Liletta: New IUD approved by the FDA

The U.S. Food and Drug Administration (FDA) recently approved Liletta™, a new hormonal intrauterine device (IUD). This levonorgestrel-releasing IUD inhibits uterine lining from thickening and has been FDA approved for up to three years to prevent pregnancy. Liletta, found to be more than 99 percent effective, is already available in Europe and should arrive in the USA within the next few months.

Liletta was developed by Actavis and the non-profit Medicines360. Given the current high cost of IUDs, Medicines360 has focused on making Liletta affordable and accessible to all women. FDA approval was based on results from the largest hormonal IUD trial conducted in the U.S. The Section of Family Planning has been proud to participate in this study since 2010, as part of our broader commitment to research that improves contraceptive access for women.

Our previous research revealed various barriers in accessing the most effective methods, including cost. One recent study, conducted with support from the Office of Population Affairs, explored systems-level barriers to IUD provision. This research led to the development of a toolkit for clinical staff and health care providers to use in identifying and addressing barriers in their own clinics. We are also currently researching the feasibility and effectiveness of using mobile applications for contraceptive counseling in clinic waiting rooms. Our current studies follow previous research on an initial application, available here as an iOS app.

The Section supports the FDA’s approval of Liletta given its effectiveness at preventing pregnancy and ease of use for most women.

“Increasing the array of available and affordable contraceptive methods helps women find a method that best helps them achieve their reproductive health goals”, said Dr. Melissa Gilliam, Chief of the Section of Family Planning and lead investigator for the Section’s study site.

 

Dr. Melissa Gilliam Featured in AP News Story on Contraception Access

AP Photo

Section Chief Dr. Melissa Gilliam was featured and quoted in an Associated Press news story regarding Illinois’ recent effort to ensure comprehensive and continuous birth control coverage for those with Medicaid.

The story, which has been picked up by outlets nationwide including CBS News, discusses a plan from Illinois Gov. Pat Quinn’s administration to improve access to family planning services for individuals with Medicaid, including long-acting birth control methods, by increasing reimbursement and education. The plan was announced at last month’s Illinois Contraceptive Equity Summit, an event hosted by the Section and EverThrive Illinois. The public is invited to comment on the plan until September 15.

According to the article, the current Illinois Medicaid payment system creates a financial barrier to doctors for offering LARC methods. For example, IUDs cost doctors’ offices between $300 and $800 each to keep in stock. Clinics pay the upfront cost of an IUD and absorb the loss of denied or delayed Medicaid claims. By implementing the Illinois Family Planning Action Plan,  the state would double doctors’ reimbursement rates for inserting IUDs and performing vasectomies, thus alleviating the cost for both patient and provider.

Dr. Gilliam commented on access to contraceptive methods within Medicaid, saying that “for some providers, [the state’s plan] will make a very big difference and will be a very welcome change.”

Photo: M. Spencer Green, AP

Illinois Family Planning Action Plan announced at Summit

Yesterday, The Section and EverThrive Illinois (formerly the Illinois Maternal and Child Health Coalition) hosted a successful Illinois Contraceptive Equity Summit at UChicago’s downtown Gleacher Center.

summitAt the Summit, Director Julie Hamos of the Illinois Department of Healthcare and Family Services (pictured), delivered a keynote address during which she announced the launch of the Illinois Family Planning Action Plan. The goal of this plan is to increase access to family planning services for women and men in the Medicaid Program by providing comprehensive and continuous coverage to ensure that every woman can fulfill her childbearing desires.

The Summit also featured an expert panel of speakers who discussed issues affecting access to family planning health services, as well as concrete action steps to ensure that all women can make sexual and reproductive health decisions free from coercion and discrimination. Topics included Medicaid coordinated care, updated Title X guidelines, the impact of the Hobby Lobby Supreme Court decision, and patient experiences as the ACA has been implemented.

Speakers included Kai Tao, Senior Policy Advisor at the Illinois Department of Healthcare and Family Services; Brigid Leahy, Director of Government Relations at Planned Parenthood of Illinois; Lorie Chaiten, Director of the Reproductive Rights Project for the Roger Baldwin Foundation of the ACLU of Illinois; and Dr. Sadia Haider, Family Planning Medical Director for the Office of Women’s Health at the Illinois Department of Public Health.

