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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03985449
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : September 4, 2020
Brigham and Women's Hospital
Mayo Clinic
Montefiore Medical Center
Barnes-Jewish Hospital
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Glyn Jones-Elwyn, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroid 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: Data analysts will be blinded to the setting randomization.
Primary Purpose: Health Services Research
Official Title: Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings: a Randomized Stepped-wedge Study
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Arm Intervention/treatment
Active Implementation phase
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)
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.

Other: Uterine Fibroid Option Grid encounter patient decision aid (text + Pictures)
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.

Other: Uterine Fibroid Option Grid encounter patient decision aid (online)
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.

Primary Outcome Measures :
  1. The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid. [ Time Frame: Month 1-14 ]

Secondary Outcome Measures :
  1. Measuring Organizational Readiness for patient Engagement (MORE) [ Time Frame: Before week 1 ]
    MORE is designed to measure a healthcare organization's willingness and ability to effectively implement patient engagement in healthcare. The measure contains 25 items each of which is scored on a four-point Likert-type scale (1=avoid/not important; 4=definitely involve/very important). Data from the measure will be analyzed to identify barriers and facilitators to implementation at each site.

  2. Attitudes toward Decision Aids fOr PatienTs (ADOPT) [ Time Frame: Month 1, Month 9, Month 22 ]
    A measure of clinician attitudes to patient decision aids (PDA)s. Clinicians are asked to select one or more words that best describes their attitudes to the potential use of PDAs from a pool of ten words. It can be completed by clinicians who have, or have not, used PDAs.

  3. Quality of shared decision making [ Time Frame: Through Month 1-6, Month 8-14 ]
    Observer OPTION-5 is a validated five-item scale, with each item rated from '0' to '4' where '0' represents absence of a shared decision making specific competency and '4' represents optimal performance.

  4. Fidelity assessment [ Time Frame: Through Month 10-14 ]
    The fidelity assessment checklist enables the investigators to determine if an Option Grid was used, how and when it was delivered to the patient, whether or not the clinician made a treatment recommendation or elicited patient preference, and the identification of the final treatment decision. The checklist will help the investigators understand if the clinicians are using the tools as intended following initiation.

  5. NoMAD Normalization Process Theory (NPT) survey [ Time Frame: Month 6 and Month 22 ]
    A 23-item instrument used for capturing the perspective of professionals who will be involved in implementing and using Option Grid in practice. The instrument contains four sections that ask questions on the various facets of implementing and using the intervention such as the effect that it has on workflow, the work and resources needed to drive implementation, and critical appraisal of the Option Grid, etc.

  6. Utility of Option Grid patient decision aids and clinician approach to implementation [ Time Frame: Month 14 and Month 22 ]
    Semi-structured interviews, guided by the Normalization Process Theory, will be conducted with clinicians to assess the utility of the Option Grid tools and how they implemented the intervention in practice

  7. Measuring shared decision making [ Time Frame: Through Month 1-6, Month 8-14 ]
    collaboRATE is a three-item, patient-reported experience measure of how patients perceive the effort that clinicians make to achieve three core aspects of shared decision making: informing patients, eliciting preferences, and integrating preferences into decisions made. Patients answer each question on a scale of 0 to 9. The measure is scored by using the percentage of patients who give the highest possible score of 9 for each item.

  8. Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) symptom severity subscale [ Time Frame: Through Month 1-6, Month 8-14 ]
    Patients will be asked to complete only the symptom severity subscale portion of the 37-item UFS-QOL questionnaire. The eight-item subscale asks patients how distressed their symptoms have made them feel over the past three months. Each item is scored on a Likert-type scale from '1' (None of the time) to '5' (All of the time).

  9. The Comprehensive Score for financial Toxicity (COST) [ Time Frame: Through Month 1-6, Month 8-14 ]
    COST is a patient-reported outcome measure to assess financial toxicity in patients with cancer. The measure contains 11 items. Study stakeholders, including patient partners, felt that the majority of the items were not applicable for this study and wanted to minimize respondents' burden, so the investigators opted to only use 1 item. The questions reads: "I worry about the financial problems I will have in the future as a result of my illness or treatment", and the response scale is from '0' (not at all) to '4' (very much).

  10. Chew Health Literacy Measure [ Time Frame: Through Month 1-6, Month 8-14 ]
    3-item validated measure of health literacy. The items are the following: How confident are you filling out medical forms by yourself? How often do you have someone (like a family member, friend, hospital/clinic worker, or caregiver) help you read hospital materials? How often do you have problems learning about your medical condition because of difficulty understanding written information? Patients who circle 'extremely' or 'quite a bit' on the Likert-type scale are considered to have high health literacy

  11. Resource utilization (ambulatory and hospital) [ Time Frame: Through Month 1-6, Month 8-14 ]
    The follow-up survey will query eligible patients to self-report the number of outpatient (or visit to primary care clinician), inpatient, or emergency visits during the three-month follow-up period.

  12. Treatment choice [ Time Frame: Through Month 1-6, Month 8-14 ]
    Patients will identify their intended treatment choice in the post-encounter survey. The investigators will also ask patients in the 3-month follow-up survey whether they have seen another clinician about another treatment, whether an Option Grid tool was used in that encounter, and to identify the final treatment option they selected.

  13. Patient demographics [ Time Frame: Through Month 1-6, Month 8-14 ]
    The investigators will collect the patient's email address, health insurance status, age, race, gender, and spoken language via the survey they complete on the tablet computer post-encounter.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03985449

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Contact: Glyn Elwyn, MD,PhD 603-653-0828
Contact: Marie-Anne Durand, PhD 603-653-0828

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United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Glyn Elwyn, MD,PhD    603-653-0828   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Brigham and Women's Hospital
Mayo Clinic
Montefiore Medical Center
Barnes-Jewish Hospital
Patient-Centered Outcomes Research Institute
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Principal Investigator: Glyn Elwyn, MD, PhD Dartmouth College
Additional Information:
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Responsible Party: Glyn Jones-Elwyn, Principal Investigator, Dartmouth-Hitchcock Medical Center Identifier: NCT03985449    
Other Study ID Numbers: D19115
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All patient survey data will be stored in a Qualtrics database, a HIPAA-compliant web-based data management system. The investigators will assign a unique study identification number to each member of the study team (including clinicians). All data including clinician demographic information (age, gender, and years of experience post-fellowship or year of residency) and the ADOPT, NoMAD and MORE survey responses will be stored in the Qualtrics database. All audio-recordings of clinical encounters and semi-structured interviews will be loaded by site-based project staff into Dartmouth's HIPAA-compliant SharePoint system that only the Dartmouth study team will be able to access. Each recording will be labeled with a unique identification number.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glyn Jones-Elwyn, Dartmouth-Hitchcock Medical Center:
Shared decision making
Patient Decision Aids
Decision Support Intervention
Uterine Fibroids
Normalization Process Theory
Consolidated Framework for Implementation Research
Picture Superiority
Electronic Health Record
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases