Family Planning Ahead
2019年1月7日 更新者：Rachel L. Thompson、Dartmouth-Hitchcock Medical Center
Family Planning Ahead is a study that aims to improve decision-making about postpartum contraception.
Family Planning Ahead will test two different strategies: a patient decision aid and a patient information leaflet.
調査の概要
研究の種類
介入
入学 (実際)
41
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
- Internet (Dartmouth College)
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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年歳以上 (子、大人、高齢者)
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
女性
説明
Inclusion Criteria:
- Currently pregnant
- Between 28 and 38 weeks' gestation at the time of enrollment
- Estimated due date in March, April, May, or June 2018
- 15 years or older
- Can read and write English
- Live in the United States
- Share a valid email address for study purposes
Exclusion Criteria
- Not currently pregnant
- Less than 28 weeks' or more than 38 weeks' gestation at the time of enrollment
- Estimated due date earlier than March 2018 or later than June 2018
- Under 15 years
- Can not read and write English
- Do not live in the United States
- Do not share a valid email address for study purposes
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：Patient Decision Aid
Birth Control After Pregnancy patient decision aid and supporting document
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A 27-page patient decision aid in portable document format (and an accompanying 3-page supporting document in portable document format) hosted online.
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アクティブコンパレータ：Patient Information Leaflet
Postpartum Birth Control patient information leaflet
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A 4-page patient information leaflet in portable document format and text format hosted online.
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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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Perceived support in decision-making
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The extent to which the person feels they received adequate support and advice without pressure to make a decision about postpartum contraceptive methods, measured using adapted versions of the Support subscale of the Decisional Conflict Scale (O'Connor, 1993).
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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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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Perceptions of being informed
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The extent to which the person feels informed of available postpartum contraceptive methods and the benefits, risks, and side effects of each, measured using an adapted version of the Informed subscale of the Decisional Conflict Scale (O'Connor, 1993).
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
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Values clarity
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The extent to which the person feels clear about personal values related to postpartum contraceptive method benefits, risks, and side effects, measured using an adapted version of the Values Clarity subscale of the Decisional Conflict Scale (O'Connor, 1993).
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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Decisional uncertainty
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The extent to which the person feels certain about which postpartum contraceptive method to choose, measured using an adapted version of the Uncertainty subscale of the Decisional Conflict Scale (O'Connor, 1993).
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
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Decision self-efficacy
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The extent to which the person has self-confidence or belief in their ability to make decisions about postpartum contraceptive methods, measured using an adapted version of the Decision Self-Efficacy Scale (O'Connor, 1995).
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
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Intended contraceptive method(s): LARC vs. other
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The proportion of people who intend to use a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) 'in the first few months after giving birth', measured using a self-developed item.
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
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Intended contraceptive method(s): Most or moderately effective vs. other
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The proportion of people who intend to use a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) 'in the first few months after giving birth', measured using a self-developed item.
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
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Intended contraceptive method(s): Method vs. no method or unsure
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The proportion of people who intend to use one or more contraceptive methods (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm, male condom, internal (female) condom, spermicide, sponge, cervical cap, lactational amenorrhea method, withdrawal, fertility awareness, male sterilization, and/or emergency contraceptive pill) 'in the first few months after giving birth', measured using a self-developed item.
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
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Intended timing of contraceptive method(s) initiation: Not unsure vs. unsure
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The proportion of people who are not unsure about how soon after giving birth they will (first) start using a contraceptive method (i.e., intend to start using a contraceptive method 'in the first 10 minutes', 'in the first few days', 'in the first few weeks', 'around 6 weeks', 'in the first few months' or 'other'), measured using a self-developed item.
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
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Values concordance of intended contraceptive method(s)
時間枠：T0 (immediately following study enrollment); T1 (one week following study enrollment)
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The proportion of people who perceive optimal values concordance of their intended postpartum contraceptive method(s) (or intention to use no contraceptive methods), measured using the Measure of Alignment of Choices (Thompson et al., 2017).
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
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Trust in health professional(s)
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The extent to which the person feels trust in the health professional(s) they talk to about postpartum contraception during and/or after pregnancy, measured using an adapted version of the Patient Trust in a Physician Scale (Dugan et al., 2005).
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Interpersonal quality of family planning care
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report high interpersonal quality of family planning care during and/or after pregnancy, measured using an adapted version of the four-item Interpersonal Quality of Family Planning Care (IQFP-R) scale (Dehlendorf et al. 2016).
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Shared decision-making
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The extent to which which the person feels they experienced shared decision-making about postpartum contraceptive methods during and/or after pregnancy, measured using the CollaboRATE measure (Barr et al., 2014).
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Concordance between preferred and actual decision-making involvement (self): Concordant vs. discordant
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report concordance between their actual and preferred involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Concordance between preferred and actual decision-making involvement (partner): Concordant vs. discordant
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report concordance between the actual involvement of their partner and their preferences pertaining to partner involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Concordance between preferred and actual decision-making involvement (health professional(s)): Concordant vs. discordant
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report concordance between the actual involvement of their health professional(s) and their preferences pertaining to health professional involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Time pressure in decision-making
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The extent to which the person feels they had (or have) enough time to make a decision about postpartum contraceptive methods, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Pressure to use a certain contraceptive method
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The extent to which the person felt (or feels) pushed to use a certain postpartum contraceptive method, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Values concordance of contraceptive method(s) used
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who perceive optimal values concordance of the postpartum contraceptive method(s) they have used, measured using the Measure of Alignment of Choices (Thompson et al., 2017).
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Effective decision
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The extent to which the person feels they made an effective decision about postpartum contraceptive methods, measured using an adapted version of the Effective Decision subscale of the Decisional Conflict Scale (O'Connor, 1993).
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Contraceptive method(s) prescribed in first 60 days: LARC vs. other
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report being given or prescribed a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) in the first 60 days after giving birth, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Contraceptive method(s) prescribed in first 60 days: Most or moderately effective vs. other
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report being given or prescribed a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) in the first 60 days after giving birth, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Contraceptive method(s) prescribed in first 3 days: LARC vs. other
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report being given or prescribed a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) in the first 3 days after giving birth, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Contraceptive method(s) prescribed in first 3 days: Most or moderately effective vs. other
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report being given or prescribed a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) in the first 3 days after giving birth, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Contraceptive method(s) used: LARC vs. other
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who, at the time of survey completion, report having used a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) since giving birth, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Contraceptive method(s) used: Most or moderately effective vs. other
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
The proportion of people who, at the time of survey completion, report having used a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) since giving birth, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Contraceptive method(s) used: Method vs. no method
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who, at the time of survey completion, report having used one or more contraceptive methods (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm, male condom, internal (female) condom, spermicide, sponge, cervical cap, lactational amenorrhea method, withdrawal, fertility awareness, male sterilization, and/or emergency contraceptive pill) since giving birth, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Timing of decision about contraceptive method(s): During pregnancy vs. since giving birth
時間枠：T2 (Approximately 7-11 weeks after self-reported estimated due date)
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The proportion of people who report deciding to use their postpartum contraceptive method(s) during pregnancy, measured using a self-developed item.
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
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Likelihood of recommending the intervention to a friend
時間枠：T1 (one week following study enrollment)
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The proportion of people who report that they are extremely likely to recommend the intervention to a friend, measured using a self-developed item.
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T1 (one week following study enrollment)
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Likelihood of reviewing the intervention in the future
時間枠：T1 (one week following study enrollment)
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The proportion of people who report that they are extremely likely to review the intervention in the future, measured using a self-developed item.
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T1 (one week following study enrollment)
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Perceived utility of the intervention
時間枠：T1 (one week following study enrollment)
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The extent to which the person perceives that the intervention was useful in preparing them to communicate with their health professional and make a decision, measured using an adapted version of the Preparation for Decision Making Scale (Graham & O'Connor, 2010).
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T1 (one week following study enrollment)
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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
- 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.
- Dehlendorf C, Henderson JT, Vittinghoff E, Grumbach K, Levy K, Schmittdiel J, Lee J, Schillinger D, Steinauer J. Association of the quality of interpersonal care during family planning counseling with contraceptive use. Am J Obstet Gynecol. 2016 Jul;215(1):78.e1-9. doi: 10.1016/j.ajog.2016.01.173. Epub 2016 Jan 28.
- 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.
- Dugan E, Trachtenberg F, Hall MA. Development of abbreviated measures to assess patient trust in a physician, a health insurer, and the medical profession. BMC Health Serv Res. 2005 Oct 3;5:64. doi: 10.1186/1472-6963-5-64.
- Graham, I., & O'Connor, A. (1995). User Manual: Preparation for Decision Making Scale. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_PrepDM.pdf
- O'Connor, A. M. (1995). Decision Self Efficacy Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf
- O'Connor, A. (2010). Decisional Conflict Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
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)
2018年3月22日
一次修了 (実際)
2018年8月23日
研究の完了 (実際)
2018年8月23日
試験登録日
最初に提出
2018年4月10日
QC基準を満たした最初の提出物
2018年4月10日
最初の投稿 (実際)
2018年4月18日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月9日
QC基準を満たした最後の更新が送信されました
2019年1月7日
最終確認日
2019年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 00030871
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 available to others for research purposes, either via data sharing on request or digital repository deposit.
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
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。