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临床试验/NCT02759939
NCT02759939已完成不适用

Right For Me: Birth Control Decisions Made Easier

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 5,038 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,038
试验地点
2
主要终点
Shared Decision-making About Contraceptive Methods

研究概览

简要总结

Right For Me is a study that aims to improve the conversations patients and health care providers have about birth control. Right For Me will test two different strategies for improving these conversations. The first strategy is to give patients a video to watch that encourages them to ask three specific questions in their health care visit, as well as a prompt card that reminds them of the three questions. The second strategy is to give health care providers a set of decision aids that describe available birth control methods, as well as training in how to use them with patients during the health care visit. Right For Me will test whether introducing one or both of these strategies leads to better conversations than providing health care as usual.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Completed a health care visit at a participating clinic
  • Assigned female sex at birth
  • Aged 15 to 49 years
  • Able to read and write English or Spanish
  • Not previously participated in the study

排除标准

  • Not completed a health care visit at a participating clinic (including a patient's parent or a person acting as a patient's legal proxy)
  • Not assigned female sex at birth
  • Aged under 15 or over 49 years
  • Unable to read and write English or Spanish
  • Previously participated in the study

结局指标

主要结局

Shared Decision-making About Contraceptive Methods

时间窗: Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]

Shared decision-making about contraceptive methods in the health care visit, measured using the three-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013). We used the version of CollaboRATE with a five-point response scale and adopted the binary scoring approach, which yields a score of 0 (no shared decision-making) and 1 (shared decision-making) for each participant. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).

次要结局

  • Conversation About Contraception(Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants])
  • Satisfaction With Conversation About Contraception(Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants])
  • Intended Contraceptive Method(s)(Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants])
  • Intention to Use a Highly Effective Contraceptive Method(Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants])
  • Values Concordance of Intended Contraceptive Method(s)(Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants])
  • Decision Regret About Intended Contraceptive Method(s)(4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])
  • Contraceptive Method(s) Used(4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])
  • Use of a Highly Effective Contraceptive Method(4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])
  • Use of Intended Contraceptive Method(s)(4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])
  • Adherence to Contraceptive Method(s) Used(4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])
  • Satisfaction With Contraceptive Method(s) Used(4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])
  • Unintended Pregnancy (Pregnancy Timing Preferences)(6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])
  • Unintended Pregnancy (Pregnancy Seeking)(6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])
  • Unwelcome Pregnancy(6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachel L. Thompson

Assistant Professor, The Dartmouth Institute

Dartmouth-Hitchcock Medical Center

研究点 (2)

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