Family Planning Ahead
7. Januar 2019 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
41
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
New Hampshire
-
Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Internet (Dartmouth College)
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
15 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver Komparator: Patient Information Leaflet
Postpartum Birth Control patient information leaflet
|
A 4-page patient information leaflet in portable document format and text format hosted online.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Perceived support in decision-making
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Perceptions of being informed
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
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Perceived utility of the intervention
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Rachel Thompson, PhD, Dartmouth College
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
22. März 2018
Primärer Abschluss (Tatsächlich)
23. August 2018
Studienabschluss (Tatsächlich)
23. August 2018
Studienanmeldedaten
Zuerst eingereicht
10. April 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. April 2018
Zuerst gepostet (Tatsächlich)
18. April 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. Januar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. Januar 2019
Zuletzt verifiziert
1. Januar 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 00030871
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Ja
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .