Telehealth to improve continuity for patients receiving buprenorphine treatment for opioid use disorder.

Context: Buprenorphine is medication-assisted treatment for opioid use disorder. It is a controlled substance and most states limit the dispensing to a 30-day supply. Patients with opioid use disorder often have social determinants of health barriers that make it difficult to engage with the health system to obtain a new supply of buprenorphine every month. Telehealth can be used to reduce barriers to accessing care and improve continuity of care for patients receiving buprenorphine treatment. Objective: To assess the rates of patient continuity for patients receiving buprenorphine treatment via tele-health versus in-person in a primary care outpatient setting. Study Design: Review of patients receiving buprenorphine treatment for opioid use disorder and rates of continuity by visit type during a 2-year time period May 2019-May 2021. Dataset: EPIC electronic medical records from an urban university-affiliated ambulatory primary care practice in New Jersey. Population Studied: Patients scheduled for a visit in the outpatient primary care clinic. Approximately 69% were African American, 22% Hispanic, and 9% other. The majority were enrolled in Medicaid. 80% of patients faced one or more barriers to social determinants of health including transportation, housing, and economic stability. Intervention: Establishment and implementation of HIPAA compliant tele-health following approved state guidelines for buprenorphine prescribing via tele-health. Appointments were scheduled in-person or tele-health by patients' preference. Outcome Measures: Rates of continuity by visit type for patients receiving buprenorphine treatment during the study time period compared by chi-square. Results: Of the 487 patients seen via tele-health, 297 (61%) continued to receive follow up care. Of the 811 patients seen in-person, 400 (49.3%) continued to receive follow up care, p<.0001. The patients who did not continue to receive follow up care were lost to follow up despite attempts to reach patients to re-engage in care. Conclusions: Our study shows that rates of continuity of care are higher using tele-health for patients receiving medication assisted therapy for opioid use disorder. In an urban underserved population, tele-health can result in improved continuity of care for patients with opioid use disorder. Telehealth may reduce barriers to accessing care including transportation, work schedule, childcare, and other competing demands.

Best practices for collecting repeated measures data using text messages.

BACKGROUND: Researchers and clinicians use text messages to collect data with the advantage of real time capture when compared with standard data collection methods. This article reviews project setup and management for successfully collecting patient-reported data through text messages. METHODS: We review our experience enrolling over 2600 participants in six clinical trials that used text messages to relay information or collect data. We also reviewed the literature on text messages used for repeated data collection. We classify recommendations according to common themes: the text message, the data submitted and the phone used. RESULTS: We present lessons learned and discuss how to create text message content, select a data collection platform with practical features, manage the data thoughtfully and consistently, and work with patients, participants and their phones to protect privacy. Researchers and clinicians should design text messages to include short, simple prompts and answer choices. They should decide whether and when to send reminders if participants do not respond and set parameters regarding when and how often to contact patients for missing data. Data collection platforms send, receive, and store messages. They can validate responses and send error messages. Researchers should develop a protocol to append and correct data in order to improve consistency with data handling. At the time of enrollment, researchers should ensure that participants can receive and respond to messages. Researchers should address privacy concerns and plan for service interruptions by obtaining alternate participant contact information and providing participants with a backup data collection method. CONCLUSIONS: Careful planning and execution can reward clinicians and investigators with complete, timely and accurate data sets.

Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing.

OBJECTIVE: To assess the impact of early versus late menstrual cycle insertion on bleeding/spotting in the 90 days following levonorgestrel (LNG) 13.5 mg intrauterine system (IUS) insertion. STUDY DESIGN: In this observational study, participants received a LNG 13.5 mg IUS and provided 90 days of bleeding/spotting data by answering the following daily text: "Have you had no flow (0), spotting (1), or bleeding (2) today?" We dichotomized insertion timing as early (days 1-7 from last menstrual period) and late (remainder of menstrual cycle) and compared bleeding/spotting between the two groups in the 90- and 30-day reference periods. We used multivariate regression methods to study associations between cycle day at insertion, parity, historical bleeding, recent hormonal contraceptive use and bleeding/spotting. RESULTS: In the 90-day dichotomous analysis (n=125), we found no differences in the number of days of bleeding/spotting, bleeding or spotting between the early and late insertion groups. In the 30-day dichotomous analysis (n=131), early insertion was associated with fewer days of bleeding than late insertion (5±3 vs. 7±4 days, p<.01). Recent hormonal contraceptive users experienced fewer days of bleeding than new users (5±4 vs. 7±3 days, p<.01). In the 90- and 30-day regression models, earlier insertion was associated with fewer days of bleeding (p=.02, p=.02). Recent contraceptive use was associated with fewer days of bleeding/spotting (90-day, p=.03) and fewer days of bleeding (30-day, p<.01). Nulliparity was associated with spotting (30-day, p=.04). CONCLUSIONS: Early cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion and recent hormonal contraceptive use decrease 30-day bleeding. IMPLICATIONS: The LNG 13.5 mg IUS may be inserted throughout the menstrual cycle with small differences in bleeding patterns in the 30 but not the 90 days following insertion. Shared decision making should determine timing of insertion.

Review of the vaginal contraceptive ring (NuvaRing).

NuvaRing represents another useful contraceptive option for women. The vaginal administration confers benefits and women do not appear to dislike this route of hormone delivery. Efficacy and cycle control are the least comparable to conventional COCs and adverse events are minimal, though vaginal side effects are reported more commonly. Women may find that trying to insert the ring in the clinic will allay any concerns they have with regard to insertion and removal.

Can ultrasound predict IUD expulsion after medical abortion?

OBJECTIVES: Our randomized trial compared early and delayed intrauterine device (IUD) insertion following medical abortion. In this planned substudy, we explore if endometrial thickness and initial IUD position were associated with IUD expulsion. We also describe IUD movement within the uterus during the 6 months after insertion. STUDY DESIGN: We recruited women undergoing medical abortion and choosing the copper IUD for contraception (n=156). Participants were randomly assigned to early insertion 1 week after mifepristone or delayed insertion 4-6 weeks later. We measured endometrial thickness by transvaginal sonogram 1 week after abortion and IUD distance from the fundal aspect of the endometrial cavity three times: at insertion, 6-8 weeks later and at 6 months. RESULTS: We analyzed endometrial thickness in 113 women, baseline IUD position in 114 women and IUD movement in 65 women. Women who expelled IUDs (n=15) had slightly thicker endometria (p=.007) and slightly lower baseline IUD positions (p=.03) than those who retained IUDs, but no clear cutoffs emerged in the receiver operating characteristic curve analysis. Retained IUDs commonly moved up and down throughout the 6 months (from 14 mm towards the fundus to 32 mm towards the cervix). Overall, retained IUDs moved a median of 2mm towards the cervix between insertion and exit (p<.0001). CONCLUSIONS: After medical abortion, the risk of IUD expulsion increases with thicker endometria and lower baseline position. Since no clear cutoffs emerged in the analysis and expulsion remained uncommon even with thicker endometria, we do not recommend restricting IUD insertion based on ultrasound data. IMPLICATION: Copper T IUDs often move within the uterus without expelling. Expulsion is uncommon, and we do not recommend restricting IUD insertion based on ultrasound data.

Predictors of noncompliance in an oral contraceptive clinical trial.

BACKGROUND: This analysis was conducted to identify the participant characteristics associated with noncompliance in an oral contraceptive (OC) clinical trial. STUDY DESIGN: We studied ovarian suppression among normal-weight and obese women during the use of levonorgestrel (LNG)-containing combination OCs. Participants underwent twice weekly phlebotomy during the study cycle and received up to $360 for participation. Along with other study assays, we analyzed 903 specimens from 181 women to measure LNG to assess OC compliance. Consistently undetectable LNG levels indicated noncompliance. To evaluate predictors of OC noncompliance during this study, we compared the characteristics of compliant and noncompliant participants using multivariable logistic regression. We assigned each participant to a relative poverty level based on US census data; all other individual characteristics came directly from participant responses during the baseline interview. RESULTS: One hundred eighty-one women completed the study; 31 were noncompliant (17%). In multivariable analyses, poverty level was the strongest predictor of noncompliance. Compared with those women in the quartile with the lowest level of residential poverty, other women were far more likely to be noncompliant, especially women in the quartile with the greatest prevalence of poverty (adjusted odds ratio, 8.4; 95% confidence interval, 1.5-46.1). Additional factors associated with noncompliance were education level less than a bachelor's degree and Hispanic ethnicity. Other demographic and psychometric measures were not associated with compliance. CONCLUSIONS: We found that noncompliance was strongly associated with residential poverty level, an indirect measure of individual income. In the United States, poverty is associated with female obesity, Hispanic ethnicity and low education, which were also associated here with noncompliance. Study compensation may motivate poor individuals to participate in clinical trials for income. Noncompliance in clinical trials, particularly differential noncompliance, jeopardizes study validity.

Timing of copper intrauterine device insertion after medical abortion: a randomized controlled trial.

OBJECTIVE: To compare intrauterine device (IUD) use at 6 months in women randomized to receive an intrauterine copper contraceptive 1 week compared with 1 month after medical abortion. METHODS: We recruited women undergoing medical abortion with mifepristone and misoprostol and choosing the copper IUD for contraception. We randomly assigned participants to "immediate" insertion 1 week after mifepristone or "delayed" insertion 4-6 weeks later. We followed rates of IUD insertion, 6-month utilization, expulsion, removal, and pregnancy. Participants recorded bleeding in a diary for 4 weeks. RESULTS: We randomized 156 participants. We inserted an IUD in 97% of participants in the immediate group and 76% in the delayed group (P<.001). At 6 months, 69% of participants in the immediate group used the IUD compared with 60% in the delayed group (P=.24). Expulsion rates were comparable; 12% (8 of 69) in the immediate group compared with 11% (7 of 65) in the delayed group. Removals occurred in 14% (10 of 69) of immediate and 8% (5 of 65) of delayed group participants (P=.21). Four pregnancies occurred in delayed group participants who did not return for IUD insertion (P=.09). The immediate and delayed groups reported a median of 20 and 19 bleeding or spotting days, respectively (P=.15). We detected no cases of serious infection, uterine perforation, or hemorrhage. CONCLUSION: Immediate insertion increased uptake of the IUD without increasing expulsions or bleeding. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinialtrials.gov, . LEVEL OF EVIDENCE: I.

Intrauterine contraceptives: a review of uses, side effects, and candidates.

This article reviews the two intrauterine devices (IUDs) available in the United States: the TCu380A, marketed as ParaGard (Duramed Pharmaceuticals, Inc. Pomona, NY), and the levonorgestrel-releasing intrauterine system (LNG-IUS), marketed as Mirena (Bayer HealthCare Pharmaceuticals, Inc., Wayne, NJ). The properties of the two devices are detailed, as well as noncontraceptive indications and appropriate candidates for use. Studies consistently demonstrate that the devices are safe, effective, and provide cost savings when compared with other reversible methods. The TCu380A may be used as postcoital contraception with close to 100% effectiveness. Menstrual blood loss is likely to increase with the TCu380A and decrease with the LNG-IUS. Reduction in menstrual blood loss and endometrial suppression make the LNG-IUS an increasingly popular treatment for menorrhagia, endometriosis, adenomyosis, and as an adjunct to estrogen therapy. IUDs may be inserted immediately after a first- or second-trimester abortion, immediately postpartum, and >or=4 weeks postpartum. Candidacy for IUDs has expanded, and includes nulliparous women, adolescents, and women with immunocompromised conditions including HIV.

Prophylaxis provided to sexual assault victims seen at US emergency departments.

OBJECTIVE: to report on prophylaxis provided to victims of sexual assault seen at hospital emergency departments in the United States. METHODS: Secondary analysis was performed on data from the National Hospital Ambulatory Medical Care Survey (NHAMCS) for 1994 to 1999. NHAMCS is a national probability sample of patient visits to US hospital emergency departments. Cases of sexual assault were identified using reason for visit, diagnostic, and injury codes. The medications provided for each case were examined. RESULTS: We identified 160 cases of sexual assault from 137 822 emergency department visits. None of these victims received the full regimen of antibiotics for sexually transmitted infections (STIs) recommended by the Centers for Disease Control and Prevention. Antibiotics for gonorrhea and chlamydia, 2 of the more frequently diagnosed STIs, were provided for only 24.8% of adults and adolescents. No antibiotics were ordered in 62.5% of all cases or in 51.3% of cases of patients 12 years and older. Twenty-one percent of those eligible received emergency contraception. Human immunodeficiency virus prophylaxis was amongthe medications ordered in one 1999 case. Roughly estimated, more than 60000 victims of sexual assault who visit US emergency departments annually may not be offered antibiotic treatment for the prevention of STIs. CONCLUSION: Even when data limitations are taken into account, our results suggest that emergency department staff may not be routinely providing antibiotic therapy for the prevention of STIs or emergency contraception to victims of sexual assault. A comprehensive national standard of care is needed for the medical treatment of victims of sexual assault along with more training for health care providers.