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

Peter Scalia, Marie Anne Durand, Rachel C. Forcino, Danielle Schubbe, Paul J. Barr, Nancy O'Brien, A. James O'Malley, Tina Foster, Mary C. Politi, Shannon K Laughlin-Tommaso, Erika Banks, Tessa Madden, Raymond M. Anchan, Johanna W.M. Aarts, Priscilla Velentgas, Joyce Balls-Berry, Carla Bacon, Monica Adams-Foster, Carrie Cahill Mulligan, Sateria VenableNancy E. Cochran, Glyn Elwyn

Research output: Contribution to journalArticle

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

Original languageEnglish (US)
Article number88
JournalImplementation Science
Volume14
Issue number1
DOIs
StatePublished - Sep 2 2019

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Decision Support Techniques
Leiomyoma
Outcome Assessment (Health Care)
Patient Participation
Pelvic Pain
Pregnancy Complications
Workflow
Coitus
Therapeutics
Uterus
Smooth Muscle
Linear Models
Decision Making

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

ASJC Scopus subject areas

  • Health Policy
  • Health Informatics
  • Public Health, Environmental and Occupational Health

Cite this

Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings : A randomized stepped-wedge study protocol. / Scalia, Peter; Durand, Marie Anne; Forcino, Rachel C.; Schubbe, Danielle; Barr, Paul J.; O'Brien, Nancy; O'Malley, A. James; Foster, Tina; Politi, Mary C.; Laughlin-Tommaso, Shannon K; Banks, Erika; Madden, Tessa; Anchan, Raymond M.; Aarts, Johanna W.M.; Velentgas, Priscilla; Balls-Berry, Joyce; Bacon, Carla; Adams-Foster, Monica; Mulligan, Carrie Cahill; Venable, Sateria; Cochran, Nancy E.; Elwyn, Glyn.

In: Implementation Science, Vol. 14, No. 1, 88, 02.09.2019.

Research output: Contribution to journalArticle

Scalia, P, Durand, MA, Forcino, RC, Schubbe, D, Barr, PJ, O'Brien, N, O'Malley, AJ, Foster, T, Politi, MC, Laughlin-Tommaso, SK, Banks, E, Madden, T, Anchan, RM, Aarts, JWM, Velentgas, P, Balls-Berry, J, Bacon, C, Adams-Foster, M, Mulligan, CC, Venable, S, Cochran, NE & Elwyn, G 2019, 'Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: A randomized stepped-wedge study protocol', Implementation Science, vol. 14, no. 1, 88. https://doi.org/10.1186/s13012-019-0933-z
Scalia, Peter ; Durand, Marie Anne ; Forcino, Rachel C. ; Schubbe, Danielle ; Barr, Paul J. ; O'Brien, Nancy ; O'Malley, A. James ; Foster, Tina ; Politi, Mary C. ; Laughlin-Tommaso, Shannon K ; Banks, Erika ; Madden, Tessa ; Anchan, Raymond M. ; Aarts, Johanna W.M. ; Velentgas, Priscilla ; Balls-Berry, Joyce ; Bacon, Carla ; Adams-Foster, Monica ; Mulligan, Carrie Cahill ; Venable, Sateria ; Cochran, Nancy E. ; Elwyn, Glyn. / Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings : A randomized stepped-wedge study protocol. In: Implementation Science. 2019 ; Vol. 14, No. 1.
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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",
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T1 - Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings

T2 - A randomized stepped-wedge study protocol

AU - Scalia, Peter

AU - Durand, Marie Anne

AU - Forcino, Rachel C.

AU - Schubbe, Danielle

AU - Barr, Paul J.

AU - O'Brien, Nancy

AU - O'Malley, A. James

AU - Foster, Tina

AU - Politi, Mary C.

AU - Laughlin-Tommaso, Shannon K

AU - Banks, Erika

AU - Madden, Tessa

AU - Anchan, Raymond M.

AU - Aarts, Johanna W.M.

AU - Velentgas, Priscilla

AU - Balls-Berry, Joyce

AU - Bacon, Carla

AU - Adams-Foster, Monica

AU - Mulligan, Carrie Cahill

AU - Venable, Sateria

AU - Cochran, Nancy E.

AU - Elwyn, Glyn

PY - 2019/9/2

Y1 - 2019/9/2

N2 - 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

AB - 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

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KW - Consolidated Framework for Implementation Research

KW - Decision support intervention

KW - Electronic health record

KW - Implementation

KW - Normalization Process Theory

KW - Patient decision aids

KW - Picture superiority

KW - Shared decision making

KW - Uterine fibroids

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