Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk: a Pilot Randomized Control Trial
Phase: NA
Conditions: Maternal Behavior, Postpartum Depression
Sponsor: University of Pennsylvania

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IMPROVING HEALTH OUTCOMES AND EQUITY BY TARGETING 
POSTPARTUM MOTHERS AT RISK: A PILOT RANDOMIZED CONTROL 
TRIAL 
 
 
 
 
 
Principal Investigator  
 
Elizabeth Howell, MD, MPP 
Department of OB/GYN 
University of Pennsylvania 
 
Funding Sponsor 
 
 
NIMHD/NIH 
 
IRB Number 
850584 
NIH Grant Number 
 
 
R01MD016029 
 
 
Initial version 
v1.0 07JAN2022 
Amended 
v2.0 19OCT2023 
Amended 
v 3.0 28NOV2023 
Amended  
v 4.0 02FEB2024 

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Table of Contents 
BACKGROUND AND STUDY RATIONALE ................................................................................................ 5 
1.1 
BACKGROUND AND RELEVANT LITERATURE ...................................................................................... 5 
2 
STUDY OBJECTIVES .......................................................................................................................... 6 
2.1 
PRIMARY OBJECTIVE ....................................................................................................................... 6 
2.2 
SECONDARY OBJECTIVES (IF APPLICABLE) ....................................................................................... 6 
3 
INVESTIGATIONAL PLAN ................................................................................................................... 6 
3.1 
GENERAL DESIGN ........................................................................................................................... 6 
3.2 
ALLOCATION TO INTERVENTIONAL GROUP ........................................................................................ 6 
3.3 
STUDY MEASURES .......................................................................................................................... 6 
3.4 
STUDY ARMS .................................................................................................................................. 7 
3.5 
STUDY ENDPOINTS ......................................................................................................................... 7 
3.5.1 
Primary Study Endpoint ........................................................................................................... 7 
3.5.2 
Secondary Study Endpoints ..................................................................................................... 7 
4 
STUDY POPULATION AND DURATION OF PARTICIPATION ......................................................... 7 
4.1 
DURATION OF STUDY PARTICIPATION ............................................................................................... 7 
4.2 
TOTAL NUMBER OF SUBJECTS AND SITES ........................................................................................ 7 
4.3 
INCLUSION CRITERIA ....................................................................................................................... 8 
4.4 
EXCLUSION CRITERIA ...................................................................................................................... 8 
4.5 
SUBJECT RECRUITMENT .................................................................................................................. 8 
4.6 
VULNERABLE POPULATIONS: ........................................................................................................... 8 
5 
STUDY PROCEDURES ........................................................................................................................ 8 
5.1 
SCREENING .................................................................................................................................... 8 
5.2 
STUDY INTERVENTION PHASE .......................................................................................................... 9 
5.2.1 
Baseline Visit ............................................................................................................................ 9 
5.2.2 
Visit 2 ........................................................................................................................................ 9 
5.2.3 
Visit 3 ........................................................................................................................................ 9 
5.3 
SUBJECT WITHDRAWAL ................................................................................................................... 9 
6 
STATISTICAL PLAN ............................................................................................................................ 9 
6.1 
SAMPLE SIZE AND POWER DETERMINATION ..................................................................................... 9 
6.2 
STATISTICAL METHODS ................................................................................................................. 10 
6.2.1 
Baseline Data ......................................................................................................................... 10 
6.2.2 
Analysis of Primary Outcome of Interest ............................................................................... 10 
7 
SAFETY AND ADVERSE EVENTS ................................................................................................... 11 
7.1.1 
Data and Safety Monitoring Plan ........................................................................................... 11 
8 
STUDY ADMINISTRATION, DATA HANDLING AND RECORD KEEPING .................................... 11 
8.1 
CONFIDENTIALITY.......................................................................................................................... 11 
8.2 
DATA COLLECTION AND MANAGEMENT .......................................................................................... 12 
8.3 
RECORDS RETENTION ................................................................................................................... 12 
9 
STUDY MONITORING, AUDITING, AND INSPECTING ................................................................... 12 
9.1 
STUDY MONITORING PLAN ............................................................................................................ 12 
10 
ETHICAL CONSIDERATIONS ........................................................................................................... 12 
10.1 
RISKS ........................................................................................................................................... 12 

