Clinical trial NCT02759939: Right For Me: Birth Control Decisions Made Easier
Official title: Right For Me: Birth Control Decisions Made Easier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Shared Decision-Making
Patient-Provider Communication
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 5038
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Shared Decision-making About Contraceptive Methods
timeFrame: Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]
Secondary outcomes:
measure: Conversation About Contraception
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Satisfaction With Conversation About Contraception
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Intended Contraceptive Method(s)
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Intention to Use a Highly Effective Contraceptive Method
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Values Concordance of Intended Contraceptive Method(s)
timeFrame: 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]
measure: Decision Regret About Intended Contraceptive Method(s)
timeFrame: 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]
measure: Contraceptive Method(s) Used
timeFrame: 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]
measure: Use of a Highly Effective Contraceptive Method
timeFrame: 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]
measure: Use of Intended Contraceptive Method(s)
timeFrame: 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]
measure: Adherence to Contraceptive Method(s) Used
timeFrame: 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]
measure: Satisfaction With Contraceptive Method(s) Used
timeFrame: 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]
measure: Unintended Pregnancy (Pregnancy Timing Preferences)
timeFrame: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
measure: Unintended Pregnancy (Pregnancy Seeking)
timeFrame: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
measure: Unwelcome Pregnancy
timeFrame: 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]
Other outcomes:
measure: Exposure to Video
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Exposure to Prompt Card
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Use of Three Questions
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Exposure to Decision Aid(s)
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Acceptability of Video
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
measure: Acceptability of Decision Aid(s)
timeFrame: Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]
Locations:
city: Lebanon
country: United States
facility: The Dartmouth Institute for Health Policy and Clinical Practice
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Rachel Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: O'Connor, A. 1996. User Manual - Decision Regret Scale. Ottawa. Retrieved from http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf
citation: Centers for Disease Control and Prevention. 2012. Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 7 Questionnaire: Topic Reference. Atlanta, GA.
citation: 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.
citation: 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.