Factors associated with a negative Patient Acceptable Symptom State (PASS) response with intrauterine device placement: A retrospective survey of HER Salt Lake participants.

OBJECTIVES: In an established cohort of HER Salt Lake Contraceptive Initiative participants with a prior intrauterine device (IUD) placement, we sought to (1) define the proportion of participants who reported a negative Patient Acceptable Symptom State (PASS) response, (2) explore factors associated with an unacceptable PASS response, and (3) identify pain management preferences for IUD placement. STUDY DESIGN: A retrospective survey was sent to 1440 HER Salt Lake IUD users. A PASS question queried IUD placement pain experience acceptability. We explored associations between an unacceptable PASS response and sociodemographic, reproductive and other individual characteristics using t-tests, chi-square tests, and multivariable logistic regression. RESULTS: Of those surveyed, 620 responded (43%), and 41.6% reported an unacceptable PASS response. Those with an unacceptable PASS response reported a significantly higher experienced pain level (79.2 mm vs 51.8 mm; p < 0.01) than those with an acceptable response, were more likely to have an anxiety diagnosis (47.7% vs 37.1%; p < 0.01), and have a trauma history (33.7% vs 25.1%; p = 0.02). Most patients were not offered pain control options, but 29.4% used ibuprofen and 25.3% had a support person. Regardless of PASS response, if offered, 59.0% desired numbing medication, 56.8% ibuprofen, 51% heating pad, 33.2% support person, and 31.8% anti-anxiety medication, among others. In our multivariable logistic regression model, higher pain was associated with unacceptable PASS response (OR 1.07, 95% CI 1.05-1.08; p < 0.01). CONCLUSIONS: The common finding of unacceptable pain experiences with IUD placement may cause negative perceptions of an otherwise desirable method. Incorporation of the PASS response into IUD pain management studies could expand our pain experience understanding. IMPLICATIONS: IUD placement resulted in unacceptable pain experiences for 41.6% of respondents. Screening for anxiety and trauma history could identify at-risk patients to individualize pain management strategies. Incorporation of the PASS into future IUD pain management studies could result in a more comprehensive, patient-centered measure of patient experiences.

Pharmacodynamic evaluation of the etonogestrel contraceptive implant initiated midcycle with and without ulipristal acetate: An exploratory study.

OBJECTIVE: To estimate the incidence of ovulation suppression within five days of etonogestrel 68 mg implant insertion in the presence of a dominant follicle with and without same-day ulipristal acetate. STUDY DESIGN: This single site non-masked, exploratory randomized trial recruited people age 18-35 years with regular menstrual cycles, no pregnancy risk, and confirmed ovulatory function. We initiated transvaginal ultrasound examinations on menstrual day 7-9 and randomized participants 1:1 to etonogestrel implant alone or with concomitant ulipristal acetate 30 mg oral when a dominant follicle reached ≥14 mm in diameter. We completed daily sonography and serum hormone levels for up to seven days or transitioned to labs alone if sonographic follicular rupture occurred. We defined ovulation as follicular rupture followed by progesterone >3 ng/mL. We calculated point estimates, risk ratios and 95% confidence intervals for ovulation for each group. Ovulation suppression of ≥44% in either group (the follicular rupture suppression rate with oral levonorgestrel emergency contraception), would prompt future method testing. RESULTS: From October 2020 to October 2022, we enrolled 40 people and 39 completed primary outcome assessments: 20 with etonogestrel implant alone (mean follicular size at randomization: 15.2 mm ± 0.9 mm) and 19 with etonogestrel implant + ulipristal acetate (mean follicular size at randomization: 15.4 mm ± 1.2 mm, p = 0.6). Ovulation suppression occurred in 13 (65%) of etonogestrel implant-alone participants (Risk ratio 0.6 (95% CI: 0.3, 1.1), p = 0.08) and seven (37%) of implant + ulipristal acetate participants. CONCLUSIONS: Ovulation suppression of the etonogestrel implant alone exceeds threshold testing for future research while the implant + ulipristal acetate does not. IMPLICATIONS: Data are lacking on midcycle ovulation suppression for the etonogestrel implant with and without oral ulipristal acetate. In this exploratory study, ovulation suppression occurred in 65% of implant participants and 37% of implant + ulipristal acetate participants. Ovulation suppression of the implant alone exceeds threshold testing for future emergency contraception research.

Efficacy of oral levonorgestrel emergency contraception with same day etonogestrel contraceptive implant: A prospective observational study.

OBJECTIVE: To determine a 1-month pregnancy rate point estimate and 95% confidence interval for guideline-supported, same-day initiation of an etonogestrel implant plus oral levonorgestrel emergency contraception. STUDY DESIGN: In this single-arm, prospective observational study, all emergency contraception clients who presented to four Planned Parenthood Association of Utah clinics from February 2021 to March 2023 received information about oral levonorgestrel with same-day etonogestrel implant insertion. Participants were ≤35 years and reported unprotected intercourse within 5 days with negative pregnancy testing. The primary outcome measure was a 1-month home pregnancy test. We calculated the efficacy using a test of proportions with Yates continuity correction. RESULTS: A total of 160 emergency contraception clients (7.6% of 2106 approached) enrolled and 153 had 1-month pregnancy outcomes. A positive pregnancy test occurred in 2 participants resulting in an overall pregnancy rate of 1.32% (95% confidence interval 0.23%-5.19%). Ultrasound gestational dating assigned conception of the first pregnancy to 8 days before enrollment. For the second pregnancy, ultrasound dating designated conception at 5 days prior to enrollment. Limiting the efficacy rate to the single pregnancy that occurred within 5 days of unprotected intercourse, we report a pregnancy rate of 0.66% (95% confidence interval 0.03%-4.19%). CONCLUSIONS: In this observational study of emergency contraception clients selecting oral levonorgestrel with same-day etonogestrel implant, we identified a pregnancy rate within the established range of oral emergency contraception methods alone. IMPLICATIONS: Clients presenting for emergency contraception may also desire ongoing highly-effective contraception, yet current clinical guidelines serve as a barrier to same-day method initiation for the etonogestrel implant and other hormonal methods. Improving access to contraceptive method initiation will reduce the ongoing risk of unwanted pregnancy for this population. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT04678817; registered 12/16/20.

Effects of the Dobbs v Jackson Women's Health Organization Decision on Obstetrics and Gynecology Graduating Residents' Practice Plans.

OBJECTIVE: To explore the association of the Dobbs v Jackson Women's Health Organization ( Dobbs ) decision on future practice locations of graduating obstetrics and gynecology residents. METHODS: This is a mixed-methods survey study of obstetrics and gynecology residents graduating from sites with Ryan Program abortion training programs (109 sites) between March 8, 2023, and April 25, 2023. We conducted both univariate and multivariable logistic regression analyses to identify factors that were associated with post- Dobbs change in career plans, particularly location. We also performed a thematic analysis using responses to the survey's optional, open-ended prompt, "Please describe how the Dobbs v Jackson Women's Health Organization decision impacted your professional plans." RESULTS: Of an estimated 724 residents graduating from residencies with Ryan Program abortion training programs, 349 participated in the survey (48.2% response rate); 17.6% of residents indicated that the Dobbs decision changed the location of intended future practice or fellowship plans. Residents who before the Dobbs decision intended to practice in abortion-restrictive states were eight times more likely to change their practice plans than those who planned to practice in protected states before the Dobbs decision (odds ratio 8.52, 95% CI 3.81-21.0). In a thematic analysis of open-ended responses, 90 residents wrote responses related to "not living in a state with abortion restrictions." Of residents pursuing fellowship, 36 indicated that they did not rank or ranked lower programs in restrictive states. CONCLUSION: These findings demonstrate reduced desire of residents in obstetrics and gynecology to practice or pursue fellowship in restrictive states after residency. This reduction in obstetrics and gynecology workforce could significantly exacerbate maternity care deserts.

Heavy Menstrual Bleeding Treatment With a Levonorgestrel 52-mg Intrauterine Device.

