Patient-Centered Support for Contraceptive Decision-Making



Status:Completed
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:15 - 45
Updated:11/21/2018
Start Date:October 2014
End Date:October 2016

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Patient-Centered Support for Contraceptive Decision-Making: A Cluster Randomized Controlled Trial of a Contraceptive Decision Support Tool

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:

1. 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.

2. The contraceptive decision support tool will increase women's knowledge, choice of, and
use of highly effective reversible contraception, compared to usual care.

3. The contraceptive decision support tool will decrease decision conflict, compared to
usual care.

4. The contraceptive decision support tool will increase patient satisfaction with the
clinic visit and with their method, compared to usual care.

5. 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.

6. The contraceptive decision support tool will increase shared patient-provider decision
making in contraceptive counseling visits, compared to usual care.

7. The contraceptive decision support tool will decrease provider frustration when
providing contraceptive counseling and increase provider job satisfaction.

8. 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.

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.

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.)
We found this trial at
4
sites
San Francisco, California 94110
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San Francisco, California 94103
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