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Completed

NCT Number: NCT02759939

Right For Me: Birth Control Decisions Made Easier

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.

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Key information

Conditions

Age range

15 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Dartmouth Institute for Health Policy and Clinical Practice

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video + Prompt Card

Other
  • 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?
  • 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.

Decision Aids + Training

Other
  • 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.
  • 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.

Primary outcomes

  1. Shared Decision-making About Contraceptive Methods

    Time frame: 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 outcomes

  1. Conversation About Contraception

    Time frame: 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).

  2. Satisfaction With Conversation About Contraception

    Time frame: 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).

  3. Intended Contraceptive Method(s)

    Time frame: 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).

  4. Intention to Use a Highly Effective Contraceptive Method

    Time frame: 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).

  5. Values Concordance of Intended Contraceptive Method(s)

    Time frame: 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).

  6. Decision Regret About Intended Contraceptive Method(s)

    Time frame: 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).

  7. Contraceptive Method(s) Used

    Time frame: 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).

  8. Use of a Highly Effective Contraceptive Method

    Time frame: 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).

  9. Use of Intended Contraceptive Method(s)

    Time frame: 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).

  10. Adherence to Contraceptive Method(s) Used

    Time frame: 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).

  11. Satisfaction With Contraceptive Method(s) Used

    Time frame: 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).

  12. Unintended Pregnancy (Pregnancy Timing Preferences)

    Time frame: 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).

  13. Unintended Pregnancy (Pregnancy Seeking)

    Time frame: 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).

  14. Unwelcome Pregnancy

    Time frame: 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).

Other outcomes

  1. Exposure to Video

    Time frame: 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).

  2. Exposure to Prompt Card

    Time frame: 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).

  3. Use of Three Questions

    Time frame: 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).

  4. Exposure to Decision Aid(s)

    Time frame: 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).

  5. Acceptability of Video

    Time frame: 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).

  6. Acceptability of Decision Aid(s)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 3, 2016
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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