approximately 30 minutes. Each 
participant will be interviewed only once. We anticipate that it will take approximately 
one month to enroll all interview participants. We estimate that the qualitative data will 
be analyzed by the end of Year 1. 
Aim 2: Individuals will participate in the study for approximately 18 months (starting 
during prenatal care and continuing 14 months after delivery). There are approximately 
200 deliveries per month at Grady. Assuming that 40% of women will be eligible (data 

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from our study suggests that 38% of women at Grady have hypertensive disorders26) 
and about 15% of women will not receive any prenatal care, and 50% will agree to 
participate in the study, we expect recruitment to take about 9 months. We estimate 
that data from the randomized trial will be analyzed during Year 5. 
RCT Pilot: The piloting will be iterative and will occur between May and July 2022. 
10. Inclusion and Exclusion Criteria
Aim 1: We will use EMR data to identify eligible women. Women will be eligible if >18 
years of age, had one of the eligible diagnoses (chronic diabetes, chronic hypertension, 
gestational diabetes, or HDP), and attended at least one prenatal visit and delivered at 
Grady Memorial Hospital for a pregnancy in the prior year. We will recruit a purposive 
sample made up of approximately equal proportions of women who were primiparous 
and multiparous and women who did and did not attend the postpartum visit. For this 
Aim, we will only recruit English-speaking patients to maximize interview/patient 
rapport and streamline analysis. 
Aim 2: We will use the EMR to identify pregnant women (all ages) between 20-34 weeks 
of gestation who have received 1 or more prenatal care visits at Grady Memorial 
Hospital, intend to deliver at Grady, speak English or Spanish, and have a diagnosis of 
chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity, 
and/or HDP (gestational hypertension or preeclampsia) documented in the EMR. 
RCT Pilot: We will use EMR data to identify eligible women (records) between 20-34 
weeks of gestation who have received 1 or more prenatal care visits at Grady Memorial 
Hospital, intend to deliver at Grady, speak English or Spanish, and have a diagnosis of 
chronic diabetes, chronic hypertension, gestational diabetes, and/or HDP documented 
in the EMR.
Study Timeline
Year 1
Year 2
Year 3
Year 4
Year 5
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
Project launch 
1 Develop questions for interviews 
1 Conduct interviews 
1 Analyze qualitative data 
2 Develop content for care system
2 Design and test EMR tool
2 Study start up 
2 Enroll women
2 Follow women for 14 months 
2 Conduct follow-up surveys
Analyze/disseminate RCT results 
Prepare manuscripts 

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Adults unable to consent, infants, and prisoners will be excluded from all Aims. We will 
include pregnant persons < 18 in Aim 2; specific protections and procedures for that 
group are detailed below. 
Community Participation: Aim 1 seeks to understand the needs of the community that is being 
targeted by the study (women who received prenatal care and delivered at Grady). This 
information will directly inform the design of the postpartum care system that will be tested in 
Aim 2. Once the study results are publicly disseminated, we will inform the study participants 
via text, email, or telephone, depending on their preferred means of contact.  
The study team will convene a Community Advisory Board (CAB) that will meet 3 times a year 
until study completion. The CAB will be composed of members of local, state, and national 
community organizations dedicated to and experienced with improving women’s health, health 
care providers who are experts in the fields of obstetrics and gynecology, maternal fetal 
medicine, women’s primary health care, and public health and women from the community 
who have experience accessing reproductive health services in Georgia and can serve as patient 
advocates. The CAB will provide guidance on strategies for reducing maternal health disparities, 
advise the study team regarding essential components of and barriers to postpartum care, and 
provide input regarding study design, implementation, interpretation, and dissemination of 
findings. The CAB members will be provided a $100 VISA gift card per meeting as 
compensation. 
11. Vulnerable Populations
Aim 2 involves pregnant women, a vulnerable population. Participants assigned to the 
control arm will receive standard prenatal and postpartum care. Participants assigned to 
the intervention will meet with a study coordinator during routine prenatal care visits, 
develop a postpartum plan, and receive follow-up phone calls or texts after delivery. 
The risks associated with participating in this study are minimal since the probability and 
magnitude of harm or discomfort anticipated in the study are not greater in and of 
themselves than those ordinarily encountered in routine care delivered at the clinic. 
There are no physical risks presented by participating in the study. The postpartum care 
system could benefit participants by enhancing their engagement with care and 
promoting the early detection and treatment of postpartum complications. Participation 
in the study will be voluntary and will in no way modify the clinical care the participants 
receive during and after their pregnancy. 
Although we anticipate that relatively few women <18 years of age will meet the 
eligibility criteria (have a diagnosis of chronic diabetes or hypertension, pre-pregnancy 
obesity, gestational diabetes, and/or HDP), these women represent a high-risk group in 
terms of adverse pregnancy outcomes and inadequate postpartum care utilization and 

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therefore warrant inclusion in the study. We are requesting a waiver of parental consent 
for pregnant women <18 years of age. Requesting a parental waiver will not adversely 
affect the rights and welfare of the participants as teens will already be visiting the clinic 
for prenatal care. Also, requiring parental consent offers no additional protection to the 
participant. Participants <18 years of age will receive the same information about the 
study as participants 18 years of age and over. We will use an under 18 informed 
consent form in the place of the assent process for participants >18 years, since these 
participants will be in the upper age group for minor subjects. If the participant does not 
appear to comprehend the consent form or the research, they will not be enrolled. If a 
participant < 18 years turns 18 during the study period, they will be invited to complete 
the full informed consent at that time. 
RCT Pilot: The pilot involves medical records for pregnant women (same eligibility 
criteria for Aim 2). Review of patient medical records will in no way modify the clinical 
care the participants receive during and after their pregnancy.
12. Local Number of Participants
Aim 1: We will recruit up to 30 women.
Aim 2: We will recruit 320 women. Based on prior studies at Grady, we assume a 
recruitment rate of 50% and expect to approach approximately 640 women. 
RCT Pilot: We will review the minimum number of records to finalize instruments, likely 
between 5-10 records. 
13. Recruitment Methods
Aim 1: We will recruit up to 30 women who attended prenatal care at Grady Memorial Hospital 
for a pregnancy complicated by the presence of chronic hypertension or diabetes, pre-
pregnancy obesity, or the occurrence of cardiometabolic complications of pregnancy 
(gestational diabetes or HDP) in the past year. We will identify potential participants using the 
electronic medical record, purposively selecting a range of parity (primiparous and multiparous) 
and postpartum visit attendance (attended and did not attend). A member of the research 
team will contact women by phone using contact information given in the electronic medical 
record and, if interested, schedule a time for a phone-based in-depth interview. The research 
team member will attempt to reach a participant up to 3 times, leaving a voicemail if 
unavailable. Prior to performing the qualitative interviews over the telephone, the research 
team member will secure written consent. Participants will be given a $25 VISA gift card for 
participation in the in-depth interviews.
Aim 2: We will recruit 320 women during scheduled prenatal care visits at Grady Memorial 
Hospital. We will identify potentially eligible women using the EMR. The study coordinator or 

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designee will either contact potentially eligible patients prior to the scheduled prenatal care 
visit, via the phone number listed in the patient’s EMR, to provide information about the study 
and obtain the patient’s interest in participating, and if the patient is interested the study team 
will arrange for consent during a scheduled prenatal care visit, or obtain written, electronic 
consent via REDCap, during phone recruiting; Or the study coordinator or designee will 
approach potentially eligible patients before or during scheduled prenatal care visits. If the 
study team is unable to recruit a potentially eligible patient during a scheduled prenatal care 
visit, a member of the study team will follow-up with the patient after the scheduled prenatal 
care visit, via the phone number listed in the patient’s EMR, to provide information about the 
study and obtain the patient’s interest in participating, and if the patient is interested the study 
team will arrange for consent during a scheduled prenatal care visit, or arrange written, 
electronic consent. If obtaining electronic consent, a member of the research team will contact 
eligible patients by phone via the patient’s contact information in the electronic medical record. 
The research team member will attempt to reach the eligible patient up to 3 times, leaving a 
voicemail if unavailable. If the patient is interested in participating the research team member 
will send the informed consent form to the patient’s preferred email via REDCap, or text the 
REDCap informed consent form survey link to the patient’s phone number on file. During the 
call, the research team member will review the informed consent form with the participant and 
obtain written consent via REDCap. 
 In an effort to increase recruiting efforts, we will also approach potentially eligible patients 
identified in the EMR to have a gestation of 18 weeks or 19 weeks to provide information about 
the study and obtain the patient’s interest in participating when they reach 20 weeks gestation. 
If the patient agrees to participate in the study, the study coordinator or designee will arrange 
for the patient to be consented during a scheduled prenatal visit, or arrange written, electronic 
consent when the patient reaches gestation of 20 to 34 weeks. The study coordinator or 
designee will either conduct the informed consent process in-person during a scheduled 
prenatal visit or provide written, electronic consent for all potentially eligible patients 
interested in participating. All potentially eligible participants will receive information on the 
purpose of the study, the procedures, expected risks and benefits, and a copy of the informed 
consent form to review. If a patient is approached during a prenatal care visit and is interested 
in participating, they will have the option of scheduling the informed consent process the same 
day or another day. The study coordinator (or member of the study team) will review the 
informed consent form with the participant and ensure comprehension through an oral review 
of key points.
The consent form will describe the purpose of the study, the procedures to be followed, and 
the risks and benefits of participation. An explanation will be provided about the use of PHI for 
research purposes and how confidentiality will be maintained as far as possible under the 

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Federal Health Insurance Portability and Accounting Act (HIPAA). Written informed consent will 
be obtained from women who agree to participate in the study. A copy of the signed consent 
form will be given to the participant and documented in the participant’s research record. No 
PHI will be retained for potential participants that do not qualify for the study or for those who 
elect not to participate in the study.
During the consent process, we will make it clear that participation is voluntary, and that there 
are no adverse consequences to choosing not to participate or to terminating participation at 
any time. The study coordinator will review the informed consent document with potential 
participants and explain in detail the purpose of the study, procedures, and risks.
In addition, we will prioritize recruitment of a bilingual, Spanish-speaking study coordinator and 
research assistants as Spanish is the most common non-English language among pregnant 
patients at Grady. If a patient agrees to participate, they will be randomized to an 
intervention/control study arm.  All participants will receive an incentive of $25 for enrolling in 
the study, $25 after completing the 12- week survey, and $25 after completing the 14-month 
survey. If randomized to the intervention arm, these participants will receive $10 after each 
completed study visit. The number of study visits offered will depend on how far along a 
participant is in their pregnancy at enrollment. Participants will be offered up to (8) study visits 
and, if needed, 4 supplemental visits for a total of up to $195 total compensation. If 
participants miss visits or do not finish the study, they will be compensated only for the visits 
and surveys they complete. Compensation will be provided via an e-gift card. Intervention arm 
participants will also be gifted a “Grady onesie” for their newborn during the delivery 
admission. 
RCT Pilot: There will be no recruitment for the pilot. 
14. Withdrawal of Participants
We do not anticipate any circumstances under which participants in Aim 1 or Aim 2 would be 
withdrawn without their consent. If participants choose to withdraw from the intervention 
study (Aim 2), the study coordinator will note this information, along with the reason, if known, 
in the study records. Medical record abstraction for this participant will be conducted for the 
period of time during which they were enrolled. 
Participants in the RCT pilot will not be withdrawn. 
15. Risks to Participants
There are potential (yet minimal) risks related to the conduct of this research study, 
including risks of breach of confidentiality and risk of some participants experiencing 
distress or revealing depression or intention for self-harm during the questionnaire and 

