Right For Me: Birth Control Decisions Made Easier

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02759939

Recruitment Status : Completed

First Posted : May 3, 2016

Results First Posted : November 19, 2019

Last Update Posted : November 19, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Rachel L. Thompson, Dartmouth-Hitchcock Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Contraception	Other: Video + Prompt Card Other: Decision Aids + Training	Not Applicable

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	5038 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Right For Me: Birth Control Decisions Made Easier
Actual Study Start Date :	July 1, 2016
Actual Primary Completion Date :	December 30, 2016
Actual Study Completion Date :	July 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1	Other: Video + Prompt Card 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.
Experimental: Arm 2	Other: Decision Aids + Training 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.
Experimental: Arm 3	Other: Video + Prompt Card 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. Other: Decision Aids + Training 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.
No Intervention: Arm 4

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Other Outcome Measures:

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).

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	15 Years to 49 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759939

Locations

Layout table for location information

United States, New Hampshire
The Dartmouth Institute for Health Policy and Clinical Practice
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

Layout table for investigator information

Principal Investigator:	Rachel Thompson, PhD	Dartmouth College

More Information

Additional Information:

Study Website This link exits the ClinicalTrials.gov site

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Rachel L. Thompson, Assistant Professor, The Dartmouth Institute, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT02759939
Other Study ID Numbers:	00028721
First Posted:	May 3, 2016 Key Record Dates
Results First Posted:	November 19, 2019
Last Update Posted:	November 19, 2019
Last Verified:	November 2019
Individual Participant Data (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.

Keywords provided by Rachel L. Thompson, Dartmouth-Hitchcock Medical Center:


Shared Decision-Making Patient-Provider Communication

To Top