Right For Me: Birth Control Decisions Made Easier

Not Applicable

Completed

Conditions: Contraception

Interventions: Other: Video + Prompt Card
Other: Decision Aids + Training

Registration Number: NCT02759939

Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5038

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 1	Video + Prompt Card	-
Arm 3	Video + Prompt Card	-
Arm 2	Decision Aids + Training	-
Arm 3	Decision Aids + Training	-

Primary Outcome Measures

Name	Time	Method
Shared Decision-making About Contraceptive Methods	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).

Secondary Outcome Measures

Name	Time	Method
Conversation About Contraception	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).
Satisfaction With Conversation About Contraception	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).
Intended Contraceptive Method(s)	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).
Intention to Use a Highly Effective Contraceptive Method	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).
Values Concordance of Intended Contraceptive Method(s)	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).
Decision Regret About Intended Contraceptive Method(s)	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).
Contraceptive Method(s) Used	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).
Use of a Highly Effective Contraceptive Method	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).
Use of Intended Contraceptive Method(s)	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).
Adherence to Contraceptive Method(s) Used	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).
Satisfaction With Contraceptive Method(s) Used	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).
Unintended Pregnancy (Pregnancy Timing Preferences)	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).
Unintended Pregnancy (Pregnancy Seeking)	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).
Unwelcome Pregnancy	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).