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interview data collection, as the postpartum period is emotional and questions about 
social support or depressive symptoms may feel invasive.
16. Potential Benefits to Participants
Participants in this research study may not receive any benefit. However, participants in 
the intervention arm of the study may benefit from better continuity of care, more one 
on one time with a provider during prenatal care, and enhanced follow-up postpartum. 
In addition, the potential benefits of this research may extend to future postpartum 
patients at Grady Memorial Hospital or in other communities as these data are 
incorporated into the design of an EMR-integrated, culturally appropriate postpartum 
planning system.  
17. Data Management and Confidentiality
Aim 1: All qualitative data will be professionally transcribed. These transcripts will be 
cleaned and de-identified prior to analysis. Once cleaned, we will use a team-based 
approach to systematically code each transcript using a qualitative software program 
called MaxQDA2020. Two researchers will review and code the transcripts with a lead 
analyst to identify emerging themes. We will use a directed approach to content 
analysis whereby the research theory will be used as guidance for data coding.
Aim 2: For Aim 2, we will conduct a randomized controlled trial to test the effectiveness of the 
comprehensive postpartum care system on postpartum care use and engagement. The primary 
outcome will be attendance at the postpartum visit occurring between 4-12 weeks after 
delivery. Secondary outcomes include receipt of early postpartum screenings for diabetes and 
hypertension (e.g., glucose testing or blood pressure checks), contraceptive initiation and use, 
use of medication for chronic conditions, pregnancy complications (including severe maternal 
morbidity), hospital readmissions, mental health status, perceived risks for SMM and 
cardiovascular disease, care plans and use, and satisfaction with care. 
We will recruit 320 pregnant women between 20-34 weeks of gestation who receive 1 
or more prenatal care visits in the Grady OB/GYN clinic, intend to deliver at Grady 
Memorial Hospital, have a documented diagnosis of chronic diabetes, chronic 
hypertension, pre-pregnancy obesity, gestational diabetes, and/or HDP and speak 
English or Spanish. We will assign participants to intervention or control arm using 
simple randomization. Participants will be randomized (1:1) to receive the postpartum 
care system (175) or standard of care (175) and will be followed for up to 14 months to 
allow ample time for attending the 4–12-week postpartum visit and to connect to 
primary and specialty care.
Power. Preliminary data suggest that 55% of women with HDP return for a postpartum follow-
up visit in the absence of the intervention. Based on this, we should have 80% power to detect 

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a risk ratio of 1.5 (or greater) with a sample of 292 women (146 in each arm), stratified evenly 
by chronic or new onset disease. To achieve this, 78% of women in the intervention arm would 
need to attend the postpartum visit, which is conservative. Assuming some (up to 15%) loss to 
follow-up, we should aim to recruit a sample of 320 women.
Analysis.
Primary outcome (Attendance at 4–12-week postpartum visit): We will compare the probability 
of attending the 4–12-week postpartum visit between intervention and control groups. We will 
fit log binomial models to estimate the effect (risk difference and relative risk) of the 
intervention on attendance at the 4–12-week visit, adjusting for diagnosis (chronic 
hypertension, chronic diabetes, pre-pregnancy obesity, gestational diabetes, or hypertensive 
disorder of pregnancy). If sample size permits, we will include relevant confounders, as 
appropriate. 
Secondary outcomes: Secondary outcomes include receipt of recommended early postpartum 
screenings for diabetes and hypertension (e.g., glucose testing or blood pressure checks), 
contraceptive initiation and use, use of medication for chronic conditions, pregnancy 
complications (including SMM), hospital readmissions, mental health status, perceived risks for 
SMM and cardiovascular disease, plans for and use of primary and specialty care, and 
satisfaction with postpartum care. We will analyze these outcomes using log-binomial models 
to estimate relative risks and risk differences and 95% confidence intervals, adjusting diagnosis.
Implementation Analysis of existing RCT data: We will also conduct implementation analysis of 
intervention records and patient outcomes data to assess intervention fidelity and influences 
on equity in participation and primary and secondary outcomes. These data include study 
records in RedCap documenting number and timing of educational sessions, referrals and 
resources provided. We will also use data from two patient surveys implemented at 12 weeks 
and 14 months postpartum. We will compute descriptive statistics to determine the number of 
patients having received the full intervention. A preliminary definition for “receipt of full 
intervention” is if individuals received all 20 modules, had a complete postpartum care plan 
logged in Epic, received referrals for care, and appointment reminders. We will also analyze 
education module logs and will categorize patients as having received the content in the 
intended duration (over 8 study visits) or in a shortened time frame (e.g., in 2-3 visits). We will 
assess the extent to which the intended primary (receipt of a comprehensive postpartum visit) 
and secondary intervention outcomes (occurrence of SMM, primary care use, contraceptive 
use, and patient satisfactory with care) differ by level of implementation fidelity (dose and 
duration) using chi-square tests for association. We will also analyze quantitative study record 
data to describe the number of social service needs (e.g. housing, food, violence, etc.) and 
health needs (e.g. mental health) participants reported during the perinatal and postpartum 

