Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02475980 |
| Other study ID # |
14-248 |
| Secondary ID |
3RX15 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 12, 2015 |
| Last updated |
October 27, 2015 |
| Start date |
February 2015 |
| Est. completion date |
July 2015 |
Study information
| Verified date |
June 2015 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this pilot study is to determine the feasibility of comprehensive
contraceptive counseling intervention in a pediatric emergency department and to determine
the impact of comprehensive contraception counseling on initiation of contraception among
sexually active adolescents presenting to a pediatric emergency department.
Description:
Adolescent pregnancy is a crippling problem. Despite declines in adolescent birth rates,
adolescent pregnancies cost taxpayers a staggering $9.4 billion in 2010. New Mexico has one
of the highest rates of adolescent pregnancy in the country.(1) In New Mexico, nearly 1 in 5
adolescent females are not using any form of contraception.(2) Long-acting reversible forms
of contraception, including the subdermal contraceptive implant known as Nexplanon, are
increasingly popular among adolescents. Nonetheless, despite an increase from 0.3% in 2000
to 4.5% in 2013, few adolescents using any contraception are using a long-acting reversible
form.(1) The American College of Obstetricians and Gynecologists issued a policy statement
in late 2012 recommending long-acting, reversible forms of contraception as first line
contraception for adolescents.(3) Long-acting, reversible forms of contraception are highly
effective at preventing pregnancy and have rates of continuation among adolescents
comparable to older women.(4) Prior studies of adolescents have demonstrated that cost,
access, and education are the primary barriers to initiation of long-acting reversible forms
of contraception and that, if these barriers are removed, acceptance rates approach
75%.(5,6) However, adolescents at highest risk of pregnancy have few opportunities to obtain
highly-effective contraception.
The contribution of the proposed research is to demonstrate the feasibility of providing
comprehensive counseling about contraception for adolescents in a novel outreach setting, a
pediatric emergency department. This contribution will be significant because, if this
counseling intervention increases initiation of contraception through a pediatric emergency
department, unintended pregnancies among vulnerable adolescents may decrease. The term
vulnerable will be used throughout this application to refer to adolescent girls who seek
care for non-emergent complaints in emergency departments, are likely to be publicly insured
or uninsured, engage in risky behaviors, have co-morbid psychiatric disorders, or have
high-risk social characteristics such as interpersonal violence, substance abuse, or
poverty.(7-9) Vulnerable adolescents are at high risk of unintended pregnancy, yet are
difficult to reach through outpatient care settings. Initiation of contraception at the time
of pediatric emergency department encounter could reduce unintended pregnancy, reduce
adverse outcomes to the woman and her child associated with adolescent pregnancy, and reduce
the financial costs borne by society.
Currently, most contraception for adolescents is initiated through an outpatient encounter.
In New Mexico, adolescent girls aged 13 to 18 who present to an outpatient clinic for
contraception can be prescribed contraception or have a contraceptive device placed during
the clinic visit without parental consent under state law.(10) This approach has enjoyed
considerable success, with a 15-fold increase in the use of intrauterine or subdermal
contraceptive implants by adolescents seeking contraception over the past decade.(1) The
Contraceptive CHOICE study has demonstrated that adolescents have high acceptance of
long-acting, reversible forms of contraception.(5) Typically, providers of highly-effective
contraception are gynecologists, advanced practice physicians, and family practice
physicians. This has resulted in a scarcity of providers who can offer the long-acting,
reversible contraception to adolescents that is recommended by the American College of
Obstetricians and Gynecologists.(3,11) Additionally, not all adolescents are able to access
clinic-based, outpatient medical care by a gynecologist or family practitioner. Adolescents
who experience poverty, coercive sexual relationships, co-morbid psychiatric disorders, and
abuse are especially vulnerable to pregnancy.(12) These risk factors for adolescent
pregnancy mirror the characteristics of adolescents who utilize emergency departments for
medical care.(7-9,13) A prior survey of female adolescents and adults seeking care in an
emergency department felt it was acceptable to have contraceptive provision in the emergency
department. (14)
It is not known whether pediatric emergency medical providers can successfully initiate
contraception for adolescents in a pediatric emergency department. Adolescent girls who
present to the UNM Pediatric Emergency Department (PED) currently receive some contraceptive
and sexual health care, but the care delivered varies based on the provider.
As a continuing education initiative at UNM, Dr. Nancy Sokkary, Adolescent Gynecologist, has
been providing educational sessions on current best contraceptive practices for adolescents
to pediatricians. Included in this education has been an FDA-approved procedural training in
the insertion of the subdermal contraceptive implant, Nexplanon. Pediatric residents and
attending physicians have begun to offer Nexplanon in the inpatient setting and in pediatric
clinics. As PED attending and fellow physicians, all of whom are board-certified
pediatricians, undergo this education, we anticipate increased knowledge on the part of PED
providers on current contraceptive recommendations. This proposed research capitalizes on an
opportunity to expand comprehensive counseling on contraception in the PED.
Patients will be recruited through the Pediatric Emergency Department (PED) of the
University of New Mexico. Investigators will enroll adolescent girls 13 to 18 years of age
who present to the PED for non-emergent complaints and who are willing to participate in the
study. Adolescent girls who present to the PED during shifts staffed by an attending
physician or fellow trained in the study counseling intervention will be eligible for
enrollment. Physicians who have completed Dr. Sokkary's continuing education on best
practices in adolescent contraception and the FDA-approved Nexplanon insertion training will
be considered trained in the counseling intervention. All consents and procedures will be
performed in the PED by a research coordinator or study investigator who will not be
involved in the patient's medical care during their emergency department encounter. All
potentially eligible participants will be approached by the research coordinator while their
parent/guardian/companion is outside of the patient room, as is routine for reproductive
health care in the PED. A unique study number will be assigned to each subject and noted on
all data collection forms containing only the study number. No patient identifiers will be
included on the data forms.
All patients will be offered clinical services regardless of their decision about
participating in the study. If a participant is withdrawn from the study either by her
desire or that of the PED provider, the PI of the study or the research staff, she may
continue to receive contraceptive care which will be up to the PED clinician providing
clinical services during the encounter.
Patients can expect that participation will involve enrollment and a subsequent
contraceptive counseling intervention consisting of a handout, 10-minute DVD, and a
one-on-one counseling by a PED attending physician or fellow that will not total longer than
one hour. For follow up, all participants will be contacted by telephone by a study team
member approximately 4 weeks after enrollment and will be administered a brief
(approximately 10 minute) survey on participant satisfaction with the counseling
intervention and on any subsequent contraceptive choices. Investigators will recruit
participants during an 8-week pilot period. Investigators anticipate recruitment to be
completed by March of 2015 and preliminary analysis to be complete by June 2015.
Participants will be recruited through the Pediatric Emergency Department (PED) at UNM.
Physicians in the Pediatric Emergency Department (PED) are trained Pediatricians who provide
specialized care in Emergency Medicine. Sixty percent of PED attendings and fellows
completed training by Dr. Sokkary on best practices in adolescent contraception and in
Nexplanon insertion during September 2014.
Usual care for contraceptive counseling in the PED:
The most common reason that adolescent girls present to the PED is persistent abdominal
pain. Other common reasons include urinary tract infections, concern for sexually
transmitted infections, pharyngitis, upper respiratory tract infections, social stressors,
and trauma. An adolescent girl's first point of care in the PED is nurse triage. PED visits
by adolescent girls average a total duration of just over 4 hours. During nurse triage, a
brief history of the presenting complaint is taken, vital signs are collected, and medical
care is initiated based on nurse-driven protocols. During triage, female adolescent patients
are routinely interviewed privately with parent/guardian/companion outside of the room to
screen for pregnancy risk factors. They are provided with a urine specimen cup in
anticipation of urine pregnancy testing. Depending on the chief complaint, the triage nurse
may privately screen for other risk factors such as substance abuse or violence. After
triage, the patient is placed in one of 12 private patient rooms in the PED. They are
evaluated by one to three physicians in the PED depending on the staffing of the PED at that
time. Medical evaluation routinely consists of a medical history and a physical exam. In
addition, routine care of adolescents in the PED includes a social history that is obtained
with the parent/guardian/companion outside of the patient's room to protect confidentiality.
During the confidential portion of the medical encounter, most adolescents are asked about
sexual behavior, contraception, healthy relationships, and substance abuse. Currently, PED
providers offer contraceptive counseling on a case-by-case basis. If contraception
counseling is included as part of the confidential medical encounter, this is not a
deviation from routine care that the adolescent would receive in an outpatient clinic visit
for simple chief complaints. If adolescents express interest in initiating contraception or
changing contraceptive methods, PED providers are able to offer a range of contraceptive
services. The range of contraceptive services available in the PED include:
- Emergency contraception (given in PED or as prescription);
- Prescription for contraception (including oral contraceptive pills, vaginal ring,
dermal patch);
- Immediate Depo-Provera injection;
- Immediate subdermal contraceptive implant insertion (only available if patient seen by
a Nexplanon-trained provider); or,
- Referral to Adolescent Gynecology or Center for Reproductive Health for outpatient
initiation of contraception, including the IUD or subdermal contraceptive implant.
Patients receiving contraceptive services in the PED are offered follow-up in Adolescent
Gynecology as an outpatient as usual care.
The proposed research is a pilot study of a contraceptive counselling intervention,
administered by Pediatric Emergency Medicine providers for adolescent girls presenting to
the University of New Mexico Pediatric Emergency Department for non-contraceptive
complaints. The primary research question is: Is it feasible to initiate comprehensive
contraceptive counseling in a pediatric emergency department? The secondary research
question is: What is the impact of comprehensive contraceptive counseling on the initiation
of contraception among sexually active adolescents presenting to a pediatric emergency
department?
The overall study design is a prospective cohort study. The two specific aims for the
proposed research reflect the two key perspectives of stakeholders in this proposed pilot
study. Specific aim #1, Determine the feasibility of comprehensive contraception counseling
in a pediatric emergency department, investigates the introduction of a contraceptive
practice within the existing time and resource constraints of emergency medical providers in
a busy emergency department. Specific aim #2, Determine the impact of comprehensive
contraceptive counseling on initiation of contraception among sexually active adolescents
presenting to a pediatric emergency department, elicits the effectiveness of providing
contraceptive counseling during an emergency department encounter from the perspective of
adolescents. Feasibility, as operationalized in this application, requires attainment of our
measurable, hypothesized outcomes by both participating emergency medical providers and
adolescents.
Eligible participants will include post-menarchal girls ages 13 - 18 who present to the
Pediatric Emergency Department for non-contraceptive complaints. Investigators will enroll
subjects during an 8-week period. Subjects will only be enrolled during a patient care shift
staffed by a Pediatric Emergency Medicine provider who has completed Dr. Nancy Sokkary's
contraceptive educational session and Nexplanon insertion training as part of continuing
education. Female adolescents will be screened for study eligibility at triage by a triage
nurse using a standardized set of criteria (see Appendix A and B). The eligibility criteria
include:
- Ages 13 to 18 years old
- Speaks English or Spanish
- Has menstrual periods
- Has Medicaid insurance
- Is not seeking contraception as their primary complaint
- Is not currently pregnant based on urine or serum pregnancy testing
- Does not have an IUD or contraceptive implant (Implanon/Nexplanon)
- Is not critically ill, hemodynamically unstable, altered mental status, developmentally
delayed, severe pain or distress, or have major trauma
The triage nurse will alert the Unit Clerk who will contact the on-call research coordinator
after verifying insurance eligibility criteria. The research coordinator will further
determine study eligibility. Per usual care in the Pediatric ED, most adolescent girls will
be screened for pregnancy by urine or serum testing as part of their routine medical care
initiated through triage. A small number of adolescent girls may not be screened for
pregnancy at triage or during their subsequent medical care according to usual care for
their specific presenting complaints. If girls are otherwise eligible for study
participation but have not undergone pregnancy testing as a routine part of their medical
care in the PED, these potentially eligible participants will be provided with a
point-of-care urine pregnancy test at no cost to the participant.
If patients are eligible and choose to participate in the research study, consent for
participation will be obtained. Under the requested waiver of parental consent, potential
participants will be consented and enrolled with the parents/guardian/companion outside of
the patient's room. The research coordinator/study investigator will explain the constraints
of confidentiality in accordance with the recruitment script (see Appendix C) and will
explain that while reproductive health care is confidential, any disclosures of intent to
self-harm, intent to harm others, or abuse perpetrated upon the participant will require
immediate disclosure to the participant's PED medical provider. At the time of enrollment,
the research coordinator/study investigator will administer a patient enrolment
questionnaire that contains questions about demographics and factors that increase risk of
adolescent pregnancy (Appendix D).
Data collection will be completed on the same day as the patient's emergency department
encounter by the research coordinator/study investigator and stored using REDCap. The REDCap
database will be stored on a secure server at the University of New Mexico Health Sciences
Center (UNM HSC), and the database will only be accessed by University of New Mexico's Human
Resources Protections Office (HRPO) approved co-investigators on UNM HSC password-protected
computers. Patients will fill out contact information on paper collection forms and the
information will then be entered into an Access database. Demographic characteristics and
any questionnaires will be collected on paper forms and entered into the REDCap database.
All data will be destroyed 7 years after HRPO completion date with patient information
destroyed via shredding of paper documents. Patient identifiers linked to the data will be
destroyed by removal of the file from the hard drive of the UNM computer used to store the
information.
The study intervention will consist of comprehensive contraceptive counseling through a
standardized bundle of services, including a 10-minute educational DVD, handouts on
contraceptive methods, and one-on-one contraceptive counseling by the PED physician.
Patients who are enrolled in the study will have a color-coded tag applied to their physical
patient chart and the door of their room at the time of enrollment. Emergency department
ancillary staff will bring the educational DVD developed specifically for this project by
UNM Family Planning and Adolescent Gynecology providers (see Appendix E) and the educational
handouts (see Appendix F) to the room at the time that the tag is displayed. Every room in
the PED is equipped with a combination DVD player/video display. All participating patients
will also receive one-on-one contraceptive counseling by one the of Pediatric Emergency
Medicine providers after watching the DVD.If study participants express interest to the PED
provider in initiating contraception or changing to a more effective method of contraception
after receiving the counseling intervention, participants will be offered all available
options in the PED for which they are medically eligible as per usual care All participants
will be contacted by telephone by a research coordinator approximately 4 weeks after
enrollment and administered a questionnaire (see Appendix G) regarding their satisfaction
with receiving contraceptive counseling in the Pediatric Emergency Department and any
subsequent changes in their contraceptive practices. Additionally, all participants will
undergo a one-time chart review at approximately 4 weeks post-enrollment to determine the
rate of successful follow-up with Adolescent Gynecology or Center for Reproductive Health
for this group.
At the end of the 8 week intervention, the Pediatric Emergency Medicine providers who
participated in Dr.Sokkary's contraceptive educational session and the study intervention
will complete a short survey (see Appendix I: Provider Questionnaire) administered by the
research coordinator. This survey is to elicit the physicians' impressions regarding patient
throughput during the clinical intervention, as well as impact on physician workflow. No
personal or identifying information will be collected from the providers. We are requesting
for a waiver of written documentation of consent for this PED provider survey.
This study will recruit adolescent girls presenting to the Pediatric Emergency Department.
Adolescents who seek care for non-emergent complaints in emergency departments may be an
especially vulnerable population, as prior research has demonstrated that these adolescents
are likely to be publicly insured or uninsured, engage in risky behaviors, have co-morbid
psychiatric disorders, or have high-risk social characteristics such as interpersonal
violence, substance abuse, or poverty (Melzer-Lange, 1996; Wilson, 2000; Ziv, 1998).
Adolescents who experience poverty, coercive sexual relationships, co-morbid psychiatric
disorders, and abuse are especially vulnerable to pregnancy (Klein, 2005). These risk
factors for adolescent pregnancy mirror the characteristics of adolescents who utilize
emergency departments for medical care. Investigators hope to improve access to
contraceptive care for this group of adolescents. However, to avoid coercion, no incentives
for study participation will be offered. Because adolescents who seek care in emergency
departments are more likely to have high-risk social characteristics, it is possible that
participants may disclose physical or sexual abuse, assault, commercial sexual activity,
suicidality, or homicidality. Any disclosures that qualify for mandated reporting that occur
within the study will be disclosed immediately to the attending PED provider so that
appropriate child safety authorities can be notified. Coordination of care with child safety
authorities is routine care in the PED and child safety authorities, including CYFD and law
enforcement agencies, are contacted by the PED daily in the course of routine care.
