Right For Me: Birth Control Decisions Made Easier

• ClinicalTrials.gov Identifier: NCT02759939
• Recruitment Status: Completed
• First Posted: May 3, 2016
• Results First Posted: November 19, 2019
• Last Update Posted: November 19, 2019
• Sponsor: Dartmouth-Hitchcock Medical Center
• Information provided by (Responsible Party): Rachel L. Thompson, Dartmouth-Hitchcock Medical Center

Tracking Information

• First Submitted Date: February 3, 2016
• First Posted Date: May 3, 2016
• Results First Submitted Date: July 24, 2018
• Results First Posted Date: November 19, 2019
• Last Update Posted Date: November 19, 2019
• Actual Study Start Date: July 1, 2016
• Actual Primary Completion Date: December 30, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 17, 2019)

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).

Original Primary Outcome Measures (submitted: April 29, 2016)

Shared decision-making about contraceptive methods [ Time Frame: Immediately after the index health care visit ]

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)

Current Secondary Outcome Measures (submitted: November 17, 2019)

• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).

Original Secondary Outcome Measures (submitted: April 29, 2016)

• Conversation about contraception [ Time Frame: Immediately after the index health care visit ]
  Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item
• Satisfaction with conversation about contraception [ Time Frame: Immediately after the index health care visit ]
  Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002)
• Intended contraceptive method(s) [ Time Frame: Immediately after the index health care visit ]
  What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist
• Intention to use a highly effective contraceptive method [ Time Frame: Immediately after the index health care visit ]
  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)
• Values concordance of intended contraceptive method(s) [ Time Frame: Immediately after the index health care visit; 4 weeks after the index health care visit; 6 months after the index health care visit ]
  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
• Decision regret about intended contraceptive method(s) [ Time Frame: 4 weeks after the index health care visit; 6 months after the index health care visit ]
  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)
• Contraceptive method(s) used [ Time Frame: 4 weeks after the index health care visit; 6 months after the index health care visit ]
  What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist
• Use of a highly effective contraceptive method [ Time Frame: 4 weeks after the index health care visit; 6 months after the index health care visit ]
  Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used
• Use of intended contraceptive method(s) [ Time Frame: 4 weeks after the index health care visit; 6 months after the index health care visit ]
  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
• Adherence to contraceptive method(s) used [ Time Frame: 4 weeks after the index health care visit; 6 months after the index health care visit ]
  Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure
• Satisfaction with contraceptive method(s) used [ Time Frame: 4 weeks after the index health care visit; 6 months after the index health care visit ]
  Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item
• Unintended pregnancy (pregnancy timing preferences) [ Time Frame: 6 months after the index health care visit ]
  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)
• Unintended pregnancy (pregnancy seeking) [ Time Frame: 6 months after the index health care visit ]
  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)
• Unwelcome pregnancy [ Time Frame: 6 months after the index health care visit ]
  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)

Current Other Pre-specified Outcome Measures (submitted: November 17, 2019)

• 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).
• 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).
• 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).
• 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).
• 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).
• 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).

Original Other Pre-specified Outcome Measures (submitted: April 29, 2016)

• Exposure to video [ Time Frame: Immediately after the index health care visit ]
  Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015)
• Exposure to prompt card [ Time Frame: Immediately after the index health care visit ]
  Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item
• Use of three questions [ Time Frame: Immediately after the index health care visit ]
  Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015)
• Exposure to decision aid(s) [ Time Frame: Immediately after the index health care visit ]
  Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item
• Acceptability of video [ Time Frame: Immediately after the index health care visit ]
  The acceptability of the video to participants, measured using a self-developed item
• Acceptability of decision aid(s) [ Time Frame: Immediately after the index health care visit ]
  The acceptability of the decision aid(s) to participants, measured using a self-developed item

Descriptive Information

• Brief Title: Right For Me: Birth Control Decisions Made Easier
• Official Title: Right For Me: Birth Control Decisions Made Easier
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Contraception

Intervention

• Other: Video + Prompt Card
  1. 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?
  2. 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.
• Other: Decision Aids + Training
  1. 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.
  2. 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.

Study Arms

• Experimental: Arm 1
  Intervention: Other: Video + Prompt Card
• Experimental: Arm 2
  Intervention: Other: Decision Aids + Training
• Experimental: Arm 3
  Interventions:

  • Other: Video + Prompt Card
  • Other: Decision Aids + Training
• No Intervention: Arm 4

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 17, 2019): 5038
• Original Estimated Enrollment (submitted: April 29, 2016): 4160
• Actual Study Completion Date: July 14, 2017
• Actual Primary Completion Date: December 30, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 49 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02759939
• Other Study ID Numbers: 00028721
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.

• Current Responsible Party: Rachel L. Thompson, Dartmouth-Hitchcock Medical Center
• Original Responsible Party: Dartmouth-Hitchcock Medical Center
• Current Study Sponsor: Dartmouth-Hitchcock Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rachel Thompson, PhD; Dartmouth College

• PRS Account: Dartmouth-Hitchcock Medical Center
• Verification Date: November 2019