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period. We will assess the relationship between patients’ social needs and barriers to meeting 
those needs with primary and secondary outcomes. We will assess the extent to which the 
intended primary (receipt of a comprehensive postpartum visit) and secondary intervention 
outcomes (occurrence of SMM, primary care use, contraceptive use, and patient satisfactory 
with care) differ by level of social needs and experiences of barriers to completing referrals 
using chi-square tests for association. We will compute descriptive statistics and tests of 
significance using SAS 9.4.
Protection against risks. As a research team, we will protect against risks and potential risks in a 
number of ways. A primary mechanism for protecting against risks will be ensuring intensive 
training of the research team. First, the MPI’s will require all of the research team members to 
complete Human Subjects Research Training, as documented through their successful 
completion of the Human Subjects Collaborative Institutional Training Initiative (CITI) modules, 
available at: https://www.citiprogram.org/. Second, the investigative team will conduct several 
in-depth trainings of all research staff prior to the recruitment of any research participants that 
will include an overview of the entire research plan and protocol and specific trainings to 
address recruitment, enrollment, and informed consent procedures; questionnaire data 
collection; and clinical data collection through the electronic medical record; and secure 
maintenance of confidentiality and security of all data streams and participant confidentiality. 
In particular, the research team members having face-to-face interaction and/or telephone 
interaction with the research participants will be trained in the following potential risks and 
strategies for protecting against these risks prior to initiation of any participant recruitment. 
Confidentiality: Confidentiality will be maintained on several levels. First, all research 
investigators and staff are fully trained, and required to maintain training, in human 
research protections, including the most up-to-date strategies for maintaining the 
confidentiality of research data. Second, all data will be protected from anyone who 
does not have a staff position in the study. Third, the raw data will be kept in password 
protected OneDrive files or on a HIPAA compliant database (e.g., REDCap), accessible 
only to a limited number of the research team. No one will have access to the data or 
the identifying information other than the study investigators and designated study 
staff, directly involved. Fourth, all data entry will be done on password-protected and 
encrypted tablet computers with REDCap, which is a software that allows for the 
transfer of data to the Emory server over the internet in a HIPAA-compliant, encrypted 
manner. Deidentified transcripts will be stored on REDCap and OneDrive, both of which 
are compliant with Emory University’s HIPAA security policies and procedures; Fifth, the 
Emory server is password-protected, encrypted, and backed up to ensure data 
confidentiality and integrity; Sixth, data for analyses will be stripped of all PHI 

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identifiers; Seventh, the data will be kept until they are fully analyzed and destroyed 
when they are no longer needed. Upon completion of the conduct of the protocol, the 
subject log linking study identifiers to subject identity and PHI will be destroyed.
RCT Pilot: We will use the same data management protocols as in Aim 2. However, data 
will be destroyed once instruments are finalized. No data will be analyzed. 
18. Provisions to Monitor the Data to Ensure the Safety of Participants
Aim 2 is a clinical trial and will have a Data and Safety Monitoring Plan. An individual’s 
participation in the clinical trial aspect of this study meets Federal Regulations defining 
minimal risk: “minimal risk means that the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of themselves than those 
ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests.” [§46.102]. The intervention itself (enhanced 
postpartum care system) does not pose a risk for adverse events, however, as eligibility 
criteria for participation in the clinical trial include having chronic hypertension or 
diabetes or experiencing cardiometabolic complications during pregnancy, it is possible 
that a non-study related adverse event may occur to enrolled participants. We believe 
that the enhanced postpartum care system may help in the early identification and 
prevention of complications, as participants in the intervention arm will receive 
additional follow-up postpartum. As part of the study, the study coordinator will 
monitor any readmissions or complications using the EMR and, as reported on the 
surveys conducted at 12-weeks and 14-months postpartum.
We have constituted a Data Safety Monitoring Board (DSMB) to review safety and study 
enrollment of participants in this study, which will meet on an annual basis. The DSMB 
will review in tabular form any and all Adverse Events (AEs); in narrative, any and all 
Serious Adverse Events (SAEs); enrollment data; attrition data; data quality and 
completeness; and narrative reports of any issues around loss of participant 
confidentiality. Serious adverse events will be reported to the IRB within 7 days of the 
study team becoming aware of the occurrence of the event; any deaths will be reported 
within 24 hours of the team becoming aware of the event. The report of DSMB’s annual 
review to the Emory University IRB annually.
The DSMB responsibilities are to:
1. Review the research protocol, informed consent documents, and plans for data 
safety and monitoring prior to beginning enrollment;

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2. Evaluate the progress of interventions, including periodic assessments of data 
quality, participant recruitment, accrual and retention, participant risk versus 
benefit, performance of the site, and other factors that can affect study 
outcome;
3. Consider factors external to the study when relevant, such as scientific or 
therapeutic developments that may have an impact on the safety of the 
participants or the ethics of the trial;
4. Ensure the rights and safety of the study participants are protected;
5. Report on the safety and scientific progress of the trial;
6. Make recommendations to the PI, and research ethics board/institutional review 
board about any determination, or other modifications of the trial based on the 
observed beneficial or adverse effects of the treatment under study.
DSMB Membership 
1. Members of the DSMB have been invited by PI Jamieson; members will be completely 
independent of the trial investigators and have no financial or scientific conflict of 
interest with the study. A potential conflict that develops during a member's tenure on 
the DSMB must be disclosed and, if significant, will lead to replacement of the DSMB 
member. 
2. Disciplines represented on the DSMB will include health professionals with expertise in 
obstetrics and gynecology, family medicine, internal medicine, and epidemiology or 
biostatistics. 
3. A Chairperson will be selected prior to the first meeting. The Chair will lead all meetings, 
coordinate meetings and communications, develop the agenda, and produce meeting 
minutes and reports. 
DSMB Meetings. The first meeting will take place before initiation of the trial to discuss 
the protocol and to establish guidelines to monitor the study. The Chair, with input from 
PI Jamieson, will prepare the initial agenda, which should address issues concerning 
commencement of the trial. The initial tasks of the DSMB are to review the protocol and 
informed consent forms with regard to subject safety, review this charter and amend it, 
if necessary, and discuss the plan for monitoring data, subject safety, and compliance. PI 
Jamieson will distribute the proposed reports to DSMB members prior to each 
subsequent meeting. Following the initial meeting, the DSMB will convene at least once 
per year to review accumulated data on safety. Meetings shall be convened face-to-face 
or by teleconference, at the DSMB members’ discretion. If a question of patient safety 
arises or if a Serious Adverse Event occurs, an emergency meeting of the Board may be 

