Clinical trial · Interventional
Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings
Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings: a Randomized Stepped-wedge Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
UPFRONT is a study that aims to use two implementation frameworks - the Consolidated Framework for Implementation Research and the Normalization Process Theory - to guide the implementation of a uterine fibroid patient decision aid, known as Option Grid, at five diverse gynecology settings across the United States. Option Grid provides evidence-based information on the various treatment options to help women across socioeconomic strata with symptomatic uterine fibroids make a preference-sensitive decision.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Uterine Fibroid Option Grid encounter patient decision aid (online) | Other | — | UNRESOLVED |
| Uterine Fibroid Option Grid encounter patient decision aid (text only) | Other | — | UNRESOLVED |
| Uterine Fibroid Option Grid encounter patient decision aid (text + Pictures) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Active Implementation phase
- description
- See the 'detailed description' section to read about the intervention(s) clinicians will use during the active implementation phase of the randomized stepped-wedge design.
- interventionNames
- Other: Uterine Fibroid Option Grid encounter patient decision aid (text only)
- Other: Uterine Fibroid Option Grid encounter patient decision aid (text + Pictures)
- Other: Uterine Fibroid Option Grid encounter patient decision aid (online)
Primary outcomes (1)
- measure
- The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid.
- timeFrame
- Month 1-14
Secondary outcomes (13)
- measure
- Measuring Organizational Readiness for patient Engagement (MORE)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients showing new or recurrent symptoms of uterine fibroids (e.g. heavy menstrual bleeding, pelvic pressure or pain, etc.) who are seeking treatment. * Assigned female sex at birth * At least 18 years of age * Speak English or Spanish * Have the ability to complete short surveys online independently or assisted by a caregiver. The investigators will also include health care professionals who will provide care to women with symptomatic uterine fibroids during the project duration at participating sites. Exclusion Criteria: * Patients who are under 18 * Patients not assigned female sex at birth * Women who are postmenopausal because they will have different treatment options than the ones presented in this study's intervention.
References
Publications (2)
- BACKGROUNDScalia P, Durand MA, Forcino RC, Schubbe D, Barr PJ, O'Brien N, O'Malley AJ, Foster T, Politi MC, Laughlin-Tommaso S, 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. Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol. Implement Sci. 2019 Sep 2;14(1):88. doi: 10.1186/s13012-019-0933-z. PMID 31477140
- DERIVEDForcino RC, Durand MA, Schubbe D, Engel J, Banks E, Laughlin-Tommaso SK, Foster T, Madden T, Anchan RM, Politi M, Lindholm A, Gargiulo RM, Seshan M, Tomaino M, Zhang J, Acquilano SC, Akinfe S, Sharma A, Aarts JWM, Elwyn G. The UPFRONT project: tailored implementation and evaluation of a patient decision aid to support shared decision-making about management of symptomatic uterine fibroids. Implement Sci. 2024 Nov 5;19(1):75. doi: 10.1186/s13012-024-01404-5. PMID 39501337