Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04514341 |
| Other study ID # |
1UH3CA233229-02 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
August 2023 |
Study information
| Verified date |
August 2022 |
| Source |
University of Chicago |
| Contact |
Karen Kim, MD |
| Phone |
773-702-2613 |
| Email |
kekim[@]medicine.bsd.uchicago.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Screening for colorectal cancer (CRC) not only detects disease early when treatment is more
effective but also prevents cancer by finding and removing precancerous polyps. Because many
of our nation's most disadvantaged and vulnerable individuals obtain health care at federally
qualified health centers, these centers play a significant role in increasing CRC screenings
among the most vulnerable populations. Furthermore, the full benefits of cancer screenings
must include timely and appropriate follow-up of abnormal results. Thus, the purpose of this
study is to implement a multilevel intervention to increase rates of CRC screenings,
follow-ups, and referrals-to-care in federally qualified health centers (FQHCs). Also, we
will examine the implementation strategies used to support the implementation process and
their contribution to the adoption, implementation, and sustainment of the multilevel
intervention. The multilevel intervention will target three different levels of influences:
organization, provider, and individual. It will have multiple components, including provider
and staff education, provider reminder, provider assessment and feedback, patient reminder,
and patient navigation.
This study is a multilevel, three-phase, stepped wedge cluster randomized trial with four
clusters of clinics from four different FQHCs. Our FQHC partners together have 40 primary
care clinics and 130 primary care providers. During Phase 1, there will be a 3-month waiting
period during which no intervention components will be implemented. After the 3-month waiting
period, we will randomize two clusters of clinics to cross from the control to the
intervention and the remaining two clusters to follow three months later. All clusters of
clinics will stay at the same phase for nine months, followed by a 3-month transition period,
and then cross over to the next phase. In Phase 1, we will implement provider and staff
education sessions. In Phase 2, we will add provider reminders, patient reminders, and
provider assessment and feedback. We will add patient navigation during the last phase.
Single level interventions are often insufficient at leading to sustainable changes.
Multilevel interventions are needed to address multilevel contextual influences
simultaneously. How to take advantage of multilevel interventions and how to implement such
interventions and evaluate their effectiveness are the ultimate goals of this study.
Description:
A. BACKGROUND
A1. Colorectal cancer control and FQHCs
Screening for CRC not only detects disease early when treatment is more effective but also
prevents cancer by finding and removing precancerous polyps. Despite strong evidence to
support CRC screening, nationally, only 68.8% of adults had up to date screening in 2018 [1].
This figure is even lower among racial/ethnic minorities and people who live in poverty
[2-5]. Racial/ethnic minorities and people with low social-economic status often lack health
insurance and a regular source of care. These populations also disproportionately receive
health care in safety-net settings, such as federally qualified health centers (FQHCs) [6-7].
In 2018, FQHCs served 28 million patients, of whom 23% were uninsured, 63% were racial/ethnic
minorities, and 91% were living below 200% poverty level [8]. Thus, FQHCs play a significant
role in increasing CRC screening among the most vulnerable populations.
A2. Challenges of colorectal cancer control in FQHCs
Due to the cost and limited availability of specialty services combined with patient
preferences, FQHCs often promote non-invasive screening methods, such as fecal occult blood
test (FOBT) or fecal immunochemical tests (FIT), as the modality for screening [9-12]. To
achieve the benefits of CRC screening using FOBT/FIT, timely follow-up of positive results
must occur. While no national estimates of the proportion of individuals without follow-up
diagnostic evaluation after receiving a positive FOBT/FIT exist, several studies report
follow-up rates ranging from less than 50% to 90% within one year of a positive test [13-22],
with integrated health care systems exhibiting higher follow-up rates by 12 months (82%-86%)
compared to FQHCs (56%-58%) [23-24].
A3. Multilevel influences on cancer screening behavior
Individuals live and seek care in a complex environment, and multiple levels of contextual
influences may affect individual decisions and actions [25-26]. Multilevel interventions
target changes in more than one contextual level (e.g., organization, provider, and patient
levels) to influence health behavior, health care practice, and health outcomes [27-28].
Although the call for multilevel interventions has increased [29-31], there is still a lack
of evidence addressing how to implement multilevel interventions or how interventions at
multiple levels interact and affect health outcomes.
