Patient-Centered Support for Contraceptive Decision-Making: A Cluster Randomized Controlled Trial of a Contraceptive Decision Support Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 786
- 试验地点
- 4
- 主要终点
- Contraceptive Continuation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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.)
研究组 & 干预措施
Usual Care (Control)
Patients in this arm will receive usual family planning care.
Contraceptive Decision Support Tool
Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit.
干预措施: Contraceptive Decision Support Tool (Behavioral)
结局指标
主要结局
Contraceptive Continuation
时间窗: 4 and 7 months post-enrollment
Whether or not a participant is still using the contraceptive method she selected at baseline.
次要结局
- Patient Contraceptive Counseling Satisfaction(Baseline, post-visit survey)
- Shared Decision Making - Satisfaction With How Provider Helped With Choice(Baseline (post-visit survey))
- Overall Satisfaction With Visit(Baseline (post-visit survey))
- Patient Satisfaction With Information Received About Side Effects During Counseling(Baseline (post-visit survey))
- Shared Decision Making - Feelings About Provider Involvement(Baseline (post-visit) and up to 24 months)
- Shared Decision Making - Provider Appropriately Expressed Preference(Baseline (post-visit survey))
- Shared Decision Making - Who Made the Decision?(Baseline (post-visit))
- Patient Knowledge of Contraceptive Options and Features(Baseline (post-visit))
- Patient Rating of Visit as "Much Better" Than Previous Family Planning Visit(Baseline (post-visit survey))
- Total Clinic Visit Time(Baseline visit)
- Shared Decision Making - Provider Preference(Baseline (post-visit survey))
- Patient Current Contraceptive Method Satisfaction(7 months follow-up)
- Newly Heard About Methods During Visit(Baseline (pre- and post-survey))
- Maslach Burnout Inventory(Change between baseline and end of study (up to 24 months post-enrollment). In multivariate analysis, follow-up score analyzed controlling for site and score at baseline (Analyses 1-3).)
- Patient Chosen Contraceptive Method Satisfaction(Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up)
- Patient Decisional Conflict in Contraceptive Choice(Baseline (post-visit))
- Patient Attitude Towards Use of Contraceptive Options(Baseline (post-visit survey))
- Time Spent With Contraceptive Counseling Provider(Baseline visit)