Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03985449 |
| Other study ID # |
D19115 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
January 15, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Dartmouth-Hitchcock Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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).
Study aims
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.
Study description
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.
