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Item Barriers and facilitators to implementing a patient-centered model of contraceptive provision in community health centers(BMC, 2016-11-08) Politi, Mary C.; Estlund, Amy; Milne, Anne; Buckel, Christina M.; Peipert, Jeffrey F.; Madden, Tessa; Obstetrics and Gynecology, School of MedicineBackground The Contraceptive CHOICE Project developed a patient-centered model for contraceptive provision including: (1) structured, evidence-based counseling; (2) staff and health care provider education; and (3) removal of barriers such as cost and multiple appointments to initiate contraception. In preparation for conducting a research study of the CHOICE model in three community health settings, we sought to identify potential barriers and facilitators to implementation. Methods Using a semi-structured interview guide guided by a framework of implementation research, we conducted 31 qualitative interviews with female patients, staff, and health care providers assessing attitudes, beliefs, and barriers to receiving contraception. We also asked about current contraceptive provision and explored organizational practices relevant to implementing the CHOICE model. We used a grounded theory approach to identify major themes. Results Many participants felt that current contraceptive provision could be improved by the CHOICE model. Potential facilitators included agreement about the necessity for improved contraceptive knowledge among patients and staff; importance of patient-centered contraceptive counseling; and benefits to same-day insertion of long-acting reversible contraception (LARC). Potential barriers included misconceptions about contraception held by staff and providers; resistance to new practices; costs associated with LARC; and scheduling challenges required for same-day insertion of LARC. Conclusions In addition to staff and provider training, implementing a patient-centered model of contraceptive provision needs to be supplemented by strategies to manage patient and system-level barriers. Community health center staff, providers, and patients support patient-centered contraceptive counseling to improve contraception provision if organizations can address these barriers.Item Changes in body composition in women using long-acting reversible contraception(Elsevier, 2017-04) De Nazaré Silva dos Santos, Priscilla; Madden, Tessa; Omvig, Karen; Peipert, Jeffrey F.; Obstetrics and Gynecology, School of MedicineOBJECTIVE: Users of hormonal long-acting reversible contraception (LARC) report weight gain as a side effect, but few studies have assessed body composition change among LARC users. We evaluated weight and body composition of healthy women using the levonorgestrel intrauterine system (LNG-IUS), copper intrauterine device (copper IUD) or etonogestrel implant (ENG implant). We hypothesized that weight gain and body composition over 12 months would not differ between copper IUD, LNG-IUS and ENG implant users. STUDY DESIGN: We performed a prospective cohort study of a subgroup of women enrolled in the Contraceptive CHOICE Project who initiated the LNG-IUS, copper IUD or ENG implant. Inclusion criteria included lack of metabolic and eating disorders or change in body weight of more than 5% in the 6 months before enrollment. We measured changes in weight and body composition (body fat percentage, total body fat mass, total lean mass and total body mass) in women who continued their method for 12 months. RESULTS: We analyzed data from 149 participants: 85 LNG-IUS users, 31 copper IUD users and 33 ENG implant users. The mean age was 25.9 years, 56.4% were White, 82.5% had some college education and 67.6% were nulliparous. Although lean body mass increased over 12 months in LNG-IUS and copper IUD users but not in ENG implant users, changes in body weight and body composition did not differ between the groups. In the adjusted model, Black race was associated with change in total body mass (p<.05). CONCLUSIONS: Among those who continued the method for 12 months, changes in body weight and composition did not differ between copper IUD, LNG-IUS and ENG implant users. IMPLICATIONS STATEMENT: Changes in body weight and composition over 12 months did not differ between copper IUD users and LNG-IUS and ENG implant users among those with 12 months of continuous use.Item Comparison of an additional early visit to routine postpartum care on initiation of long-acting reversible contraception: A randomized trial(Elsevier, 2018) Bernard, Caitlin; Wan, Leping; Peipert, Jeffrey F.; Madden, Tessa; Obstetrics and Gynecology, School of MedicineObjective To investigate whether an early 3-week postpartum visit in addition to the standard 6-week visit increases long-acting reversible contraception (LARC) initiation by 8 weeks postpartum compared to the routine 6-week visit alone. Study design We enrolled pregnant and immediate postpartum women into a prospective randomized, non-blinded trial comparing a single 6-week postpartum visit (routine care) to two visits at 3 and 6 weeks postpartum (intervention), with initiation of contraception at the 3-week visit, if desired. All participants received structured contraceptive counseling. Participants completed surveys in-person at baseline and at the time of each postpartum visit. A sample size of 200 total participants was needed to detect a 2-fold difference in LARC initiation (20% vs. 40%). Results Between May 2016 and March 2017, 200 participants enrolled; outcome data are available for 188. The majority of LARC initiation occurred immediately postpartum (25% of the intervention arm and 27% of the routine care arm). By 8 weeks postpartum, 34% of participants in the intervention arm initiated LARC, compared to 41% in the routine care arm (p=.35). Overall contraceptive initiation by 8 weeks was 83% and 84% in the intervention and routine care arms, respectively (p=.79). There was no difference between the arms in the proportion of women who attended at least one postpartum visit (70% vs. 74%, p=.56). Conclusion The addition of a 3-week postpartum visit to routine care does not increase LARC initiation by 8 weeks postpartum. The majority of LARC users desired immediate rather than interval postpartum initiation.Item Comparison of Unintended Pregnancy at 12 Months between Two Contraceptive Care Programs; a Controlled Time-Trend Design(Elsevier, 2019) Madden, Tessa; Paul, Rachel; Maddipati, Ragini; Buckel, Christina; Goodman, Melody; Peipert, Jeffrey F.; Obstetrics and Gynecology, School of MedicineObjectives To compare unintended pregnancy rates at 12 months between women receiving structured contraceptive counseling plus usual contraceptive care and women receiving structured contraceptive counseling, healthcare provider education and cost support for long-acting reversible contraceptive (LARC) methods. Study design Using a controlled time-trend study design, we first enrolled 502 women receiving structured contraceptive counseling in addition to usual care (“Enhanced Care”) and subsequently enrolled 506 women receiving counseling plus healthcare provider education and cost support for LARC methods (“Complete CHOICE”) at three federally qualified health centers (FQHCs). Cost support included funds to health centers for “on-the-shelf” LARC methods and no-cost LARC methods for uninsured women. Participants completed in-person baseline surveys and follow-up surveys by telephone at 3, 6 and 12 months. We used Kaplan–Meier survival function to estimate 12-month unintended pregnancy rates and Cox proportional-hazards regression to compare unintended pregnancy rates between the two groups. We imputed pregnancy outcomes for women lost to follow-up (9%) prior to 12 months. Results “Complete CHOICE” participants were less likely to report an unintended pregnancy at 12 months compared to “Enhanced Care”; 5.3 vs. 9.8 pregnancies per 100 women-years (p=.01). After adjusting for confounders (recruitment site, race, age and federal poverty level), women in “Complete CHOICE” had a 40% lower risk of unintended pregnancy at 12 months (adjusted hazard ratio 0.60; 95% confidence interval 0.37–0.99). Conclusions Contraceptive provision that includes cost support and healthcare provider education in addition to patient counseling reduced unintended pregnancy at 12 months compared to counseling plus usual contraceptive care. Implications A program of contraceptive care that includes comprehensive counseling; healthcare provider education; cost support; and on-the-shelf, long-acting reversible contraception can reduce unintended pregnancy compared to contraceptive counseling in addition to usual health center care in the FQHC setting.Item Contraception and Ectopic Pregnancy Risk: A Prospective Observational Analysis(Elsevier, 2021-02) Schultheis, Paige; Montoya, Melissa Natalie; Zhao, Qiuhong; Archer, Johanna; Madden, Tessa; Peipert, Jeffrey F.; Obstetrics and Gynecology, School of MedicineItem Effect of Staff Training and Cost Support on Provision of Long-Acting Reversible Contraception in Community Health Centers(Elsevier, 2019) Buckel, Christina; Maddipati, Ragini; Goodman, Melody; Peipert, Jeffrey F.; Madden, Tessa; Obstetrics and Gynecology, School of MedicineObjective To compare the proportion of women receiving same-day long-acting reversible contraception (LARC) between two different models of contraceptive provision adapted from the Contraceptive CHOICE Project. Study Design We used a controlled time-trend study design to compare 502 women receiving structured contraceptive counseling in addition to usual care (“Enhanced Care”) to 506 women receiving counseling plus healthcare provider education and cost support for LARC (“Complete CHOICE”) at three federally qualified health centers. We provided funds to health centers to ensure an “on-the-shelf” supply and no-cost LARC for uninsured women. We recorded the contraceptive method chosen after contraceptive counseling and the healthcare provider appointment as well as the contraceptive method received that day. Among women choosing LARC, we calculated proportions and performed Poisson regression with robust error variance to estimate relative risks for same-day insertion. Results Participant demographics reflected the health center populations; 69% were black, 66% had a high school diploma or less, 57% were publicly insured, and 75% reported household income less than 101% federal poverty line. There were 153 (30.5%) women in “Enhanced Care” and 273 (54.0%) in “Complete CHOICE” who chose LARC (p<0.01). Among women who chose LARC (n=426), those in “Complete CHOICE” were more likely to receive a same-day insertion, 53.8% vs. 13.7% (RRadj 4.73; 95%CI 3.20-6.98) compared to “Enhanced Care.” Conclusions A contraceptive care model