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10.2 
BENEFITS ..................................................................................................................................... 13 
10.3 
RISK BENEFIT ASSESSMENT .......................................................................................................... 14 
10.4 
INFORMED CONSENT PROCESS / HIPAA AUTHORIZATION............................................................... 14 
11 
STUDY FINANCES ............................................................................................................................. 14 
11.1 
FUNDING SOURCE ........................................................................................................................ 14 
11.2 
CONFLICT OF INTEREST ................................................................................................................. 14 
11.3 
SUBJECT STIPENDS OR PAYMENTS ................................................................................................ 14 
 

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Study Summary 
 
Title 
Improving Health OutcoMes and Equity by targeting postpartum mothers 
at risk: a pilot randomized control trial 
Short Title 
HOME RCT 
IRB Number 
850584 
Methodology 
Randomized controlled trial  
Study Duration 
18 months  
Study Center(s) 
Single-center 
Objectives 
To assess feasibility, acceptability, and target effect size and potential efficacy 
of the intervention to reduce ED visits and postpartum readmissions at 30-days 
postpartum. 
Number of Subjects 
214 subjects  
Main Inclusion and 
Exclusion Criteria 
Black women planning on delivering a baby at the Hospital of University of 
Pennsylvania and are 18 or above years old. 
Intervention  
Education Intervention  
Statistical 
Methodology 
Our primary analysis will focus on a categorical outcome: postpartum ED visit 
or readmission within 30 days after discharge. A chi square test will be used to 
determine the difference in the proportion of patients who experience ED visits 
or readmissions between the two study groups. Poisson regression will be 
used to estimate and compare the ED and readmission rates between the two 
groups. 
 
 

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Background and Study Rationale 
This study will be conducted in full accordance with all applicable University of Pennsylvania Research 
Policies and Procedures and all applicable Federal and state laws and regulations. 
 
This study is the third phase/aim of a four-phase mixed method study to better identify Black and Latina 
women most at risk for poor outcomes following delivery, the problems they experience, and to adapt an 
evidence-based intervention that aims to improve quality of postpartum care for high-risk women. The 
aims of our research study, “Improving Health Outcomes and Equity by Targeting Postpartum Mothers at 
Highest Risk” are to: 1) Develop a risk prediction model using sociodemographic, clinical, behavioral, and 
neighborhood factors to identify high-risk mothers using ED visits and postpartum readmissions as a 
marker of severe maternal morbidity. 2) Use qualitative methods to adapt and intensify an evidence-
based behavioral educational intervention aimed at improving quality of care to reduce severe maternal 
morbidity as measured by postpartum ED use and hospital readmission, 3) Conduct a pilot RCT utilizing 
the cohort identified by the risk prediction model in Aim 1 to assess feasibility, acceptability, and target 
effect size and potential efficacy of the refined intervention to reduce ED visits and postpartum 
readmissions, and 4) Evaluate the pilot study results and procedures to inform the refinement of the 
intervention and to prepare for a larger implementation trial of this intervention. This study is the third 
phase, a pilot randomized controlled trial to assess the postpartum intervention. 
 
1.1 
Background and Relevant Literature  
Significant racial and ethnic disparities in maternal mortality persist in the US. Black women and birthing 
people are three to four times more likely to die a pregnancy-related death as compared with white 
women, and in some regions Latinas are also at increased risk.1,2 This disparity is rooted in the fact that 
Black and Latina women experience elevated maternal health risks throughout the pregnancy-postpartum 
continuum. Women of color are more likely to begin pregnancy with a chronic health condition such as 
hypertension or diabetes, experience a complication while pregnant, and to suffer a life-threatening 
morbidity during delivery.3-5 Less recognized is that heightened maternal health risks extend into the 
postpartum period. Black women are more likely to have an emergency department (ED) visit after 
delivery,6 and Black and Latina women have a two-fold increased risk of postpartum hospital readmission 
relative to white women.7,8 Black women are also more likely to experience severe morbidity and suffer 
life-threatening complications such as pulmonary edema and heart failure during the readmission.9 The 
majority of pregnancy-related deaths across the pregnancy-postpartum continuum and a significant 
proportion of severe maternal complications are preventable, suggesting that evidence-based 
interventions addressing maternal health disparities have great potential to be impactful.10 
Many Black and Latina women with chronic illness such as hypertension and diabetes fail to get 
appropriate medical follow-up postpartum, putting their short and long-term health at risk. These chronic 
health conditions not only contribute to the significant excess maternal morbidity and mortality burden 
among women of color in the short term but lead to elevated risk of cardiometabolic disease in later 
life.11 In prior research, we implemented an evidence-based postpartum intervention to improve receipt 
of postpartum care for high risk women (e.g., women with hypertension, gestational diabetes, positive 
depression screens).12 Our primary outcome was to increase the timely postpartum visit rate. The 
behavioral educational intervention successfully increased postpartum visit rates.12 However, high rates 
of ED use and readmissions for mothers within the first month postpartum occurred even among this 
cohort with supplemental care. Our results suggest a dire need to look beyond individual clinical risk 
factors to incorporate social context to identify high-risk mothers, and to develop a more comprehensive 
intervention to improve the postpartum health of Black and Latina women.  
Our mixed methods study aims to do exactly that - design and test an effective postpartum intervention 
to improve postpartum health. In Phases 1 and 2 we are developing a risk-prediction model to identify 
women at high risk for postpartum ED visits or readmission and we are conducting qualitative interviews 
to inform the adaptation of the behavioral educational intervention discussed above. The goal of the 