Section Chief Dr. Melissa Gilliam welcomed the participants and discussed the importance of affordable, quality contraceptive care that recognizes women’s individual needs. Janine Lewis of EverThrive Illinois delivered closing remarks and summarized action items going forward, including the need to assist women and their families in gaining insurance coverage and the opportunity to comment on the Illinois Family Planning Action Plan.

The Summit was attended by a range of key stakeholders, including health care providers, clinic administrators, social service providers, health advocates, and government program staff. Stay tuned for additional materials and video footage from the Summit, and read the Chicago Tribune’s coverage of the event.

The Illinois Contraceptive Equity Summit was made possible thanks to generous support from Emlyn Eisenach and The Irving Harris Foundation.

Photo by Ashley Heher.

 

Clear communication during appointment scheduling can increase LARC uptake

Portrait of a female doctor using a computer while being on the phone

UPDATE: the final version of this article is now online. Read the abstract and download the full article in PDF format.

A new study from Dr. Melissa Gilliam and former Section staff discusses why some scheduled IUD appointments do not result in placement.

“Impact of a revised appointment scheduling script on IUD service delivery in three Title X family planning clinics” was published in the June 2014 online issue of Contraception.

This study began by reviewing clinic administrative data, which showed that women did not receive a desired IUD because of cancellations, no-shows, the need for an IUD-specific appointment, lack of awareness of clinic guidelines, and unknown pregnancy status.

With these systems-level barriers in mind, the researchers created a simple and scalable intervention: revising the appointment scheduling call script. The revised script used by telephone schedulers at a call center addressed these common mishaps and met national Title X guidelines. Along with the revised script, visual tools reminded schedulers to explain behavior prerequisites such as “Do not have unprotected sex at least two weeks prior to an appointment” and “Continue to use pills, patches, or rings up until the appointment”. The script also prompted schedulers to communicate logistical requirements such as bringing an ID, proof of insurance or cash to pay for the procedure, and instructions to call and cancel an appointment if necessary.

Before the new script was instituted, only 47 percent of patients at these sites successfully received an IUD at their scheduled appointment. After implementation of the revised script, 60 percent of scheduled appointments resulted in the desired IUD insertion. Additionally, the no-show rates decreased from 40 to 23 percent, and in particular, young women were more likely to keep their scheduled appointment.

This study shows that a simple IUD appointment scheduling script with clear communication improves LARC uptake. Additionally, as many clinics in the US move forward to computerized and centralized call centers, improving patient communication during the scheduling process may have a broad impact on clinical efficiency.

Related: Development and testing of an iOS waiting room “app” for contraceptive counseling in a Title X family planning clinic

 

Use of an iOS Waiting Room “App” Improves LARC Knowledge

image from www.securedgenetworks.comSection Chief and Ci3 Founder and Director Dr. Melissa Gilliam has published a research article in the American Journal of Obstetrics and Gynecology called Development and Testing of an iOS Waiting Room “App” for Contraceptive Counseling in a Title X Family Planning Clinic.

Data shows that long-acting reversible contraception (LARC) methods (the IUD and implant) are highly effective forms of contraception, but used by less than 10 percent of US women. After talking to clinic staff and analyzing appointment data at three Title X clinics in Chicago, this study found that a lack of contraceptive counseling during a scheduled appointment contributes to the under-use of LARC methods.

This study began by identifying key failures in IUD service delivery, including inadequate counseling time, non-use of waiting room pamphlets, and failure to counsel all women on LARC methods. As a result, the research team opted to create a counseling “app” to increase women’s contraceptive knowledge and interest in the most effective methods.

Results showed that users were highly satisfied with the app and it was easy to use. A brief (<15 min) app session significantly improved women’s knowledge scores on the relative effectiveness of LARC compared with other methods—before she even met with the healthcare provider. App testers (n=17) preferred the interactive, visually appealing design and video testimonials. In the pilot RCT (n=52), app users had significantly higher knowledge of contraceptive effectiveness (p=0.0001) and increased interest in the implant (7.1% to 32.1%, p=0.02) post-intervention. While app users reported increased interest in the contraceptive implant, the app had no discernible impact on women’s interest in the IUD.

The study concluded that integrating app usage into the Title X setting is highly acceptable, informative, and easily integrated into waiting room situations or downloaded onto smartphones in advance of a visit. Thus, apps could be a mechanism for implementing timely, evidenced-based educational information to a wide network of clinics and clients.