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. 2019 Sep 2;14(1):88.
doi: 10.1186/s13012-019-0933-z.

Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol

Peter Scalia  1 , Marie-Anne Durand  1 , Rachel C Forcino  1 , Danielle Schubbe  1 , Paul J Barr  1 , Nancy O'Brien  1 , A James O'Malley  1 , Tina Foster  1 , Mary C Politi  2 , Shannon Laughlin-Tommaso  3 , Erika Banks  4 , Tessa Madden  2 , Raymond M Anchan  5 , Johanna W M Aarts  6 , Priscilla Velentgas  7 , Joyce Balls-Berry  8 , Carla Bacon  9 , Monica Adams-Foster  1 , Carrie Cahill Mulligan  1 , Sateria Venable  10 , Nancy E Cochran  1 , Glyn Elwyn  11
Affiliations

Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol

Peter Scalia et al. Implement Sci. .

Abstract

Background: Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA.

Methods: We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics.

Discussion: This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences.

Trial registration: Clinicaltrials.gov , NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449.

Keywords: Co-production; Consolidated Framework for Implementation Research; Decision support intervention; Electronic health record; Implementation; Normalization Process Theory; Patient decision aids; Picture superiority; Shared decision making; Uterine fibroids.

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Conflict of interest statement

Past: 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 has in the past provided consultancy for organizations, including (1) Emmi Solutions LLC who developed patient decision support tools, (2) National Quality Forum on the certification of decision support tools, (3) Washington State Health Department on the certification of decision support tools, and (4) SciMentum LLC, Amsterdam (workshops for shared decision making).

Current: Founder and Director of &think LLC which owns the registered trademark for Option Grids™ patient decision aids. Founder and Director of SHARPNETWORK LLC, a provider of training for shared decision making. He provides consultancy in the domain of shared decision making and patient decision aids to (1) Access Community Health Network, Chicago (Federally Qualified Medical Centers) and (2) EBSCO Health Option Grids™ patient decision aids.

Non-financial: Glyn Elwyn’s academic interests are focused on shared decision making and co-production. 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.

Dr. Marie-Anne Durand is a consultant to Access Community Health Network. Together with Professor Elwyn, she has developed the Option Grid™ patient decision aids, which are licensed to EBSCO Health. She receives consulting income from EBSCO Health and may receive royalties in the future.

Dr. Johanna WM Aarts is an advisor of EBSCO Health Option Grid patient decision aids. This position does not include financial compensation.

Figures

Fig. 1
Fig. 1
Stepped-wedge study design and timeline
Fig. 2
Fig. 2
The uterine fibroid Option Grid patient decision aid
Fig. 3
Fig. 3
Paper-pad mockup to identify the number of eligible patients receiving the uterine fibroid Option Grid in the clinic
See this image and copyright information in PMC

References

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