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Right For Me: Birth Control Decisions Made Easier

17. listopadu 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

5038

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • New Hampshire
      • Lebanon, New Hampshire, Spojené státy, 03756
        • The Dartmouth Institute for Health Policy and Clinical Practice

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

15 let až 49 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Rameno 1
Jiný: 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.
Experimentální: Rameno 2
Jiný: 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.
Experimentální: Rameno 3
Jiný: 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.
Jiný: 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.
Žádný zásah: Rameno 4

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Shared Decision-making About Contraceptive Methods
Časové okno: 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]

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Conversation About Contraception
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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]

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Exposure to Video
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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]

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Dartmouth-Hitchcock Medical Center

Vyšetřovatelé

  • Vrchní vyšetřovatel: Rachel Thompson, PhD, Dartmouth College

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. července 2016

Primární dokončení (Aktuální)

30. prosince 2016

Dokončení studie (Aktuální)

14. července 2017

Termíny zápisu do studia

První předloženo

3. února 2016

První předloženo, které splnilo kritéria kontroly kvality

29. dubna 2016

První zveřejněno (Odhad)

3. května 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. listopadu 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. listopadu 2019

Naposledy ověřeno

1. listopadu 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 00028721

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ano

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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