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Patient-centred medicine
Protocol
Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods
  1. Rachel Thompson1,
  2. Ruth Manski1,
  3. Kyla Z Donnelly1,
  4. Gabrielle Stevens1,
  5. Daniela Agusti1,
  6. Michelle Banach2,
  7. Maureen B Boardman3,
  8. Pearl Brady2,
  9. Christina Colón Bradt2,
  10. Tina Foster1,
  11. Deborah J Johnson3,
  12. Zhongze Li3,
  13. Judy Norsigian4,
  14. Melissa Nothnagle5,
  15. Ardis L Olson3,
  16. Heather L Shepherd6,
  17. Lisa F Stern7,
  18. Tor D Tosteson3,
  19. Lyndal Trevena8,
  20. Krishna K Upadhya9,
  21. Glyn Elwyn1
  1. 1 The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire, USA
  2. 2 Patient Partner
  3. 3 Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA
  4. 4 Stakeholder Partner
  5. 5 Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA
  6. 6 Psycho-Oncology Cooperative Research Group, The University of Sydney, Sydney, New South Wales, Australia
  7. 7 Planned Parenthood Northern California, Concord, California, USA
  8. 8 School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
  9. 9 School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
  1. Correspondence to Dr Rachel Thompson; rachel.thompson{at}dartmouth.edu

Abstract

Introduction Despite the observed and theoretical advantages of shared decision-making in a range of clinical contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This paper describes the protocol for a study to assess the comparative effectiveness of patient-targeted and provider-targeted interventions for facilitating shared decision-making about contraceptive methods.

Methods and analysis We will conduct a 2×2 factorial cluster randomised controlled trial with four arms: (1) video+prompt card, (2) decision aids+training, (3) video+prompt card and decision aids+training and (4) usual care. The clusters will be clinics in USA that deliver contraceptive care. The participants will be people who have completed a healthcare visit at a participating clinic, were assigned female sex at birth, are aged 15–49 years, are able to read and write English or Spanish and have not previously participated in the study. The primary outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the occurrence of a conversation about contraception in the healthcare visit, satisfaction with the conversation about contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy and unwelcome pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the healthcare visit, four weeks later and six months later.

Ethics and dissemination We will disseminate results via presentations at scientific and professional conferences, papers published in peer-reviewed, open-access journals and scientific and lay reports. We will also make an anonymised copy of the final participant-level dataset available to others for research purposes.

Trial registration number ClinicalTrials.gov Identifier: NCT02759939.

  • gynaecology
  • primary care
  • public health
  • shared decision-making
  • contraception

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017830

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    Footnotes

    • Contributors RT, KZD and GE conceived the study. All authors contributed to the design of the study (eg, selection of interventions, development of participant and clinic eligibility criteria, selection of assignment approach, selection of study outcomes) and/or the development of study interventions, recruitment materials (eg, study posters, information sheets) and data collection materials and protocols (eg, patient surveys, survey invitation and reminder schedules). RT drafted the manuscript. All authors contributed to revisions of the draft and gave approval for publication of the manuscript.

    • Funding Research reported in this protocol was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CDR-1403-12221). Apart from requiring adherence to Methodology Standards that specify best practices in the design and conduct of patient-centred outcomes research, the funder has had no role in study design, writing of the protocol or the decision to submit the report for publication.

    • Disclaimer The views presented in this protocol are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee. PCORI can be contacted at info@pcori.org.

    • Competing interests RT reports a grant from the Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study and non-financial support from PCORI outside the submitted work. RT also reports ownership of copyright in several patient decision aids and a role as an editor of the text, ‘Shared Decision Making in Health Care’ but has not received any personal income connected to this ownership or role. RM, KZD, GS, DA, TF, DJJ, ZL, ALO, and TDT report a grant from PCORI during the conduct of the study. MB and KKU report personal fees from Dartmouth College during the conduct of the study. MBB reports a grant from PCORI and other payments from Dartmouth College during the conduct of the study. PB reports personal fees and non-financial support from Dartmouth College during the conduct of the study and non-financial support from Dartmouth College outside the submitted work. CCB reports personal fees and non-financial support from Dartmouth College during the conduct of the study. JN reports personal fees from Dartmouth College during the conduct of the study and non-financial support from PCORI outside the submitted work. MN reports personal fees and other payments from Dartmouth College during the conduct of the study. MN also reports a role as a healthcare provider and clinic representative in a clinic participating in the study. HLS reports a role as a developer of the AskShareKnow programme intervention components and related survey items that were adapted for use in the study but has not received any personal income connected to this role. LFS reports personal fees from Dartmouth College during the conduct of the study; grants from Bayer Health Care Inc., Teva Pharmaceuticals and Gilead Pharmaceuticals Inc. outside the submitted work; and personal fees from Hologic Inc. outside the submitted work. LT reports other payments from Dartmouth College during the conduct of the study. GE reports a grant from PCORI during the conduct of the study and personal fees from Emmi Solutions LLC, Washington State Health Department, Oxford University Press, the National Quality Forum, SciMentum LLC, EBSCO Health, & think LLC and ACCESS Federally Qualified Health Centers outside the submitted work. GE also reports ownership of copyright in the CollaboRATE measure of shared decision-making, the Observer OPTION measure of shared decision-making and several patient decision aids.

    • Ethics approval The Dartmouth College Committee for the Protection of Human Subjects.

    • Provenance and peer review Not commissioned; externally peer reviewed.