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.

 

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New Section publication discusses reproductive counseling and weight-loss surgery

Women of reproductive age often pursue weight-loss surgery; in fact, they account for nearly half of all bariatric surgery patients. The relationship between reproduction and rapid weight loss has been well documented and includes an increased risk of infertility, menstrual irregularities, and changing sexual function. Women who receive bariatric surgery are also more likely to have an unplanned pregnancy. Because of these reproductive risks, the American Society for Metabolic and Bariatric Surgery recommends using effective birth control methods when experiencing rapid weight loss and the American College of Obstetricians and Gynecologists recommends delaying pregnancy one to two years after bariatric surgery.

Yet, according to one survey, 31 percent of female bariatric surgery patients planned to become pregnant after obtaining surgery, and nearly one-third planned to do so within two years. These intentions, as well as contraceptive efficacy following weight loss, warrant close collaboration between bariatric surgeons and women’s health providers.

Section faculty Dr. Julie Chor conducted a national survey of bariatric surgeons to assess perioperative reproductive counseling and contraceptive provision. Her findings were published in Surgery for Obesity and Related Diseases.

http://www.soard.org/

Image courtesy of http://www.soard.org

The study found that 74% of bariatric surgeons preoperatively screen patients regarding contraceptive use more than 50% of the time. The most common method prescribed, however, were oral contraceptive pills, which may have decreased efficacy in the obese and in the postoperative state, depending on the type of surgery.

Most respondents (90 percent) recommended delaying pregnancy 12 to 24 months, yet 84% did not require a gynecologic consultation for female patients of reproductive age and 35% further stated that they did not know how their patients obtained contraception.

One-fifth of respondents did not assess their patients’ pregnancy intentions. This disparity suggests that practitioners should counsel patients preoperatively about reproductive changes that can occur after weight loss from bariatric surgery as well as discuss contraception with all women of reproductive age, whether or not they desire a future pregnancy.

Dr. Chor’s findings suggest implementing a routine gynecology consultation for female bariatric surgery patients prior to an operation. These women would greatly benefit from increased education on fertility changes associated with weight loss and on highly effective methods of contraception, such as intrauterine devices and contraceptive implants.

Read the full article here.

Three new studies focus on lowering clinic barriers to help women obtain desired contraceptive method

Contraception is the cornerstone of pregnancy prevention and the intrauterine device (IUD) is one of the most effective methods available. IUDs require little user maintenance, last between 7 and 12 years, and are more than 99 percent effective at preventing pregnancy. Thus, it is critical to remove unnecessary obstacles that prevent women from receiving a desired IUD.

The University of Chicago Section of Family Planning (the Section) has published three articles that discuss research on implementing interventions to the systematic barriers to IUD care. This research was funded by the Office of Population Affairs.

In collaboration with three Planned Parenthood of Illinois clinics, the research began with an in depth evaluation of all aspects of IUD service delivery called Failure Modes Effects and Criticality Analysis (FMECA). Health care providers and patients were interviewed to see the way in which the system could be redesigned to better deliver care. This step-by-stop process identified “failures” using qualitative and quantitative data, and determined the frequency and impact in order to prioritize redesign and improvements.

A systematic approach to improving intrauterine device services in family planning clinics appeared in Contraception. This publication outlines the Section’s analysis of the FMECA approach and identification of three main failures during the scheduling and intake processes: 1) The patient does not show up for appointment or cancels; 2) The patient recently had unprotected intercourse; and 3) Limited time for counseling, informing, and placing IUDs.

After reviewing the FMECA data, the research and clinical care teams created two solutions to the identified failures: implementing a revised scheduling call script, and developing an iOS counseling app to be used in the waiting room.

Impact of a revised appointment scheduling script on IUD service delivery in three Title X family planning clinics, also published in Contraception, discusses the implementation of the revised scheduling script.

Mindful of the systems-level barriers identified by the FMECA, Section researchers created a simple and scalable intervention: revising the appointment-scheduling call script. 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.

Through implementation of the revised script, no-show rates decreased from 40 to 23 percent, and in particular, young women were more likely to keep their scheduled appointment.

Development and Testing of an iOS Waiting Room “App” for Contraceptive Counseling in a Title X Family Planning Clinic, published in the American Journal of Obstetrics and Gynecology, describes the Section’s development and testing of a theory-based behavioral app. The app, developed with young women, features young women describing their contraceptive experiences. Testers were highly satisfied with the app and found it 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.

The Section continues to research the app for comprehensive contraceptive counseling.

The research team has also developed an online toolkit describing processes, procedures, and tools for an FMECA and shared with Title X clinics nationally.

For more about recent Section research and publications, visit familyplanning.uchicago.edu or our Sexual and Reproductive Health and Justice blog.

Special thanks to the Office of Population Affairs and Planned Parenthood of Illinois for their support.

