US clinicians' perspectives on how mifepristone regulations affect access to medication abortion and early pregnancy loss care in primary care.

OBJECTIVE: Protocols including mifepristone are the most effective medication regimens for medication abortion and early pregnancy loss (EPL) management. Both can be safely and effectively offered in primary care settings. Despite mifepristone's excellent safety record, the United States (US) Food and Drug Administration (FDA) heavily regulates provision. This exploratory study examines US primary care clinicians' perspectives on the effects of mifepristone restrictions, including FDA regulations, on access to medication abortion and EPL management in primary care. STUDY DESIGN: In 2019, we conducted an online qualitative survey of US primary care clinicians recruited from six reproductive health-focused listservs. Open-ended questions queried about barriers to providing mifepristone and effects on patients when unable to access mifepristone in primary care. We iteratively coded and analyzed qualitative data using inductive thematic analysis. RESULTS: Of our analytic sample of 113 respondents, one-third had mifepristone available in their current primary practice setting. Key barriers to provision stemmed from the FDA rule to stock and dispense mifepristone onsite, including logistical difficulties and resistance from health center leadership. Clinicians believed that lack of mifepristone in primary care resulted in negative patient experiences, including disrupted continuity of care, medically-unnecessary appointments, and undesired aspiration procedures. CONCLUSIONS: FDA regulations that inhibit mifepristone provision in primary care create structural barriers to provision. This may result in physical, emotional, and financial burdens for patients. IMPLICATIONS: When mifepristone is unavailable in primary care, some patients in need of abortion or EPL care may experience physical, emotional, and financial harms. Removing FDA restrictions is a critical step in reducing primary care barriers to mifepristone provision and improving access to timely, patient-centered medication abortion and EPL care.

Barriers and Enablers to Family Physicians' Provision of Early Pregnancy Loss Management in the United States.

BACKGROUND: Early pregnancy loss (EPL) is a common experience. Treatment options include expectant management, medication, and uterine aspiration. Although family physicians can offer comprehensive EPL treatment in their office-based settings, few actually do. This study explored the postresidency provision of EPL management and factors that inhibit or enable providing this care among family physicians trained in early abortion during residency. METHODS: Using an exploratory sequential mixed-methods design, we studied a sample of family physicians trained in early abortion during residency. We initially interviewed a subset trained in uterine aspiration during residency, then surveyed the entire sample. Interview transcripts were coded and analyzed using grounded theory; results informed survey development. On survey responses, we used Pearson χ2 to examine the association between certain variables and provision of EPL care options. RESULTS: Most of the 15 interview and 231 survey respondents provided expectant management of EPL. Of the survey respondents, 47.2% provided medication management and 11.4% manual vacuum aspiration. Key challenges and facilitators involved referral, training, ultrasound access, and managing systems-level issues. In bivariate analyses, providing prenatal care, offering abortion care, access to ultrasound, and competency were positively associated with providing EPL management options (p < .05). CONCLUSIONS: Clinical training alone is insufficient to expand access to comprehensive EPL care in family medicine office-based settings. Supporting family physicians during and after residency with training and technical assistance to address barriers to care may strengthen their abilities to champion practice change and expand access to comprehensive EPL management options.

Ectopic Pregnancy: Diagnosis and Management.

Ectopic pregnancy occurs when a fertilized ovum implants outside of the uterine cavity. In the United States, the estimated prevalence of ectopic pregnancy is 1% to 2%, and ruptured ectopic pregnancy accounts for 2.7% of pregnancy-related deaths. Risk factors include a history of pelvic inflammatory disease, cigarette smoking, fallopian tube surgery, previous ectopic pregnancy, and infertility. Ectopic pregnancy should be considered in any patient presenting early in pregnancy with vaginal bleeding or lower abdominal pain in whom intrauterine pregnancy has not yet been established. The definitive diagnosis of ectopic pregnancy can be made with ultrasound visualization of a yolk sac and/or embryo in the adnexa. However, most ectopic pregnancies do not reach this stage. More often, patient symptoms combined with serial ultrasonography and trends in beta human chorionic gonadotropin levels are used to make the diagnosis. Pregnancy of unknown location refers to a transient state in which a pregnancy test is positive but ultrasonography shows neither intrauterine nor ectopic pregnancy. Serial beta human chorionic gonadotropin levels, serial ultrasonography, and, at times, uterine aspiration can be used to arrive at a definitive diagnosis. Treatment of diagnosed ectopic pregnancy includes medical management with intramuscular methotrexate, surgical management via salpingostomy or salpingectomy, and, in rare cases, expectant management. A patient with diagnosed ectopic pregnancy should be immediately transferred for surgery if she has peritoneal signs or hemodynamic instability, if the initial beta human chorionic gonadotropin level is high, if fetal cardiac activity is detected outside of the uterus on ultrasonography, or if there is a contraindication to medical management.

Effectiveness of clinical decision support to enhance delivery of family planning services in primary care settings.

PURPOSE: There is a need to improve delivery of family planning services, including preconception and contraception services, in primary care. We assessed whether a clinician-facing clinical decision support implemented in a family medicine staffed primary care network improved provision of family planning services for reproductive-aged female patients, and differed in effect for certain patients or clinical settings. METHODS: We conducted a pragmatic study with difference-in-differences design to estimate, at the visit-level, the clinical decision support's effect on documenting the provision of family planning services 52 weeks prior to and after implementation. We also used logistic regression with a sample subset to evaluate intervention effect on the patient-level. RESULTS: 27,817 eligible patients made 91,185 visits during the study period. Overall, unadjusted documentation of family planning services increased by 2.7 percentage points (55.7% pre-intervention to 58.4% intervention). In the adjusted analysis, documentation increased by 3.4 percentage points (95% CI: 2.24, 4.63). The intervention effect varied across sites at the visit-level, ranging from a -1.2 to +6.5 percentage point change. Modification of effect by race, insurance, and site were substantial, but not by age group nor ethnicity. Additionally, patient-level subset analysis showed that those exposed to the intervention had 1.26 times the odds of having family planning services documented after implementation compared to controls (95% CI: 1.17, 1.36). CONCLUSIONS: This clinical decision support modestly improved documentation of family planning services in our primary care network; effect varied across sites. IMPLICATIONS: Integrating a family planning services clinical decision support into the electronic medical record at primary care sites may increase the provision of preconception and/or contraception services for women of reproductive age. Further study should explore intervention effect at sites with lower initial provision of family planning services.

Intention to provide abortion upon completing family medicine residency and subsequent abortion provision: a 5-year follow-up survey.

OBJECTIVE: Among family physicians who graduated from residencies with abortion training, we explore the association between intention to provide abortion at the end of residency and abortion provision 5 years postresidency. STUDY DESIGN: We invited 2009-2012 graduates from US family medicine residency programs with a required opt-out abortion training rotation or elective abortion training opportunities, and who had completed a baseline end-of-residency survey (N=477) to take our follow-up survey 5 years postresidency (2014-2017). We used logistic regression to examine the association between intention to provide abortion postresidency and abortion provision 5 years later. RESULTS: One hundred and seventy-two of 477 (36.1%) family physicians responded to our survey. More responders compared to nonresponders had intended to provide uterine aspiration and medication abortion at baseline (p≪.01) and attended residency in states considered hostile and middle ground toward abortion rights (p=.03). Of the 155 eligible respondents for analysis, 27.1% offered some type of abortion care in their practice. Of those that provided abortion, 100% provided medication abortion and 71.4% uterine aspiration. Most respondents that provided uterine aspiration abortion did so in abortion/family planning clinics or in sites that already established routine abortion care. Those who had intended to provide any abortion care at baseline had 4.03 times the odds of providing any abortion care 5 years later (95% confidence interval: 1.72-9.47). Administrative and systems-level barriers to integrate abortion were mentioned most frequently compared to personal beliefs or safety factors to explain why respondents did not provide abortion. CONCLUSIONS: We found an association between intention to provide abortion after residency and providing abortion in practice 5 years later. However, only 27.1% of respondents provided some abortion care. Factors beyond intention to provide care appear to inhibit or facilitate family physicians' abilities to practice abortion in primary care. IMPLICATIONS: Supporting family physicians who express intention to provide abortion after residency with additional training and technical assistance may contribute toward expanding access and availability of abortion care.

Feasibility study of family planning services screening as clinical decision support at an urban Federally Qualified Health Center network.

OBJECTIVE: The objective was to assess the feasibility of an intervention introducing family planning services screening clinical decision support to improve provision of contraception and/or preconception services for women of reproductive age in our primary care Federally Qualified Health Center (FQHC) network. STUDY DESIGN: We implemented a family planning services screening prompt for support staff to ask women 13-44 years at nonobstetric visits at specified time intervals. The response was displayed in the electronic medical record for the provider to review, linked to a documentation tool. We evaluated staff comfort with the screening before and after rollout at all seven FQHC sites. At the pilot site, we examined implementation feasibility by assessing screening rate and the outcome measure of family planning (contraception and/or preconception) documentation during visits by women 13-44 years before and during the intervention's first year. RESULTS: At baseline, support staff reported high level of comfort (60% very, 25% somewhat) in asking the family planning services screening question; this increased to 80% reporting they were "very comfortable" in the postsurvey (p = <.01). From mid-December 2016-mid-January 2018, the screening question was displayed for 1503 visits at the pilot site, of which 96% had a documented response. Family planning documentation rate at the pilot site showed a 6% increase from 64% during the preintervention period to 70% during the 13-month intervention period (p<.01). Time series analysis demonstrated more positive upward trend attributed to the intervention period (intervention R2=0.15 vs. preintervention R2=0.01). CONCLUSION: Our study demonstrated high staff acceptability of the intervention at all sites and a high screening rate with a significant increase in family planning documentation rate at the pilot site during the intervention period. This suggests that this family planning services screening decision support intervention is feasible in an FQHC setting. IMPLICATIONS: Implementation of a family planning services screening decision support intervention is feasible in an FQHC setting. Further evaluation of performance at multiple sites, accounting for variable site characteristics, is needed.

