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Family Planning Ahead

7 stycznia 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

41

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • New Hampshire
      • Lebanon, New Hampshire, Stany Zjednoczone, 03756
        • Internet (Dartmouth College)

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

15 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Patient Decision Aid
Birth Control After Pregnancy patient decision aid and supporting document
Inny: Birth Control After Pregnancy
A 27-page patient decision aid in portable document format (and an accompanying 3-page supporting document in portable document format) hosted online.
Aktywny komparator: Patient Information Leaflet
Postpartum Birth Control patient information leaflet
Inny: Postpartum Birth Control
A 4-page patient information leaflet in portable document format and text format hosted online.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Perceived support in decision-making
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Perceptions of being informed
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Intended contraceptive method(s): LARC vs. other
Ramy czasowe: 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)
Intended contraceptive method(s): Most or moderately effective vs. other
Ramy czasowe: 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)
Intended contraceptive method(s): Method vs. no method or unsure
Ramy czasowe: 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)
Intended timing of contraceptive method(s) initiation: Not unsure vs. unsure
Ramy czasowe: 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.
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Values concordance of intended contraceptive method(s)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Concordance between preferred and actual decision-making involvement (self): Concordant vs. discordant
Ramy czasowe: 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)
Concordance between preferred and actual decision-making involvement (partner): Concordant vs. discordant
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Pressure to use a certain contraceptive method
Ramy czasowe: 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)
Values concordance of contraceptive method(s) used
Ramy czasowe: 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)
Effective decision
Ramy czasowe: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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).
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) prescribed in first 60 days: LARC vs. other
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Contraceptive method(s) prescribed in first 3 days: Most or moderately effective vs. other
Ramy czasowe: 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)
Contraceptive method(s) used: LARC vs. other
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report deciding to use their postpartum contraceptive method(s) during pregnancy, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Likelihood of recommending the intervention to a friend
Ramy czasowe: T1 (one week following study enrollment)
The proportion of people who report that they are extremely likely to recommend the intervention to a friend, measured using a self-developed item.
T1 (one week following study enrollment)
Likelihood of reviewing the intervention in the future
Ramy czasowe: T1 (one week following study enrollment)
The proportion of people who report that they are extremely likely to review the intervention in the future, measured using a self-developed item.
T1 (one week following study enrollment)
Perceived utility of the intervention
Ramy czasowe: T1 (one week following study enrollment)
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).
T1 (one week following study enrollment)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Dartmouth-Hitchcock Medical Center

Śledczy

  • Główny śledczy: Rachel Thompson, PhD, Dartmouth College

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 marca 2018

Zakończenie podstawowe (Rzeczywisty)

23 sierpnia 2018

Ukończenie studiów (Rzeczywisty)

23 sierpnia 2018

Daty rejestracji na studia

Pierwszy przesłany

10 kwietnia 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 kwietnia 2018

Pierwszy wysłany (Rzeczywisty)

18 kwietnia 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 stycznia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 stycznia 2019

Ostatnia weryfikacja

1 stycznia 2019

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 00030871

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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