Providing Adolescent Contraception in the Emergency Room
Condition: Contraception
MeSH terms: Emergencies
Study type: Observational

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.
    

Detailed 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.
    

Intervention name(s): Comprehensive contraception counseling
Intervention type(s): Behavioral
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescent girls presenting to a pediatric emergency department for non-emergent complaints
      
Keywords: Adolescent; Contraception; Counseling