OBJECTIVE: To evaluate heavy menstrual bleeding treatment outcomes with levonorgestrel 52-mg intrauterine device (IUD) use in participants without body mass index (BMI) or parity restrictions. METHODS: Investigators included participants aged 18-50 years with no pelvic or systemic pathology causing heavy menstrual bleeding at 29 U.S. centers in a prospective trial. Participants had up to three screening cycles with menstrual product collection for alkaline hematin blood-loss measurements. Investigators enrolled those with two menses with blood loss of 80 mL or more (values averaged for baseline blood loss), placed the IUD, and followed participants for up to six 28-day cycles. Participants collected any menstrual products used during cycles 3 and 6 for blood-loss measurement. We evaluated outcomes in participants with at least one follow-up assessment for the primary outcome of median absolute blood-loss change and, secondarily, treatment success , defined as the proportion with a final measured blood loss less than 80 mL and at least 50% reduction from baseline. We evaluated exploratory outcomes of differences in blood-loss changes by BMI and parity using Wilcoxon rank sum test. RESULTS: Of 105 enrolled participants, 47 (44.8%) had obesity (BMI 30.0 or higher) and 29 (27.6%) were nulliparous. Baseline mean blood loss ranged from 73 to 520 mL (median 143 mL, interquartile range 112-196 mL). Eighty-nine (84.8%) had at least one evaluable follow-up evaluation. Participants had median (interquartile range) absolute blood-loss decreases at cycles 3 (n=86) and 6 (n=81) of 93.3% (86.1-97.7%) and 97.6% (90.4-100%), respectively. At cycle 6, participants without obesity (n=43) and with obesity (n=38) had similar median [interquartile range] decreases (97.6% [91.8-100%] and 97.5% [90.3-100%], respectively; P =.89), with comparable findings for nulliparous (n=25) and parous (n=56) participants (97.0% [91.7-99.1%] and 98.1% [89.9-100%], respectively; P =.43). Treatment success occurred in 81.8% (95% CI 74.2-89.4%) of 99 participants, excluding those with no outcomes due to lost to follow-up or consent withdrawal, and did not vary by BMI or parity. The most common adverse events leading to discontinuation were bleeding or cramping (n=6 [5.7%]) and expulsion (n=5 [4.8%]). CONCLUSION: This levonorgestrel 52-mg IUD reduces blood loss by more than 90% over 6 months compared with baseline for most users with heavy menstrual bleeding. FUNDING SOURCE: Medicines360. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT03642210.

Women's Health Provider Perspectives on Reproductive Services Provision in the Veterans Health Administration.

OBJECTIVES: Women veterans are a fast-growing population in the Veterans Health Administration (VHA), and ensuring reproductive service availability is a VHA priority. As such, we sought to explore barriers and facilitators to VHA reproductive service provision across a catchment area from women's health providers' perspectives. METHODS: We performed a mixed-methods study, including semistructured, qualitative provider interviews with a quantitative survey on training, comfort, and knowledge of reproductive services. All women's health providers and their support staff from the Salt Lake City Veterans Affairs Medical Center and nine VHA community-based outpatient clinics were asked to participate. We conducted qualitative interviews and knowledge surveys with providers and staff to explore training, care processes, and improvement opportunities in reproductive service provision. We completed descriptive analyses of all of the quantitative data and used an open, iterative process to analyze provider interviews for emergent themes. RESULTS: We interviewed 15 providers (7 advanced practice nurses, 4 registered nurses, and 4 physicians) across nine sites (50% response rate). The commonly identified barriers included provider training and staffing, scheduling/referral processes, inconsistent services/supplies, and lack of veteran awareness of reproductive services. Facilitators included prior non-VHA reproductive health experience among providers, invested support staff, and the integrated VHA health system. CONCLUSIONS: Addressing barriers to VHA reproductive healthcare provision may overcome reproductive service variations related to clinic location and improve reproductive health outcomes for women veterans.

Single dose letrozole and misoprostol for termination of pregnancy through 63 days' gestation: A pilot study.