Long-Acting Reversible Contraception: Difficult Insertions and Removals.

The use of long-acting reversible contraception is on the rise across the United States and has contributed to a decrease in teen pregnancies. With the increased use of long-acting reversible contraception, physicians may encounter difficult insertions and removals of intrauterine devices (IUDs) and the contraceptive implant. Uterine structure (e.g., extreme anteversion or retroversion, uterine tone during the postpartum period and breastfeeding) can pose challenges during IUD insertion. Special consideration is also needed for IUD insertions in patients who are transgender or gender nonconforming, such as psychosocial support and management of vaginal atrophy. Missing IUD strings may complicate removal, possibly requiring ultrasonography and use of instruments such as thread retrievers, IUD hooks, and alligator forceps. Regarding implant removal, those that are barely palpable (e.g., because of an overly deep insertion or excessive patient weight gain), removal may require ultrasonography, use of vas clamps and skin hooks, and extra dissection.

Women's experiences with early pregnancy loss in the emergency room: A qualitative study.

OBJECTIVES: To understand the reasons why women present to the Emergency Room (ER) for Early Pregnancy Loss (EPL)-related care, how they perceive care and counseling there, and their overall experience during and after their visit. STUDY DESIGN: This qualitative study utilized semi-structured telephone interviews. Participants were recruited in a large urban ER; women who experienced EPL were interviewed by telephone about their experiences 1-3 weeks after their visit. Audio recordings were transcribed and coded by two independent coders. MAIN OUTCOME MEASURES: This qualitative study utilized semi-structured interviews without the use of formal outcome measurement tools. RESULTS: Of the sixty-seven women recruited, ten completed the full telephone interview. Interview participants' responses were grouped into four categories: Feelings about EPL, reasons for going to the ER, experience in the ER, and experience after leaving the ER. Women had mixed feelings about their ER experiences; many reported chaos, lack of information or lack of emotional support, while a few felt informed and supported. Many did not know much about EPL before their experience. CONCLUSIONS: ER care for women experiencing suspected or confirmed EPL may not be addressing the emotional needs and knowledge gaps of women. Patient education, emotional support, and clear plans for outpatient follow up are critical. Further research is needed to guide interventions to improve care.

Beyond the Surface: Care Seeking Among Patients Initiating Contraceptive Implant in an Urban Federally Qualified Health Center Network.

PURPOSE: To describe rates of and reasons for follow-up among adolescents and adults receiving contraceptive implants in a Federally Qualified Health Center (FQHC). METHODS: Retrospective comparison of patient-initiated implant-related contacts during the 6 months postinsertion among adolescents (110) and adults (154) who had implants placed at a FQHC network. RESULTS: Forty percent of adolescents and 26% of adults initiated follow-up ( P = .016). Bleeding changes and discussing removal were the most common reasons for follow-up for both groups. Adolescents (5.5%) and adults (9.0%) had similar removal rates ( P = .348). However, among patients who discussed implant removal, adults were more likely to have removals compared with adolescents ( P = .002). CONCLUSIONS: Other FQHCs may anticipate a similar experience to ours, where adolescents may be more likely than adults to initiate implant-related follow up, with removal rates of less than 10% at 6 months. Further study of physician decision making and patient autonomy regarding implantable contraception removal requests is warranted.

Association of reproductive health training on intention to provide services after residency: the family physician resident survey.

