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 : August 26, 2019
|First Submitted Date ICMJE||June 6, 2019|
|First Posted Date ICMJE||June 13, 2019|
|Last Update Posted Date||August 26, 2019|
|Actual Study Start Date ICMJE||August 1, 2019|
|Estimated Primary Completion Date||May 30, 2021 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid. [ Time Frame: Month 1-14 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03985449 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings|
|Official Title ICMJE||Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings: a Randomized Stepped-wedge Study|
|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.|
Background & significance
Uterine fibroids are non-cancerous overgrowths of smooth muscle in the uterus. As they grow, a proportion of fibroids give rise to problems, such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and/or difficulty becoming pregnant. Some fibroids cause miscarriage, preterm birth, and increase the risk of cesarean birth. Multiple treatments are available: medication, removal of the inner layer of the uterus wall (endometrial ablation), removal of the uterus (hysterectomy) or part of the fibroid (myomectomy), or blocking some of the blood supply to the uterus (uterine artery embolization). Given the different consequences of treatment options, such as time away from work and impact on fertility, choosing the best option is sensitive to individual preferences. This study seeks to improve healthcare delivery and treatment choices for women of different socioeconomic status (SES) and health literacy levels experiencing symptoms from uterine fibroids.
Approximately 50% of women of reproductive age have fibroids, and at least 50% of these women have significant symptoms. These women report substantial impairment in quality of life and increased costs associated with the impact on daily living. While existing evidence is inconclusive about disparities in treatment choice, the associated socioeconomic burden is even greater in African-American women and those of lower SES. Despite a greater incidence and severity of symptomatic fibroids among African-American women, Hispanic women, and women of lower SES, one study shows that these women are less likely to undergo laparoscopic intervention, while another study found no significant differences between procedure rates between African-American and white women. Nevertheless, African-American women are more likely to experience poor treatment outcomes than white women.
A systematic review (2002) indicated that insufficient evidence exists about the comparative effectiveness of treatments for uterine fibroids. Viswanathan confirmed this view in 2007, saying that "the dearth of high-quality evidence is remarkable given how commonly this problem occurs." A report by Velentgas et al demonstrated similar outcomes between the uterine-sparing treatment options (endometrial ablation, uterine artery embolization, and myomectomy) on the onset of new or recurrent symptoms post-treatment. Myomectomy and uterine artery embolization led to a reduced risk of having a subsequent procedure compared to endometrial ablation. The lack of comparative evidence demonstrating superiority of any one treatment reinforces the role of shared decision making (SDM) in this context.
SDM is considered the pinnacle of patient-centered, ethical care and aims to promote two-way communication between clinicians and patients. Patient decision aids are interventions that provide evidence-based information to patients so they can make decisions that align with their preferences, thus facilitating the SDM process. For example, Option Grid encounter patient decision aids (ePDAs) are available in various formats (paper, picture, online interactive) and present information in a tabular format so patients can compare options. The use of Option Grids, and other similar ePDAs in other settings, also provide evidence that these tools are effective. A stepped-wedge study showed higher levels of SDM when Option Grid decision aids were used with patients who had knee osteoarthritis, as well as an increase in patient knowledge, without lengthening the encounter's duration. Similar results were found when Option Grid ePDAs were used by pediatricians with parents facing decisions about circumcision. In addition, five randomized trials using ePDAs at the Mayo Clinic, Rochester, Minnesota, have demonstrated their impact on SDM, whereas there is less evidence that PDAs used solely by patients before clinical encounters lead to observed changes in SDM.
The investigators have clear evidence from existing research and their own consultation with patient partners that women with fibroids wish to consider treatment trade-offs and engage in decision making processes. A trial of a pre-ePDA for women with uterine fibroids demonstrated impact on knowledge and satisfaction but no effect on concordance between preferences and decisions. A pre-post study by the current team has demonstrated that using the existing uterine fibroids Option Grid led to higher levels of SDM according to both observational and patient-reported measures. Despite interest among patients with uterine fibroids to participate in their healthcare decisions, and the positive impact of uterine fibroids ePDAs on SDM, implementation of SDM approaches in routine care remains challenging.
Implementation of SDM remains difficult across a range of healthcare settings, and success depends on more than simply distributing PDAs to patients. System and organizational barriers exist, related to incentives and established behavior patterns. There is evidence, however, that it is possible to implement SDM, particularly if it is supported by clinical champions, organizational strategies, and effective electronic medical record integration efforts, especially where tools fit well into workflows) and are useful with a diverse range of patients. The investigators searched for, but were unable to find, implementation studies of uterine fibroids ePDAs in clinical settings and conclude that a relevant gap exists.
