Right For Me: Birth Control Decisions Made Easier
17 listopada 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
5038
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
New Hampshire
-
Lebanon, New Hampshire, Stany Zjednoczone, 03756
- The Dartmouth Institute for Health Policy and Clinical Practice
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
15 lat do 49 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Ramię 1
|
|
|
Eksperymentalny: Ramię 2
|
|
|
Eksperymentalny: Ramię 3
|
|
|
Brak interwencji: Ramię 4
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Shared Decision-making About Contraceptive Methods
Ramy czasowe: 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]
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Conversation About Contraception
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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]
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Exposure to Video
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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]
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Rachel Thompson, PhD, Dartmouth College
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 lipca 2016
Zakończenie podstawowe (Rzeczywisty)
30 grudnia 2016
Ukończenie studiów (Rzeczywisty)
14 lipca 2017
Daty rejestracji na studia
Pierwszy przesłany
3 lutego 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 kwietnia 2016
Pierwszy wysłany (Oszacować)
3 maja 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 listopada 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 listopada 2019
Ostatnia weryfikacja
1 listopada 2019
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 00028721
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAk
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Video + Prompt Card
-
Carevive Systems, Inc.ZakończonyRak piersi | Rak ginekologiczny | Rak płucStany Zjednoczone
-
University Hospital Inselspital, BerneWycofaneObjawy dolnych dróg moczowych | Pęcherz neurogenny | Urodynamika
-
IRCCS Fondazione Stella MarisMinistry of Health, ItalyZakończonyDziecięca apraksja mowyWłochy
-
The Cleveland ClinicAktywny, nie rekrutującyPierwotna nadczynność przytarczyc | Wole wieloguzkoweStany Zjednoczone
-
University College, LondonZakończonyNowotwory złośliwe CD19 +: nawrót po przeszczepie allogenicznymZjednoczone Królestwo
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentRekrutacyjnyDemencja | Zachowanie stanowiące wyzwanie | Rezydent Domu Pomocy SpołecznejHolandia
-
University of MiamiSociety of Critical Care MedicineZakończonyŚmiertelna choroba | Syndrom Oddziału Intensywnej TerapiiStany Zjednoczone
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research...ZakończonyZaprzestanie paleniaStany Zjednoczone
-
VA Office of Research and DevelopmentZakończony
-
Chang Gung Memorial HospitalZakończonyZnieczulenie, generale | Intubacja, dotchawicza | LaryngoskopyTajwan