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.
調査の概要
研究の種類
介入
入学 (実際)
5038
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- The Dartmouth Institute for Health Policy and Clinical Practice
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
15年～49年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：アーム1
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実験的：アーム 2
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実験的：アーム3
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介入なし：アーム 4
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Shared Decision-making About Contraceptive Methods
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Conversation About Contraception
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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]
|
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)
時間枠：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)
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Exposure to Video
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Rachel Thompson, PhD、Dartmouth College
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年7月1日
一次修了 (実際)
2016年12月30日
研究の完了 (実際)
2017年7月14日
試験登録日
最初に提出
2016年2月3日
QC基準を満たした最初の提出物
2016年4月29日
最初の投稿 (見積もり)
2016年5月3日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月19日
QC基準を満たした最後の更新が送信されました
2019年11月17日
最終確認日
2019年11月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 00028721
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。