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current phase, Phase 3, is to conduct a pilot RCT in 214 postpartum women to test whether the adapted 
behavioral educational intervention reduces postpartum ED visits or readmissions within 30 days from 
discharge.   
2 
Study Objectives 
2.1 
Primary Objective 
• 
To obtain data on feasibility, acceptability, and target effect size and potential efficacy of the 
intervention for the primary outcome of postpartum morbidity and mortality as measured by 
Emergency Department (ED) visits and hospital readmissions in the 30-day post discharge 
period. 
2.2 
Secondary Objectives (if applicable) 
• 
To detect the intermediate outcome: ability of participants to “obtain needed services” and ability 
for patients to see their provider when they need to, in the 30-day post discharge period as one of 
the main pathways of unnecessary ED visits. 
• 
Depressive symptoms 
3 
Investigational Plan  
3.1 
General Design 
This will be a pilot randomized control trial with an intervention arm consisting of a 1. patient-navigator 
postpartum education and resources component and 2. a control arm which consists of usual postpartum 
care. 
3.2 
Allocation to Interventional Group  
After successful screening, each participant will be assigned a screening number and a randomization 
number that determines the treatment group according to a predetermined randomization scheme. The 
randomization scheme will be a blocked scheme (e.g., random block 
 of size 4 and 6). The treatment assignment will be obtained electronically through a web-based interface, 
REDCap.  
3.3 
Study Measures 
Participants in both arms of this RCT will be surveyed at three time points by a research staff member 
Visit 1 or baseline will occur during the delivery hospitalization, after consent but prior to randomization. 
Visit 2 will occur 3-6 weeks postpartum, and Visit 3 will occur approximately six-months postpartum The 
surveys will assess symptoms of depression and anxiety, experiences of discrimination, social support, 
emotional/physical symptoms, and self-efficacy (see survey). The baseline survey conducted in-person at 
discharge will last 10 minutes, and surveys for visits 2 and 3 will last 25 minutes and will be conducted by 
telephone or other electronic modality. Computerized survey instruments will be administered by trained 
staff. 
 
We will utilize the surveys we developed, piloted, and used for the RWJF (a previous) intervention, with 
minor revisions. The surveys include validated scales where possible. Maternal depressive symptoms are 
assessed using the Edinburgh Postnatal Depression Scale (EPDS).13,14 Social support domains important 
during the postpartum period (e.g., help with infant, household, emotional support) will be assessed.15,16-18 
Questions also assess physical symptoms, emotional symptoms (depression and anxiety)19, 146 infant- 
related role function,16 and self-efficacy,22.  
 
 
We will utilize the EMR and phone review with patient during surveys to ascertain whether patients have 
an ED visit or are readmitted within 30 days post discharge.   

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3.4 
Study Arms 
Study Intervention Arm 
The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually 
accessible) that will educate and prepare post-partum participants about health conditions (hypertension, 
diabetes, and depression), important health behaviors, physical and emotional postpartum symptoms, 
teach self-management skills, enhance social support, and connect post-partum participants with 
community resources. The education materials will provide simple actions that participants can utilize to 
address symptoms, realistic time frames for healing, danger signs to look out for and contact their 
physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 
minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will 
contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address 
questions and link participants to medical and community resources (see patient navigator 
communication schedule).  
 
To assess understanding, participants will also be asked a short set of true-false questions about the 
session material and to summarize its objectives after the in-hospital education session (see assessment 
of understanding document). Participants will receive a text and email reminding them to review the 
booklet. Participants who have misplaced their booklets will be encouraged to email or call research staff 
and new booklets will be sent to them or shared electronically through text or MyPennMedicine. At the 
one-month survey, participants will be asked a set of questions about their use of the booklet, how helpful 
it was, review specific content areas and ask whether certain sections were more helpful than others, and 
how many times they reviewed the booklet.  
 
For the purposes of training the patient navigator, and to ensure the consistency of the intervention over 
time for each patient randomized to the intervention, we will use detailed scripts and training sessions 
(including face-to-face didactics by the PI, interactive role-play, and supervised patient contact). These 
will be led mainly by the project manager and will continue for the first full month of recruitment. 
 
Control Arm 
The control arm will consist of usual postpartum care. Usual care participants will receive the hospital’s 
standard postpartum education and discharge materials that include nurse discussions and written 
materials on breastfeeding, infant care, wound care, and other routine peripartum care issues.  
 
Patients in both arms of the study will complete the surveys as described above in section 3.3. 
3.5 
Study Endpoints  
3.5.1 Primary Study Endpoint 
The primary endpoint will be number of ED visits and re-hospitalizations in the 30-day post discharge 
period. 
3.5.2 Secondary Study Endpoints 
• Assessment of ability to obtain needed services at 30-days post discharge, including patient 
access to providers when they needed them. 
• Depressive Symptoms 
4 
Study Population and Duration of Participation  
4.1 
Duration of Study Participation  
Each subject’s participation in the study will be for approximately 6 months.   
4.2 
Total Number of Subjects and Sites  
214 subjects will be enrolled in the study. 

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4.3 
Inclusion Criteria 
• 
Postpartum patients who have delivered a baby at the Hospital of University of 
Pennsylvania  
• 
Ages 18 or older 
• 
Self-identify as Black (listed on chart) 
• 
Speak English  
• 
Able to read 
• 
Other characteristics defined by our risk prediction model (algorithm) 
• 
PI discretion for enrollment safety 
4.4 
Exclusion Criteria 
• 
Unable to provide informed consent 
• 
Speaks a language other than English 
4.5 
Subject Recruitment  
For the pilot RCT, patients will be approached during their postpartum hospital stay. Potential patients will 
be identified using the Hospital of the University of Pennsylvania EPIC system. . Research staff will have 
access to the schedules of all patients who become pregnant. The data analytic centers as well as 
electronic medical records (EMR) recruitment tools such as SlicerDicer, patient reports, and best practice 
announcements (BPA), may be utilized to provide a list of potential subjects based on clinical practice 
information. Patients will be approached for recruitment (either in-person, via direct messaging through 
the electronic medical record platform (MPM), phone, text, or email). The subset of covariates identified 
by predictive modeling as the most predictive of ED visit/readmission will be used to create a screening 
checklist to enroll patients into the study. We will use coefficients from the logistic model equation for the 
predictors determined to be the best fit across models. We programmed coefficients into a free online 
custom calculator (https://app.calconic.com/public/calculator/6591cebbe36573001e25f34f?layouts=true) 
which is fast and convenient for the research coordinator. Patient responses to the checklist will be input 
into the equation to determine a risk score and categorized as eligible based on previously determined 
risk threshold. We will take the subset of neighborhood attributes which were in the final predictive model 
and calculate average values for each census tract. Census tracts in the riskiest quartile of each 
predictive attribute will be flagged as “high risk”, and living in one of those census tracts will be an 
eligibility item on the checklist.  
 
Once identified as eligible, the patient navigator/coordinator will introduce the study to the patient and 
assess interest in participating and will give out IRB-approved information postcards. If the patient meets 
all initial criteria for inclusion and is willing to participate in the study, a more detailed discussion will 
occur. All questions will be answered, and appropriate informed consent will be obtained from the patient. 
Patients interested in the study and who meet eligibility criteria will be given consent forms for them to 
read. Information provided at the time of informed consent will clearly state that participation is voluntary, 
the person can withdraw from the study at any time, the fact that the project will protect the confidentiality 
of patient information, and who to contact for questions regarding the research. The study team member 
will obtain consent electronically and will co-sign the consent form on REDCap using a study specific 
iPad., and a copy of the consent form will be emailed to the subject. IRB approval for the informed 
consent and waiver of authorization will be obtained before recruitment. 
4.6 
Vulnerable Populations:  
Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study. 
5 
Study Procedures  
5.1 
Screening  
Informed consent will be obtained from subjects as noted in section 4.5. The Baseline Visit will be 
conducted after the participant is consented and has delivered. 

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5.2 
Study Intervention Phase  
5.2.1 Baseline Visit   
After informed consent is obtained, the 10 minute survey will be administered via REDCap to participants 
using computerized survey instruments on an iPad in the hospital during the postpartum visit, which ask 
about social support domains, experiences of racism, health factors such as sleep and physical well-
being as well as the  PHQ-9. If needed the surveys can be completed with hardcopies or via entry by a 
study team member. 
 
Once the surveys are completed participants will be randomized to the intervention or control arm of the 
trial. For subjects randomized to the control arm, the visit will then end.  
 
For subjects randomized to the intervention, the patient navigator will introduce the intervention, and 
review the patient education pamphlet and partner sheet with the participant and her partner. The patient 
navigator will spend approximately 20 minutes with the participants. The patient will then be given the 
assessment of understanding the materials (True/False questions). 
 
Following this introductory meeting, the patient navigator will be in contact with the subject for the 
remainder of the study. This contact will last up until the 3rd study visit (as described below). The subject 
may be contacted anywhere from about 4 to 20 times, depending on the patient’s needs during the 
postpartum time (see attached patient navigator message schedule). 
 
5.2.2 Visit 2 
Visit 2 occurs around the one-month postpartum mark, and patients will be contacted over the phone, 
text, patient portal, or by email. The visit window for Visit 2 is 3 to 6 weeks post discharge. This window 
allows our team to capture as many patients as possible. The patients will be asked to complete a survey 
like the one administered at the Baseline Visit (with the addition of some postpartum-specific related 
questions). All surveys will be sent via REDCap as an email, patient portal message, or text, whichever 
the patient prefers. These surveys can be completed over the phone with a study team member, if 
needed. 
 
Data from the EMR will be collected from this time period between the Baseline Visit and Visit 2 to 
ascertain whether participants have an ED visit or are readmitted within 30 days post discharge.  We will 
also abstract from the EMR data on past medical illness, comorbidities, medications, complications during 
pregnancy, delivery, and the postpartum hospital stay.  
5.2.3 Visit 3 
Visit 3 occurs around the six-month postpartum mark. The visit window for this visit is 5 to 8 months post 
discharge to maximize participation. Patients will be sent the Visit 3 surveys via email, patient portal, or 
text, whichever the patient prefers. If a patient does not complete the surveys electronically, study team 
members may reach out to the participant over the phone to complete the survey. The same survey 
instruments will be administered as in the previous two time points via REDCap. 
5.3 
Subject Withdrawal  
Subjects may withdraw from the study at any time without impact to their care. It will be documented 
whether each subject completes the study.  
6 
Statistical Plan 
6.1 
Sample Size and Power Determination 
We base the sample size of our pilot RCT by first calculating the needed sample size for a definitive RCT 
with the primary outcome of ED Visit/Readmission, then following Cocks et al calculate our pilot sample 
size as 9% of the sample size needed for the main trial.149 To detect a decrease in ED 

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Visits/Readmissions from 12% to 7% at 90% power, we will need a sample size of n=721 per arm. We 
therefore calculated the sample sized needed for the pilot RCT as n=65 per arm. However, we sought to 
additionally power the study to detect the intermediate outcome “able to obtain needed services”, as one 
of the main pathways to ED visits. We estimate that 82% in the treatment group and 65% in the control 
group will be able to obtain services, indicating a sample size of 90 per arm is needed. We assume an 
attrition rate of 16% (based on our previous intervention), increasing the needed recruitment sample size 
to 107 participants per arm. Based on our prior research,96 our limited sample size will allow us to the 
precision as detailed in this table for feasibility, acceptability, and intermediate outcomes. 
 
Sample Size Calculations 
Primary & Intermediate Outcomes 
Control 
% 
Treatment 
% 
Power 
(alpha=0.05) 
n=90 
n=90 
 
30-day Readmission/ED Visit 
21% 
6% 
81% 
Felt unprepared for postpartum experience 
26% 
10% 
80% 
Able to obtain needed services 
65% 
82% 
80% 
 
 
6.2 
Statistical Methods 
 
The aim of this phase of the study is to conduct a pilot randomized controlled trial and evaluate those 
results to inform a definitive RCT. The primary outcome will be the prevention of postpartum ED visits and 
readmissions within 30 days following discharge for delivery. Our primary analysis will focus on a 
categorical outcome: postpartum ED visit or readmission within 30 days after discharge. A chi square test 
will be used to determine the difference in the proportion of patients who experience ED visits or 
readmissions between the two study groups. Poisson regression will be used to estimate and compare 
the ED and readmission rates between the two groups. We will conduct exploratory analyses to 
determine if the intervention was successful for patients with the most common conditions predicting 
readmission, e.g. hypertension. We will also conduct exploratory analyses to assess the impact of the 
intervention at six-months. Since the intent of this analysis is to obtain estimates of the effect sizes, we 
will not use a correction to account for the multiplicity of the tests. All analyses will be conducted 
according to an intention-to-treat principle. All statistical tests will be two-sided at of 0.05 significance 
level.  
6.2.1 Baseline Data 
 
 
Baseline and demographic characteristics will be summarized by standard descriptive statistics (including 
mean and standard deviation for continuous variables such as age and standard percentages for 
categorical variables such as gender). To determine comparability of the two groups at randomization, we 
will compare baseline characteristics between the two trial arms, using the t test for continuous variables 
and the chi square or Fisher’s exact test as appropriate for dichotomous/categorical variables. We will 
also examine differences in dropout rates between the two arms.  
 
6.2.2 Analysis of Primary Outcome of Interest 
.   
Our primary analysis will focus on a categorical outcome: postpartum ED visit or readmission within 30 
days after discharge. A chi square test will be used to determine the difference in the proportion of 
patients who experience ED visits or readmissions between the two study groups. Poisson regression will 
be used to estimate and compare the ED and readmission rates between the two groups. 

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7 
Safety and Adverse Events 
 
We have developed a referral plan for all women (in both trial arms) with severe depressive symptoms as 
defined by an EPDS score >13 or a PHQ-9 score >20. For all patients who meet these criteria, we will 
follow the safety protocol that was used for our previous intervention studies. All patients at HUP receive 
an EPDS prior to discharge so this safety pathway and assurance of evaluation is already set up and in 
place for postpartum patients, even outside of this study. All patients will be given the phone numbers, for 
the psychiatric clinic, and community sites that provide mental health services. The patient navigator 
conducting the intervention will be trained by Drs. Howell and Levine on the safety protocol and will be 
monitored by the program manager. Staff will automatically get notified by email if a participant score is 
>11 or the patient endorses suicidal ideation on the EPDS. Within 24 hours of the research team 
receiving the alert, at least 2 initial contacts will be attempted (by phone and email). The research staff 
will provide the patient with any resources they have not yet received/they request and staff will offer to 
facilitate a conversation with their provider. Concurrently, study staff will send a message through 
PennChart (electronic medical record) to the patients’ provider or social work team documenting the steps 
taken thus far. Staff will ask the clinician to follow up with the patient as necessary. The PI and all study 
team members will be cc’ed on every message to the clinical team. This is a survey based minimal risk 
study, so not all events that would traditionally be defined as AEs will be collected for this trial.  
 
7.1.1 Data and Safety Monitoring Plan 
Our proposed pilot RCT poses minimal risk to enrollees. The project leader, Co-investigator, and program 
manager will monitor the scientific integrity and patient safety for the full duration of this study. The project 
leader (Dr. Howell), the study program manager, patient navigator, coordinator, and Co-Investigator (Dr. 
Levine (Maternal-Fetal Medicine Specialist) will meet bi-weekly to discuss trial accrual, intervention 
progress, study patient safety, and adverse events. The referral to appropriate care for subjects who have 
severe depressive symptoms will be monitored at this meeting. In addition, we will systematically collect, 
evaluate, and report all adverse events (including suicidal ideation and or suicidal intent) to the University 
of Pennsylvania Institutional Review Board via HRP-224 form, Reportable New Information. This form 
reports the description of the incident, the description of action steps the investigator has put in place to 
handle this incident and to prevent such occurrence in the future and if there is no action steps were 
required, we will explain the reasons (i.e. no action steps required, safety protocol followed). We will 
check “written reports of study monitors, internal audit reports, data safety monitoring reports, etc.” and 
submit the form in real time as the University of Pennsylvania IRB currently requires the reporting of this 
information within five business days. A PICA form will be submitted annually at the time of Continuing 
Review to ensure quality assurance. 
.  
8 
Study Administration, Data Handling and Record Keeping 
8.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
• 
What protected health information (PHI) will be collected from subjects in this study 
• 
Who will have access to that information and why 
• 
Who will use or disclose that information 
• 
The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study 
period. 

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8.2 
Data Collection and Management  
Data will be collected prospectively by designated research personnel. Original source documents will be 
kept in the study subject folder. Well-designed data collection forms will be developed to minimize data 
collection and recording errors. Administrative forms, such as visit procedure checklists, will be designed 
to assist the research staff in complying with protocol procedures. Data will be collected solely for the 
purpose of research, and these will not become part of the participant’s medical record.   
 
