Family Planning Ahead
7 de enero de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
41
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Internet (Dartmouth College)
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
15 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived support in decision-making
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceptions of being informed
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
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Values concordance of intended contraceptive method(s)
Periodo de tiempo: 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)
|
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Trust in health professional(s)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).
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T2 (Approximately 7-11 weeks after self-reported estimated due date)
|
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Effective decision
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
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Likelihood of recommending the intervention to a friend
Periodo de tiempo: 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)
|
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Likelihood of reviewing the intervention in the future
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Rachel Thompson, PhD, Dartmouth College
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de marzo de 2018
Finalización primaria (Actual)
23 de agosto de 2018
Finalización del estudio (Actual)
23 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
10 de abril de 2018
Primero enviado que cumplió con los criterios de control de calidad
10 de abril de 2018
Publicado por primera vez (Actual)
18 de abril de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
7 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 00030871
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .