The specific aims of this study are to determine if patient use of the “Decide + Be Ready: A Birth Control Decision Aid” mobile application is associated with a woman’s satisfaction with her contraceptive method, contraception adherence, and avoidance of unintended pregnancy. A secondary objective is to determine the level of user engagement with the mobile application during the study.
Design: The Decide + Be Ready (D+BR) app is a decision aid that was designed to include information
particularly relevant to military women when choosing a method of contraception. A pragmatic clinical
trial (PCT) will be conducted to compare the use of D+BR to usual care as a way to help women make
their choice of a contraceptive method. Participants will be introduced to the D+BR prior to a
contraceptive counseling session with a provider so that they can explore the app, use features in the app,
and share their resulting contraceptive preferences with the provider during the contraceptive counseling
visit. The comparison group will have had routine care prior to the onset of this study that resulted in their
contraceptive method decision.
Rationale: A PCT is designed to inform decision-makers (clients and providers) about the balance of the
benefits and burdens of a health intervention. It can be conducted in the clinical setting with the
population for whom the decision is relevant. In this study, the clients are women seeking contraceptive
care, the health intervention is the D+BR, and the setting is the clinic where she seeks routine care. In a
PCT, the outcomes of the intervention are compared to a real-word alternative, such as the usual care
provided to women in the same clinic, and therefore focus on the effectiveness of an intervention. The
benefits of a using a PCT design are that it contributes evidence for the realistic use of an intervention
with less cost and time than that of a randomized controlled trial. This makes a PCT well suited for
testing this low risk intervention that addresses a current critical knowledge gap in the healthcare of
military women and has the potential for immediate implementation.
Methods: The intervention to be tested is the use of the D+BR app prior to a study visit with a provider
for contraceptive counseling. The sample will consist of active duty women and spouses of active duty
members who have received, or are scheduled for, reproductive healthcare at a military treatment facility.
Outcome measures of satisfaction with their chosen contraceptive method, adherence to their chosen
method, and the occurrence of pregnancy will be administered to both the intervention and comparison
groups. Data collection will be conducted by online surveys administered by a nationally recognized
research and data storage system (REDCap).

N20-A07FR

2020-08-01

2021-09-30