OBJECTIVES: We conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion STUDY DESIGN: We enrolled 40 participants seeking medication abortion up to 63 days' gestation at a site in Salt Lake City, UT. Participants received a single dose of letrozole 30 mg in-clinic followed 2 days later by misoprostol 800 mcg buccally at home. They took a second dose of misoprostol if they had no bleeding within 24 hours of the first. Participants returned 7 to 10 days later for assessment of abortion outcome and side effects RESULTS: Thirty-seven participants (93%) returned for follow-up and 2 (5%) went to another facility from which research staff obtained outcome data. Three-fourths (29/39, 74%, 95% CI: 60%-89%) had a complete abortion; 4 (10%, 95% CI: 0.3%-20%) had an incomplete abortion and opted for aspiration, and 6 (15%, 95% CI: 4%-27%) had an ongoing pregnancy. All subjects with follow-up reported taking the first dose of misoprostol. Ten (27%) took the second dose as well; only three did so due to no bleeding. Nineteen participants (51%) reported side effects after letrozole prior to misoprostol and two people (5%) rated these effects as severe. Side effects following misoprostol occurred in 33 participants (89%) and were as expected based on previous literature. No serious adverse events were reported CONCLUSION: A single dose of letrozole 30 mg followed by misoprostol had lower than desirable efficacy and does not warrant further study. IMPLICATIONS: A single dose of letrozole does not appear to be an effective adjunct to misoprostol for medication abortion.

One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial.

BACKGROUND: Recent evidence demonstrates the effectiveness of the levonorgestrel 52-mg intrauterine device for emergency contraception vs the copper T380A intrauterine device. Of note, 1-year pregnancy and continuation rates after intrauterine device placement for emergency contraception remain understudied. OBJECTIVE: This study compared 1-year pregnancy and intrauterine device continuation rates and reasons for discontinuation among emergency contraception users randomized to the levonorgestrel 52-mg intrauterine device or the copper intrauterine device. STUDY DESIGN: This participant-masked, randomized noninferiority trial recruited emergency contraception individuals desiring an intrauterine device from 6 Utah family planning clinics between August 2016 and December 2019. Participants were randomized 1:1 to the levonorgestrel 52-mg intrauterine device group or the copper T380A intrauterine device group. Treatment allocation was revealed to participants at the 1-month follow-up. Trained personnel followed up the participants by phone, text, or e-mail at 5 time points in 1 year and reviewed electronic health records for pregnancy and intrauterine device continuation outcomes for both confirmation and nonresponders. We assessed the reasons for the discontinuation and used Cox proportional-hazard models, Kaplan-Meier estimates, and log-rank tests to assess differences in the continuation and pregnancy rates between the groups. RESULTS: The levonorgestrel and copper intrauterine device groups included 327 and 328 participants, respectively, receiving the respective interventions. By intention-to-treat analysis at 1 year, the pregnancy rates were similar between intrauterine device types (2.8% [9/327] in levonorgestrel 52-mg intrauterine device vs 3.0% [10/328] in copper intrauterine device; risk ratio, 0.9; 95% confidence interval, 0.4-2.2; P=.82). Most pregnancies occurred in participants after intrauterine device removal, with only 1 device failure in each group. Of note, 1-year continuation rates did not differ between groups with 204 of 327 levonorgestrel 52-mg intrauterine device users (62.4%) and 183 of 328 copper T380A intrauterine device users (55.8%) continuing intrauterine device use at 1 year (risk ratio, 1.1; 95% confidence interval, 1.0-1.2; P=.09). There were differences concerning the reasons for discontinuation between intrauterine device types, with more bleeding and cramping cited among copper intrauterine device users. CONCLUSION: The pregnancy rates were low and similar between intrauterine device types. Of note, 6 of 10 intrauterine device emergency contraception users continued use at 1 year. Moreover, 1-year continuation rates were similar between intrauterine device types.

"It's Not a Top Priority": A Qualitative Analysis of Provider Views on Barriers to Reproductive Healthcare Provision for Homeless Women in the United States.

Women experiencing housing insecurity are at an elevated risk for adverse reproductive health outcomes due to the prevalence of chronic health conditions and higher risk behaviors. Social service and healthcare providers are front line in addressing women's needs when they seek support. Thus, we sought to explore reproductive healthcare barriers using in-depth interviews with 17 providers at 11 facilities serving housing-insecure women in Salt Lake County, Utah, USA from April to July 2018. Providers noted a number of system-, provider-, and individual-level barriers. Dominant themes include reliance on unstable funding, lack of provider training on reproductive health, and perceived logistical challenges to care. Due to the prevalence of immediate needs among housing-insecure women, providers attest that reproductive health needs often do not emerge as their urgent concern. Our findings suggest that addressing policy and funding challenges to prioritizing reproductive needs among housing-insecure women can help mitigate the potential for long-term adverse reproductive outcomes.

Mifepristone for miscarriage treatment in Utah: A survey of clinician knowledge and assessment of an educational video on future use.

Objectives: We aimed to: (a) describe current use of mifepristone for early pregnancy loss (EPL) management in Utah, (b) identify predictors of knowledge pre- and posteducational video, and (c) explore postvideo impacts on the likelihood to use mifepristone. Mifepristone is subject to the Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategy (REMS) requirements. Methods: Between September 2020 and March 2021 we surveyed Utah clinicians from six specialties caring for people experiencing EPL, recruited through professional organizations and hospital listservs. Participants viewed a 3.5-minute educational video on mifepristone for EPL and completed pre- and postvideo questionnaires. We evaluated predictors of high prevideo and improved postvideo knowledge using random forest regression conditional importance measures and partial dependency plots. We described current mifepristone use and video effects on likelihood to use mifepristone. Results: Of 506 participants, most specialize in emergency medicine (172, 34%) and practice in private settings (253, 51%). Two-thirds had heard of mifepristone (328/471, 70%). Of 176/471 (37%) attempting provision of mifepristone, actual provision occurred for 59% (104/176). Baseline knowledge scores were low (mean 4.81/13 [37%] correct). Predictors of high prevideo knowledge include provision or attempted provision of mifepristone, having heard of mifepristone, providing EPL management expectantly or via medication, and specialty type. Mean postvideo knowledge scores improved by 3.27 points (68% improvement, paired t-test; 95% confidence interval 2.82-3.72, p < 0.0001). Postvideo, 66% (242/364) stated they are much more or somewhat more likely to use mifepristone, with compliance with FDA requirements cited as a barrier to utilization. Conclusions: Among Utah providers, baseline mifepristone knowledge and use for EPL management are low. An educational video improved knowledge and likelihood of use, but FDA REMS requirements continue to be a barrier to including mifepristone in medication management of EPL.

Evaluating the MyPath web-based reproductive decision support tool in VA primary care: Protocol for a pragmatic cluster randomized trial.

BACKGROUND: Counseling to identify and support individuals' desires for family formation is a key component of preventive health care that is often absent in primary care visits. This study evaluates a novel, web-based, person-centered intervention to increase the frequency and quality of communication about reproductive goals and healthcare needs in Veterans Health Administration (VA) primary care. METHODS: We describe a hybrid type 1 effectiveness-implementation cluster randomized controlled trial in seven VA healthcare systems testing a web-based reproductive health decision support tool (MyPath). VA primary care providers are enrolled and randomized to intervention or usual care arms. Veterans scheduled to see intervention-arm providers receive a text message inviting them to use MyPath ahead of their appointment; Veterans scheduled to see control-arm providers receive usual care. Target enrollment is 36 providers and 456 Veterans. Outcomes are assessed by Veteran self-report after the visit and at 3- and 6-months follow-up. The primary outcome is occurrence of reproductive health discussions involving shared decision making; secondary outcomes include measures of communication, knowledge, decision conflict, contraceptive utilization, and receipt of services related to prepregnancy health. Data on implementation barriers, facilitators and cost are collected. RESULTS: The trial is ongoing with no results to report. We have enrolled 36 primary care providers across 7 VA healthcare systems and recruitment of Veterans is ongoing. CONCLUSIONS: Results will inform efforts to increase the quality and person-centeredness of reproductive healthcare delivery in primary care and to operationalize and scale up use of digital decision support tools in clinical settings. TRIAL REGISTRATION: http://ClinicalTrials.gov Identifier: NCT04584294 Trial Status: Recruiting.

