Right For Me: Birth Control Decisions Made Easier
17 november 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
5038
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756
- The Dartmouth Institute for Health Policy and Clinical Practice
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år till 49 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Arm 1
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Experimentell: Arm 2
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Experimentell: Arm 3
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Inget ingripande: Arm 4
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Shared Decision-making About Contraceptive Methods
Tidsram: 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).
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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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Conversation About Contraception
Tidsram: 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).
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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
Tidsram: 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)
Tidsram: 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).
|
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
Tidsram: 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)
Tidsram: 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).
|
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)
Tidsram: 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
Tidsram: 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]
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Use of a Highly Effective Contraceptive Method
Tidsram: 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]
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Use of Intended Contraceptive Method(s)
Tidsram: 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
Tidsram: 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).
|
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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Exposure to Video
Tidsram: 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).
|
Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
|
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Exposure to Prompt Card
Tidsram: 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]
|
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Use of Three Questions
Tidsram: 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)
Tidsram: 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
Tidsram: 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).
|
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)
Tidsram: 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]
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Rachel Thompson, PhD, Dartmouth College
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2016
Primärt slutförande (Faktisk)
30 december 2016
Avslutad studie (Faktisk)
14 juli 2017
Studieregistreringsdatum
Först inskickad
3 februari 2016
Först inskickad som uppfyllde QC-kriterierna
29 april 2016
Första postat (Uppskatta)
3 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 november 2019
Senast verifierad
1 november 2019
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 00028721
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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