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Randomized Controlled Trial
. 2024 Nov 5;19(1):75.
doi: 10.1186/s13012-024-01404-5.

The UPFRONT project: tailored implementation and evaluation of a patient decision aid to support shared decision-making about management of symptomatic uterine fibroids

Rachel C Forcino  1 , Marie-Anne Durand  2   3   4 , Danielle Schubbe  2 , Jaclyn Engel  2 , Erika Banks  5 , Shannon K Laughlin-Tommaso  6 , Tina Foster  7 , Tessa Madden  8 , Raymond M Anchan  9 , Mary Politi  10 , Anne Lindholm  9 , Rossella M Gargiulo  9 , Maya Seshan  9 , Marisa Tomaino  11 , Jingyi Zhang  2 , Stephanie C Acquilano  2 , Sade Akinfe  2 , Anupam Sharma  2 , Johanna W M Aarts  12   13 , Glyn Elwyn  2
Affiliations
Randomized Controlled Trial

The UPFRONT project: tailored implementation and evaluation of a patient decision aid to support shared decision-making about management of symptomatic uterine fibroids

Rachel C Forcino et al. Implement Sci. .

Abstract

Objective: To evaluate implementation of a patient decision aid for symptomatic uterine fibroid management to improve shared decision-making at five clinical settings across the United States.

Methods: We used a type 3 hybrid effectiveness-implementation stepped-wedge design and the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) planning and evaluation framework. We conducted clinician training, monthly reach tracking with feedback to site clinical leads, patient and clinician surveys, and visit audio-recordings. Implementation strategies included assessment of organizational readiness for shared decision-making, synchronous clinician training, audit and feedback of decision aid reach, and access to multiple decision aid formats. Outcomes and analyses included patient-level reach, clinician-level adoption, and associations of patient-reported decision aid exposure (as treated) and setting-level implementation (intention-to-treat) with patient-reported (collaboRATE measure) and observed (OPTION-5 measure) shared decision-making. We also designed and assessed setting-level plans for sustainability and other factors impacting sustained decision aid use.

Results: The decision aid was adopted by 72 of the 74 eligible gynecologists (97%) and reached 2553 patients across five settings. CollaboRATE scores improved among patients who reported receiving the decision aid (as-treated analysis, 69% vs. 59%; OR 1.6, 95% CI 1.16-2.27). CollaboRATE scores remained consistent before and after setting-level decision aid implementation (intention-to-treat analysis, 64% vs. 63%; OR 0.86, 95% CI 0.61-1.22). Participants would prefer to receive a decision aid at multiple time points (91.9% before the visit, 90.7% during the visit, 86.5% after the visit). Shared decision-making experiences did not improve when comparing pre vs. post-implementation collaboRATE scores across included settings (intention-to-treat, 64% vs. 63%; OR 0.86, 95% CI 0.61-1.22).

Conclusion: When patients with symptomatic uterine fibroids are given decision aids, they report higher shared decision-making scores. However, the differences we observed between the as-treated and intention-to-treat results suggest that unaddressed implementation challenges continue to limit the extent to which patients receive decision aids and likely hinder their overall impact. Future efforts to implement decision aids should explore enhancing their integration into clinical workflows and standard operating procedures, supported by organizational incentives that prioritize shared decision-making.

Trial registration: ClinicalTrials.gov NCT03985449; registered 6 June 2019.

Keywords: Conversation aid; Implementation science; Patient decision aid; Shared decision making training; Symptomatic uterine fibroids.

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Conflict of interest statement

Financial

Glyn Elwyn has edited and published books that provide royalties on sales by the publisher: the books include Shared Decision Making (Oxford University Press) and Groups (Radcliffe Press). He currently is Founder and Director of &think LLC which owns the registered trademark for Option Grids™ patient decision aids. Marie-Anne Durand has contributed to the development of the Option Grid™ patient decision aids, which are licensed to EBSCO Health. She receives consulting income from EBSCO Health and royalties. Shannon K. Laughlin-Tommaso authors UpToDate articles related to fibroids; she receives royalties.

Non-financial

Glyn Elwyn’s academic interests are focused on shared decision making and coproduction. He owns copyright in measures of shared decision making and care integration, namely collaboRATE, integRATE, Observer OPTION-5, and Observer OPTION-12. These measures are freely available for use by researchers.

Figures

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Fig. 1
Study phases
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