Oral Emergency Contraception Provision in the Veterans Health Administration: a Retrospective Cohort Study.

BACKGROUND: In the USA, oral emergency contraception (EC) use to prevent unintended pregnancy is increasing. Oral EC methods include levonorgestrel (LNG) and ulipristal acetate (UPA), with increased UPA efficacy over LNG in high BMI users and those beyond 3 days post intercourse. The Veterans Health Administration (VHA) provides oral EC at low or no cost, yet prescription-level Veteran data are lacking. OBJECTIVE: To describe oral EC provision in VHA, including method type and Veteran user and prescriber characteristics. DESIGN: A retrospective cohort study using VHA administrative data. PARTICIPANTS: All VHA oral EC prescriptions from January 1, 2016, to December 31, 2020. MAIN MEASURES: We linked Veteran-level sociodemographic and military characteristics and provider-level data with each prescription to identify variables associated with oral EC method. KEY RESULTS: A total of 4280 EC prescriptions (85% LNG) occurred for 3120 unique Veterans over 5 years. While prescriptions remained low annually, the proportion of UPA prescriptions increased from 12 to 19%. Compared to LNG users, UPA users were older (34% vs 25% over age 35 years, p <0.001); more likely to identify as white (57% vs 46%) and non-Hispanic (84% vs 79%) (p <0.001); and more likely to have a BMI ≥ 25 (76% vs 67%, p <0.001). UPA prescriptions originated most frequently from VA Medical Centers (87%) and women's health clinics (76%) compared to community-based or other clinic types. In multivariable regression models, race, ethnicity, BMI ≥30, and prescriber facility type of a VA Medical Center or a women's clinic location were predictive of UPA prescription. CONCLUSIONS: Oral EC provision in VHA remains low, but UPA use is increasing. LNG prescription occurs frequently in high BMI Veterans who would benefit from increased efficacy of UPA. Interventions to expand oral EC access in VHA are essential to ensure Veterans' ability to avert unwanted pregnancies.

"I just had to pay the money and be supportive": A qualitative exploration of the male-partner role in contraceptive decision-making in Salt Lake City, Utah family planning clinics.

OBJECTIVES: Peers and intimate partners can influence contraceptive decision-making and use. We aimed to explore the male-partner role in contraceptive decision-making, and describe ideal male-partner roles and how they relate to contraceptive use, specifically uptake of long-acting reversible contraception (LARC). STUDY DESIGN: We used a phenomenological approach to explore cis-hetero partner involvement in contraceptive decision-making and conducted semi-structured in-depth interviews with 30 cisgender women and 30 cisgender men in heterosexual relationships who presented to Salt Lake City family planning clinics. Participants, stratified by sex assigned at birth and current contraceptive method (LARC vs non-LARC), described the male-partner's role in the most recent contraceptive decision and discussed how ideal-partner involvement could look in contraceptive decision-making. We iteratively developed a codebook and identified dominant themes using a constant content and comparative analysis. RESULTS: We did not identify thematic differences by LARC vs non-LARC users. Participants universally considered that contraceptive responsibility falls on women. At the time of the interviews, both men and women indicated a strong desire to prevent pregnancy, and felt that men's actual contributions to decision-making were limited. Themes around gendered-differences of contraceptive knowledge, responsibility and risk, and sexual priorities emerged, as well as inadequate knowledge and contraception options for men. In analyzing discussion around ideal partner support, participants suggested emotional, financial, and logistical support options and placed high importance on interpersonal communication. CONCLUSIONS: The decision to use a method of LARC did not influence sentiments around male-partner involvement or stated desire for partner involvement. Limited contraceptive knowledge and male options restrict the contraceptive decision-making role and contraceptive engagement for men, although participants suggested other supportive options. IMPLICATIONS: This work suggests the desire of both men and women for men to participate in contraceptive decision-making, but their role remains limited. Future interventions focused on comprehensive contraceptive education and modeling of communication strategies for men are tangible steps to support men in this role.

"It's a Vicious Cycle": A Mixed Methods Study of the Role of Family Planning in Housing Insecurity for Women.

We sought to explore family planning needs and experiences in housing-insecure women. We recruited 90 women (median age 29y) across Salt Lake County, Utah to complete a self-administered survey, and 15 of them also completed a qualitative interview. Of those at risk for unintended pregnancy, 27 (59%) reported not using their ideal contraceptive method. Reported barriers included cost and inability to find a provider. Participants described the conflicting role of pregnancy as a window to health care and other services, as well as the competing challenges of high-risk sex and physical safety. Addressing comprehensive reproductive needs is essential during times of housing insecurity. Doing this may avert homelessness.

Quantitative and qualitative impact of One Key Question on primary care providers' contraceptive counseling at routine preventive health visits.

OBJECTIVES: One Key Question (OKQ) is a clinical screening tool to assess pregnancy desire in the next year. We aimed to 1) describe the effect of OKQ implementation on contraceptive counseling rates at preventive health visits and 2) evaluate primary care providers' perception of OKQ implementation on their contraceptive counseling practices. STUDY DESIGN: We performed a quantitative retrospective chart review of preventive health visits at eight federally qualified health centers in Utah between 2014 and 2017. Implementation of OKQ included a brief training and inclusion of OKQ in the electronic medical record. Providers received OKQ training in August 2015 and re-training in March 2017. We assessed OKQ and contraceptive counseling documentation rates using interrupted-time-series analysis. We then conducted semi-structured interviews with providers and queried them about the impact of OKQ. We identified dominant themes using modified grounded theory to create an explanatory framework. RESULTS: Abstracting 6634 charts yielded 9840 visits with 56 unique providers (51% physician assistant, 34% physician, 14% nurse practitioner). Interrupted-time-series analysis showed a documentation increase of OKQ in late 2015 (2.6%) and again in spring 2017 (9%), however rates remained low. Contraceptive counseling rates (39.7%) did not change after OKQ implementation. Charts with evidence of a current contraceptive method were less likely to have a OKQ response documented. Interviewees reported OKQ's algorithm did not alter their contraceptive counseling. CONCLUSIONS: OKQ did not change documented rates of contraceptive counseling and uptake was low in quantitative and qualitative analyses. Our study suggests limited usefulness of OKQ in the primary care setting. IMPLICATIONS: Implementation of the One Key Question tool through training and optional EHR field did not increase documented rates of contraceptive counseling in a large federally qualified health center or affect provider contraceptive counseling. Our study suggests limited usefulness of OKQ as a robust screening tool in this primary care setting.

Determining the impact of the Zika pandemic on primary care providers' contraceptive counseling of non-pregnant patients in the US: a mixed methods study.

BACKGROUND: Global pandemics like Zika (ZIKV) factor into pregnancy planning and avoidance, yet little is known about how primary care providers (PCPs) incorporate public health guidance into contraceptive counseling. Study objectives include: 1) determining the impact of the ZIKV pandemic on contraceptive counseling changes; and 2) assessing PCP knowledge and practice regarding contraception, ZIKV, and CDC ZIKV guidelines. METHODS: Study components included: (1) a retrospective review of electronic health records of non-pregnant, reproductive age women presenting for preventive health visits between 2014 and 2017 assessed using interrupted time series analyses (ITSA) to identify changes in documentation of ZIKV risk assessment and contraceptive counseling; and (2) a sequential, cross-sectional study with quantitative surveys and qualitative, semi-structured interviews of PCPs providing preventive care to non-pregnant patients at eight federally qualified health centers in Utah. We performed descriptive analyses on survey data and analyzed qualitative data for dominant themes using a modified Health Belief Model. RESULTS: We conducted 6634 chart reviews yielding 9840 visits. The ITSA did not reveal changes in ZIKV risk assessment or contraceptive counseling. Twenty-two out of 40 (55%) eligible providers participated in the provider component. Participants averaged 69 and 81% correct on contraceptive and ZIKV knowledge questions, respectively. Sixty-five percent reported counseling consistent with CDC ZIKV guidelines. Qualitative analysis found providers unlikely to prioritize ZIKV risk assessment in contraceptive counseling for non-pregnant patients. CONCLUSIONS: PCPs who care for non-pregnant women are knowledgeable about contraception and ZIKV; however, there was no change in ZIKV risk assessment or contraceptive counseling. This stresses the importance of developing strategies to improve guideline uptake.