BACKGROUND AND OBJECTIVES: High rates of unintended pregnancy and need for reproductive health services (RHS), including abortion, require continued efforts to train medical professionals and increase availability of these services. With US approval 12 years ago of Mifepristone, a medication abortion pill, abortion services are additionally amenable to primary care. Family physicians are a logical group to focus on given that they provide the bulk of primary care. METHODS: We analyzed data from an annual survey (2007--2010) of third-year family medicine residents (n=284, response rate=48%--64%) in programs offering abortion training to examine the association between such training and self-reported competence and intentions to provide RHS (with a particular focus on abortion) upon graduation from residency. RESULTS: The majority of residents (75% in most cases) were trained in each of the RHS we asked about; relatively fewer trained in implant insertion (39%), electric vacuum aspiration (EVA) (58%), and manual vacuum aspiration (MVA) (69%). Perceived competence on the part of the graduating residents ranged from high levels in pregnancy options counseling (89%) and IUD insertion (85%) to lows in ultrasound and EVA (both 34%). Bivariate analysis revealed significant associations between number of procedures performed and future intentions to provide them. The association between competence and intentions persisted for all procedures in multivariate analysis, adjusting for number of procedures. Further, the total number of abortions performed during residency increased the odds of intending to provide MVA and medication abortion by 3% and 2%, respectively. CONCLUSIONS: Findings support augmenting training in RHS for family medicine residents, given that almost half (45%) of those trained intended to provide abortions. The volume of training should be increased so more residents feel competent, particularly in light of the fact that combined exposure to different abortion procedures has a cumulative impact on intention to provide MVA and medication abortion.

Women's satisfaction with abortion care in academic family medicine centers.

BACKGROUND AND OBJECTIVES: The primary study aim was to describe patient satisfaction regarding abortion experiences in urban academic family medicine centers (FMCs). METHODS: We conducted a cross-sectional survey of 210 women obtaining a first trimester medication or aspiration abortion at four FMCs. The 32-item written survey consisted of multiple choice, open-ended questions and Likert scale measures (for satisfaction: 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied, for quality of care: 1=poor, 2=average, 3=good, 4=excellent). We used Fisher's exact test to examine bivariate relationships. Responses to open-ended questions were coded and categorized. RESULTS: The majority of women (93%) were very satisfied with their abortion experience in their FMC, regardless of clinical site or abortion method. Mean scores for the quality of the staff, doctor, abortion counseling, and contraceptive counseling were all at least 3.9 (out of 4). Women most commonly cited positive interactions with the staff and physicians as the best part of their experience. CONCLUSIONS: This study demonstrates that women who receive abortion services at academic FMCs are highly satisfied with their care.

Intrauterine devices at six months: does patient age matter? Results from an urban family medicine federally qualified health center (FQHC) network.

BACKGROUND: Federally qualified health centers (FQHCs) can address high rates of unintended pregnancy among adolescents in the United States by increasing access to intrauterine devices (IUDs) in underserved settings. Despite national guidelines endorsing adolescent use of IUDs, some physicians remain concerned about IUD tolerance and safety in adolescents. Therefore we compared adolescents and adults in a family physician staffed FQHC network with regard to (1) IUD postinsertion experience, (2) device discontinuation, and (3) sexually transmitted infection (STI) rates. METHODS: We conducted a retrospective cohort study among women <36 years old who had an IUD inserted in 2011 at a New York City FQHC staffed by family physicians. RESULTS: We included 684 women (27% adolescents, 73% adults). During the 6-month postinsertion period, 59% of adolescents and 43% of adults initiated IUD-related clinical contact after insertion, most commonly for bleeding changes and pelvic or abdominal pain. There were no significant differences between groups in IUD expulsion or removal or STI rates. CONCLUSIONS: Urban FQHC providers may anticipate that, compared with their adult IUD users, adolescents will initiate more clinical follow-up visits after insertion. Both groups will, however, have similar clinical concerns about, reasons for, and rate of device discontinuation and low STI rates.

Interest in and experience with IUD self-removal.

OBJECTIVES: In the United States, the popularity of intrauterine devices (IUDs) is low despite many positive attributes such as high effectiveness and ease of use. The requirement that a clinician remove the IUD may limit US women's interest in the method. Our objective was to describe women's experience with self-removal and its effect on attitudes toward the method. STUDY DESIGN: We assessed interest in attempting and success in IUD self-removal among women seeking IUD discontinuation from five US health centers. Women were given the option of attempting self-removal of the IUD. Participants were asked to complete two surveys about their reasons for desiring IUD removal, attitudes toward IUD use and experience with self-removal and/or clinician removal. RESULTS: Three hundred twenty-six racially diverse women participated (mean age, 28 years; body mass index, 27; duration of IUD use, 3 years); more than half were willing to try self-removal [95% confidence interval (CI): 45-65%], and among those who tried, one in five was successful (95% CI: 14-25%). More than half of participants (54%) reported they were more likely to recommend IUD use to a friend now that they know that it might be possible to remove one's own IUD; 6% reported they were less likely to recommend the IUD to a friend. African American women were particularly interested in the option of IUD self-removal. CONCLUSIONS: Many women are interested in the concept of IUD self-removal, although relatively few women currently succeed in removing their own IUD. IMPLICATIONS: Health educators, providers and advocates who inform women of this option potentially increase IUD use, reducing rates of undesired pregnancy.