Right For Me: Birth Control Decisions Made Easier

NCT02759939 | Completed Results

• 1 other identifier: 00028721
• Study Type: interventional
• Target: 5,038
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Shared Decision-Making; Patient-Provider Communication

Outcome Measures

Primary Outcomes (1)

• Shared Decision-making About Contraceptive Methods

  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).

  Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]

Secondary Outcomes (14)

• Conversation About Contraception

  Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

• Satisfaction With Conversation About Contraception

  Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

• Intended Contraceptive Method(s)

  Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

• Intention to Use a Highly Effective Contraceptive Method

  Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

• 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]

Other Outcomes (6)

• Exposure to Video

  Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

• Exposure to Prompt Card

  Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

• Use of Three Questions

  Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Study Arms (4)

Arm 1

EXPERIMENTAL

Other: Video + Prompt Card

Arm 2

EXPERIMENTAL

Other: Decision Aids + Training

Arm 3

EXPERIMENTAL

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

Arm 4

NO INTERVENTION

Interventions

Video + Prompt Card OTHER

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.

Arm 1; Arm 3

Decision Aids + Training OTHER

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.

Arm 2; Arm 3

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

The Dartmouth Institute for Health Policy and Clinical Practice

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (9)

• 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.

  PMID: 26364752 BACKGROUND

• 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.

  PMID: 24389354 BACKGROUND

• 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.

  PMID: 23768763 BACKGROUND

• 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.

  PMID: 11879761 BACKGROUND

• 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.

  PMID: 12926578 BACKGROUND

• O'Connor, A. 1996. User Manual - Decision Regret Scale. Ottawa. Retrieved from http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf

  BACKGROUND

• Centers for Disease Control and Prevention. 2012. Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 7 Questionnaire: Topic Reference. Atlanta, GA.

  BACKGROUND

• 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.

  PMID: 20444179 BACKGROUND

• 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.

  PMID: 29061624 DERIVED

Related Links

• Study Website

MeSH Terms

Interventions

Videotape Recording; Decision Support Techniques

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Investigative Techniques

Limitations and Caveats

Suboptimal retention at follow-up undermined our power to detect intervention effects on most secondary outcomes. Modest rates of intervention implementation, according to patient-reported data, should be considered when results are interpreted.

Results Point of Contact

• Title: Rachel Thompson
• Organization: Dartmouth College

rachel.thompson@dartmouth.edu

6036530860

Study Officials

• Rachel Thompson, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, The Dartmouth Institute

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: May 3, 2016
• Study Start: July 1, 2016
• Primary Completion: December 30, 2016
• Study Completion: July 14, 2017
• Last Updated: November 19, 2019
• Results First Posted: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)