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Right For Me: Birth Control Decisions Made Easier

17 de novembro de 2019 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

5038

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • The Dartmouth Institute for Health Policy and Clinical Practice

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

15 anos a 49 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Completed a health care visit at a participating clinic
  2. Assigned female sex at birth
  3. Aged 15 to 49 years
  4. Able to read and write English or Spanish
  5. Not previously participated in the study

Exclusion Criteria:

  1. 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)
  2. Not assigned female sex at birth
  3. Aged under 15 or over 49 years
  4. Unable to read and write English or Spanish
  5. Previously participated in the study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição fatorial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Braço 1
Outro: Video + Prompt Card
  1. A brief video (available in English and Spanish) intended to be viewed by patients immediately before the health care visit. The video aims to enhance patients' motivation, skills, and self-efficacy to ask their health care providers three specific questions: (1) What are my options? (2) What are the pros and cons of those options? and (3) How likely are those pros and cons to happen to me?
  2. A prompt card (available in English and Spanish) intended to be provided to patients when they view the video and kept. The card aims to remind patients of the three questions presented in the video.
Experimental: Braço 2
Outro: Decision Aids + Training
  1. Seven one-page decision aids on contraceptive methods (available in English and Spanish) intended to be used by health care providers with patients during the health care visit.
  2. A five-minute training video and accompanying written guidance (available in English) intended to be reviewed by health care providers before implementing the decision aids (and as frequently as desired thereafter). The training aims to enhance providers' motivation, skills, and self-efficacy to use the decision aids to facilitate shared decision-making in the health care visit.
Experimental: Braço 3
Outro: Video + Prompt Card
  1. A brief video (available in English and Spanish) intended to be viewed by patients immediately before the health care visit. The video aims to enhance patients' motivation, skills, and self-efficacy to ask their health care providers three specific questions: (1) What are my options? (2) What are the pros and cons of those options? and (3) How likely are those pros and cons to happen to me?
  2. A prompt card (available in English and Spanish) intended to be provided to patients when they view the video and kept. The card aims to remind patients of the three questions presented in the video.
Outro: Decision Aids + Training
  1. Seven one-page decision aids on contraceptive methods (available in English and Spanish) intended to be used by health care providers with patients during the health care visit.
  2. A five-minute training video and accompanying written guidance (available in English) intended to be reviewed by health care providers before implementing the decision aids (and as frequently as desired thereafter). The training aims to enhance providers' motivation, skills, and self-efficacy to use the decision aids to facilitate shared decision-making in the health care visit.
Sem intervenção: Braço 4

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Shared Decision-making About Contraceptive Methods
Prazo: Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Conversation About Contraception
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Satisfaction With Conversation About Contraception
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Intended Contraceptive Method(s)
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Intention to Use a Highly Effective Contraceptive Method
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Values Concordance of Intended Contraceptive Method(s)
Prazo: 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]
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).
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]
Decision Regret About Intended Contraceptive Method(s)
Prazo: 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' 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).
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]
Contraceptive Method(s) Used
Prazo: 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]
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).
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]
Use of a Highly Effective Contraceptive Method
Prazo: 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]
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).
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]
Use of Intended Contraceptive Method(s)
Prazo: 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]
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).
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]
Adherence to Contraceptive Method(s) Used
Prazo: 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' 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).
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]
Satisfaction With Contraceptive Method(s) Used
Prazo: 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).
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]
Unintended Pregnancy (Pregnancy Timing Preferences)
Prazo: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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).
6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Unintended Pregnancy (Pregnancy Seeking)
Prazo: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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).
6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Unwelcome Pregnancy
Prazo: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
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).
6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Exposure to Video
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Exposure to Prompt Card
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Use of Three Questions
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Exposure to Decision Aid(s)
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Acceptability of Video
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Acceptability of Decision Aid(s)
Prazo: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
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).
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Dartmouth-Hitchcock Medical Center

Investigadores

  • Investigador principal: Rachel Thompson, PhD, Dartmouth College

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de julho de 2016

Conclusão Primária (Real)

30 de dezembro de 2016

Conclusão do estudo (Real)

14 de julho de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

3 de fevereiro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de abril de 2016

Primeira postagem (Estimativa)

3 de maio de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de novembro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de novembro de 2019

Última verificação

1 de novembro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 00028721

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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