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called at any time by the Chairperson. The format for DSMB meetings will consist of two 
sessions. The first session will be attended by the PIs where the conduct and progress of 
the study, subject accrual, and subjects’ compliance with protocol, general safety issues, 
and any other problems encountered will be discussed. The second session will be open 
only to DSMB members. Safety and efficacy data, the general conduct of the trial, 
outcome results, and adverse events are presented at this session.
19. Provisions to Protect the Privacy Interests of Participants
Aim 1: In-depth interviews will be conducted via phone, Zoom, FaceTime or Google Duo 
(according to patient preference). Patients will have the ability to decide when and 
where to take part in the interview. The privacy interests of all participants will be 
protected during the interviews. We will describe the study procedures at the time of 
the screening call as well as at the beginning of the interview. This information will 
detail our procedures for collecting, storing, and de-identifying the qualitative interview 
data. In addition, we will explain the interview process and identify each staff member 
(interviewer, note taker) who will be present during the interview. If a participant 
expresses concerns about his/her privacy or confidentiality, we will respond accordingly. 
This may include asking the note taker not to participate in the interview or not to 
record the interview.
Aim 2: The study coordinator will approach potential participants either before or after 
their prenatal care visit and will invite them to a private clinic room for recruitment. For 
women in the intervention arm, postpartum planning visits will also take place in a 
private room before or after prenatal care. After women deliver, the coordinator will 
schedule a time to meet with participants in their private room and finalize their 
postpartum care plan. 
RCT Pilot: There will be no recruitment or participation during the pilot phase. 
20. Economic Burden to Participants
There are no costs to the study participants.
21. Consent Process
Aim 1: 
a) We are requesting a partial HIPPA waiver for the purpose of identifying and 
recruiting prospective research participants for enrollment. We will use the 
Grady Obstetric and Gynecologic Outcomes database (IRB00103211) to identify 
women meeting the study criteria who delivered at Grady during the past year. 

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Review of PHI is necessary to determine whether potential participants are 
eligible for this study, and it is impracticable to ask all women delivering at GMH 
to sign an authorization to access their PHI to determine eligibility. Only the PI 
and study coordinator will have access to PHI. No PHI will be retained for 
potential participants that do not qualify for the study. If the potential 
participant does qualify for the study, PHI will be retained for recruitment 
purposes.
b) We will obtain written consent prior to the start of the remote follow-up session 
using REDCap. This consent process will take approximately 5 minutes and will 
allow for the participants to ask questions about the consent process or study 
purpose.
Aim 2: 
a) We are requesting a partial HIPPA waiver for the purpose of identifying and 
recruiting prospective research participants for enrollment. We will use the daily 
appointment schedules and medical record data to identify women with 
prenatal care visits who meet the study criteria. Review of PHI is necessary to 
determine whether potential participants are eligible for this study, and it is 
impracticable to ask all women attending a prenatal care visit to sign an 
authorization to access their PHI to determine eligibility. Only the PI and study 
coordinator will have access to PHI. No PHI will be retained for potential 
participants that do not qualify for the study. If the potential participant does 
qualify for the study, PHI will be retained for recruitment purposes.
b) We will obtain informed consent from all women who agree to participate in the 
study. The consent process will take place in a private clinic room or office when 
conducting consent in-person, and in a private space when conducting and 
obtaining written, electronic consent via REDCap, during phone recruiting and 
will take approximately 15 minutes.  During the consent process, we will make it 
clear that participation is voluntary, and that there are no adverse consequences 
to choosing not to participate or to terminating participation at any time. The 
study coordinator will review the informed consent document with potential 
participants and explain in detail the purpose of the study, procedures, and risks. 
A copy of the signed consent form will be given to the participant and 
documented in the participant’s research record. No PHI will be retained for 
potential participants that do not qualify for the study or for those who elect not 
to participate in the study.

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c) For women who report receiving care outside of Grady in the year postpartum, 
we will ask women to sign an ‘Authorization of Release of Information’ allowing 
the study team to access their medical records at the other provider.
RCT Pilot: We are requesting a full HIPPA waiver for this pilot phase, for the purposes of 
review and abstraction only, of the EMR for patients that meet the criteria for 
enrollment. These patients will not actually be recruited or consented/enrolled; the 
purpose of review and abstraction is solely to design and test the REDCap instruments 
and EMR (Epic) care plan to prepare for implementation and start of the randomized 
trial (Aim 2). 
Non-English-Speaking Participants  
Approximately 23% of Grady obstetric patients are non-native English speakers. Spanish 
is the predominant language of non-English speaking women (76%), followed by 
Amharic (12%) and French (6%). 
Aim 1: Due to budget concerns associated with transcription and translation costs for 
interviews conducted in languages other than English, will only recruit English-speaking 
participants for the in-depth interviews. All consents and interviews will be in English. 
Aim 2: We will recruit English and Spanish speaking participants. It is not practicable to 
translate all study material and surveys into multiple languages, and English and Spanish 
are the most common languages among pregnant Grady patients. We will translate all 
consent forms, educational materials, and surveys into Spanish and will hire a bilingual 
study coordinator. 
Participants who are not yet adults (infants, children, teenagers)  
For Aim 2, we will use EMR data to determine the age of prospective participants. If 
patients are eligible (have a diagnosis of chronic hypertension or diabetes, gestational 
diabetes, and/or HDP), we will include pregnant women <18 years of age in Aim 2. As 
women ages 14-18 years of age are able to receive prenatal care without parental 
consent in Georgia, we will request a waiver of parental consent for enrolling pregnant 
minors into the study. For pregnant minors, a member of the study team with 
experience working with minors will conduct the informed consent process. Minors will 
receive the same information as women ≥ 18 years of age but will undergo a longer 
conversation to ensure comprehension. Minors will sign the informed consent form if 
they agree to participate, and the study team member determines they understand the 
information on the study. 
Cognitively Impaired Adults  

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We will not include cognitively impaired adults as they may require additional support 
for postpartum care planning and therefore would not be appropriate candidates for 
this intervention.
Adults Unable to Consent  
We will not include adults unable to consent.
22. Setting
Aim 1: Recruitment and in-depth interviews will take place over the phone or virtually. 
Aim 2: Recruitment will take place at the OB/GYN at Grady Memorial Hospital. For 
participants in the intervention arm, postpartum care planning visits will take place in 
the Grady clinic and in the postpartum ward (after delivery). All participants will fill out 
surveys remotely. The study coordinator will be assigned a dedicated space in the Emory 
Faculty Building, adjacent to Grady. 
RCT Pilot: This pilot phase will take place in the OB/GYN clinic at Grady Memorial 
Hospital. 
23. Resources Available
Describe the resources available to conduct the research: The PI for this study, Dr. 
Jamieson, is the Associate Chief of Service at Grady’s OB/GYN clinic, where about 200 
women receive prenatal care each month. The research team for this NIH-funded study 
includes 3 clinicians, Dr. Jamieson, Dr. Franklyn Geary (Morehouse OB/GYN), and Dr. 
Daniel Wu (Chief Medical Information Officer for the Grady Health System) an 
epidemiologist (Dr. Boulet), 1-2 post-docs, 2 study coordinators, and 2-4 master’s level 
students. The study takes place in Grady Memorial Hospital, which is a formal affiliate of 
the Emory Health Sciences Center. It is staffed by Emory School of Medicine (80%) and 
Morehouse School of Medicine (20%). Faculty, Residents, and Nurse Midwives staff the 
Women and Infants Center, a center for the provision of prenatal and obstetrical care. 
Grady Hospital has a bed capacity of 953 and is among the largest in the Southeast, 
serving a population that is more than 75% African American. The hospital has a 
regional perinatal center for high-risk mothers and babies, and a state-of-the-art 
neonatal intensive care unit. Grady has recently completed an approximate $30 million 
renovation of the Women’s and Infants Center, including the outpatient gynecology and 
obstetrics clinics, as well as the inpatient labor and delivery. These state-of-the-art 
facilities to support patient-centered reproductive health and obstetrical care for the 
women and families who access their health services through this system. 

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A mental health practitioner will be on the hospital premises. In any event that study 
personnel are concerned about the immediate safety or well-being of the participant 
(e.g., as a result of psychological stress or injury), a PI will be notified, and emergency 
care will be arranged.
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