Multi-level Intervention to Reduce Pregnancy Risk Among Adolescents: A Feasibility Trial in the Emergency Department
Phase: NA
Conditions: Contraception, Adolescent Behavior, Emergency Department
Sponsor: Children's Mercy Hospital Kansas City

SHORT TITLE: Reducing Pregnancy in the ED 
 
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Multi-level Intervention to Reduce Pregnancy Risk Among Adolescents:  A 
Feasibility Trial in the Emergency Department  
NCT 04744155 
12Apr2022 
 
 

SHORT TITLE: Reducing Pregnancy in the ED 
 
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PROTOCOL TITLE: 
Multi-level Intervention to Reduce Pregnancy Risk Among Adolescents:  A 
Feasibility Trial in the Emergency Department  
PRINCIPAL INVESTIGATOR: 
Melissa Miller, MD., MS-Cr, Associate Professor of Pediatrics 
Department of Emergency Care 
816-234-3665 
mmiller@cmh.edu 
 
CMH Co-Investigators: 
 
Kathy Goggin, PhD 
 
Vincent Staggs, PhD 
 
Stephani Stancil, PhD 
 
Other Co-Investigators: 
Cynthia Mollen, MD (CHOP) 
Elizabeth Miller MD, PhD (Pittsburgh) 
 
VERSION NUMBER/DATE: 
Version 8 April, 2022 
 
REVISION HISTORY. 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
11-3-20 
Removal of Phase 1- Addition of APPs to study, 
consent updates, REDCap screening tools, and 
medication listed 
yes 
2 
4-2-21 
Allow the option is in-person or remote 
recruiting, allow pediatricians to participate as 
intervention providers, removal of employment 
time period criteria, update to wards of the state 
verbiage and inclusion/exclusion criteria 
no 
3 
07-02-21 
Removal of Provider Limit, updated verbiage 
for training payment for providers,  
yes 
4 
12-06-21 
Clarifying adolescent exclusion criteria to 
include teens on contraception for medical 
purposes.   
no 
5 
01-17-22 
Compensation updates: 
1. Adolescents: Increase two gift card amounts:  
• Post-intervention/enrollment: $25 to 
$75   
• 30 days: $30 to $50  
Yes 

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This would increase the total amount possible 
for teens in group 1 to $225 and those in group 2 
to $195. 
 
2. Study clinicians: Addition of gift cards: 
• Site 1: Provide training materials and 
$15 gift card to clinicians for 
participating in a short, self-paced 
session to cover additional 
counseling tips. This is in lieu of 
hosting in-person session where 
refreshments would be provided 
• Site 2: Provide $10 gift card to study 
clinician each time they deliver a 
study counseling session as gratitude 
for the extra time and effort to 
perform study-related tasks during 
the pandemic. 
 
 
6 
04-08-22 
Compensation Update: 
 
For both sites (CMH and CHOP), the 
providers who provide counseling will be 
offered a $25 gift card payment if they 
choose to participate in a "semi structured 
interview," about how their 
thoughts/comments about the feasibility 
study. This language has been added to the 
end of both the CMH and CHOP verbal 
consent for the providers. All providers who 
are currently on the study or who were at 
any point of the study will be notified of 
these changes, as we would love any 
feedback about the study, if they choose to 
complete the semi-structured interview. 
These providers will be notified either in 
person or via a Microsoft Teams meeting if 
needed (to accommodate their schedules). 
Yes (For 
OPP 
verbal 
consent 
only) 
 
 
 

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Table of Contents 
1.0 
Study Summary ........................................................................................................ 5 
2.0 
Objectives ................................................................................................................ 7 
3.0 
Background .............................................................................................................. 7 
4.0 
Study Endpoints ....................................................................................................... 8 
5.0 
Study Intervention/Investigational Agent ................................................................ 9 
6.0 
Procedures Involved................................................ Error! Bookmark not defined. 
7.0 
Data and Specimen Banking .................................................................................. 15 
8.0 
Genetic Analysis Information ................................................................................ 15 
9.0 
Sharing of Results with Subjects ........................................................................... 15 
10.0 Study Timelines ..................................................................................................... 15 
11.0 Inclusion and Exclusion Criteria ............................................................................ 15 
12.0 Vulnerable Populations .......................................................................................... 17 
13.0 Local Number of Subjects ..................................................................................... 17 
14.0 Screening and Recruitment Methods ..................................................................... 17 
15.0 Reimbursement, Payment and Tangible Property provided to subjects ......... Error! 
Bookmark not defined. 
16.0 Withdrawal of Subjects .......................................................................................... 20 
17.0 Risks to Subjects .................................................................................................... 21 
18.0 Potential Benefits to Subjects ................................................................................ 21 
19.0 Investigator Assessment of Risk/Benefits Ratio. ................................................... 22 
20.0 Data Management and Confidentiality .................................................................. 22 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 23 
22.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 23 
23.0 Compensation for Research-Related Injury ........................................................... 24 
24.0 Economic Burden to Subjects ................................................................................ 24 
25.0 Permission/Assent/Consent Process ...................................................................... 24 
26.0 Process to Document Permission/Assent/Consent................................................. 25 
27.0 Setting .................................................................................................................... 25 
28.0 Resources Available............................................................................................... 25 
29.0 Multi-Site Research ............................................................................................... 26 
30.0 International Research ........................................................................................... 26 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Multi-level Intervention to Reduce Pregnancy Risk Among 
Adolescents:  A Feasibility Trial in the Emergency 
Department  
Study Design 
Randomized Clinical Trial 
This project will involve human subjects in a clinical trial 
conducted at Children’s Mercy (CM) and the Children’s 
Hospital of Philadelphia (CHOP). We will train advanced 
practice practitioners to deliver the contraception 
intervention to adolescents and both practitioners and 
adolescents will complete surveys after the intervention. 
After recruitment for the intervention is completed, we will 
conduct interviews with key stakeholders at each institution. 
CM will be the primary site and CHOP will ultimately seek 
reliance on our IRB. 
Primary Objective 
Conduct a randomized clinical trial to evaluate intervention 
feasibility constructs: acceptability, demand, 
implementation, practicality, adaptation, integration, 
expansion, and limited-efficacy. 
Secondary 
Objective(s) 
NA 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
We will evaluate our novel approach to increase access to 
contraception comparing our multi-level intervention (MLI) 
to enhanced standard of care (eSOC). All adolescents receive 
the MI-enhanced counseling and clinic referral. Those 
randomized to MLI will be offered immediate, ED-based 
contraception (i.e., oral pill, transdermal patch, vaginal ring, 
injection, subdermal implant) in addition to receive a warm 
referral (provider helping to schedule follow-up 
appointment) to follow-up on selected method (or to initiate 
in clinic, if preferred). Per usual care, eSOC participants may 
obtain contraception only at the referral. 
IND/IDE #  
NA 
Study Population 
Adolescents: Females (assigned at birth) aged 15-18 years 
who report past/anticipated intercourse with a male, do not 
desire pregnancy, and are not using hormonal 
contraception/copper IUD. 
Personnel: Study providers including advanced practice 
practitioners (APPs) and pediatricians, adolescent medicine 
specialists, and nursing/administrative leaders. 
Sample Size 
Adolescents: 98 (49 CMH/49 CHOP) 
Personnel: study providers = 30 (15 CMH/15 CHOP); other 
organizational personnel (OOP)  = 30 (15 CMH/15CHOP) 

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Study Duration for 
Individual 
Participants 
Adolescents: 6 months  
Personnel: Study providers will participate for the duration 
of training and adolescent recruitment; other personnel are 
involved only once in the study (about 60-90 minutes). 
Study Specific 
Abbreviations/ 
Definitions  
MLI = multi-level intervention 
eSOC = enhanced standard of care 
IUD = intrauterine device 
ED = emergency department 
APP = advanced practice practitioner 
OOP = other organizational personnel 
EMR = electronic medical record 
CHOP=Children’s Hospital of Philadelphia 
CM= Children’s Mercy  
 

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2.0 
Objectives 
Evaluate intervention feasibility constructs: acceptability, demand implementation, 
practicality, adaptation, integration, expansion, and limited-efficacy. We will 
conduct a small randomized trial to assess feasibility and use mixed-methodology to 
explore contextual factors at the patient, provider, and system levels. In evaluating 
limited-efficacy, we compare two arms (MLI vs. eSOC) to determine size of effect rates 
on contraception initiation. 
Hypothesis 1.1: The intervention will be deemed feasible by stakeholders: adolescents 
and organizational personnel (i.e., study providers, adolescent medicine specialists, 
hospital nursing and administrative leaders). 
Hypothesis 1.2: Adolescents in the MLI arm will have greater contraception initiation 
rates relative to the eSOC arm at 30 days after the index ED visit.  
 
3.0 
Background 
Unintended adolescent pregnancy is a major public health problem linked to pregnancy-
induced hypertension, low birthweight, and prematurity.1-2 In addition, adolescent 
pregnancies cost an estimated $9.4 billion annually.3-4 Though declining, U.S. rates 
remain among the highest in the developed world.5-7 Highly effective methods exist, but 
adolescents face unique, multi-level barriers to contraceptive access and use. 3-4 Thus, the 
vast majority of pregnancies are due to contraceptive non-use or incorrect use.5 Many, 
especially minority and uninsured youth, do not attend health maintenance visits;6 among 
those who do, 36 seconds is spent discussing sexuality and contraceptive use is not 
routinely assessed.6 Multi-level interventions to increase access to contraceptive 
counseling and all contraceptive types are desperately needed.7 
As adolescent access to affordable, confidential contraceptive care has worsened in recent 
years, one approach to increase access is to utilize non-traditional settings, such as 
Emergency Departments (EDs).7 The Society for Academic Medicine recognizes the ED 
as an “effective site for preventive care,” evidenced by organizational conferences, 
consensus statements, and specialized training opportunities to reduce disparities 
stemming from social determinants of health.8-11 Adolescents make 19 million ED visits 
annually, commonly for non-urgent or reproductive complaints; for many, this may be 
their only contact with a provider.12-14 Adolescents in the ED frequently report 
unprotected intercourse.25,40 The pregnancy risk index (PRI), an estimate of pregnancy 
risk in the subsequent 12 months, for adolescent females in two EDs was more than three 
times greater than the national average.15-16 Lacking a primary provider was associated 
with higher PRI scores. While the need for reproductive care is evident,17,18 the majority 
of ED-based studies have focused on screening for sexually transmitted infections (STIs) 
including HIV19-20 and a few, primarily single-site studies have reported on acceptability 
of hypothetical reproductive care.21,22-26 Among the few addressing pregnancy 
prevention, most focused on emergency contraception or increasing clinic referral, with 
mixed results.27,28-31 A small open trial provided counseling and clinic referral for those 
wanting to initiate contraception. Only 22% completed the referral and one was found to 
be pregnant at her first clinic visit.32 Lack of transportation was the most common reason 
for not completing referral. Because interventions to address multi-level barriers and 

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increase contraception access are sorely needed, we aim to evaluate the feasibility of a 
novel ED-based intervention, utilizing a mixed methods approach. 
Scientific Premise: Many adolescents in the ED are at high-risk of pregnancy yet 
accepting of reproductive intervention; however, no work describes best practices for 
ED-based contraceptive provision. Thus, we propose a randomized trial to evaluate MLI, 
which includes ED-based contraceptive initiation (i.e., oral pill, transdermal patch, 
vaginal ring, injection, or subdermal implant) vs. eSOC, for adolescents in two EDs 
utilizing medical providers in a collaborative care model. Thus, we use a rigorous 
framework from Bowen et al. to evaluate feasibility constructs (see Table 1 for construct 
definitions) among adolescents and organizational personnel (i.e., medical providers, 
adolescent medicine specialists, ED nursing and administrative leaders) in two unique 
EDs.33 
 
4.0 
Study Endpoints 
 
The primary endpoint will be the determination of feasibility. Methods for establishing 
feasibility vary and include levels of acceptability, satisfaction, or usefulness. Drawing on 
similar published criteria, the intervention will be deemed feasible if the average score 
across all items is ≥ 3 on closed-ended survey items for adolescents, providers, and OOPs 
(Table 1).   
 
Secondary endpoints will include the following:  
• 
The completion of a referral for any contraceptive care as assessed through EMR 
review or follow-up phone calls.  
• 
The initiation of contraception as assessed through EMR review or follow-up 
phone calls.   
• 
Saturation of themes from qualitative interviews that have been coded and 
analyzed.   
 
Hypotheses 1.1 and 1.2: To establish feasibility, we assess multiple constructs via 
survey items among all stakeholders (Table 1).  
Hypotheses 1.2: We will determine referral completion and date for contraception 
initiation (Time 0) via participant contact and review of study/medical records at 
thirty days after the index visit. 
Table 1: Mixed-Methodology Feasibility Assessment with Adolescent and 
Personnel Stakeholders  
Construct 
Source 
Index 
Visit: 
Post-
intervent
ion 
Time 
from 
Index 
Visit 
Time from 
Initiation (Time 
0) 
30 
Days* 
3 
mos* 
6 mos* 
Acceptability - How do stakeholders 
react to the intervention? 
Adolescent 
S 
 S 
 S 
S 
Providers 
S 
  
  
SSI 
Other personnel 
  
  
  
S, SSI 
Demand - To what extent is the 
innovation likely to be used? 
Providers 
  
  
  
S, SSI 
Other personnel 
  
  
  
S, SSI 

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Study/Medical 
Record* 
  
  
  
SMRR 
Implementation - To what extent can 
the intervention be implemented as 
planned (including intervention 
fidelity)? 
Providers 
S 
  
  
SSI 
Other personnel 
  
  
  
S, SSI 
Study/Medical 
Record* 
SMRR 
SMRR 
  
 
Practicality - What factors make 
intervention delivery challenging or 
facilitate delivery? 
Providers 
S 
  
  
S, SSI 
Other personnel 
  
  
  
S, SSI 
Study/Medical 
Record* 
  
  
  
SMRR 
Adaptation – How does model 
perform in new setting? 
Providers 
 
 
 
SSI 
Study/Medical 
Record* 
 
 
 
SMRR 
Integration - To what extent can 
model be integrated within the 
system? 
Providers 
  
  
  
S, SSI 
Other personnel 
  
  
  
S, SSI 
Expansion - To what extent can 
model be expanded to provide 
service? 
Providers 
  
  
  
S, SSI 
Other personnel 
  
  
  
S, SSI 
Study/Medical 
Record* 
  
  
  
SMRR 
Limited efficacy testing - What are 
rates of contraception 
initiation/continuation and referral 
completion? 
Adolescent 
  
S 
S 
S 
Study/Medical 
Record* 
SMRR 
  
  
SMRR 
Legend: S=Survey, SSI= Semi-Structured Interview, SMRR= Study/Medical Record Review *=+/- 10 days 
 *Additional assessments include proportion enrolled, drug interaction or contraindications, intervention 
fidelity and duration, length of stay (participants vs. non-participants), rates of contraception 
initiation/continuation/referral completion, cost estimates 
 
Data Sources: Sources include: surveys (via Research Electronic Data Capture – 
REDCap), semi-structured interviews, medical records, and study records (i.e., 
recruitment logs, interview transcripts, Providers/investigator field notes) (Table 1) 
 
5.0 
Study Intervention/Investigational Agent 
5.1 
The study intervention is the implementation of Emergency 
Department-based contraceptive counseling. A provider will 
provide this confidential, comprehensive, 10-15-minute counseling. 
The counseling will assess patients’ preferences regarding different 
methods, knowledge about methods, personal motivations, and 
environmental factors that may influence contraceptive use, such as 
partner preference.  After counseling is complete, enrolled subjects 
that have been randomized into the MLI group will have the 
opportunity to accept birth control and a referral for follow-up care.   
 
 
For Emergency Contraception  
Plan B (also called levonorgestrel) is taken by mouth by a woman to prevent 
pregnancy after she has already had unprotected sex. It is available over-the-
counter for any person to buy. Plan B has no serious or lasting side-effects and 
leaves the body within a few days. Some women (fewer than one in five) have 
mild and short-term side-effects, including irregular bleeding from the vagina, 
belly pain, being tired, nausea (feeling like you might throw up).  

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For hormonal contraception 
Many formulations of hormonal contraception exist including those with estrogen 
and progesterone combined (e.g., Sprintec, Ortho-Evra, Yaz).  The most common 
side effects from combination hormonal contraception are mild and include: 
irregular vaginal bleeding, breast tenderness, nausea, and mood changes. Serious 
adverse events may occur. Older women who smoke are at increased risk of 
myocardial infarction or stroke. There is no increased risk of myocardial 
infarction or stroke among healthy nonsmoking women who use the pill. Blood 
clots in the legs and elsewhere are slightly more frequent with contraceptive use, 
but the risk is very low, and lower than the increased risk of clotting that occurs 
with pregnancy. There is no increased risk of birth defects in babies born to 
women who have taken hormonal contraception while pregnant, but a woman 
should not use hormonal contraception if she is pregnant. 
Medroxyprogesterone acetate: The most common side effects from DMPA are 
mild and include: irregular menstrual cycles, cessation of menstrual periods, 
headache, and weight gain. Serious adverse events may occur. Use of DMPA may 
cause loss of bone mineral density, which may lead to an increased risk of 
developing osteoporosis. The decrease in bone calcium is most concerning if the 
patient has bone disease, family history of osteoporosis, or anorexia nervosa. 
Older women who smoke are at increased risk of myocardial infarction or stroke. 
There is no increased risk of myocardial infarction or stroke among healthy 
nonsmoking women who use the pill. Blood clots in the legs and elsewhere are 
slightly more frequent with contraceptives, but the risk is very low, and lower 
than the increased risk of clotting that occurs with pregnancy. There is no 
increased risk of birth defects in babies born to women who have taken hormonal 
contraception while pregnant, but a woman should not use hormonal 
contraception if she is pregnant. 
Ortho Evra and Xulane (Norelgestromin/ethinyl estradiol) is birth control patch 
that works by stopping ovulation. It may also change cervical mucus to prevent 
the sperm from reaching the egg and change the lining of the uterus to prevent a 
fertilized egg from implanting in the uterus. Side effects can include: breast 
tenderness or enlargement; headache; menstrual cramps; mild fluid retention or 
weight gain; mild skin irritation at the application site; nausea; stomach pain, 
cramps, or bloating; vaginal spotting or breakthrough bleeding; vomiting. 
NuvaRing (ethinyl estradiol and etonogestrel) is a birth control vaginal ring that 
contains female hormones that stop ovulation (the release of an egg from an 
ovary). This medicine also causes changes in the cervical mucus and uterine 
lining, making it harder for sperm to reach the uterus and harder for a fertilized 
egg to attach to the uterus. Side effects may include: headache; vaginal irritation 
or discharge, cervical pain; menstrual cramps; mood changes, decreased sex 
drive; nausea, vomiting, stomach pain; breast pain or tenderness; acne; or weight 
gain. 

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The most common side effects from subdermal implants include changes in 
menstrual bleeding patterns; headaches; vaginitis; weight gain; acne; breast pain; 
viral infection such as sore throats or flu-like symptoms; stomach pain; painful 
periods; mood swings, nervousness, or depressed mood; back pain; nausea; 
dizziness; pain and pain at the site of insertion.  
For Non-Hormonal Contraception 
Common side effects for non-hormonal contraception (Copper IUD, Phexxi) 
include irritation, dryness and/or allergic reactions.   
 
Risk of emotional distress: Participants may experience increased stress over the 
sensitive survey questions. However, we feel this risk is minimal and we have 
included information in the consent process that reminds participants that they are 
not required to answer questions that make them feel uncomfortable. In the 
emergency department, there are always advocates available for patients and 
families, if needed, including health care providers, social workers, and patient 
advocates. In this study setting, if a participant expresses a concern or need that is 
outside of the scope of this project (e.g., sexual assault), we will refer those 
participants back to their ED treating team, as is our standard practice. During the 
consent process, we will inform participants that most of the information they 
share during the study will be kept confidential except in rare cases where their 
safety is at risk or mandated reporting is in effect 
5.2 
To decrease risk of serious adverse events, we will follow 
regulations and recommendations in accordance with the Food and 
Drug Administration. We will prescribe the dosage regimen which 
contains the least amount of estrogen and progesterone that is 
compatible with a low failure rate and the needs of the individual 
patient. We will screen participants for predisposing conditions 
and duration of previous DMPA use. Women with these conditions 
should not use hormonal contraceptives: women with stroke or 
blood clot, circulation problems (especially if caused by diabetes), 
a hormone-related cancer such as breast or uterine cancer, 
abnormal vaginal bleeding, liver disease or liver cancer, severe 
high blood pressure, migraine headaches, or a heart valve disorder. 
Further, DMPA should not be used as a long-term method (i.e., 
longer than 2 years) unless other methods are considered 
inadequate. 
5.3 
Participants will be advised of all potential adverse events and 
instructed to seek care if symptoms develop or they have concern 
about such an event. In the case of illness or injury resulting from 
this study, treatment is available at CM or CHOP, and can be 
provided at the usual charge. Participants may also see care at the 
hospital-affiliated Title X Clinic, which provides reproductive care 
at reduced cost. 

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6.0 
Procedures Involved 
 
We propose a randomized trial of our contraceptive counseling intervention (MLI 
vs. eSOC) with mixed methods feasibility evaluation at patient, provider, and 
system levels. Feasibility constructs are: acceptability, demand, implementation, 
practicality, adaptation, integration, expansion, and limited-efficacy. 
Using an electronic board that tracks patient data in real time, the research study 
staff will identify and enroll adolescent participants (N=98) before they meet with 
a provider. Due to possible COVID precautions, research staff will have the 
capability of recruiting patients remotely.  Consenting and the study visit will take 
place on the same day of enrollment during the patients ED visit.  If necessary, a 
member of the research team may call into the patient room via Microsoft Teams 
or CMH office phones to contact the patient up to five times.  Follow up surveys 
at thirty-days, three months, and six months are administered via REDCap and 
may be sent through Twilio or e-mail.  Members of the research team may also 
call participants up to five times to administer the surveys verbally using either 
Microsoft Teams or CMH phones.   
We will use a care model demonstrated as best practice in clinic-based settings36 
and train providers using adapted materials publicly available (e.g., slide decks, 
written materials).37-40 Adaptations are needed for vulnerable adolescent 
populations that are mindful of coercion and will include use of brief Motivational 
Interviewing (MI) strategies to facilitate autonomy and focus on patient 
preference. MI training for providers will focus on these skills: open questions, 
reflective listening, and pulling for change talk.41-45 Providers will receive nine 
hours of training (e.g., prescribing, adolescent-centered counseling, technology) 
and demonstrate competency (mean fidelity score ≥3, appendix 1) prior to 
continued recruitment. 
As adolescents mature along different trajectories, we plan open-ended questions 
to ask about intention, experiences (self/referents), and contraceptive qualities. 
Given that many in our ED reported relationship abuse, we will use a trauma-
informed approach (i.e., realize, recognize, respond, resist re-traumatization) to 
foster collaboration, explore safety, and offer harm reduction strategies.48-49 We 
will help participants 1) map information onto values and lifestyle, and 2) 
anticipate and  solve problems, including identification of a trusted adult. We will 
address risk misperceptions use visual aids, and counsel dual protection with 
condoms. Based on our work and others, providers will provide 10-15 minutes for 
counseling; this is easily integrated into most ED visits.  Counseling sessions will 
occur after patients have completed triaging, without interrupting the evaluation 
of standard of care services.   
Providers will also have access to educational material, which can be distributed 
to adolescents randomized in MLI arm.  These documents include the following:  
FDA Approved factsheets (Ring, Pill, Patch, Mini Pill, Progestin IUD, Implant, 
Non-Hormonal Gel, Emergency Contraception, and Depo), Switching Birth 

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Control, IUD Facts, Implant Facts, Contraception Choices, and CMH Clinic 
Hours and Locations.  The contraception handouts that are being provided will 
help to provide further clarifications regarding medication effectiveness, 
adherence instructions, as well as medication side effects.   
C6eii. Adolescent Randomization and Treatment: Randomization will be in a 1:1 
ratio. Due to potential influence of previous contraception use on uptake, we will 
use block randomization with randomly selected blocks of 4 or 8 to balance 
allocation of those with previous use equally between arms.48  Dr. Staggs will 
create the master randomization list for both Children’s Mercy and Children’s 
Hospital of Philadelphia, placing each assignment in a sealed envelope numbered 
sequentially from 001.54 Participant IDs will be assigned beginning with 001. 
After consent, a research assistant will open the corresponding envelope to carry 
out the arm assignment, notifying the providers before counseling is completed. 
All participants receive contraceptive counseling. Per evidence-based 
guidelines,52-53 MLI participants can receive contraception (one injection, three-
month supply of pill/patch/ring, or subdermal implant) in the ED, or prescription 
for another method if desired. If a patient in this group desires another method 
that is not being covered by the study, patient will be made aware of their 
responsibility to cover the cost of the medication either out of pocket, or by using 
their own insurance.  Due to credentialing and staffing constraints, intrauterine 
devices will only be available at referral clinics.  MLI participants who want to 
initiate contraception must complete a urine pregnancy test, which must be 
negative. MLI participants who initiate contraception will be given a take home 
pregnancy test that is to be completed two weeks after enrollment.  eSOC 
participants will have the opportunity of being referred to a follow-up 
appointment to discuss and begin contraception.   Subjects in this group will not 
begin contraception in the Emergency Department or given a prescription.  All 
participants will be referred to an adolescent gynecologist, hospital-affiliated 
adolescent clinic, or Title X clinic for additional care and to initiate or follow-up 
on contraception.  
MLI participants will have a “warm transfer” to follow-up on or initiate, if 
preferred, selected method. Warm transfers occur with the assistance of a provider 
scheduling the follow-up appointment.  Doing this in such a way should help to 
minimize barriers with navigating the healthcare system.  The provider will share 
detailed clinic information including hours of operation and contact the receiving 
site. We will assist with scheduling (sending multiple reminders) and 
transportation. eSOC participants will be given printed information on clinics. 
C6eiii. Intervention Fidelity: Counseling sessions will be audio-recorded and 
reviewed periodically to ensure for fidelity to content and use of MI strategies 
using a tool adapted from our previous work and the CHOICE Project, a clinic-
based intervention efficacious for increasing contraception uptake in family-
planning clinics.54-55 We will provide feedback to individual APPs if mean fidelity 
score ≤ 3.  
 
6.1  

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Prior to adolescent patients being enrolled, providers will be enrolled to 
participate in the study.  Providers will be trained on motivational 
interviewing practices, contraception methods, as well as medication 
ordering practices.   
Research team staff will screen potential study candidates via electronic 
tracking board. The research team will approach patients to ensure that 
they meet qualifications for the study.  If qualifications are meet, the 
research team will provide consent/assent to the patient, conduct a pre-
counseling survey, then notify a study provider of study status.  Once the 
subject has been enrolled, the study provider will provide contraception 
counseling, while incorporating motivational interviewing techniques. 
Counseling sessions will be audio recorded and analyzed periodically for 
fidelity. At the completion of counseling, the study provider will offer the 
participant various contraception options and incorporate warm-referral 
practices to encourage follow-up at a local health clinic.  The subject and 
provider will complete the Adolescent Post-Counseling Survey via 
REDCap at the end of their initial enrollment .  
Immediately after the initial enrollment and at thirty-days post 
intervention, the research team staff will conduct a medical chart review.  
At thirty days, three months and six months post-intervention, a follow-up 
survey will be sent to the participant.  OOP and provider staff will 
participate in semi-structured interviews that can be completed either in-
person, virtually, or via telephone at 6-months to evaluate the feasibility of 
the study.   
 
6.2  
To help ensure the safety and validity of this study, we will ensure that 
provider staff are properly trained prior to enrollment.  Training sessions 
will cover interviewing techniques, contraception, and ordering practices.   
Members of the study team will also review audio recordings periodically 
for intervention fidelity.   
6.3  
Prior to approaching an adolescent participant, research team members 
will view the medical chart to ensure eligibility.  Team members will look 
for the following, date of birth, custody status, and current contraception 
usage.  In the post-intervention medical chart review, team members will 
look to see if a follow-up visit had been completed, and it so, if any 
services were obtained. 
Surveys from adolescent participants will assess attitudes towards 
contraception, pregnancy prevention methods, perceived risk of 
contraception, and barriers to follow-up care. 
6.4   

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Enrolled adolescents will receive follow-up surveys at 30-days, 3-months, 
and 6-months after their initial enrollment at their ED visit.  The questions 
asked will assess subjects’ attitudes towards contraception methods, 
access to care, and contraception efficacy.  Enrolled patients may 
complete the survey over the phone with a member of the research team.  
A link may also be sent via text messaging using Twilio or other approved 
messaging system or to their email address.   
7.0 
Data and Specimen Banking  
 
No data or specimens will be retained or banked used for future use. 
 
8.0 
Genetic Analysis Information NA 
 
 
9.0 
Sharing of Results with Subjects NA 
 
 
10.0 Study Timelines 
 
Timeline 
 
Year 1 
Year 2 
Prepare study materials 
X 
 
 
 
 
 
 
 
Provide all Provider training and booster 
 
X 
 
X 
 
 
 
 
Recruit adolescents 
 
 
X 
X 
X 
 
 
 
Complete adolescent follow-up (electronic 
medical record/surveys) 
 
 
 
X 
X 
X 
X 
 
Conduct semi-structured interviews 
 
 
 
 
X 
X 
 
 
Perform data analysis and write 
manuscripts 
 
 
 
 
X 
X 
X 
X 
 
We will conduct training for our study providers.  We anticipate that adolescent 
recruitment will begin around month 6. We anticipate reaching our enrollment goals 
within 6 months, as described in the recruitment plan. We plan for adolescent follow-up 
into year 2. Semi-structured interviews will begin after all adolescents have been enrolled 
and qualitative data analysis begins as soon as the first interviews are completed. 
Duration of individual subject’s participation 
Adolescents: 6 months  
Personnel: Study providers will participate for the duration of training and adolescent 
recruitment; other personnel are involved only once in the study (about 60-90 minutes). 
 
11.0 Inclusion and Exclusion Criteria 
 

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Study APPs  
Inclusion Criteria  
1. Work in the Emergency Department 
2. Are interested in participating in study procedures 
Exclusion Criteria 
      1.   Because they often lack organizational familiarity and may be temporarily     
 
working in the ED, providers in training will be excluded.   
      2.   AP provider who were otherwise eligible, but have declined to participate in 
 
training activities.  
 
Adolescents  
Inclusion Criteria 
1. Females aged 15-18 years who are at risk of pregnancy, defined as those who 1) 
report previous sexual activity or intent to be sexually active with a male partner 
in the next few months, 2) do not desire pregnancy within the next year, and 3) 
are not currently using hormonal contraception or copper IUD.   
2. Eligible individuals must be comfortable speaking in English 
Exclusion Criteria 
1. Females who are currently using hormonal contraception or the copper 
intrauterine device 
2. Females who report current pregnancy or have positive urine pregnancy test 
3. Patient has a developmental delay limiting participation 
4. Patients is presenting in the ED after sexual assault  
5. Patient is too ill to be screened 
6. Minor adolescent who is ward of the state is eligible to enroll for the study but 
may not be eligible for Nexplanon insertion (if desired) unless proper parental or 
legal guardian permission is obtained (Nexplanon insertion is not available 
without parental or legal guardian permission due to hospital guidelines.   Without 
the proper consent, wards of the state may opt for another form of contraception) 
7. Patients who receive contraceptive medications as part of their Emergency 
Department clinical care (e.g., treatment for heavy menses). 
 
Other Organizational Personnel 
Inclusion Criteria  
1.  Employed at CM or CHOP with experience or expertise in hospital administration, 
adolescent medicine, or clinical care 
2.  Are interested in participating in study procedures 
Exclusion Criteria 

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      1 .   Provider/staff who were otherwise eligible, but have declined to participate in 
training activities. 
 
12.0 Vulnerable Populations 
 
We will make it clear during the Provider consent process that participation is entirely 
voluntary. The decision to participate or not will not affect their current or future 
relationship with CM or CHOP. If a provider decides to participate, they may withdraw 
from the study at any time without affecting their employment status. They may skip any 
questions they do not feel comfortable answering. Drs. Miller and Mollen have 
established relationships with ED Providers and have collaborated on similar projects in 
the past. 
 
To participate in this research study, adolescent participants must be between the 
ages of 15-18 years of age.  Local state contraception laws enables adolescents to 
have capabilities to make decisions regarding their own contraception care.  
Because of this, the research team is requesting a waiver of parental permission in 
order to help maintain confidentiality for patients. Adolescents will be provided as 
much time as they want to make their decision.  
13.0 Local Number of Subjects 
 
13.1 There will be up to 98 total adolescent participants we expect to 
enroll between each site.  49 subject participants will enroll from 
CM and CHOP.   
Up to 30 other professional participants will be eligible to enroll in 
the study.   
13.2 Screening for adolescent participants will take place via electronic 
tracking board.  Using that, study staff will have the capability of 
selecting viable subjects who meets the qualifications of the study.  
Once approached, potential subjects have the option of refusing to 
continue participation in the study.    
14.0 Screening and Recruitment Methods 
 
Adolescent subjects will be recruited from the Emergency Departments of 
Children’s Mercy Adele Hall and Children’s Hospital of Philadelphia 
Emergency Departments.  Research staff will evaluate for potential patients via 
electronic tracking boards.  Recruitment for adolescent subjects will take place 
while patients are within the Emergency Department.  Once a subject is deemed 
potential eligible, research staff will approach a patient to ensure eligibility, 
provide informed consent, and continue with study procedures. Patients will be 
approached after they have become admitted in the Emergency Department 
from triage.  Parents and patients will be told basic information regarding 
research at Children’s Mercy, and parents will be asked to step out of the room 

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to further discuss details of the study.  If any parent refuses to step out of the 
room, the research team will not be allowed to continue in their recruitment 
efforts for that patient. Once a patient decides that they would like to continue 
with screening for the study, they can also decide if they would like to have 
their parent to participate in the study. If a patient refuses to participate, basic 
demographics including age and race as well as their reasoning for refusal will 
be tracked in the REDCap Refusal survey.  The research team will also track the 
participant and language preference.  Understanding this information will 
generate a better understanding a patient needs for future research studies.  This 
information will be used for data analysis purposes.   
Study providers and OOP will be recruited via word of mouth, email, workplace 
OOP Recruitment e-mail and flyer.   
A screening log will be used to maintain records for screening and eligibility 
purposes.  The screening log will maintain minimal PHI such as the patients 
age. 
Adolescent subjects will be approached once for recruitment. 
Study providers and other personnel may receive more than one communication 
about study participation as we will use email and workplace announcements 
and postings to facilitate recruitment. 
We are requesting a Waiver of HIPAA Authorization based on the following: 
1) Description of the PHI for which use or access is necessary for recruitment: 
see PHI chart below 
2) The use or disclosure of PHI involves no more than minimal risk to the 
privacy of individuals based upon the following: 
a. Plan to protect PHI from improper use and disclosure: All PHI will be 
accessible by the study team.  All storage units will be password protected 
(Cerner and REDCap) and devices will be stored in locked cabinets within 
the research team office. 
b. Plan to destroy PHI at the earliest opportunity, unless there is a health or 
research justification for retaining the PHI: Study related PHI will be 
maintained throughout the completion of enrollment and data analysis.  
Information will later be kept and destroyed in accordance with Children’s 
Mercy records retention requirements. 
c. Assurance that PHI will not be reused or disclosed to any other person or 
entity:  PHI will only be accessed by study team personnel and Good 
Clinical Practice guidelines will be followed in order to ensure that 
information will not be disclosed to unauthorized persons. 
3) Reason why the research cannot practicably be conducted without the waiver:  
Without the waiver, obtaining parental consent compromises validity of 
responses from subjects, as well as patient rights to privacy regarding 
reproductive health services.   

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4) Reason why the research cannot practicably be conducted without access to 
and use of the PHI:  This study requires the research team to notate and access 
qualifying information such as age, personal health information, and date of 
birth. 
 
*PHI chart: 
1. Name/Initials 
  Accessed only 
  Recorded 
2. All elements of date (except year) directly 
related to an individual (e.g., date of birth, 
admission date, discharge date, date of death) 
  Accessed only 
  Recorded 
3. Medical record number 
  Accessed only 
  Recorded 
4. Account number 
  Accessed only 
  Recorded 
5. Health plan identification number 
  Accessed only 
  Recorded 
6. Social Security Number 
  Accessed only 
  Recorded 
7. Device identifiers and serial number 
  Accessed only 
  Recorded 
8. Certificate/License number 
  Accessed only 
  Recorded 
9. Telephone number 
  Accessed only 
  Recorded 
10. Fax number 
  Accessed only 
  Recorded 
11. Email addresses 
  Accessed only 
  Recorded 
12. Web addresses (URLs); Internet IP addresses 
  Accessed only 
  Recorded 
13. Street address, city, county, precinct, zip 
code or equivalent geographical codes 
  Accessed only 
  Recorded 
14. Full face photographic images and any 
comparable images 
  Accessed only 
  Recorded 
15. Biometric identifiers, including finger and 
voice print 
  Accessed only 
  Recorded 
16. Vehicle identifiers and serial numbers, 
including license plate number 
  Accessed only 
  Recorded 
17. Any other unique identifying number, 
characteristic or code that may help identify 
individual participants including their initials 
(e.g., student or employee ID number) 
  Accessed only 
  Recorded 
18. Elements of date, including year, for persons 
90 years or older 
  Accessed only 
  Recorded 
 
We will be collecting minimal PHI for data collection purposes.  This information will be 
recorded on a screening log and submitted in REDCap at the end of the screening day.  
REDCap will be used to collect all identifiable information and only accessible to 
members of the research team.  The screening logs will be locked in a secured location 
only accessible by the research team and destroyed at the end of the study.   
Without the waiver, parents/guardians may have access to confidential 
information with may compromise the integrity of the study.  Requesting this, will 
provide the opportunity to proceed with study procedures, while remaining 
HIPPA compliant.   

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15.0 Reimbursement, Payment and Tangible Property provided to 
subjects 
 
Study providers will be compensated their normal hourly rate for completing study 
related training activities. A one time electronic gift card of $15.00 would be given to 
CMH clinicians for participating in a short, self-paced session to cover additional 
counseling tips. Clinicians at CHOP will be provided a $10 gift card each time they 
deliver a study counseling session for their effort to perform study specific tasks during 
the pandemic. Compensation for participation will be considered taxable income.  OOPs 
will not be compensated. For both sites (CMH and CHOP), the providers who 
provide counseling will be offered a $25 gift card payment if they choose to 
participate in a "semi structured interview," about how their thoughts/comments 
about the feasibility study. This language has been added to the end of both the 
CMH and CHOP verbal consent for the providers. 
 
 
Study related training activities 
Additional Gift Card 
Site 1: CMH 
Clinicians 
normal hourly rate 
$15 for the additional counseling session 
(one-time) 
Site 2: CHOP 
Clinicians  
normal hourly rate 
$10 for each study counseling session 
delivered 
 
 
 
Adolescents: Payment will be received on a gift card.  After the completion of each study 
point, adolescent subjects will receive additional payments as indicated in the table 
below. 
 
 
 
Post 
Intervention/ 
Enrollment 
2-wks 
pregnancy test 
(Group 1 
only) 
30-Days 
3-months 
6-months 
Maximum 
compensation 
Group 1 
$75 
$30 
$50 
$30 
$40 
$225 
Group 2 
$75 
---- 
$50 
$30 
$40 
$195 
 
 
16.0 Withdrawal of Subjects 

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All subjects may withdraw from the research study at any time.  If they would like 
to withdraw, they are asked to notify any member of the research team 
immediately.  
If an adolescent, study provider, or OOP withdraws from the study, any data 
collected will be kept and deidentified for analysis purposes.   
17.0 Risks to Subjects 
 
Providers/OOP: Risks to study providers/OOPs will likely be minimal as they are 
receiving contraceptive training and completing brief surveys to share their perceptions. 
There is minimal risk of loss of confidentiality which will be explained during consent. 
 
Adolescents: Using the various birth control methods can cause minimal side 
effects that are listed in Section 5 of this document and will be described during 
the consent process.  We will follow best practice guidelines for administering 
and prescribing medications. 
Risks to participants are anticipated to be minimal. ED patients with severe illness 
or who experienced sexual assault will be excluded from this study to minimize 
the physical and emotional harm to study participants. Counseling sessions will be 
administered by trained providers in a confidential setting to avoid emotional 
discomfort to participants when discussing sensitive matters. There is minor risk 
of variance of counseling content, but this will be avoided by extensive training 
that will be provided to the providers by an adolescent family planning expert at 
each site. Counseling sessions will be continuously reviewed for quality. 
Additionally, there is minor risk of unauthorized disclosure of confidential 
information, which will be made known to participants and will be minimized by 
the research team’s efforts to ensure confidentiality. Every effort will be made to 
keep data coded. All recruitment materials (e.g., signed consent forms) and 
information linking unique identification numbers to participant names will be 
stored in password-protected electronic files within REDCap. Only Dr. Miller and 
designated study staff will have access to these files. Risks are greatly reduced by 
using secure files, storing data on secure computers, and coding of data. Patients 
may choose not to participate. 
As with any study involving collection of data, there is a possibility of breach of 
confidentiality of data.  There is also a risk to confidentiality when using the 
internet or a mobile network.  Corresponding through email and text messaging is 
not a secure method of sending information and others may be able to access the 
information sent.  Every precaution will be taken to secure participants’ personal 
information.   
18.0 Potential Benefits to Subjects 
 
Study providers may benefit from additional training in contraception counseling. 
Adolescent participants may benefit from learning about birth control methods 
and ways to reduce their risk of unintended pregnancy.  

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Findings of this study could contribute to a reduction in unintended pregnancies 
among adolescents. The data obtained through this study may be used to inform 
new guidelines for adolescent-centered contraceptive services, which could offer 
benefits for adolescents in the future. The minimal risks of participation are 
reasonable in relation to these generalizable benefits. 
19.0 Investigator Assessment of Risk/Benefits Ratio: (IRB makes the 
final determination) Based upon your response in Sections 17.0 and 18.0, 
please provide your assessment of risk and benefits in below table. 
 
 
Select as applicable: 
Pediatric Risk Category: 
x 
Category 1  Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
Select if applicable: 
Adult Risk Category: 
☒ 
Not Greater than Minimal Risk 
☐ 
Greater than Minimal Risk 
 
As there is no more than minimal risk to study participation, and potential for minimal 
direct benefits and significant indirect benefits, we feel that the benefit outweighs the risk 
of participation. 
 
20.0 Data Management and Confidentiality 
 
Participants will be informed that their participation in all aspects of the proposed study is 
entirely voluntary, and that they are free to withdraw at any time. Strict measures will be 
taken to ensure participant privacy and confidentiality. All data will be coded and then 
stored in the secure REDCap database, and all participants will be assigned a unique 
identification number. The master list linking identification numbers to identifying 
information will be stored separately from the study database. All personally identifiable 
information will be kept strictly confidential and stored in an encrypted document, on a 
dedicated research server only accessible by Dr. Miller and the designated study staff. 
Contact information for the study team will be included on consent forms to allow 
participants to ask questions or raise concerns about the study. Should any specific 
concerns arise, the study team would intervene to address problems including, if needed, 
a change or discontinuation of study procedures. The mentor team and site IRB’s will be 
informed of any concerns, and the IRB and NIH will be informed of any adverse events. 
 
Secure Storage of Data 
Records to be kept and Secure Storage of Data:  Survey development, data collection and 
handling will be conducted through Children’s Mercy’s REDCap Research software.  
The Redcap database is protected by Gazzang's zNcrypt product. zNcrypt transparently 
encrypts and secures data at rest without any changes to your applications or database and 
ensures there is minimal performance lag in the encryption or decryption process. 
Advanced key management and process-based access controls enable organizations to 
meet compliance regulations and ensure unauthorized parties or malicious actors never 

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gain access to the encrypted data. zNcrypt meets compliance for HIPAA, PCI-DSS, 
FISMA, EU Data Protection, and more. 
Data will be exported from REDCap to statistical programs for analysis (i.e. SAS, SPSS, 
Excel.) All data will be securely stored on password-protected servers. 
 
