Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings

NCT03985449 | Completed

• 1 other identifier: D19115
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

Brief Summary

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

Uterine Fibroid

Keywords

Implementation; Shared decision making; Patient Decision Aids; Decision Support Intervention; Uterine Fibroids; Normalization Process Theory; Consolidated Framework for Implementation Research; Picture Superiority; Electronic Health Record; Coproduction

Outcome Measures

Primary Outcomes (1)

• The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid.

  Month 1-14

Secondary Outcomes (13)

• Measuring Organizational Readiness for patient Engagement (MORE)

  Before week 1

• Attitudes toward Decision Aids fOr PatienTs (ADOPT)

  Month 1, Month 9, Month 22

• Quality of shared decision making

  Through Month 1-6, Month 8-14

• Fidelity assessment

  Through Month 10-14

• NoMAD Normalization Process Theory (NPT) survey

  Month 6 and Month 22

Study Arms (1)

Active Implementation phase

OTHER

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.

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)

Interventions

Uterine Fibroid Option Grid encounter patient decision aid (text only) OTHER

The uterine fibroid Option Grid patient decision aid facilitates choice awareness and deliberation about treatment options when clinicians and patients discuss the management of uterine fibroids. The content is organized in a tabular format and is based on patients' frequently asked questions.

Active Implementation phase

Uterine Fibroid Option Grid encounter patient decision aid (text + Pictures) OTHER

The Picture Option Grid uses the same evidence as the text version while integrating images and simpler text, thus utilizing pictorial superiority to help patients better understand and remember information more easily compared to just using words.

Active Implementation phase

Uterine Fibroid Option Grid encounter patient decision aid (online) OTHER

Clinicians can click a link in the electronic health record that will lead them to the EBSCO Health website where they can click the treatment options relevant to the patient and generate a decision aid.

Active Implementation phase

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Brigham and Women's Hospital: collaborator
• Mayo Clinic: collaborator
• Montefiore Medical Center: collaborator
• Barnes-Jewish Hospital: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (2)

• Scalia 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 BACKGROUND

• Forcino 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 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Glyn Elwyn, MD, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Data analysts will be blinded to the setting randomization.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped wedge trial with randomization at the clinic level. Patient enrollment will occur at five gynecology clinics in the United States. The uterine fibroid Option Grid patient decision aid intervention will be implemented in the 'active' implementation phase of the trial following a brief initiation session at each clinic to introduce clinicians to the intervention.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 13, 2019
• Study Start: August 1, 2019
• Primary Completion: December 15, 2022
• Study Completion: January 15, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)