Family Planning Ahead
2019년 1월 7일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
41
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Internet (Dartmouth College)
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
15년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceived support in decision-making
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceptions of being informed
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Rachel Thompson, PhD, Dartmouth College
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 3월 22일
기본 완료 (실제)
2018년 8월 23일
연구 완료 (실제)
2018년 8월 23일
연구 등록 날짜
최초 제출
2018년 4월 10일
QC 기준을 충족하는 최초 제출
2018년 4월 10일
처음 게시됨 (실제)
2018년 4월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 1월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 1월 7일
마지막으로 확인됨
2019년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 00030871
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
임신 관련에 대한 임상 시험
-
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