20.1 A Certificate of Confidentiality has been granted for this study 
because it is funded by the NIH 
20.2 Audio data for study provider interviews will be periodically 
checked to ensure fidelity of the study.   
Study data and information will be kept according to CM Record 
Retention guidelines.   
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
We will convene a Data Safety Monitoring Board comprised of experts in 
adolescent reproductive health, health services research, and public health that are 
not connected to this project or to our Institutions. The Board will meet regularly 
to monitor participant safety and assess study progress and will be available to 
meet on an ad hoc basis if an immediate safety concern arises. 
22.0 Provisions to Protect the Privacy Interests of Subjects 
Study staff will take greatest measures to protect the privacy of research subjects.  
All data collected will be deidentified for data analysis purposes.  Participants will 
be assigned a study number. Surveys will be completed confidentially and will 
not contain identifying information. Contact information will be recorded 
separately, via a separate REDCap data collection tool.  PHI to be accessed and 
recorded will include medical record number, date of birth, address, and phone 
number.  
All data will be managed in accordance with hospital institutional review board 
and HIPAA requirements to ensure confidentiality and protection of research 
participants. The Investigator and other site personnel will not use such data and 
records for any purpose other than for conducting the study.  Human subject’s 
names will be kept on a password protected database and will be linked only with 
a study identification number for this research.  There are no patient identifiers 
recorded in the research record. All computer entry and networking programs will 
be done using study identification only.  All data will be entered into a computer 
that is password protected.  Clinical information will not be released without 
written permission of the subject, except as necessary for monitoring by IRB, the 
FDA, the OHRP, the Sponsor, or the Sponsor’s designee.  Data will be stored in a 
locked office of the investigators and maintained for a minimum of three years 
after the completion of the study. 
The consent for the study will encompass the contraceptive counseling and 
follow-up call or text and medical record review to assess the primary and 
secondary outcomes. All participants will be given the opportunity to ask 
questions and decline participation. Completed consent documentation will be 

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signed and dated by the designated study staff, and a copy will be provided to the 
participant.  
23.0 Compensation for Research-Related Injury 
 
Provider/OOP: Research-related injury would be highly unlikely and there will be no 
compensation for research-related injury. If study providers feel they need to receive 
care, they will need to obtain it on their own. 
 
Adolescents: Being in this study involves no more than minimal risk, therefore we 
do not require compensation for research-related injuries.   
 
Economic Burden to Subjects 
 
Training for providers will be provided free of cost and there should be no additional 
economic burden to study providers. 
A 3-month supply of non-LARC study related medications, plus 1 etonogrstrel 
implant for adolescents in the MLI will be provided free of charge.  Urine 
pregnancy testing will be provided free of charge if not already included in usual 
ED care for adolescents.  
Adolescents must provide their own transportation for any medical follow-up 
visits that may be needed.  If an adolescent decides to begin a method of 
contraception, follow-up care may be sought at a local Title X clinic or any 
medical facility preferred by the adolescent and adolescents will be responsible 
for any out-of-pocket expenses which may be incurred.    
24.0 Permission/Assent/Consent Process 
Providers: A study team member will obtain providers’ verbal informed consent 
for study procedures. 
 
OOP: A study team member will obtain verbal consent for study procedures (i.e., 
semi-structured interview). 
 
Adolescent: If eligible, a study team member will obtain the adolescent patient’s 
informed consent if they are 18 years of age or assent if they are less than 18 
years of age for the study procedures. HIPAA Authorization will be obtained as 
part of the consent procedures. Study team members will verify with the clinical 
care team that the patient has the capacity to consent/assent.  
For both sites, subjects who are 18 years old will provide written consent and 
HIPAA authorization for their own participation. For all minors, we will request a 
waiver of parental permission and waiver of HIPAA authorization and the minor 
will provide assent for their own participation. Minors may elect to have their 

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parent or legal guardian involved in the consent process, if desired. All parents of 
minor patients who are present in the ED will receive an information sheet that is 
available in English and Spanish about the study and have the opportunity to state 
that they would not like for their child to participate in the study prior to 
participant assent procedures. Though the parent information sheet will be 
available in English or Spanish, only English-Speaking patients will be recruited 
for the intervention.  
A waiver of parental permission is requested for participants under 18 years of 
age as this study is no more than minimal risk and could not be practicably carried 
out without a waiver. Finally, the waiver or alteration will not adversely affect the 
rights and welfare of the subjects. Given that teen subjects may not want to 
involve their parent in a study about their reproductive health, it would not be 
reasonable to require permission from a parent or legal guardian to discuss study 
information with the minor, and mechanisms are in place to protect the children. 
The adolescents will be asked to provide assent. We will follow best practice 
guidelines established for adolescent participation in sexual health research. For 
any adolescent who desires placement of a subdermal contraceptive implant, we 
will follow established clinical practice at each site and obtain written consent 
from the procedure from the participant (if aged 18 years) or a guardian (for 
minor participants).  
Process to Document Permission/Assent/Consent 
Staff at each site will follow institutional standards for documentation. 
Documentation will be stored in a secured setting only accessible to study staff.   
25.0 Setting 
Research will take place within Children’s Mercy Adele Hall campus and the 
Children’s Hospital of Philadelphia. Most of the study procedures will be 
conducted in the emergency department. 
26.0 Resources Available 
 
Providers: Study team members and leaders will be readily available by email and in-
person to resolve any issues that arise. The leadership teams representing the ED 
Providers also support this project and are available to provide assistance if needed. 
 
Adolescents: Participants are not required to answer questions that make them feel 
uncomfortable. In the emergency department, there are always advocates available for 
patients and families, if needed, including health care providers, social workers, and 
patient advocates. In this study setting, if a participant expresses a concern or need that is 
outside of the scope of this project (e.g., sexual assault), we will refer those participants 
back to their ED treating team, as is our standard practice. During the consent process, we 
will inform participants that most of the information they share during the study will be 
kept confidential except in rare cases where their safety is at risk or mandated reporting is 
in effect. 
 

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27.0 Multi-Site Research 
Drs. Miller and Mollen have a detailed plan for study oversite that was reviewed and 
approved by the NIH. Communication between study sites will take place via conference 
calls and emails.  Regular conference calls will take place to discuss study updates, 
discuss any potential barriers and concerns and discuss other study logistics.  Our 
estimated recruitment plan is detailed in the table below.  
 
 
CMH 
CHOP 
Total  
Providers 
Approximately 
30 
Approximately 
30 
60 
Adolescents 
49 
49 
98 
Other personnel 
15 
15 
30 
Total 
74 
74 
158 
   
 
28.0 International Research NA 
 
 
 

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1. 
Madden T, Mullersman JL, Omvig KJ, Secura GM, Peipert JF. Structured 
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2. 
Miller MK, Champassak S, Goggin K, Kelly P, Dowd MD, Mollen CJ, Humiston 
SG, Linebarger J, Apodaca T. Brief behavioral intervention to improve 
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3. 
Walton MA, Chermack ST, Shope JT, Bingham CR, Zimmerman MA, Blow FC, 
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Miller MK, Mollen CJ. Critical Access to Care: Bringing Contraception to 
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Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken 
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