Patient-Centered Support for Contraceptive Decision-Making
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About
The investigators have designed a tablet-based decision support tool to help women learn more about their birth control options and support them in choosing a method they are happy with. The investigators will test whether the decision support tool helps women choose a birth control method they can continue using successfully by having some women use the tool before their birth control-related visit to a health care provider, and some women not use the tool before their visit. The investigators will then follow up with all the women at four months and seven months after their visit to see if they are still using the birth control method they chose at the visit and how happy they are with the method.
Hypotheses:
- Women who use the contraceptive decision support tool will be more likely to continue using their chosen method at 4 and 7 months follow-up, compared to women who receive usual care.
- The contraceptive decision support tool will increase women's knowledge, choice of, and use of highly effective reversible contraception, compared to usual care.
- The contraceptive decision support tool will decrease decision conflict, compared to usual care.
- The contraceptive decision support tool will increase patient satisfaction with the clinic visit and with their method, compared to usual care.
- Women who use the contraceptive decision support tool will have fewer unintended pregnancies during the follow-up period, compared to women who received usual care.
- The contraceptive decision support tool will increase shared patient-provider decision making in contraceptive counseling visits, compared to usual care.
- The contraceptive decision support tool will decrease provider frustration when providing contraceptive counseling and increase provider job satisfaction.
- Women using the tool will be more likely to report use of any moderately or highly effective method of contraception at 4 and 7 months follow-up, compared to women not using the tool.
Full description
The impacts of unintended pregnancy include adverse maternal and infant outcomes for women who continue their pregnancies, with higher rates of infant low birth weight, infant mortality, and maternal mortality and morbidity for these pregnancies as compared to planned pregnancies. In addition, children resulting from unplanned pregnancies have been found to be more likely to experience developmental delay.
Over the past several decades, the proportion of unintended pregnancy in the United States has remained stubbornly high at approximately 50%. Each year, one in 20 women of reproductive age experiences an unintended pregnancy, and it is estimated that over half of women will have an unintended pregnancy in their lifetime. This high rate of unintended pregnancy in the United States places a heavy burden on both women and the health care system. A disproportionate amount of this burden is experienced by minority women and women of lower socioeconomic status. Given the high rate of unintended pregnancies in this country, interventions designed to help women achieve their fertility goals could have a substantial impact on their health outcomes and life course. In addition, identifying strategies that are appropriate for use in high-risk, diverse populations could address disparities in women's ability to plan their pregnancies.
The investigators propose a cluster randomized trial to investigate the effect of an interactive, tablet-based contraceptive decision support tool that women will use immediately prior to their contraceptive counseling visits. The goal of the tool is to facilitate shared decision-making between the woman and her health care provider, with the ultimate goal of helping the woman to choose a contraceptive method that is consistent with her values and preferences, and is therefore best suited to helping her to avoid an unplanned pregnancy. The tool will be available in both English and Spanish.
The investigators will measure the tool's effect on women's contraceptive continuation, as well as on their experience of contraceptive counseling, measured both quantitatively and qualitatively. In addition, the investigators will collect quantitative and qualitative data to determine the impact of the implementation of this tool on the experiences of providers and the clinics in which they work.
Enrollment
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Inclusion criteria
Patients
- Women of reproductive age (15-45)
- Wish to discuss starting or changing a contraceptive method during their visit
- Speak, read, and understand English or Spanish (Note: for the pre- and post-intervention audio recording phases, only patients who can speak, read, and understand English easily will be enrolled.)
- History of sexual activity with men
Providers
- Provide contraceptive counseling in one of the participating clinics
- Plan to remain in job role for at least six months
Clinic staff
- Work at one of the participating clinics
- Had a job that included patient contact, but did not solely consist of family planning counseling at the time of the implementation of the intervention
Exclusion criteria
Patients
- Previously enrolled in the study
- Previously used the decision support tool at the Women's Community Clinic in San Francisco
- Are unable to get pregnant
- Appointment reason is for insertion of IUD or contraceptive implant
- Currently pregnant
- Desire pregnancy currently or in the next seven months (Note: The last criterion is designed to ensure we will have limited numbers of women that will discontinue their contraceptive methods during the study due to planning a pregnancy.)
Trial design
Primary purpose
Allocation
Interventional model
Masking
786 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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