Results Summary
What was the research about?
More than half of all pregnancies in the United States are unplanned. Unplanned pregnancies often happen because women don’t have a birth control method that fits their needs.
Women use some methods, such as the pill, daily. Long-acting reversible contraceptives, or LARCs, are birth control methods that last for multiple years. LARC methods include implants or intrauterine devices, called IUDs. Once inserted, women don’t need to do anything else for birth control.
In this study, the research team compared two birth control programs to see how well they reduced unplanned pregnancies. The two programs were Enhanced Care and Complete CHOICE. In both programs, women received counseling about different birth control methods. The team gave patients information about how long each method lasts, how to use it, and common side effects. The Complete CHOICE program also
- Covered costs of LARC methods for women without health insurance
- Offered women the choice to get a LARC method on the same day as their healthcare visit
- Gave doctors and nurse practitioners training on birth control methods, including LARCs
What were the results?
Compared with women in the Enhanced Care program, women in the Complete CHOICE program
- Had a lower risk of unplanned pregnancies one year later
- Were more likely to choose a LARC method over other birth control methods such as the pill or condoms
- Were more likely to get a LARC method the same day as their healthcare visit
After the counseling session, women in the two programs didn’t differ in satisfaction with their healthcare visit or birth control counseling. Also, after one year, women in the two programs didn’t differ in satisfaction with the birth control method they chose or whether they kept using their chosen birth control method.
Who was in the study?
This study included 1,008 women, ages 15–45, receiving care at three health clinics that serve people with fewer resources. Of the women, 69 percent were black, 25 percent were white, and 6 percent were other races. In addition, 58 percent had public health insurance, 27 percent had no insurance, and 15 percent had private health insurance.
What did the research team do?
First, the research team offered the Enhanced Care program to women who visited the clinics for their regular appointments until the team reached the number of women needed for the study. Next, the team gave training about birth control methods to healthcare professionals at the clinics. Then, clinics offered the Complete CHOICE program until the team reached the number of women needed for the study.
Women in the two groups took a survey about birth control methods and unplanned pregnancies after their healthcare visit and again 3, 6, and 12 months later.
Patients, doctors, and community members gave input on the study design.
What were the limits of the study?
Women in the Complete CHOICE program were older. They were also more likely to be Hispanic and uninsured and were less likely to be black, single, or report that they would be upset if they got pregnant in the next 12 months. These differences may have affected results. The three clinics were in the Midwest and served mostly patients with fewer resources. Results may differ for women living in other areas or getting health care at a different type of clinic.
Future research could test Complete CHOICE in other locations and healthcare settings.
How can people use the results?
Health clinics can use these results when considering how best to provide birth control services to women with few resources.
Professional Abstract
Objective
To compare the effectiveness of two contraceptive care programs on reducing the rate of unintended pregnancies
Study Design
| Design Elements | Description |
|---|---|
| Design | Controlled time-trend analysis |
| Population |
1,008 women, ages 15–45, receiving care at 3 federally qualified health centers in the Midwest |
| Interventions/ Comparators |
|
| Outcomes |
Primary: rate of unintended pregnancies Secondary: choice of contraceptive, same-day LARC method insertion, contraceptive method received, contraceptive method continuation, contraceptive method satisfaction, satisfaction with contraceptive counseling, satisfaction with healthcare visit |
| 1-year follow-up for primary outcome | |
This controlled time-trend analysis study compared two contraceptive healthcare programs, Enhanced Care and Complete CHOICE. Both programs counseled patients about different contraceptive methods, including information about how long each method lasts, instructions for use, and common side effects. In the Complete CHOICE program, providers also took part in education sessions about reversible contraception, including intrauterine devices (IUDs) and implants. In addition, the Complete CHOICE program provided same-day availability of long-acting reversible contraceptive (LARC) methods and covered LARC costs for patients without health insurance.
Researchers first provided the Enhanced Care program to women who visited the health centers for their regular appointments. When researchers approached the target sample size for Enhanced Care participants, they initiated the provider contraceptive education sessions that would be part of the Complete CHOICE program with doctors, nurses, and other healthcare professionals at the health centers. Researchers then provided a second group of women at the same health centers with the Complete CHOICE program until the study reached the target sample size.
The study included 1,008 women at three federally qualified health centers in the Midwest. Of these women, 69% were black, 25% were white, and 6% were other races. In addition, 58% were publicly insured, 27% were uninsured, and 15% had private health insurance.
After their contraceptive counseling session, women in the two groups completed a survey to assess demographic and reproductive characteristics. Women also completed telephone surveys 3, 6, and 12 months later.
Patients, doctors, and community members provided input on the study design.
Results
Compared with women in the Enhanced Care program, women in the Complete CHOICE program
- Had a lower risk of unintended pregnancies at one-year follow-up (p=0.01)
- Were more likely to choose a LARC method over other contraceptive methods (54% in Complete CHOICE versus 31% in Enhanced Care, p <0.01)
- Were more likely to receive a LARC method the same day as the healthcare visit (54% in Complete CHOICE versus 14% in Enhanced Care, p <0.01)
Women in the two programs did not differ in satisfaction with contraceptive counseling, satisfaction with the healthcare visit at baseline, or contraceptive method continuation or satisfaction after one year.
Limitations
Women in the Complete CHOICE program were older, more likely to be Hispanic and uninsured, and less likely to be black, single, or report that they would be upset if they got pregnant in the next 12 months. These differences may have affected study outcomes. The study included patients at three health centers in one region of the country. Results may differ for other healthcare settings or geographic regions.
Conclusions and Relevance
In this study, after one year, a program that included financial support, same-day access to LARC methods, patient counseling about contraception, and provider education on contraceptive methods resulted in a lower risk of unintended pregnancies for women with limited resources.
Future Research Needs
Future research could examine Complete CHOICE in other healthcare settings and other parts of the country.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- The reviewers expressed concern that the study did not adjust for baseline differences between the Complete CHOICE and Enhanced Care groups, which could have contributed to the results for the unintended pregnancy outcome. The researchers explained that they performed several analyses to assess the relationship between baseline variables and the outcome, and that their multivariable model adjusted for confounders. The researchers added a description of the statistical methods that they used and the results from these analyses to the report.
- Reviewers asked whether the research team collecting outcome measures were masked to study condition and if not, why not. The researchers explained that masking was not possible because recruitment to the different conditions occurred at different times. They added the lack of masking of study condition to their limitations section.
- The report indicated that the analyses did not account for missing data, so reviewers asked that the researchers make explicit that almost 10 percent of their participants did not have 12-month outcome data. The researchers explained that they did use multiple imputation to account for missing data for the primary outcome and added a description of the imputation to their methods.
- The reviewers noted that the study design did not take into account the fact that the use of long-acting reversible contraceptives (LARC) has increased over time and that rates of unintended pregnancy have decreased. They also noted that choosing to run the Complete CHOICE phase of the study after the Enhanced Care phase of the study at the same sites gave a major advantage to the Complete CHOICE arm. The researchers disagreed that the observed benefits of the Complete CHOICE program were due primarily to timing since they saw improved LARC use and reduced unintended pregnancy during the Complete CHOICE program implementation period. However, the researchers did acknowledge that other factors may have contributed to the overall results in their conclusions.