Section/Ci3 Study Featured in IUD Community Newsletter

Ci3 launch

A research study co-authored by Section staff, Ci3 Founder and Director Dr. Melissa Gilliam and Ci3 Executive Director Dr. Brandon Hill was recently featured in the IUD Community Newsletter. “Impact of a theory-based video on initiation of long-action reversible contraception after abortion” was published online ahead of print in the American Journal of Obstetrics & Gynecology and presented at the 2014 Annual Meeting of the Fellowship of Family Planning in April 2014. Read the abstract here.

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

New Section research assesses systematic barriers to IUD care

iudAt the Section of Family Planning & Contraceptive Research, we are committed to conducting quality research about the effectiveness of IUDs as birth control, especially for young women.

IUDs require little user maintenance, last between 7 and 12 years, and are highly effective at preventing pregnancy. As our earlier research has shown, in order to reduce undesired pregnancy amongst young women, it is critical to remove unnecessary barriers to choosing the IUD. One way to improve the quality of IUD services and the number of women receiving this contraceptive method is to assess the underlying problems that prevent women from receiving an IUD at their scheduled appointment.

Section Chief Dr. Melissa Gilliam’s research on these systematic barriers to IUD care was published in the July 2014 online edition of Contraception.

This article describes the novel use of a systematic approach to evaluating clinical care, called Failure Modes Effects and Criticality Analysis (FMECA). This step-by-step approach was originally developed by engineers to evaluate high-risk industries such as nuclear power and commercial aviation in order to identify practices that contribute to poor quality, unsafe, or unreliable inefficiencies. When adapted to healthcare, team members use FMECA to evaluate the systems and processes of a specific type of clinic care (eg IUD care). “Failures” are identified from qualitative and quantitative data, determining the frequency and impact in order to prioritize redesign and improvements.

For example, a failure in IUD delivery would be a patient calling and cancelling an appointment, but the cancellation is not entered into the scheduling system.

Dr. Gilliam’s study used the FMECA process to evaluate IUD services at three Title X clinics and identified three main failures during the scheduling and intake processes: 1) The patient does not show up for appointment or cancels; 2) The patient recently had unprotected intercourse; and 3) Limited time for counseling, informing, and placing IUDs. This FMECA drew upon interviews with IUD clients, the clinical care team, and reviewed administrative data at all three clinics.

After reviewing the failures, the researchers and clinical care team created solutions to the identified failures: implementing a revised scheduling call script and developing an app to be used in the waiting room. To address cancellations and no-shows, the new call center script reminded patients to keep their appointment or call to cancel beforehand. The script also addressed the need to abstain from unprotected intercourse prior to the appointment. The third failure, limited time, was also addressed by this revision, which identified potentially eligible IUD patients beforehand and saved time at the actual appointment. The barrier of limited time was also addressed with the waiting room “app”, which maximized the wait time by counseling women about contraceptive options.

After the completion of this study, the research team developed an online toolkit describing processes, procedures, and tools for an FMECA and shared with Title X clinics nationally.

To read our published research on the impact of the revised call script and the waiting room app, click here and here.

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.

Research: Immediate vs delayed IUD insertion after a cesarean delivery

Section of Family Planning and Contraceptive Research faculty Dr. Amy Whitaker and Section chief Dr. Melissa Gilliam co-authored an article e-published in December 2013 in the journal Contraception that discusses their randomized controlled trial (RCT) designed to compare levonorgestrel intrauterine device (LNG-IUD) use at one year after delivery between women who received the device at the time of cesarean delivery and those who underwent delayed insertion 4-8 weeks after delivery.

Long-acting reversible contraceptives are excellent methods for postpartum use because they allow adequate time between births and do not require repeat visits to a physician or pharmacy. Postplacental IUD insertion refers to the practice of inserting the IUD within 10 minutes of delivery of the placenta, which can occur through the uterine incision during cesarean delivery. Placement immediately after delivery may help to overcome some of the many barriers to insertion which occur during other time periods, and ensures that women receive the IUD even if they do not return for the postpartum visit.

Our trial showed that after twelve months, 60% of women who had the LNG-IUD inserted immediately after their cesarean delivery were still using the device, while 41% of the women who underwent delayed insertion were still using theirs. This difference, however, is not statistically significant. The women in the postplacental arm experienced significantly higher rates of expulsion (20% vs. 0%).

Future researchers can learn from the challenges of conducting a randomized controlled trial in this population. Due to slow enrollment and high losses to follow-up, the trial was stopped early. The fundamental challenge of conducting this type of research stems from the difficulties in studying an intervention that is most likely to benefit women who do not follow- up for a postpartum visit. However, those women may also be less likely to participate in an RCT. Thus, in our study and in similar trials, more women followed up for insertion in the delayed group than would be expected from the observational literature or clinical experience, making comparisons difficult.

Nonetheless, this trial does provide valuable insights for further study in this area. Immediate insertion of an IUD during a cesarean delivery may improve use of highly effective contraception during the postpartum period. Our results show higher expulsion rates after postplacental insertion compared to delayed insertion, but suggest similar IUD use at 12 months.