To fill this gap, the investigators will use a multi-component SDM implementation strategy guided by the Consolidated Framework for Implementation Research and the Normalization Process Theory. The strategy includes: (1) assessment of organizational readiness for SDM using Measuring Organizational Readiness for patient Engagement (MORE) - a team-based survey to develop a tailored strategy at each site addressing potential organizational barriers to implementation; (2) online or in-person introduction to SDM and the Option Grid tools (this will include feedback and coaching); (3) clinician access to multiple formats of Option Grid ePDAs (text, picture, and online interactive version and printed Spanish versions), and; (4) the integration of a suggested SDM approach and new evidence (as appropriate) into existing clinical practice guidelines where feasible (e.g., the American College of Obstetricians and Gynecologists).
The investigators propose to incorporate new comparative effectiveness evidence about uterine fibroid treatments into a multi‐component SDM implementation strategy. The investigators will evaluate the impact of a multi‐component SDM implementation strategy for the care of women who seek treatment for uterine fibroids at five diverse gynecology settings and across socioeconomic strata. The investigators will also examine the real-world clinical context from the five participating sites to determine the characteristics of a successfully (or not successfully) sustained a multi‐component SDM strategy.
Procedure Prior to the pre-implementation phase, a minimum of 10 stakeholders from each site will complete the Measuring Organizational Readiness for patient Engagement (MORE) survey which is designed to measure a healthcare organization's willingness and ability to effectively implement patient engagement in healthcare. Participating clinicians will also complete the ADOPT survey to assess their attitudes toward patient decision aids at the start of the pre-implementation phase.
During the pre-implementation phase, eligible patients will be identified in advance by the project team at each project site through the sites' outpatient appointment systems. After their clinical encounter, clinic staff will provide eligible patients with a tablet computer to complete the consent form and fill out the survey. Patients will provide their email address in the survey so they can receive the follow-up survey three months post-encounter. To measure the extent to which clinicians involve patients in decision-making process, research assistants at each site will randomly audio-record five clinical encounters for each participating clinician.
The study interventions will be carefully described during a two-month initiation period for clinicians at participating sites, to occur between the pre- and active implementation periods.
Each site will decide which intervention (or a combination) they want to implement, as well as potentially suggest new ways of introducing the tool(s) to patients. This will be part of the implementation strategy and informed by the assessment of organizational readiness for patient engagement at each site completed during the pre-implementation phase. The study staff at each site will identify eligible patients ahead of their visits through their outpatient scheduling systems and will have the opportunity to mail or, where allowed by clinic policy, email the Option Grid before their appointment. Patients receiving the tools in advance would be instructed (with a cover letter) to use the tool to prepare for their encounter with their clinician. Patients will be encouraged to assess whether the frequently asked questions are issues that are also of concern to them, and to ask clinic staff to explain any parts which seem unclear to them.
The clinician will also have the option of presenting the Option Grid during the clinical encounter. To facilitate this process, the reception staff (or someone else in the clinic) could provide the tool to the patient before the visit just in case they did not bring their mailed copy. Or, the medical assistant can provide the tool to the patient upon rooming. The method of Option Grid presentation will be tailored to best fit the clinic flow at each site. Clinicians who have access to the online version of Option Grid will record use of the electronic tool into the patient's electronic medical record. Third, clinicians can give the Option Grid to the patient at the end of the encounter, so they can take it home and review its contents with others. This can be done by printing a paper copy, or if using the online version, by sending a URL link to the patient via email. Following the encounter, the patient will be provided with a tablet computer in order to provide consent and fill out the study surveys. Patients will be sent a follow-up link via email three months after the encounter to complete the follow-up survey. Like the pre-implementation phase, a research assistant at each site will audio-record five consecutive clinical encounters for each participating clinician to measure the extent to which clinicians involve patients in the decision-making process and complete the fidelity checklist.
To assess whether the intervention was sustainably implemented, the investigators will capture the perspective of professionals directly involved in the work of implementing complex interventions in healthcare using the NOMAD Normalization Process Theory instrument. The investigators will also assess clinician attitude using the ADOPT survey and conduct interviews with participating clinicians to determine the utility of the intervention, conduct a fidelity assessment, and calculate the percentage of eligible patients receiving the intervention. In addition, the investigators will have interview data which will help the investigators determine if systemic use is sustained.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||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)
Data analysts will be blinded to the setting randomization.Primary Purpose: Health Services Research
|Condition ICMJE||Uterine Fibroid|
|Study Arms ICMJE||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.
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||May 30, 2021|
|Estimated Primary Completion Date||May 30, 2021 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
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.
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT03985449|
|Other Study ID Numbers ICMJE||D19115|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Glyn Jones-Elwyn, Dartmouth-Hitchcock Medical Center|
|Study Sponsor ICMJE||Dartmouth-Hitchcock Medical Center|
|PRS Account||Dartmouth-Hitchcock Medical Center|
|Verification Date||August 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP