Case study : Claudia is a 26-year-old mother of two G2P2, she recently delivered her last child 9 months ago

Assignment: Contraceptive Choice Discussion
Assignment: Contraceptive Choice Discussion

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Week 2 Claudia is a 26-year-old mother of two G2P2, she recently delivered her last child 9 months ago, and has been using condoms for birth control for the last 7 months. Today she is requesting a more reliable birth control, she is not sure of her current pregnancy plans, however, she does not wish to discuss sterilization. No religious contraindications for treatment. Previous methods include condoms, and oral contraceptive pills. PMH: positive for mild hypertension with first pregnancy, seasonal allergies. Surgeries: Right inguinal hernia and tonsillectomy. Family history: Mother HTN and Father colon CA both living Social History: Denies tobacco use, wine one to two glasses a week, denies recreational drugs, exercises twice a week. Drug allergies-Sulfa causes a rash. Current medications-MVI with Fe, Calcium chews, prn Allegra for allergies. Height 65 inches, weight 137 pounds, BP 110/75, P 70, R 16. PAP collected today, breast exam WNL, urine pregnancy negative. Physical exam is normal. What are your treatment goals for Claudia today? What are two possible contraceptive methods for Claudia? Please give brief rationale for each. Pick one method and list five (5) patient-centered teaching points for the method you chose today. What would your contraceptive choice be if Claudia smoked 10-15 cigarettes per day? Explain your answ
Of the 6 million pregnancies that occur each year in the United States, approximately half are unintended.1 Among women who experience an unintended pregnancy, half report using a contraceptive method in the month when the pregnancy occurred.2 Because most women use a contraceptive method with adherence requirements, the majority of pregnancies result from incorrect or inconsistent method use rather than from method failure.3 Despite their proven safety, effectiveness, and cost-effectiveness less than 3% of women in the U.S. use a long-acting reversible method of contraception (LARC), which includes intrauterine contraception (IUC) and subdermal implants.4 Reasons for lack of use include women’s knowledge of and attitudes towards the methods,5, 6 practice patterns among providers,7, 8 and high initial up-front cost associated with these methods.9

In response to the under-utilization of LARC, the Contraceptive CHOICE Project (CHOICE) was developed to promote the use of long-acting methods in the St. Louis region. Our primary objective is to provide no-cost contraception to a large number of women in our region and to promote the use of long-acting reversible contraception (LARC = intrauterine contraception (IUC) and the subdermal implant). To accomplish this objective, we sought to remove two major barriers to LARC use: financial obstacles and lack of patient awareness of LARC method safety and efficacy. By increasing the acceptance and use of LARC, CHOICE seeks to reduce unintended pregnancy at the population level in the St. Louis region. In this analysis, we describe baseline contraceptive method choice and the demographic, reproductive, and behavioral characteristics of the first 2,500 participants enrolled.

MATERIALS AND METHODS
The Contraceptive CHOICE Project is a prospective cohort study of 10,000 women in the St. Louis region. Each participant is provided the contraceptive method(s) of her choice at no cost to her for three years duration. The CHOICE protocol was approved by the Washington University in St. Louis School of Medicine Human Research Protection Office prior to initiation of participant recruitment.

CHOICE is a convenience sample of women in the St. Louis region. Participants are recruited at specific clinic locations and via general awareness about CHOICE through their medical providers, newspaper reports, study flyers, and word of mouth. Recruitment sites include university-affiliated clinics and providers, two facilities providing abortion services, and community clinics that provide family planning, obstetric, gynecologic, and/or primary care. Women are eligible to participate if they are 14-45 years of age, reside in or seek clinical services in designated recruitment sites in the St. Louis region, have been sexually active with a male partner in the past six months or anticipate sexual activity in the next six months, have not had a tubal ligation or hysterectomy, do not desire pregnancy in the next year, and are not currently using a contraceptive method or are interested in starting a new reversible contraceptive method.

Women are screened for eligibility in person at a recruitment site or on the telephone by calling the CHOICE telephone number. Every screening encounter is conducted by a trained staff person who provides a brief scripted introduction to LARC methods: levonorgestrel intrauterine contraception (LNG-IUC), copper intrauterine contraception (copper IUC), and the subdermal implant (See Appendix A). The screener asks a series of questions to determine eligibility and, when eligible, offers the opportunity to enroll in CHOICE. Using a standardized data collection form, the screener documents each eligibility criterion, the final eligibility status, and whether the woman enrolls in the project that day or is scheduled to enroll on a future date. For women scheduled to enroll, the screener collects contact information to facilitate reminder calls prior to the enrollment appointment. Thus, all women screened are introduced to LARC methods regardless of their initial contraceptive preference or whether they are ultimately enrolled.

