Right For Me: Birth Control Decisions Made Easier
17 de noviembre de 2019 actualizado por: Rachel L. Thompson, Dartmouth-Hitchcock Medical Center
Right For Me is a study that aims to improve the conversations patients and health care providers have about birth control.
Right For Me will test two different strategies for improving these conversations.
The first strategy is to give patients a video to watch that encourages them to ask three specific questions in their health care visit, as well as a prompt card that reminds them of the three questions.
The second strategy is to give health care providers a set of decision aids that describe available birth control methods, as well as training in how to use them with patients during the health care visit.
Right For Me will test whether introducing one or both of these strategies leads to better conversations than providing health care as usual.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
5038
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
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- The Dartmouth Institute for Health Policy and Clinical Practice
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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 a 49 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Completed a health care visit at a participating clinic
- Assigned female sex at birth
- Aged 15 to 49 years
- Able to read and write English or Spanish
- Not previously participated in the study
Exclusion Criteria:
- Not completed a health care visit at a participating clinic (including a patient's parent or a person acting as a patient's legal proxy)
- Not assigned female sex at birth
- Aged under 15 or over 49 years
- Unable to read and write English or Spanish
- Previously participated in the study
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Brazo 1
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Experimental: Brazo 2
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Experimental: Brazo 3
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Sin intervención: Brazo 4
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shared Decision-making About Contraceptive Methods
Periodo de tiempo: Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]
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Shared decision-making about contraceptive methods in the health care visit, measured using the three-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013).
We used the version of CollaboRATE with a five-point response scale and adopted the binary scoring approach, which yields a score of 0 (no shared decision-making) and 1 (shared decision-making) for each participant.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Conversation About Contraception
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Satisfaction With Conversation About Contraception
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002).
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Intended Contraceptive Method(s)
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Intention to Use a Highly Effective Contraceptive Method
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Whether participants intend to use at least one highly effective contraceptive method in the next four weeks, derived from data on intended contraceptive method(s).
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Values Concordance of Intended Contraceptive Method(s)
Periodo de tiempo: Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants]
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Participants' perceptions of the degree of concordance between the contraceptive method(s) they intend(ed) to use and their individual values, needs, and preferences, measured using a self-developed item.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants]
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Decision Regret About Intended Contraceptive Method(s)
Periodo de tiempo: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Participants' feelings of decision regret about the contraceptive method(s) they intended to use, measured using an adaptation of the five-item Decision Regret Scale (Brehaut et al., 2003; O'Connor, 1996).
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Contraceptive Method(s) Used
Periodo de tiempo: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Use of a Highly Effective Contraceptive Method
Periodo de tiempo: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Use of Intended Contraceptive Method(s)
Periodo de tiempo: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Whether participants used their intended contraceptive method(s) in the last four weeks, derived from data on intended contraceptive method(s) and contraceptive method(s) used.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Adherence to Contraceptive Method(s) Used
Periodo de tiempo: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Satisfaction With Contraceptive Method(s) Used
Periodo de tiempo: 4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
|
Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Unintended Pregnancy (Pregnancy Timing Preferences)
Periodo de tiempo: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy timing preferences), measured using an adapted item (Centers for Disease Control and Prevention, 2012).
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Unintended Pregnancy (Pregnancy Seeking)
Periodo de tiempo: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy seeking), measured using an adapted item (Kavanaugh & Schwarz, 2009).
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Unwelcome Pregnancy
Periodo de tiempo: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Participants' experience of one or more unwelcome pregnancies since the health care visit, measured using an adapted item (Centers for Disease Control and Prevention, 2012).
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exposure to Video
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015).
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Exposure to Prompt Card
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Use of Three Questions
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015).
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Exposure to Decision Aid(s)
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Acceptability of Video
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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The acceptability of the video to participants, measured using a self-developed item.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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Acceptability of Decision Aid(s)
Periodo de tiempo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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The acceptability of the decision aid(s) to participants, measured using a self-developed item.
Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
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Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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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
- Shepherd HL, Barratt A, Jones A, Bateson D, Carey K, Trevena LJ, McGeechan K, Del Mar CB, Butow PN, Epstein RM, Entwistle V, Weisberg E. Can consumers learn to ask three questions to improve shared decision making? A feasibility study of the ASK (AskShareKnow) Patient-Clinician Communication Model((R)) intervention in a primary health-care setting. Health Expect. 2016 Oct;19(5):1160-8. doi: 10.1111/hex.12409. Epub 2015 Sep 14.
- 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.
- Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
- Weisman CS, Maccannon DS, Henderson JT, Shortridge E, Orso CL. Contraceptive counseling in managed care: preventing unintended pregnancy in adults. Womens Health Issues. 2002 Mar-Apr;12(2):79-95. doi: 10.1016/s1049-3867(01)00147-5.
- Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
- O'Connor, A. 1996. User Manual - Decision Regret Scale. Ottawa. Retrieved from http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf
- Centers for Disease Control and Prevention. 2012. Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 7 Questionnaire: Topic Reference. Atlanta, GA.
- Kavanaugh ML, Schwarz EB. Prospective assessment of pregnancy intentions using a single- versus a multi-item measure. Perspect Sex Reprod Health. 2009 Dec;41(4):238-43. doi: 10.1363/4123809.
- 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.
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)
1 de julio de 2016
Finalización primaria (Actual)
30 de diciembre de 2016
Finalización del estudio (Actual)
14 de julio de 2017
Fechas de registro del estudio
Enviado por primera vez
3 de febrero de 2016
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2016
Publicado por primera vez (Estimar)
3 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de noviembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
17 de noviembre de 2019
Última verificación
1 de noviembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 00028721
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 and essential analysis syntax available to others for research purposes, either via data sharing on request or via digital repository deposition, before October 2018.
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
producto fabricado y exportado desde los 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. .
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