Family Planning Ahead
7. januar 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
41
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Internet (Dartmouth College)
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Patient Decision Aid
Birth Control After Pregnancy patient decision aid and supporting document
|
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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Perceived support in decision-making
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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).
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceptions of being informed
Tidsramme: T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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).
|
T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
|
Values clarity
Tidsramme: T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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).
|
T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
|
Decisional uncertainty
Tidsramme: T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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).
|
T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
|
Decision self-efficacy
Tidsramme: 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).
|
T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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Intended contraceptive method(s): LARC vs. other
Tidsramme: T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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.
|
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
Tidsramme: T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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.
|
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
Tidsramme: T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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.
|
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
Tidsramme: T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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)
Tidsramme: T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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).
|
T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
|
Trust in health professional(s)
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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).
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Interpersonal quality of family planning care
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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).
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Shared decision-making
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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).
|
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
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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.
|
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
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Concordance between preferred and actual decision-making involvement (health professional(s)): Concordant vs. discordant
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Time pressure in decision-making
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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Pressure to use a certain contraceptive method
Tidsramme: 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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Values concordance of contraceptive method(s) used
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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).
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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Effective decision
Tidsramme: 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
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Contraceptive method(s) prescribed in first 60 days: Most or moderately effective vs. other
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Contraceptive method(s) prescribed in first 3 days: LARC vs. other
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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.
|
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
Tidsramme: T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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Contraceptive method(s) used: LARC vs. other
Tidsramme: 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 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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Contraceptive method(s) used: Most or moderately effective vs. other
Tidsramme: 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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Contraceptive method(s) used: Method vs. no method
Tidsramme: 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 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.
|
T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
|
Timing of decision about contraceptive method(s): During pregnancy vs. since giving birth
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Rachel Thompson, PhD, Dartmouth College
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. marts 2018
Primær færdiggørelse (Faktiske)
23. august 2018
Studieafslutning (Faktiske)
23. august 2018
Datoer for studieregistrering
Først indsendt
10. april 2018
Først indsendt, der opfyldte QC-kriterier
10. april 2018
Først opslået (Faktiske)
18. april 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 00030871
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .