Feasibility Testing of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
Phase: NA
Conditions: Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage, Depression, Weight, Birth
Sponsor: Children's Hospital of Philadelphia

 
Template version: May 28, 2014 
  
Title: 
A protocol for care coordination and motivational interviewing for 
women with a recent preterm birth 
Short Title 
Iteratively test care coordination protocol 
Regulatory Sponsor: 
 
eIRB Number 
IRB 20-017871 
Protocol Date: 
August 5, 2020 
Amendment 1 Date: August 7, 2020 
Amendment 3 Date: July 28th 2022 
Amendment 2 Date: December 21, 2021 
Amendment 4 Date: March 16th 2023 
 
Sponsor 
Eunice Kennedy Shriver National Institute of Child Health and Development  
1 Center Drive, Bethesda, MD, 20892 
USA 
 
Study Principal Investigator  
Emily Gregory 
Roberts Center for Pediatric Research 
Philadelphia, PA 
Cell Phone: 617-335-7337 
Email: gregorye@email.chop.edu 
 
 

  
 
 
 
 
 
 
 
ii 
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms ............................................................................. iv 
Abstract .................................................................................................................................. v 
Figure 1: Study Diagram ..................................................................................................... vii 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION .................................... 1 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 1 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 2 
2 
STUDY OBJECTIVES .............................................................................................................................. 3 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 3 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 3 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 3 
3.1.1 
Screening Phase .............................................................................................................................. 3 
3.1.2 
Study Intervention Phase ................................................................................................................. 3 
3.1.3 
Follow-up Phase .............................................................................................................................. 4 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ........................................................................ 4 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 4 
3.3.1 
Duration of Study Participation ...................................................................................................... 4 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................. 5 
3.4 
STUDY POPULATION ............................................................................................................................. 5 
3.4.1 
Inclusion Criteria ............................................................................................................................ 5 
3.4.2 
Exclusion Criteria ........................................................................................................................... 5 
4 
STUDY PROCEDURES ............................................................................................................................ 5 
4.1 
SCREENING PHASE ................................................................................................................................ 5 
4.2 
BASELINE ASSESSMENT ........................................................................................................................ 6 
4.3 
INTERVENTION PHASE ........................................................................................................................... 6 
4.3.1 
3-month assessment ......................................................................................................................... 7 
4.3.2 
6-month assessment (end of study) .................................................................................................. 8 
4.4 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................. 8 
4.4.1 
Early Termination Study Visit ......................................................................................................... 8 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................. 9 
5.1 
SCREENING MEASURES ........................................................................................................................ 9 
5.1.1 
Medical Record Review ................................................................................................................... 9 
5.2 
MEASURES OF TREATMENT FEASIBILITY AND ACCEPTABILITY (PRIMARY OUTCOME) ........................ 9 
5.3 
MEASURES OF MODIFIABLE HEALTH BEHAVIORS AND SOCIODEMOGRAPHIC CHARACTERISTICS ...... 10 
5.3.1 
Modifiable health behaviors .......................................................................................................... 10 
5.3.2 
Sociodemographic factors ............................................................................................................. 11 
5.4 
SAFETY EVALUATION ......................................................................................................................... 12 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 12 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 12 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 12 
6.3 
CONTROL OF BIAS AND CONFOUNDING .............................................................................................. 12 
6.4 
STATISTICAL METHODS ...................................................................................................................... 13 
6.4.1 
Primary outcome: Feasibility data ................................................................................................ 13 
6.4.2 
Quantitative secondary outcomes .................................................................................................. 13 

 
 
 
 
 
 
 
 
iii 
6.4.3 
Qualitative data ............................................................................................................................. 13 
6.4.4 
Safety Analysis ............................................................................................................................... 14 
6.5 
SAMPLE SIZE AND POWER .................................................................................................................. 14 
7 
SAFETY MANAGEMENT ..................................................................................................................... 15 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 15 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 15 
8 
STUDY ADMINISTRATION ................................................................................................................. 15 
8.1 
TREATMENT ASSIGNMENT METHODS ................................................................................................. 15 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 15 
8.3 
CONFIDENTIALITY .............................................................................................................................. 16 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS ................................................................................. 16 
8.4.1 
Data and Safety Monitoring Plan .................................................................................................. 16 
8.4.2 
Risk Assessment ............................................................................................................................. 18 
8.4.3 
Potential Benefits of Trial Participation ....................................................................................... 18 
8.4.4 
Risk-Benefit Assessment ................................................................................................................ 18 
8.5 
RECRUITMENT STRATEGY .................................................................................................................. 18 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 19 
8.6.1 
Waiver of HIPAA Authorization to Screen Medical Records ........................................................ 19 
8.6.2 
Combined Informed Consent-Authorization of HIPAA for Study Procedures .............................. 19 
8.7 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................................... 20 
8.7.1 
Payments to parent for time and inconvenience (i.e. compensation) ............................................ 20 
8.7.2 
Gifts ............................................................................................................................................... 20 
9 
PUBLICATION ........................................................................................................................................ 20 
10 
REFERENCES ................................................................................................................................. 20 
  

  
 
 
 
 
 
 
 
iv 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
AE 
 
Adverse event 
SAE 
 
Serious Adverse Event 
EHR 
 
Electronic Health Record 
CoC 
 
Certificate of Confidentiality 
MI 
 
Motivational Interviewing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
 
 
 
 
v 
ABSTRACT 
Context: 
Preterm births occur in 10% of US births, cause 36% of infant mortality, and cost $26 
billion each year. Repeat preterm births represent approximately 20% of total prematurity. 
Preventive care that effectively addresses modifiable risks (e.g. tobacco use, weight status, 
interpregnancy interval) among women with a prior preterm birth could plausibly reduce 
overall preterm birth rates by 10% or more. Leveraging existing contact between pediatric 
health systems and new mothers, this research proposes a pediatric-based intervention as a 
novel strategy to reduce prematurity. 
Objectives: 
The primary objective of this study is to determine whether the behavioral intervention Care 
Coordination After Preterm Birth is feasible and acceptable to women following preterm 
birth. 
Study Design: 
This is a preliminary pilot non-randomized open trial of Care Coordination after Preterm 
Birth with baseline and post-intervention assessments.  
Setting/Participants: 
The setting for this study is the CHOP primary care network. Women who intend to seek 
pediatric care for their new infants at CHOP primary care sites (Karabots, Cobbs Creek) will 
be enrolled from the Hospital of the University of Pennsylvania postpartum unit / newborn 
care units before hospital discharge or by phone within 4 weeks of a preterm birth. A 
maximum of 106 women will participate in this preliminary pilot trial. Enrollment will stop 
once feasibility is established. 
Study Interventions and Measures:  
Care Coordination after Preterm Birth is a behavioral intervention for women following 
preterm birth. Interventionists will provide health education, health care navigation, and 
motivational interviewing to ensure health care needs are met, positive health behaviors are 
adopted or sustained, and barriers to health are addressed. 
The primary outcome of this study is acceptability and feasibility of the intervention. In 
addition, this preliminary trial will monitor postpartum visit attendance and other modifiable 
risk factors for recurrent adverse pregnancy outcomes.  
 
 
 
 

  
 
 
 
 
 
 
 
vi 
 
 
Table 1: Schedule of Study Procedures 
 
 
 
 
 
Procedure 
Screening & 
eligibility 
Pre- 
intervention 
Interventio
n
3 mon 
6 mon 
Measures to determine eligibility 
Screening eligibility 
Health records review  
X 
 
 
 
 
Measures of treatment feasibility and acceptability 
Recruitment rates 
Study-team documented 
 
X 
 
 
 
Reasons for non-participation 
Study team documented (if available) 
 
X 
 
 
 
Intervention fidelity 
Study team documented  
 
 
X 
 
 
Retention rate 
Study team recorded 
 
 
 
X 
X 
Treatment acceptability 
interview 
Participant reported 
 
 
 
 
X 
Demographics, health utilization, and modifiable health behavior 
Participant demographics 
Health record review and participant 
report 
 
 
X 
 
 
Health care receipt 
Health record review and participant 
report 
 
 
 
X 
X 
Autonomy Support (Health Care 
Climate Questionnaire) 
Participant reported 
 
X 
 
 
X 
Autonomous Motivation 
(Treatment self-regulation 
questionnaire) 
Participant reported 
 
X 
 
 
X 
Contraceptive use 
Health record review and participant 
report 
 
X 
 
X 
X 
Participant weight 
Measured on scale or heath record 
review or participant report 
 
X 
 
 
X 
Tobacco use (30 days any versus 
none) 
Participant reported 
 
X 
 
X 
X 
Mental health symptoms 
(Edinburgh Postnatal Depression 
Scale, Perceived Stress Scale) 
Participant reported 
 
X 
 
X 
X 
Barriers to care 
Participant reported 
 
X 
 
X 
X 
Sleep-related Impairment scale 
 
 
X 
 
X 
X 
Intervention Acceptability 
Participant report 
 
 
 
 
X 
Intervention 
Care Coordination 
Care navigation, health education, 
screening, care planning, addressing 
barriers 
 
 
X 
 
 
Motivational Interviewing 
 
 
 
X 
 
 
 

 
page vii 
  
 
 
 
1 
FIGURE 1: STUDY DIAGRAM 
 
 
 
Identify potentially eligible women 
and confirm eligibility
Written or electronically obtained
informed consent
Care coordination intervention
6 month study data collection (by 
member of study team)
Baseline assessment
3 month study data collection 
(phone call, video, or in person)
10 – 14 weeks post enrollment
24 – 30 weeks post enrollment
0 – 24 weeks post enrollment
0 – 2 weeks post enrollment

 
  
 
 
 
1 
2 
BACKGROUND INFORMATION AND RATIONALE 
2.1 Introduction 
In the United States (US) in 2017, prematurity occurred with 10% of births1 and was 
associated with 36% of infant deaths. Due to short- and long-term medical and 
developmental morbidities, prematurity costs $26.2 billion annually in the US.2–5 Early 
preterm births carry particularly high burdens, but late preterm births are also associated 
with morbidities and with infant costs double those of term births.6–10 We propose testing an 
intervention for women at high-risk for preterm birth with a goal of increasing receipt of 
preventive health care and supporting positive health behaviors. 
Among women with a prior preterm birth, more than 20% of second births are also 
preterm.11–15 Most of these women have modifiable risks influencing birth outcomes.16 Both 
prenatal and population-wide interventions addressing modifiable risks have yielded 
reductions in preterm birth, demonstrating that many preterm births are preventable.17–20 For 
women with a prior preterm birth, addressing risks before pregnancy could reduce individual 
risk of preterm birth by approximately 30% and overall preterm birth rates by approximately 
10%.12,14,16,21 This proposal focuses on modifiable risks that are universally relevant to 
women with a history of preterm birth including health care receipt, interpregnancy interval, 
and postpartum weight retention.4,18,22,23 The intervention may also address tobacco use and 
mental health for subgroups experiencing these additional modifiable risks.19,24  
 
2.2 Name and Description of Investigational Product or Intervention 
Care Coordination after Preterm Birth is a behavioral intervention for women 
following preterm birth. The program combines strategies of health education, care 
navigation, and motivational interviewing to improve receipt of recommended preventive 
health care and to support positive health behavior change. The intervention is based in the 
pediatric primary care setting, in recognition that this is the health care setting with which 
women most frequently interact following a preterm birth.25 However the intervention is 
designed to address the needs of mothers directly.  
2.3 Relevant Literature and Data 
Interconception preventive health care is recommended by NICHD, the Centers 
for Disease Control and Prevention, and the National Academy of Medicine as a strategy to 
prevent preterm birth and decrease health disparities.3,4,26–28 Yet many women receive no 
preventive care between pregnancies and we lack effective approaches to increase care 
receipt.29–31 Though many women lack preventive care, most infants do receive 
preventive care in the IC period. Our preliminary work with Medicaid claims found that 
43% of women received no preventive care in the first year following a preterm birth.25 For 
approximately half of these women, their infants competed pediatric preventive care at or 
above median levels. 
Pediatric preventive care provides an opportunity to identify maternal health 
risks, but traditional health care models do not fully address risks. A Family Medicine 
collaborative demonstrated the feasibility of using infant preventive visits to implement 
universal maternal risk screening.32 Pediatricians, who provide preventive care to 80% of 
infants in the US, also consider maternal interconception risks within their scope of 

 
  
 
 
 
2 
practice.33–36 However, without strategies to ensure evidence-based care, screening alone 
will not improve outcomes.37–40  
Care coordination can improve receipt of recommended care. Care coordination is 
defined as “the deliberate organization of patient care activities between two or more 
participants (including the patient)… to facilitate the appropriate delivery of health care 
services.”41 In pediatric settings, including CHOP, care coordination has addressed needs of 
children with medical complexity, increasing receipt of recommended preventive care.42–47 
While models vary, defining features include proactive enrollment of children with 
complexity, comprehensive screening, health care navigation, education, and addressing 
barriers to care. The care coordination model has been articulated through recent reviews 
and reports of successful programs.42–46,48,49 
Motivational Interviewing (MI) can address modifiable behavioral risks. MI is a 
patient-centered approach that uses strategies such as reflective listening, agenda setting, 
articulating ambivalence, and eliciting “change talk” to promote positive behavior change.50 
MI values patient autonomy, including the autonomy not to change, but typically functions 
where there is a clear desired outcome.50 It has been implemented in a range of health care 
settings, including primary care, and has yielded benefits for behaviors that pose a risk in the 
interconception period, including physical activity, diet, contraceptive access, and tobacco 
use.51–57 MI can be carried out by practitioners with a variety of professional 
backgrounds.58,59 The supportive approach of MI may be particularly well suited to new 
mothers, who have high rates of depression and anxiety, and frequently face trade-offs when 
accessing health care or changing behaviors.60 When maternal screening identifies a 
modifiable behavioral risk (e.g. poor diet), this intervention will use MI as an approach to 
address these risks.   
In summary, many women with a prior preterm birth have modifiable risk factors for 
repeat preterm birth and experience gaps in preventive care. Addressing modifiable risks and 
gaps in care could reduce overall preterm births by 10% or more. Care coordination for 
children with medical complexity serves as the initial model for this intervention. This 
study will adapt existing care coordination models to meet the needs of women 
following a preterm birth and integration of MI with care coordination to better 
address modifiable behavioral risks.  
2.4 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46 and the Good Clinical Practice: Consolidated Guideline 
approved by the International Conference on Harmonisation (ICH). All episodes of 
noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  

 
  
 
 
 
3 
3 
STUDY OBJECTIVES 
3.1 Primary Objective (or Aim) 
The primary objective of this study is to determine the whether the Care Coordination after 
Preterm Birth intervention is feasible and acceptable to women following a preterm birth.  
3.2 Secondary Objectives (or Aim) 
The secondary objectives of this study are to examine the changes in health care utilization, 
behavioral constructs of autonomy support and autonomous motivation, and modifiable risks 
from pre- to post-intervention. 
4 
INVESTIGATIONAL PLAN 
4.1 General Schema of Study Design 
4.1.1 Screening Phase 
First, Potential subjects will be identified from the postpartum unit and from the 
newborn nursery and Neonatal Intensive Care Unit for the Hospital of the University of 
Pennsylvania. Potential subjects will first be identified based on key criteria such as age, 
described in greater depth below. For the screening methods we are requesting a waiver of 
HIPAA authorization to screen the health records to ensure that potential participants meet 
the basic eligibility criteria for the study.   
4.1.2 Study Intervention Phase  
This is a preliminary single arm open trial of Care Coordination after Preterm Birth, a 
multicomponent behavioral intervention that will last up to 24 weeks post enrollment. 
This intervention includes screening and care planning, focused health education, 
health care navigation, addressing barriers to care and MI. Fidelity will be assessed by 
proportion of planned tasks (proactive enrollment, screening, navigation, education, 
addressing barriers) that are attempted and completed with a goal of 80% completed. We 
will test these components separately or together to optimize: 
• Activities prior to hospital discharge:  
Shortly following enrollment (within 4 weeks and potentially much sooner) the care 
coordinator will engage participants in screening for unmet health needs, knowledge 
deficits, modifiable risks, and goals for care. In addition, care coordinators will assess 
sources of social support for participants as well as potential barriers to care. This process 
will involve chart review, participant report, and eliciting input from the participant’s 
clinical care teams. This process will conclude with development of a care plan designed to 
summarize goals for health care and behavior change in the postpartum period. The 
participant will be actively involved in determining priorities for the care plan. This plan 
will be communicated to the clinical teams working with the participant and her infant, as 
well as other services involved with the family, as appropriate and as approved by the 
participant (e.g. home visiting services).  
 
• Supporting completion of health care: 

 
  
 
 
 
4 
Next the care coordinator will follow-up with the participant by phone, video, or 
during infant office visits in primary care. These contacts will assess for progress on goals of 
care, provide health education and health care navigation as needed, and continually reassess 
barriers to care and help participants identify and access resources to remove barriers. 
Health education will focus on optimizing reproductive health and will utilize materials 
already in use at the clinical sites utilized by participants, or from sources recommended by 
the clinical care team.  
• Incorporation of Motivational Interviewing: 
Concurrently with care navigation, the Care Coordinator will engage women in 2 – 4 
sessions of MI focused on one modifiable behavior selected by the participant and the care 
coordinator during the goal setting process. Timing of MI sessions may vary somewhat by 
participant preference and other needs, but we expect they will start 4 – 8 weeks postpartum 
and occur over a period of approximately 4 – 8 weeks. MI sessions may occur in-person, by 
phone, or by video and are expected to last 10 – 30 minutes each.  
 
The intervention will conclude when the participant and the care coordinator have 
met the goals of care and completed the recommended health care visits outlined on the plan 
of care, or at six months post enrollment. Participants will be informed from the start of the 
intervention that this is a time-limited intervention. Any outstanding needs at the time of 
program completion will be summarized in an updated plan of care and communicated to 
the participant’s clinical care team.  
Details such as timing of intervention components, mode of delivery, communication 
with participants may be modified over the course of this preliminary pilot intervention. 
Subjects may not complete all study procedures that are outlined, it may depend on 
when they enroll in the study and the feasibility measures that are being assessed at the time. 
Women will be informed at enrollment about which components we are currently testing. 
 
4.1.3 Follow-up Phase 
Study data will be collected at enrollment, and at 3 months and 6 months after enrollment. 
For some participants the intervention may conclude several weeks prior to the 6-month data 
collection period, however all participants will be included in the 3-month and 6-month data 
collection assessments. 
4.2 Allocation to Treatment Groups and Blinding 
This is a preliminary, open, non-randomized trial of the Care Coordination after Preterm 
Birth intervention. All women who consent will receive the intervention. Blinding is not 
applicable.  
4.3 Study Duration, Enrollment and Number of Sites 
4.3.1 Duration of Study Participation 
The study duration is 6 months.  

 
  
 
 
 
5 
4.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
This study will occur at two sites within the CHOP Primary Care Network (Karabots and 
Cobbs Creek). In addition, research activities will occur at UPenn (Hospital of the 
University of Pennsylvania). Recruitment will stop when feasibility and acceptability have 
been established. We plan to enroll a maximum of 106 participants. 
4.4 Study Population 
4.4.1 Inclusion Criteria 
1) Females age 14 – 45. 
2) History of preterm birth at < 34 weeks gestation OR history of preterm birth at 34 – 36 
weeks gestation with risk factors for recurrent preterm birth including: low preventive 
care utilization, tobacco use, obesity, depression or anxiety, history of unmet 
contraceptive needs.  
3) Intention to seek infant pediatric primary care at one of the two study sites (Karabots and 
Cobbs Creek). 
4) Medicaid insurance. 
4.4.2 Exclusion Criteria 
1) History of sterilization procedure. 
2) Plan to move away from the area or transfer pediatric primary care within six months of 
enrollment.  
3) Limited English proficiency 
We are excluding younger women and women with Limited English proficiency from this 
pilot work because we expect that their health care navigation and education needs, patterns 
of health care utilization, and barriers to health will be distinct from those of older women 
and women with English proficiency, and would not be well represented in this small pilot 
study. Subjects that do not meet all of the enrollment criteria may not be enrolled. Any 
violations of these criteria must be reported in accordance with IRB Policies and Procedures.  
5 
STUDY PROCEDURES 
5.1 Screening phase 
Procedures for screening are described above in greater detail (section 3.1.1). The screening 
phase will include the following activities. Details of data collection tools and definitions are 
included below in section 5.  
• Health record review by study team member to assess gestational age. 
• Phone, in person, or video confirmation of eligibility and scheduling of informed 
consent and baseline assessment.  

 
  
 
 
 
6 
5.2 Baseline assessment 
During the baseline assessment we will collect data on participant demographics, behavioral 
constructs related to motivational interviewing, modifiable health behaviors, and potential 
barriers to health care and health behavior. This data will be collected in person, by phone, 
or by video, with the exception of participant weight which will be measured with a scale in 
a health care setting. This assessment is intended to be completed prior to participant 
discharge from the hospital following birth, but may occur after that time. Details of data 
collection tools and definitions are included below in section 5.  
• Informed consent 
• Demographic characteristics (age, race, gender, ethnicity, residential address, 
educational attainment, insurance, household income, marital status) 
• Timing of first prenatal visit / prenatal visit count 
• Autonomy support  
• Autonomous motivation 
• Contraceptive use prior to pregnancy 
• Weight, height 
• Tobacco use 
• Mental health symptoms 
• Barriers to care / health behavior  
5.3 Intervention phase 
The Care Coordination After Preterm Birth Intervention will be provided over 4 – 6 months. 
We will (e.g. reproductive health education topics). Fidelity will be assessed by proportion 
of follow existing institutional protocols in which experienced peers model and then certify 
competence in tasks. The study team will supplement training for procedures that differ 
from existing protocols planned tasks (proactive enrollment, screening, navigation, 
education, addressing barriers) that are attempted and completed with a goal of 80% 
completed. The goal of this phase is to test the intervention protocol for feasibility with the 
proposed population and setting and refine focus on tasks most likely to benefit participants. 
We will test the following components of the intervention separately or together 
 
• Activities prior to hospital discharge:  
Shortly following enrollment (within 4 weeks and potentially much sooner) the care 
coordinator will engage participants in screening for unmet health needs, knowledge 
deficits, modifiable risks, and goals for care. In addition, care coordinators will assess 
sources of social support for participants as well as potential barriers to care. This process 
will involve chart review, participant report, and eliciting input from the participant’s 
clinical care teams. This process will conclude with development of a care plan designed to 
summarize goals for health care and behavior change in the postpartum period. The 
participant will be actively involved in determining priorities for the care plan. This plan 
will be communicated to the clinical teams working with the participant and her infant, as 
well as other services involved with the family, as appropriate and as approved by the 
participant (e.g. home visiting services).  

 
  
 
 
 
7 
• Supporting completion of health care: 
Next the care coordinator will follow-up with the participant by phone, video, or during 
infant office visits in primary care. These contacts will assess for progress on goals of care, 
provide health education and health care navigation as needed, and continually reassess 
barriers to care and help participants identify and access resources to remove barriers. 
Health education will focus on optimizing reproductive health and will utilize materials 
already in use at the clinical sites utilized by participants, or from sources recommended by 
the clinical care team.  
• Incorporating Motivational Interviewing: 
Concurrently with care navigation, the Care Coordinator will engage women in 2 – 4 
sessions of MI focused on one modifiable behavior selected by the participant and the care 
coordinator during the goal setting process. Timing of MI sessions may vary somewhat by 
participant preference and other needs, but we expect they will start 4 – 8 weeks postpartum 
and occur over a period of approximately 4 – 8 weeks. MI sessions may occur in-person, by 
phone, or by video and are expected to last 10 – 30 minutes each.  
 
The intervention will conclude when the participant and the care coordinator have met the 
goals of care and completed the recommended health care visits outlined on the plan of care, 
or at six months post enrollment. Participants will be informed from the start of the 
intervention that this is a time-limited intervention. Any outstanding needs at the time of 
program completion will be summarized in an updated plan of care and communicated to 
the participant’s clinical care team.  
 
Details such as timing of intervention components, mode of delivery, communication with 
participants may be modified over the course of this preliminary pilot intervention.  
 
Subjects may not complete all study procedures that are outlined, it may depend on when 
they enroll in the study and the feasibility measures that are being assessed at the time. 
Women will be informed at enrollment about which components we are currently testing. 
5.3.1 3-month assessment 
The study team will conduct chart review and a telephone call or video call 10 – 14 weeks 
post-enrollment to assess the following. Details of data collection tools and definitions are 
included below in section 5.  
• Health care utilization  
• Autonomy support  
• Autonomous motivation 
• Contraceptive use 
• Tobacco use 
• Mental health symptoms (EDPS and PSS) 
• Barriers to health care or to positive health behavior  
• Sleep related impairment 
 

 
  
 
 
 
8 
5.3.2 6-month assessment (end of study) 
The study team will conduct chart review and an in-person visit, telephone call, or video call 
at 24 – 30 weeks post-enrollment to assess the following. Details of data collection tools and 
definitions are included below in section 5.  
• Health care utilization  
• Autonomy support  
• Autonomous motivation 
• Contraceptive use 
• Tobacco use 
• Mental health symptoms (EPDS and PSS) 
• Barriers to health care or to positive health behavior  
• Sleep related impairment 
• Participant weight (the study team will accept either data recorded in the health 
record during this window during a clinical visit, measured by the study team in a 
clinical setting, or if neither of those are available participant report.  
5.4 Subject Completion/Withdrawal 
Participants may withdraw from the study at any time without prejudice to their care. They 
may also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to the study treatment or visit schedule, because of emergence of exclusion 
criteria, or to protect the subjects for reasons of safety or for administrative purposes. 
Participants who do not receive all components of the intervention will still be included in 
the 3-month and 6-month assessments. Because the primary aim of this study is to determine 
feasibility and acceptability, efforts will be made to retain participants and to assess reasons 
for non-completion or withdrawal from the study.  
If any adverse events occur that require clinical intervention during the course of 
participation, the PI or a co-investigator who is a licensed clinician will conduct a risk and 
safety assessment and make appropriate clinical referrals. If the investigators become aware 
of any serious, related, adverse events after study completion or withdrawal, the event will 
be recorded in a separate, coded REDCap database used to track attrition and adverse 
events.  
5.4.1 Early Termination Study Visit 
For subjects who withdraw before the end of the study, we will request that they indicate 
why they have chosen to withdraw and whether any study modifications would have made 
participation more valuable for them. 

 
  
 
 
 
9 
6 
STUDY EVALUATIONS AND MEASUREMENTS 
6.1 Screening Measures 
6.1.1 Medical Record Review 
Medical record review will assess initial eligibility criteria for women in the postpartum 
period.  
• Age (years) 
• Gestational age at recent delivery 
• Insurance 
• History of sterilization procedure 
• Timing of first prenatal visit 
• Number of prenatal visits 
• Tobacco use prior to or during pregnancy 
• Gestational Diabetes 
• Pregnancy Induced Hypertension 
• Treatment for depression or anxiety during pregnancy 
• Weight and height 
• Planned site of infant pediatric care 
• Plans to move out of the area during the upcoming six months 
The last two items listed above (planned site of infant pediatric care and plans to move out 
of the area during the upcoming six months) may not be consistently documented in the 
health record. Potential participants will be informed that we are seeking these 
characteristics in study participants.  
6.2 Measures of Treatment Feasibility and Acceptability (Primary Outcome)  
The primary outcome of this study is to assess feasibility and acceptability of the Care 
Coordination After Preterm Birth intervention. We will assess feasibility and acceptability 
using the following measures.  
• Screening rate (feasibility): The study team will compare the number of potentially 
eligible participants to those who complete screening questionnaires. The number of 
potentially eligible participants will be considered the number or preterm births with 
Medicaid insurance in a given month.  
• Recruitment rate (feasibility): The study team will track the proportion of eligible 
women screened who enroll in the study.  
• Reasons for non-participation (acceptability): For women who decline screening or 
enrollment we will ask them, if they are willing, to provide reasons for non-
participation and potential study modifications that might have encouraged them to 
participate. Responses will be tabulated and reviewed for potential themes. 
• Retention rate (feasibility): The study team will track the proportion of enrolled 
participants who complete the intervention and the study assessments. 
• Assessment process (feasibility): The study team will track the proportion of the 
baseline, 3-month, and 6-month assessments that are completed. 

 
  
 
 
 
10 
• Intervention usability (feasibility): Study interventionists will keep records of 
barriers and facilitators of the intervention content and procedures. 
• Family engagement and adherence (feasibility): Study interventionists will keep 
track of the proportion of contacts initiated that are completed, contacts initiated by 
participants, and participant use of resources and strategies discussed during the 
intervention, based on participant feedback.  
• Intervention fidelity (feasibility) 
o Care coordination fidelity: We will quantify interventionist completion of 
screening tools, as well as other tasks outlined in the care plan, including 
focused education, navigation, and addressing barriers to care, screening. 
o Motivational interviewing fidelity: OnePass is a validated tool used to 
evaluate MI practice and assess fidelity based on review of a single session, 
using 23 items to assess MI components.61 This tool yields a global score 
while also identifying specific areas for additional practice and training. 
Scores range from 1 – 7 with 5 considered a minimum for competence. 
Interventionists will complete at least one OnePass within a month of starting 
MI sessions with participants.  
• Intervention acceptability (participants): Care givers will complete a brief (10 – 15 
minutes) audio-recorded, open-ended qualitative interview with questions related to 
acceptability domains such as attitude towards intervention, intervention burdens, 
perceived effectiveness of the intervention, willingness to participate again or 
recommend intervention to a friend, and satisfaction with the intervention.   
• Intervention acceptability (participants): We will use an adapated version of the 
validated Acceptability of the Intervention Measure to measure acceptability 
quantitatively.  
6.3 Measures of Modifiable Health Behaviors and Sociodemographic 
characteristics 
6.3.1 Modifiable health behaviors 
Modifiable health behaviors will be measured at baseline, 3-months, and 6-months as 
described here. We will also measure autonomous motivation and autonomy support as 
outcomes related to the motivational interviewing component of the project. Details are 
provided here.  
• Care utilization will be abstracted from the medical record whenever possible. 
Available data will include all data from the CHOP and Penn health records. In 
addition, participants will be asked to report on all health care.  
• Tobacco use will be assessed as any tobacco use in the past 30 days, a meaningful 
measure of continuous abstinence.62  
• Contraceptive use will be assessed by asking about any current contraceptive 
methods.  
• Mental health symptoms will be measured with the Edinburgh Postnatal 
Depression Scale – This 10 item rating scale has been validated in diverse 
populations (range 0 – 30, Cronbach alpha 0.87). and widely used in both clinical 

 
  
 
 
 
11 
practice and research settings. In clinical settings, a cutoff of 10 is typically 
considered concerning for potentially meaningful clinical symptoms of depression.63  
• Perceived stress will be measured using the Perceived Stress scaled. This 10-item 
scale has been validated in diverse populations (range 0 – 40, Cronbach alpha 0.80). 
• Participant weight will be measured at baseline and 6 months. All efforts will be 
made to obtain a weight in a clinical setting (either during a pediatric visit or from 
the participants own health record). If these efforts are not successful, we will record 
participant reported weight.  
• Autonomy support reflects individuals’ perception of the degree to which the health 
care team understands individuals’ perspectives and trusts they will make the best 
decisions for themselves. Autonomy support will be measured with the short form of 
the Health Care Climate Questionnaire (6 items, range 6 – 42, Cronbach alpha 
0.82).64 
• Autonomous motivation reflects the degree to which individuals are driven by 
concerns consistent with their own values or identity. Validated tools exist to 
measure autonomy support and autonomous motivation.64,65 Autonomous motivation 
will be measured using the Autonomous Motivation and External Regulation scales 
of the Treatment Self-Regulation Questionnaire (10 items, range 7 – 70, Cronbach 
alpha 0.90).65 
• Sleep-related impairment will be measured using the PROMIS Item Bank 8-item 
measure (range 8 – 40, Cronbach alpha 0.89).  
6.3.2 Sociodemographic factors  
The following sociodemographic factors will be assessed at baseline only:  
• Maternal age (years) (Health record review) 
• Race (participant self-report) 
• Ethnicity (Participant self-report) 
• Educational attainment (Participant self-report) 
• Estimated household income (Participant self-report) 
• Prior pregnancies (Health record review) 
• Complications of pregnancy including gestational diabetes or pregnancy-induced 
hypertension (Health record review) 
• Chronic conditions including diabetes, asthma, hypertension, depression, or anxiety 
(Health record review) 
The following demographic factors will be assessed at baseline and at 6-month follow-up 
and will both be collected via participant self-report: 
• Household composition  
• Relationship with other biological parent of child (if applicable) including married, 
cohabitating, not cohabitating but still in a relationship, no longer in a relationship 
but other parent actively involved in parenting  
The following potential barriers to positive health behaviors will be assessed at baseline and 
at 3-month and 6-month follow-up and will all be collected via participant self-report: 

 
  
 
 
 
12 
• Health insurance will be assessed using item structure used in the Behavioral Risk 
Factors Surveillance Survey (at time of enrollment all participants should have 
Medicaid, however this may vary over time).66  
• Transportation needs will be assessed using items from the WellRx screening, which 
was developed in a Family Medicine setting and has been widely used.67 
• Child care will be assessed using items from the WellRx screening, which was 
developed in a Family Medicine setting and has been widely used.67  
• Food insecurity will be assessed with a two item screen that has been previously 
validated with families in pediatric settings. The two items are “within the past 12 
months we worried whether our food would run out before we got money to buy 
more” and “within the past 12 month the food we bought just didn’t last and we 
didn’t have money to get more.”68 
• Employment status will be assessed using item structure used in the Behavioral Risk 
Factors Surveillance Survey and the Pregnancy Risk Assessment Monitoring 
System.66,69 
6.4 Safety Evaluation 
Participant safety will be monitored by adverse events throughout the study. Please see the 
Data Safety and Monitoring Plan (Section 8.4.1) for further information.  
7 
STATISTICAL CONSIDERATIONS  
7.1 Primary Endpoint 
The primary endpoints are overall rating of intervention feasibility and acceptability of the 
intervention. 
7.2 Secondary Endpoints 
As secondary endpoints we will assess modifiable behaviors and will include the following: 
• Health care utilization over the study period 
• Change in Autonomous Motivation over the study period 
• Change in Autonomy Support over the study period 
 
7.3 Control of Bias and Confounding 
This is a single arm feasibility study. Our participants may differ in important ways from 
those who choose not to participate in the study, which will limit generalizability of our 
findings. We will mention this as a limitation in any study data dissemination. In addition, 
we well compare demographic and utilization characteristics of enrolled participants to 
available summary data on women delivering at the enrollment sites.  

 
  
 
 
 
13 
7.4 Statistical Methods 
7.4.1 Primary outcome: Feasibility data 
We will examine the following quantitative feasibility and acceptability outcomes through 
the use of descriptive statistics, which include means for continuous variables and 
proportions for categorical variables. In some cases, we will compare them to a priori goals 
for feasibility. See above (Section 5) for more detail about measurement of these outcomes.   
• Screening rate: Proportion of potentially eligible participants screened.  
• Recruitment rate: Proportion of screened women who enroll.  
• Retention rate: Proportion of enrolled participants who complete the intervention and 
the study assessments. 
• Assessment process: Proportion of the baseline, 3-month, and 6-month assessments 
that are completed. 
• Family engagement and adherence: Proportion of contacts initiated that are 
completed within 3 days will be compared to an a priori threshold of 80%, # of 
contacts initiated by participants, # of recommended resources utilized.  
• Intervention fidelity 
o Care coordination fidelity: # of screenings completed, # of care plan goals 
achieved 
o Motivational interviewing fidelity: OnePass score will be compared to an a 
priori threshold of 5, considered a minimum threshold for competence. 
 
7.4.2 Quantitative secondary outcomes 
We will also examine the following quantitative secondary outcomes through the use of 
descriptive statistics, which include means for continuous variables and proportions for 
categorical variables. 
• Count of preventive care visits 
• Proportion of preventive care recommended in care plan that is completed 
• Change in autonomy support  
• Change in autonomous motivation  
7.4.3 Qualitative data 
Qualitative data (itemized below) will be reviewed and assessed for themes using a priori 
codes related to theories of acceptability and feasibility,70 as well as a grounded theory 
approach where we allow themes to emerge from data. (For more details on how these data 
will be defined and collected, see Section 5 above.)  
• Reasons for non-participation 
• Intervention usability 
• Family engagement and adherence (participant feedback)  
• Intervention acceptability  

 
  
 
 
 
14 
7.4.4 Safety Analysis 
This is a minimal risk study and therefore we do not anticipate any adverse events related to 
study participation. However, for all subjects who consent to participation we will track and 
describe any adverse events that occur during the study. 
7.5 Sample Size and Power 
This open single arm study is not designed to have power to test the efficacy or significance 
of the intervention effects. A power analysis was thus not appropriate. The sample size for 
this study was identified through review of the literature on testing preliminary 
interventions.  
 

 
  
 
 
 
15 
8 
SAFETY MANAGEMENT 
8.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
8.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  
9 
STUDY ADMINISTRATION 
9.1 Treatment Assignment Methods 
There will be no randomization and no blinding in this study.   
9.2 Data Collection and Management 
Here we describe a data collection and management plan that is consistent with CHOP 
Policy A-3-6: Acceptable Use of Technology Resources that defines the requirements for 
encryption and security of computer systems 
Confidentiality: All study data (with the exception of qualitative audio recordings, see 
below) will be maintained on in a password-protected RedCap database that will only be 
available to members of the study team. This database will contain Protected Health 
Information. At the conclusion of data collection (i.e. after completing the 6-month study 
assessment), study staff will convert each record to a “Coded” record through two steps. 
First, we will create creating a separate RedCap database (the Master List) that includes only 
the study identification number, subject name, and subject date of birth. Second, we will 
remove all PHI from the main study database but removing identifying information and 
converting dates into times from most recent birth. Data entry into RedCap will involve a 
combination of direct participant entry, study team entry from participant report, and study 
team entry from health record review. Only coded data will be downloaded from RedCap for 
analysis. When coded data is downloaded, it will be stored in password protected folders on 
the CHOP network drives. 
All paper consent forms will be stored in a locked filing cabinet in the Roberts 
Center for Pediatric Research. They will also be scanned and stored in password protected 
files on the CHOP network drive.  
Qualitative data will be collected via audio-recording in-person or over the phone or 
video. All audio files will be stored on the secure CHOP computer network drive in 
password protected folders accessible only to members of the study team. Transfer of audio 
files from the audio device to the CHOP network drive will via cable directly from the 
device to the computer or via an encrypted flash drive. In the password protected file, audio 

 
  
 
 
 
16 
files will be labeled with only the participants’ study ID. Audio files will be transcribed by a 
professional transcription agency that functions in accordance with all CHOP technology 
transfer policies. We will contact OTT to ensure that a Business Associate Agreement is in 
place for the transcription agency. Transcripts will be stored in password protected files on 
the CHOP network drives and will be de-identified by removing any references to names, 
dates, or specific addresses. Audio files will be maintained until analysis is complete, to 
assist with any uncertainties in the analysis of the data.  
 
Security: The CHOP REDCap system operates with back-up recovery systems in place. 
Consent forms will have a paper back-up system available. Qualitative transcripts will have 
a back-up stored locally on the CHOP-issued computer of the study PI in a password 
protected folder. 
 
Anonymization, de-identification, or destruction of data: Plans to de-identify and code 
data are described above (see “Confidentiality”). All study data will be retained a minimum 
of 6 years from study start completion, consistent with current CHOP policies on retention 
and destruction of records for Human Subjects Research with minimal risk. Data files will 
include instructions about study start date to assist the study team with completing 
destruction of data.  
9.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. The PI and all members of the study 
team will not use data and records for any purpose other than conducting the study. All 
members of the study team will complete training on confidentiality in research. All data 
will be safeguarded as described above.   
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 
any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI 
limited to dates and zip codes).  
9.4 Regulatory and Ethical Considerations 
9.4.1 Data and Safety Monitoring Plan 
In this minimal risk study, the primary anticipated safety risk relates to disclosure of 
sensitive information to study team members. This information includes information on 
mental health symptoms which are explicitly included in study data collection (Edinburgh 
Postnatal Depression Scale). In addition, though we are not explicitly asking participants to 
report on or discuss instances of abuse and neglect for either themselves or their infants, 
these issues may be disclosed. Finally, study team members may directly observe signs of 
abuse or neglect or signs of mental health deterioration.  
We will ensure that all study team members have completed training for identifying 
abuse and neglect as well as severe mental health symptoms, and are also trained in 
reporting requirements. In addition, we have developed the following protocol to address 
any instances of safety concerns. 

 
  
 
 
 
17 
• Mild to moderate behavioral health concerns that are not currently being 
treated: Research staff will offer a resource sheet (included in IRB application as 
attachment) for community resources. This intervention will be embedded in two 
CHOP primary care sites. Therefore, study staff may also remind participants that 
social workers associated with their child’s care site are available to help parents 
navigate access to behavioral health services for themselves. 
• Severe behavioral health concerns that are not currently being treated: This 
includes any mention of current thoughts or acts of self-harm or harm to others. In 
these situations, staff will notify the Principal Investigator (a licensed pediatrician) 
who will speak to the participant immediately, if time permits, or by phone as soon 
as possible. If indicated, suicidality will be assessed using the suicidal thoughts item 
from the Edinburgh Postnatal Depression Scale, which is currently the standard scale 
to assess maternal mental health in the Care Network. Item 10 of this scale reads 
“Over the last two weeks, the thought of harming myself has occurred to me…” 
response options include “yes, quite often,” “sometimes,” “hardly ever,” and 
“never.” Should there be an imminent risk to caregiver safety, study staff or the 
Principal Investigator will contact emergency services (911 or Pennsylvania mobile 
crisis services) for further suicide/homicide/risk assessment. If for some reason the 
Principal Investigator is not available in an emergency situation, study team 
members will contact the social work team associated with the child’s care site for 
guidance. 
• Child abuse or neglect: Should a caregiver spontaneously disclose incidents of 
abuse or neglect, we will file a report with Department of Human Services.  
• Intimate partner violence: If a caregiver spontaneously discloses incidents of 
intimate partner violence, they will be offered a resource sheet (included in the IRB 
application as an attachment) about IPV resources. If they report ongoing intimate 
partner violence, they will be connected with the IPV specialist affiliated with the 
study sites to conduct further assessment and develop a safety plan. If there is 
concern for an immediate safety issue, study team members will immediately notify 
the principal investigator or, if she is not available for some reason, the IPV 
specialist associated with the child’s care site.  
Any referrals or follow-up activities related to the above safety concerns will not be 
documented in patient health records by the study team. In situations where an immediate 
safety concern was noted in study materials (recordings / transcripts), the transcript will be 
annotated to indicate any immediate or follow-up actions taken to address those concerns.  
Resource sheets were adapted from sheets used for a parenting intervention currently 
underway in the Care Network with oversite from the CHOP IRB. In addition, this protocol 
has been in place for CHOP IRB exempt qualitative work preliminary to the current study.  
This study is covered by a Certificate of Confidentiality to protect identifiable 
information from forced disclosure. The CoC will allow all individuals who have access to 
research records to refuse to disclose identifying information on research participants in any 
civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, 
or local level. By protecting researchers and institutions from being compelled to disclose 
information that would identify research subjects, the CoC will help achieve the research 
objectives and promote participation in the study by ensuring confidentiality and privacy.  