Long-Term Failure Rates of Interval Filshie Clips As a Method of Permanent Contraception.

Background: In 1996, the U.S. Collaborative Review of Sterilization (CREST) reported permanent contraception failure rates by method, but did not include the Filshie clip. Subsequent research provides data for Filshie clip failure rates up to 24 months, but rigorously designed and executed studies examining failure rates beyond 2 years are lacking. Objectives: To describe non-Filshie and Filshie procedures, identify failures, and calculate 10-year pregnancy rates among patients who have undergone interval permanent contraception procedures with Filshie clips. Study Design: We performed chart review for patients who underwent interval permanent contraception procedures between 2000 and 2014 at our institution. We identified births after permanent contraception by utilizing both chart review and the Utah Population Database. We report results from life table analysis, with censoring at failure, 49 years of age, or last observed date of service. Results: In this cohort of 693 patients, surgeons most commonly used Filshie clips for interval permanent contraception (N = 547, 78.8%). We classified pregnancies after Filshie clip procedures as verified (n = 4) or self-reported (n = 3). We obtained 5 years of data for 411 patients (59.3% of all permanent contraception procedures), and more than 10 years of data for 257 patients (37.1%). We calculated a cumulative 5- and 10-year pregnancy rate to be the same, including both verified and self-reported pregnancies, of 9.8 (95% confidence interval [CI] 4.1-23.3)/1000 women using Filshie clips. The 10-year rate of verified pregnancy is 2.8 (95% CI 1.0-15.7)/1000 women. Conclusion: Overall, long-term failure of Filshie clip interval permanent contraception procedures is infrequent, with a 10-year cumulative probability of failure of 4.1-23.3/1000 procedures performed. Filshie clips compare favorably with other methods of permanent contraception included in the CREST study, where the 10-year cumulative probability of failure ranged from 7.5 to 36.5/1000 procedures performed.

Pregnancy Risk Screening and Counseling for Women Veterans: Piloting the One Key Question in the Veterans Healthcare Administration.

OBJECTIVES: Women veterans have a high prevalence of comorbidities that increase the risk of adverse pregnancy outcomes. Screening for pregnancy desires in primary care provider (PCP) visits offers an opportunity to optimize preconception health. This pilot quality improvement initiative sought to assess Veterans Healthcare Administration provider preferences on One Key Question (OKQ) implementation, identification of veterans' reproductive needs, and the effect of training on documentation in a women's primary care clinic in Salt Lake City, Utah. METHODS: We hosted OKQ training sessions for providers and staff, audio recorded group discussions on implementation barriers, and explored themes. Women veterans presenting for a PCP visit in July 2018 self-completed a paper OKQ screening tool. We calculated summary statistics on responses. We conducted a pre-post analysis, with respect to training sessions, to measure for changes in family planning documentation during PCP visits. RESULTS: Nineteen providers and staff completed the training. They acknowledged the importance, but believed that the screening tool should be completed by veterans and not be provider prompted. Forty-two women veterans completed the screening tool: 21% desired pregnancy in the next year and 26% desired contraceptive information. Chart reviews found a nonsignificant increase in current contraceptive method documentation between periods (20% vs 37%; P = 0.08), a decline in documentation of reproductive goals (22% vs 3%; P = 0.02), and no significant change in counseling. CONCLUSIONS: Veterans identify reproductive needs via the OKQ screening tool, but provider documentation did not reflect changes in care following training. Further study is necessary to develop an optimal, patient-centered tool and implementation plan to support women veterans in their reproductive goals.

Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.

BACKGROUND: In the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose. METHODS: This randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points. RESULTS: Among the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, -0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group. CONCLUSIONS: The levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.).