Right For Me: Birth Control Decisions Made Easier
2019年11月17日 更新者：Rachel L. Thompson、Dartmouth-Hitchcock Medical Center
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.
研究概览
研究类型
介入性
注册 (实际的)
5038
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- The Dartmouth Institute for Health Policy and Clinical Practice
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 至 49年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：手臂 1
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实验性的：手臂 2
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实验性的：手臂 3
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无干预：手臂 4
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Shared Decision-making About Contraceptive Methods
大体时间：Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]
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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).
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Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Conversation About Contraception
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item.
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Satisfaction With Conversation About Contraception
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002).
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Intended Contraceptive Method(s)
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist.
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Intention to Use a Highly Effective Contraceptive Method
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Whether participants intend to use at least one highly effective contraceptive method in the next four weeks, derived from data on intended contraceptive method(s).
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Values Concordance of Intended Contraceptive Method(s)
大体时间：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]
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Participants' perceptions of the degree of concordance between the contraceptive method(s) they intend(ed) to use and their individual values, needs, and preferences, measured using a self-developed item.
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).
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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]
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Decision Regret About Intended Contraceptive Method(s)
大体时间：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]
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Participants' feelings of decision regret about the contraceptive method(s) they intended to use, measured using an adaptation of the five-item Decision Regret Scale (Brehaut et al., 2003; O'Connor, 1996).
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).
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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]
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Contraceptive Method(s) Used
大体时间：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]
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What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist.
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).
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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]
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Use of a Highly Effective Contraceptive Method
大体时间：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]
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Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used.
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).
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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]
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Use of Intended Contraceptive Method(s)
大体时间：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]
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Whether participants used their intended contraceptive method(s) in the last four weeks, derived from data on intended contraceptive method(s) and contraceptive method(s) used.
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).
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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]
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Adherence to Contraceptive Method(s) Used
大体时间：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]
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Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure.
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).
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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]
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Satisfaction With Contraceptive Method(s) Used
大体时间：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]
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Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item.
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).
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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]
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Unintended Pregnancy (Pregnancy Timing Preferences)
大体时间：6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy timing preferences), measured using an adapted item (Centers for Disease Control and Prevention, 2012).
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).
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6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Unintended Pregnancy (Pregnancy Seeking)
大体时间：6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy seeking), measured using an adapted item (Kavanaugh & Schwarz, 2009).
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).
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6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Unwelcome Pregnancy
大体时间：6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Participants' experience of one or more unwelcome pregnancies since the health care visit, measured using an adapted item (Centers for Disease Control and Prevention, 2012).
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).
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6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Exposure to Video
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015).
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Exposure to Prompt Card
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item.
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Use of Three Questions
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015).
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Exposure to Decision Aid(s)
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item.
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Acceptability of Video
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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The acceptability of the video to participants, measured using a self-developed item.
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Acceptability of Decision Aid(s)
大体时间：Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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The acceptability of the decision aid(s) to participants, measured using a self-developed item.
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).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rachel Thompson, PhD、Dartmouth College
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Shepherd HL, Barratt A, Jones A, Bateson D, Carey K, Trevena LJ, McGeechan K, Del Mar CB, Butow PN, Epstein RM, Entwistle V, Weisberg E. Can consumers learn to ask three questions to improve shared decision making? A feasibility study of the ASK (AskShareKnow) Patient-Clinician Communication Model((R)) intervention in a primary health-care setting. Health Expect. 2016 Oct;19(5):1160-8. doi: 10.1111/hex.12409. Epub 2015 Sep 14.
- Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085. Erratum In: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32.
- Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
- Weisman CS, Maccannon DS, Henderson JT, Shortridge E, Orso CL. Contraceptive counseling in managed care: preventing unintended pregnancy in adults. Womens Health Issues. 2002 Mar-Apr;12(2):79-95. doi: 10.1016/s1049-3867(01)00147-5.
- Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
- O'Connor, A. 1996. User Manual - Decision Regret Scale. Ottawa. Retrieved from http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf
- Centers for Disease Control and Prevention. 2012. Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 7 Questionnaire: Topic Reference. Atlanta, GA.
- Kavanaugh ML, Schwarz EB. Prospective assessment of pregnancy intentions using a single- versus a multi-item measure. Perspect Sex Reprod Health. 2009 Dec;41(4):238-43. doi: 10.1363/4123809.
- Thompson R, Manski R, Donnelly KZ, Stevens G, Agusti D, Banach M, Boardman MB, Brady P, Colon Bradt C, Foster T, Johnson DJ, Li Z, Norsigian J, Nothnagle M, Olson AL, Shepherd HL, Stern LF, Tosteson TD, Trevena L, Upadhya KK, Elwyn G. Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods. BMJ Open. 2017 Oct 22;7(10):e017830. doi: 10.1136/bmjopen-2017-017830.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月1日
初级完成 (实际的)
2016年12月30日
研究完成 (实际的)
2017年7月14日
研究注册日期
首次提交
2016年2月3日
首先提交符合 QC 标准的
2016年4月29日
首次发布 (估计)
2016年5月3日
研究记录更新
最后更新发布 (实际的)
2019年11月19日
上次提交的符合 QC 标准的更新
2019年11月17日
最后验证
2019年11月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The investigators will make an anonymized copy of the final participant-level data set and essential analysis syntax available to others for research purposes, either via data sharing on request or via digital repository deposition, before October 2018.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Video + Prompt Card的临床试验
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development招聘中
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Université Blaise Pascal, Clermont-Ferrand撤销
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University of TorontoPublic Health Agency of Canada (PHAC); Wholehealth Pharmacy Partners尚未招聘
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Ottawa Hospital Research InstituteThe Hospital for Sick Children; University of Ottawa; Children's Hospital of Eastern Ontario; Alberta... 和其他合作者未知