Enrollment in CHOICE occurs during a 1.5 to 2 hour in-person process. Prior to obtaining informed consent to participate in CHOICE, women undergo pregnancy testing to rule out pregnancy. Those identified with an occult pregnancy are counseled about options and offered the opportunity to participate in CHOICE after resolution of the pregnancy. Approximately 74% (1845/2500) of CHOICE enrollments occur at the university-based recruitment site. At this site contraceptive counseling is provided by research assistants who are trained contraceptive counselors. Among the remaining 26% (655/2500) of enrollments, clinic staff and or health care providers at the clinical facility provide the counseling. Our goal was to promote LARC, but to also offer the CHOICE Project to as many outpatient facilities in our region as possible. All women undergo contraceptive counseling prior to providing informed consent.

Given space constraints and logistical issues, research staff could not provide the counseling at all recruitment sites. Thus, the content of the contraceptive counseling session varies by recruitment site. The clinic staff that provides the counseling at the community clinic sites is not engaged in the research protocol; the counseling is considered part of routine family planning care that she receives during her clinic visit prior to enrollment in CHOICE. Counseling at the university-affiliated recruitment site includes a non-biased description of all contraceptive methods available including method effectiveness, advantages and disadvantages. To assist the participant in making an informed decision, research staff attempt to dispel misinformation or myths about contraceptive methods and to answer any questions or concerns regarding each method. During this session, the research assistant collects clinical information using a standardized form to identify contraindications or conditions that may influence the use of a particular contraceptive method. Once the woman has chosen her method, the counselor obtains the approval of the clinician for the chosen method regardless of recruitment location. If a method is medically contraindicated, the clinician consults with the participant to identify a more suitable contraceptive method; otherwise participants receive their initial method of choice.

After contraceptive counseling is completed, informed consent is obtained to participate in CHOICE by engaged research staff at the recruitment location. For women under the age of 18 years, we obtain their assent and the consent of one parent or legal guardian. For minors who do not know the whereabouts of their parent or legal guardian or are fearful of their parent or legal guardian’s knowledge of her seeking contraception, we have obtained Human Research Protection Office approval to waive parental consent. Emancipated minors are consented as adults.

Following informed consent, research staff administers a standardized survey instrument and collects detailed contact information. Comprehensive contact information (e.g., residence address, telephone, cell phone, email) is documented for the participant and two additional contacts (e.g., partner, relative, or friend) to increase the likelihood of sustained contact with the participant during the 3-year follow-up period. The participant is then screened for sexually transmitted infections (STIs; Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and syphilis) and HIV, and the chosen contraceptive method is provided. Participants are compensated for their time with a $15.00 gift card.

Once pregnancy is ruled out, women who choose a LARC method undergo insertion by a trained clinician at the time of enrollment. Emergency contraception is offered to patients who have had recent unprotected intercourse, and “bridge methods” such as oral contraceptive pills (OCPs), vaginal ring, transdermal patch, depo-medroxyprogesterone acetate (DMPA), or condoms are offered to women when pregnancy cannot be excluded. Participants are encouraged to immediately initiate their contraceptive method,10–12 and can return in 3-4 weeks for a repeat pregnancy test and LARC insertion, if desired.

Following the enrollment session participants are interviewed by phone 3, 6, 12, 18, 24, 30, and 36-months post-enrollment using standardized survey instruments. They are compensated with a $10.00 gift card for every completed survey. Participants are initially notified by mail or e-mail two weeks prior to their next follow-up contact, and are then called to schedule the interview. Participants are screened again for C. trachomatis and N. gonorrhoeae at the 12, 24 and 36-month contacts.

The baseline and follow-up survey instruments collect comprehensive information on demographic characteristics, past and current reproductive history including contraceptive experience (e.g., continuation, side effects, reasons for discontinuation or non-compliance, and satisfaction), menstrual bleeding patterns, sexual behavior with male and female partners, main and casual sex partners, pregnancy, incident STI, and experiences of discrimination and violence. During both scheduled and interim contacts research staff also collect and record clinically relevant data including complaints, complications, side effects, method expulsions and removals, pregnancies and outcomes, and STI occurrence and treatment.

CHOICE provides all contraceptive methods at no cost to the participant through two processes. Women who choose a LARC method can receive the method at their enrollment site or can request that their regular healthcare provider insert the method. CHOICE has established a network of private providers who refer patients to CHOICE for enrollment. Research staff travels to these physician offices or recruitment sites with LARC methods and provide the clinician with the method for insertion.

CHOICE has partnered with two community affiliates to provide OCPs, vaginal ring, transdermal patch, or DMPA to participants. Following enrollment, every participant, regardless of method choice, receives a CHOICE prescription card that documents her participation in CHOICE and allows her to obtain her OCPs, vaginal ring, or transdermal patch on a monthly basis at a local pharmacy chain located throughout the St. Louis region. Participants who are established patients of the local family planning clinic may obtain their monthly refills or DMPA at selected family planning clinics in the St. Louis