Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods

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.

Keywords: contraception; gynaecology; primary care; public health; shared decision-making.

Conflict of interest statement

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.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1

Data collection schematic

Figure 2

Survey invitation and reminder schedule.

Figure 3

Estimated sample sizes per trial arm. *Estimates of the total number of patients eligible for the study will be provided by clinics based on routinely collected data. ^Sample for primary outcome analyses.