 
  
 
 
 
18 
The PI for this study to review data storage and integrity, safety events, and other 
adverse events at least once every six month. These will be reported during continuing 
reviews to the IRB and the study sponsor. Any unanticipated severe events or episodes of 
reported abuse or neglect will be urgently reviewed by the PI to ensure reporting to the 
CHOP IRB and the study sponsor and the review protocols to assess for any needed 
revisions to ensure participant safety.  
9.4.2 Risk Assessment 
This is a minimal risk study. The safety plan described relates primarily to 
identification of safety risks not related to study procedures (i.e. the study should not 
increase the risk of mental health symptoms, but may identify these symptoms incidentally). 
Related to study procedures, it is possible that discussion with the study interventions or 
study data collection forms will cause psychological distress to participants. There is also 
some risk that increased monitoring from the health care team will increase utilization of 
health care services, which may carry some economic cost to participants. We do not 
anticipate any physical or societal harms. Our study design intends to minimize these harms 
by ensuring that study interventionists are trained to recognize distress, provide immediate 
support, and connect families to resources to that may assist with management of mental 
health symptoms, or with economic barriers to health care receipt. 
9.4.3 Potential Benefits of Trial Participation 
Benefits may benefit from increased access to preventive health care during the 
study period, and increased support for positive behaviors. These benefits may improve 
short-term health and wellbeing, medium range health outcomes such as improved outcomes 
in subsequent births, and long-term cardiovascular health. In addition, this trial may benefit 
participant offspring, if increased wellbeing allows greater attention to parenting activities, 
or if interventionists provide some care navigation relevant to infant health care.  
9.4.4 Risk-Benefit Assessment 
The risks associated with this study are minimal and generally no greater than the risks 
of receiving standard of care in the community (e.g. routine postpartum care).  
9.5 Recruitment Strategy 
Potentially eligible participants will be identified by screening health records in the 
newborn nursery and the neonatal intensive care unit at the Hospital of the University of 
Pennsylvania or by identifying women whose infants present for primary care at Karabots or 
Cobbs Creek. Chart review of women within four weeks of delivering a preterm infant (< 37 
weeks) will assess for potential modifiable health risks, as well as other inclusion and 
exclusion factors. Next, potentially eligible women will be approached for recruitment and 
informed consent. Two eligibility factors may not be consistently documented in a health 
record (planned site of pediatric care for infant, any plans to move out of the area in the 
upcoming six months). These factors will be confirmed verbally before proceeding with 
other enrollment activities. Women will be approached by study staff via phone or in person 
during hospitalization following delivery, or when visiting their infant in the hospital. In the 
event that conditions related to COVID or other unanticipated events prevent the physical 
presence of study staff in the clinical setting we will develop a flier to be distributed at 

 
  
 
 
 
19 
discharge, allowing women to call a number to opt out of the study. This flier will be 
submitted to the IRB for review prior to use. We are requesting a waiver of consent and 
authorization for screening. Preliminary chart review estimates that approximately 100 
eligible women deliver at HUP each year and choose to take their infants for pediatric care 
at one of the study primary care sites. We therefore expect it will be feasible to enroll 106 
participants over two years.  
9.6 Informed Consent/Assent and HIPAA Authorization 
9.6.1 Waiver of HIPAA Authorization to Screen Medical Records 
We are requesting a waiver of HIPAA authorization to screen health records for 
women following birth to identify potentially eligible participants. This will ensure that 
women who are contacted appear to be eligible based on chart review. 
The use of health record data for eligibility screening involves no more than a 
minimal risk to the privacy of individuals. Identifiers for potentially eligible participants 
(name, room number, telephone number) will be stored in a secure REDCap database and 
will be destroyed within two weeks for any potentially eligible participant who has not been 
contacted or who has been contacted by declined enrollment. As noted above, screening 
summary data will be retained (number potentially eligible, number completed screening, 
number consented to study participation) but these data will not include any protected health 
information. Individual screening data will not be used for study purposes (beyond 
screening). Screening data will not be reused or disclosed for any reason. 
The research could not practicably be conducted without the waivers. Due to the 
large number of women delivering at HUP and the frequency of rapid discharges, a 
requirement to obtain HIPAA authorization for screening could introduce bias into 
recruitment with women with longer length of stay more likely to be identified as potentially 
eligible. In addition, the research could not be conducted without access to this data as there 
would be no practicable way to identify potentially eligible women.  
9.6.2 Combined Informed Consent-Authorization of HIPAA for Study Procedures 
Members of the study team will be responsible for obtaining informed consent for study 
participation. For eligible participants, informed consent using a combined consent-HIPAA 
authorization will occur either in person or electronically, via a secure REDCap portal, 
pending participant preference and availability. When consent takes place in person, it will 
take place in the postpartum unit at HUP in a private room or in areas such as waiting areas 
that are semi-private and far enough away from other patients to maintain confidentiality. If 
informed consent is obtained electronically, the participant will receive a link to a secure 
REDCap portal in which they will be asked to enter their name and the date to indicate their 
consent. The participants name will associate the consent document with the enrolled 
participant. The REDCap portal will contain the exact same information in the same format 
as the paper consent form. The study team will email a copy of the completed electronic 
consent to the participant, with instructions to save a copy of this form.  
For all consent procedures, potential participants will be given unlimited time to decide 
on participant. Potential participants will be informed of the nature of the research, the study 
procedures, the potential benefits and possible risks. Families will be informed that they are 

 
  
 
 
 
20 
free to decline to participate or to withdraw from the study, and that this decision will not 
influence any future medical care. 
Though this study may enroll individuals aged 14 – 18, all participants will be 
considered adults for the purpose of this research. According to 45 CFR 46.402 children are 
persons who have not attained the legal age for consent to treatments or procedures involved 
in the research, under the applicable law of the jurisdiction where the research will be 
conducted. In Pennsylvania, individuals 14 years of age and older are legally able to consent 
to treatment related to reproductive health care and to care for their children. Because this 
research relates to reproductive health, in Pennsylvania women 14 years of age and older 
will be able to consent for this study independently. 
9.7 Payment to Subjects/Families 
9.7.1 Payments to parent for time and inconvenience (i.e. compensation) 
Compensation for study participation will be provided to participants as described below. 
All payments will be provided by ClinCard or by gift cards. 
• $30 for completion of the baseline assessment 
• $30 for completion of the 3-month assessment 
• $60 for completion of the 6-month assessment 
The total possible payment for completion of all assessments is $120.  
9.7.2 Gifts 
During the intervention participants may be provided with diapers, infant thermometers, or 
other items that are sometimes donated to the study sites and provided to new parents.  
10 PUBLICATION 
We intend to present results of this project at national conferences and to publish project 
results in peer-reviewed journals.  
 
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