Family Planning Ahead
7. januar 2019 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
41
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Internet (Dartmouth College)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
15 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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)
|
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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)
|
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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).
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T0 (immediately following study enrollment); T1 (one week following study enrollment)
|
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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).
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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
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.
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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
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.
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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
Tidsramme: 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)
Tidsramme: 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)
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).
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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
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)
|
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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)
|
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)
|
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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)
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Rachel Thompson, PhD, Dartmouth College
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
22. mars 2018
Primær fullføring (Faktiske)
23. august 2018
Studiet fullført (Faktiske)
23. august 2018
Datoer for studieregistrering
Først innsendt
10. april 2018
Først innsendt som oppfylte QC-kriteriene
10. april 2018
Først lagt ut (Faktiske)
18. april 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. januar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. januar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 00030871
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .