Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings (UPFRONT)
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|ClinicalTrials.gov Identifier: NCT03985449|
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : September 4, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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.
- The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid. [ Time Frame: Month 1-14 ]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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).
- 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).
- 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
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03985449
|Contact: Glyn Elwyn, MD,PhDfirstname.lastname@example.org|
|Contact: Marie-Anne Durand, PhD||603-653-0828||Marie-Anne.Durand@dartmouth.edu|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03766|
|Contact: Glyn Elwyn, MD,PhD 603-653-0828 email@example.com|
|Principal Investigator:||Glyn Elwyn, MD, PhD||Dartmouth College|