Study data will be managed using REDCap (Research Electronic Data Capture), a secure web 
application designed to support data capture for research studies, providing user-friendly web-based case 
report forms, real-time data entry validation, audit trails, and a de-identified data export mechanism to 
common statistical packages (SPSS, SAS, Stata, R/S-Plus). Database access for REDCap is granted on 
a study-by-study basis. At the start of the trial when the database is created, all research personnel will 
be given defined user roles and assigned a unique username and password. There is a 90-day password 
update policy for all REDCap users.  The REDCap database sits behind an application firewall and the 
data are stored on a virtual machine at the University of Pennsylvania that is backed up daily.  
 
Subjects will be assigned a study ID number. Any PHI data will be collected and recorded into password-
protected files. Furthermore, a separate spreadsheet containing the link that identifies the patient by their 
study ID number will be kept securely in a password-protected computer file. Only study personnel who 
will need access to the identifying data - either to schedule the follow-up research visits or to collect 
pregnancy outcomes from the medical record, will have access to the link. Identifiable data will not be 
shared with any other study personnel or included on any data shared with other investigators or future 
collaborators.  
 
8.3 
Records Retention 
Research data will be collected by research staff and stored in study-specific files kept in a locked area in 
one of the research locations during the active phase of the study.  Any electronic data will be kept in a 
secured database on REDCap. Only the PI and study staff listed will have access to these data.  There 
should not be a need to transmit data files containing personal health information for this study.  At the 
conclusion of the study, data will be retained on site in the same secured manner for a minimum of two 
years and may be transferred to a long-term storage facility (Iron Mountain) thereafter.  
 
To comply with Good Clinical Practice (GCP) requirements, investigators must maintain the master log 
that identifies all patients entered into the study for a period of two years after the study ends so that the 
subjects can be identified by audit.  The PI must maintain adequate records pertaining to subjects’ files 
and other source data for a minimum of 5 years after completion of the study. 
9 
Study Monitoring, Auditing, and Inspecting 
9.1 
Study Monitoring Plan 
The study PI will be responsible for ensuring the ongoing quality and integrity of the research study.  
10 Ethical Considerations 
No study procedures will take place until the protocol and consent form have been approved by the Penn 
IRB.  
10.1 
Risks 
Participation in this study should not subject patient to any new risks beyond those inherent in having a 
baby including pregnancy complications, or chronic illnesses (i.e. hypertension and diabetes). The 
intervention elements are educational, and we do not anticipate any significant physical, psychological, or 

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social risk to the patients in the intervention arm. Patients could face risks from breach of confidentiality in 
data collection and analyses procedures. We are instituting rigorous data confidentiality and privacy 
protections to minimize the chance that this will occur. Please see Procedures to minimize RCT risk 
below, #1-6. 
 
Procedures to Minimize Risk 
We will be conducting the pilot RCT among Black patients. We plan to enroll 214 Black patients. All 
patients will be consented for medical chart review. All data at the Hospital of the University of 
Pennsylvania (HUP) are stored on secure password protected HIPAA compliant server systems. 
 
To protect patients’ confidentiality, we will observe the standard institutional and departmental operating 
procedures to secure PHI, including the following: 
1) 
All staff with access to project data must obtain HIPAA training certification and completion of all 
University of Pennsylvania IRB (Program for the Protection of Human Subjects (PPHS)) CITI Research 
Education Requirements. 
2) 
Study data will be entered and stored in REDCap database. REDCap is a secure web platform 
for building and managing online databases and surveys. The REDCap server to be used to capture 
survey data for this project resides on a separate DMZ network in the hospital data center. Data at rest is 
stored on fully AEA-encrypted disks and all network interactions are over TLS-encryption sessions that 
require logins. 
3) 
Sensitive hardcopies of consents will be processed in a centralized location with controlled 
physical access, and it will be secured in locked file cabinets when not in use. All research information 
containing patient identifiers will be kept in locked files in research offices. 
4) 
Patients will be assigned a unique, numeric identifier and the link for this identifier will be stored 
on a password protected encrypted computer drive. Patients will be identified by a study ID in REDCap. 
During a trial the site study coordinator will maintain a separate list of participating patients, their contact 
information, and their study identifiers in a secure location. This list will be used by study coordinators to 
maintain patient contact for follow-up This separate list containing patient contact information will be 
destroyed at the end of the trial as part of the closeout procedure.  
5) 
The research team will remove names, addresses and other direct identifiers from hardcopy and 
computer readable data after they are no longer necessary for patient tracking and then using encrypted 
notes for subsequent identification of patients. 
6) 
Destroy all identifiable linkages to data after data accuracy has been verified and final analyses 
have been completed. 
Questionnaires 
Some questions may make a subject feel embarrassed or uncomfortable while answering. They do not 
have to answer any questions which make them uneasy (missed answers or surveys will not be 
considered protocol deviations). 
 
Safety standard of procedures for EPDS The clinical team will handle any concerns with EPDS results 
at the first visit (postpartum stay) due to the survey being routinely collected as part of standard of care. 
The study team will implement a specific safety protocol for Visit 2 and 3 EPDS results. Staff will 
automatically get notified by email if a participant score is >11 or the patient endorses suicidal ideation on 
the EPDS. Within 24 hours of the research team receiving the alert, at least 2 initial contacts will be 
attempted (by phone and email). The research staff will provide the patient with any resources they have 
not yet received/they request, and staff will offer to facilitate a conversation with their provider. 
Concurrently, study staff will send a message through PennChart (electronic medical record) to the 
patients’ provider or social work team documenting the steps taken thus far. Staff will ask the clinician to 
follow up with the patient as necessary. The PI and all study team members will be cc’ed on every 
message to the clinical team.   
10.2 
Benefits 
Potential Benefits of the Proposed Research to Research Participants and Others: Our survey tools will 
be equipped to monitor certain behaviors or combinations of behaviors that will identify women with 

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postpartum depressive symptoms, specifically patients with severe depressive symptoms and chronic 
illnesses (i.e. hypertension and diabetes). Patients may benefit by receiving additional follow up from the 
research team and in addition, opportunities to receive the intervention may translate into improved 
quality of postpartum care, management of chronic conditions and or other relevant clinical outcomes 
(reduce ED/readmission utilization rates and increase in continuity of care) Without this trial, those needs 
may have gone untreated or untreated longer than necessary. 
 
Importance of the Knowledge to be Gained: The knowledge acquired from this project may offer guidance 
on how to improve care for postpartum women, reduce ED utilization, and reduce postpartum hospital 
readmissions that can be sustained beyond the grant-funded cycle. These potential benefits far outweigh 
the minimal risks of the study. 
10.3 
Risk Benefit Assessment 
This study confers no more than minimal risk to the study subjects. While the subjects themselves have 
no real potential for direct benefit from participating in the study, there is a possibility that this research 
will be useful in advancing pregnancy and postpartum care which would be beneficial to society. 
Identifying the information obtained from this study is critical for the overall health of this study population. 
Therefore, the potential benefits for this study outweigh any of the risks stated above. 
.  
10.4 
Informed Consent Process / HIPAA Authorization  
Potential participants will be approached to participate by the research coordinator or non-care providing 
physician through the EMR patient portal, email, telephone, or in person. Informed consent may be 
completed in person, by telephone call or via telehealth. At this time, study details will be explained.  
Risks and benefits will be thoroughly discussed, and the IRB-approved consent given to the patient to 
review. The study team will obtain the participant’s consent prior to any study procedures being 
performed.  During the consenting process, study staff will discuss alternatives to participation, and 
privacy and confidentiality. Participants will be informed that their participation in the study is voluntary, 
and that they may change their mind at any time if they wish to discontinue. In addition, the consent form 
will be written in simple English that will ensure adequate understanding by the subject. Subjects will be 
provided ample time to review the consent form and ask questions. The participant should have the 
opportunity to discuss the study with their family or surrogates or think about it prior to agreeing to 
participate. We have included the elements of HIPAA authorization within the consent form and will be 
using a combined informed consent and HIPAA authorization form.  Both the subject and the study 
personnel who is obtaining the consent will sign the consent form and the subject will be provided with a 
copy. 
  
11 Study Finances 
11.1 
Funding Source 
This study is supported by an R01 grant from the NIMHD/NIH 
11.2 
Conflict of Interest 
All University of Pennsylvania Investigators will follow the University of Pennsylvania Policy on Conflicts of 
Interest Related to Research.  
11.3 
Subject Stipends or Payments 
Subjects will be given up to $125 
• 
$40 to compensate for patient time and effort for initial participation and completion of baseline 
surveys.  
• 
$45 compensation will be given after completing the second visit.   
• 
$40 will be given after completing the final visit.  
Subject compensation will be distributed via Greenphire ClinCard at University of Pennsylvania.   

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