that included healthcare provider education and cost support for LARC in addition to structured contraceptive counseling resulted in higher rates of same-day LARC insertion compared to contraceptive counseling and usual care alone.Item Evaluation of a computerized contraceptive decision aid: a randomized controlled trial(Elsevier, 2020) Madden, Tessa; Holttum, Jessica; Maddipati, Ragini; Secura, Gina M.; Nease, Robert F.; Peipert, Jeffrey F.; Politi, Mary C.; Obstetrics and Gynecology, School of MedicineObjective: To evaluate the effectiveness of a contraceptive decision aid in reducing decisional conflict among women seeking reversible contraception. Study design: We conducted a randomized trial of a computer-based decision aid compared to a control group for women presenting for reversible contraception at two clinics affiliated with an academic medical center. The primary outcome was change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale. We hypothesized the decision aid would reduce the decisional conflict score by 10 points on a 100-point scale (0 = no conflict, 100 = high conflict) compared to the control group. Secondary outcomes included contraceptive method chosen and satisfaction with the healthcare visit. Results: We enrolled and randomized 253 women, and 241 had complete data for our primary outcome. Overall, pre-visit decisional conflict scores were low, reflecting low levels of decisional conflict in our sample; median score 15 (range 0-80) in the decision aid and 10 (0-85) in the control group (p = 0.45). Both groups had a similar reduction in median decisional conflict after the healthcare visit: -10 (-80 to 25) and -10 (-60 to 5) in the decision aid and control groups respectively (p = 0.99). Choice of contraception (p = 0.23) and satisfaction with healthcare provider (p = 0.79) also did not differ by study group. Conclusions: Decisional conflict around contraception was low in both groups at baseline. Use of a computerized contraceptive decision aid did not reduce decisional conflict, alter method choice, or impact satisfaction compared to the control group among women choosing reversible contraception. Implications: Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception. Future studies could focus on testing the decision aid in different clinical settings, especially where barriers to providing comprehensive contraceptive counseling exist.Item Medicaid savings from the Contraceptive CHOICE Project: a cost-savings analysis(Elsevier, 2018-12) Madden, Tessa; Barker, Abigail R.; Huntzberry, Kelsey; Secura, Gina M.; Peipert, Jeffrey F.; McBride, Timothy D.; Obstetrics and Gynecology, School of MedicineBackground Forty-five percent of births in the United States are unintended, and the costs of unintended pregnancy and birth are substantial. Clinical and policy interventions that increase access to the most effective reversible contraceptive methods (intrauterine devices and contraceptive implants) have potential to generate significant cost savings. Evidence of cost savings for these interventions is needed. Objective The purpose of this study was to conduct a cost-savings analysis of the Contraceptive CHOICE Project, which provided counseling and no-cost contraception, to demonstrate the value of investment in enhanced contraceptive care to the Missouri Medicaid program. Study Design The Contraceptive CHOICE Project was a prospective cohort study of 9256 reproductive-age women who were enrolled between 2007 and 2011. Study follow-up was completed October 2013. This analysis includes 5061 Contraceptive CHOICE Project participants who were current Missouri Medicaid beneficiaries or were uninsured and reported household incomes <201% of the federal poverty line. We created a simulated comparison group of women who were receiving care through the Missouri Title X program and modeled the contraception and pregnancy outcomes that would have occurred in the absence of the Contraceptive CHOICE Project. Data about contraceptive use for the comparison group (N=5061) were obtained from the Missouri Title X program and adjusted based on age, race, ethnicity, and income. To make an accurate comparison that would account for the difference in the 2 populations, we used our simulation model to estimate total Contraceptive CHOICE Project costs and total comparison group costs. We reported all costs in 2013 dollars to account for inflation. Results Among the Contraceptive CHOICE Project participants who were included, the uptake of intrauterine devices and implants was 76.1% compared with 4.8% among the comparison group. The estimated contraceptive cost for the simulated Contraceptive CHOICE Project group was $4.0 million vs $2.3 million for the comparison group. The estimated numbers of unintended pregnancies and births averted among the simulated Contraceptive CHOICE Project group compared with the comparison group were 927 and 483, respectively, which represented a savings in pregnancy and maternity care of $6.7 million. We estimated that the total cost savings for the state of Missouri attributable to the Contraceptive CHOICE Project was $5.0 million (40.7%) over the project duration. Conclusion A program providing counseling and no-cost contraception yields substantial cost savings because of the increased uptake of highly effective contraception and consequent averted unintended pregnancy and birth.