B. STUDY OBJECTIVES
The overall objective of this study is to provide the evidence base for multilevel
interventions that increase rates of CRC screening, follow-up, and referral-to-care at
federally qualified health centers, and to understand how to improve the adoption,
implementation, and sustainment of these interventions. In this study, we will test the
effectiveness of our multilevel intervention while simultaneously observing and gathering
information on the implementation process. The selection of our multilevel intervention
components is based on extensive literature review, the strength of evidence, and findings
from our previous studies and projects. The multilevel intervention will target three
different levels of influence (organization, provider, and individual) to improve rates of
CRC screening, follow-up, and referral-to-care at our partner FQHCs. Our multilevel
intervention will have multiple components, including provider and staff education, provider
reminder, provider assessment and feedback, patient reminder, and patient navigation.
The aims this study are fourfold: (1) use a stepped wedge design to implement a multilevel
intervention in three phases, (2) collect quarterly data to track changes over time, (3)
evaluate the implementation process and the effectiveness of implementation strategies
through observations, interviews, and annual survey, and (4) evaluate the effectiveness of
the multilevel intervention using multilevel and longitudinal modeling.
C. METHODS
CRC screening and follow-up processes are complex and include several steps and interfaces.
However, very few interventional studies have simultaneously targeted patient-, provider-,
and organization-level factors. Interventions that focus on reducing barriers across several
levels will likely be more effective for increasing rates of CRC screening, follow-up, and
referral-to-care.
C1. Multilevel Intervention and Implementation Strategy
Provider Level Component
Provider education
Numerous studies indicate the importance of physician recommendation in influencing a
patient's CRC screening decision [31-44], and this factor is a primary predictor for patient
adherence with screening guidelines [45-47]. The research team will provide tailored
education and guidance on best practices for participating health professionals. The
educational sessions will focus on CRC risk assessment, screening guidelines, cultural
competency, shared decision making, and communication skills using an academic detailing
approach. The academic detailing approach involves trained experts visiting health care
professionals in their settings to provide tailored education and guidance on best practices,
which have shown to have a significant effect on increasing rates of CRC screening [48-53].
Each session will last about 15 to 20 minutes and will take place during routine staff and
provider meetings. These academic detailing sessions will be ongoing throughout the study
period.
Provider assessment and feedback
We will combine academic detailing with practice facilitation, which includes assessment and
feedback on aggregate and individual provider screening behavior and practice performance
[54]. The reports will include CRC screening order rates, screening completion rates,
follow-up rates for abnormal results, and referral to oncology care. Providers will be able
to see each other's performances, which allows providers to compare and learn from each
other's successes.
Provider reminder
Given the multitude of competing priorities during a patient encounter, CRC screening
recommendations can be overlooked. A provider prompt generated electronically or manually by
staff members will be implemented to remind providers to screen their eligible patients.
Provider prompts have been shown to increase CRC screening rates [55].
C2. Organization and Individual Level Component
Patient reminder
Provider recommendation alone does not guarantee the completion of CRC screening, which
involves patient compliance. We will implement a patient reminder component using a
text-based platform, also known as short message service (SMS), to engage and remind patients
to complete the screening. For patients who use colonoscopy as a screening method, the SMS
will also include instruction on bowel preparation and dietary restrictions five days before
the procedure. Studies have demonstrated that SMS patient reminders not only had a positive
impact on screening rates but also improved the quality of bowel preparation [56-61].
Patient navigation
Patient navigation services will address both organization and individual influences. Patient
navigation focuses on eliminating barriers by guiding a patient through a complex healthcare
system, addressing education, sociocultural, and logistical needs using trained staff. We
will hire and train two full-time CRC navigators and adapt and modify the well-studied New
Hampshire Colorectal Cancer Screening Program (NHCRCSP) Patient Navigator Model [62-64].
C3. Implementation Strategy
The effectiveness of an intervention, in part, depends on the strength of the implementation
process. We will conduct a pre-implementation organizational readiness assessment (ORA). We
will use the Consolidated Framework for Implementation Research (CFIR) to guide our ORA. We
will conduct key informant interviews with health system leadership and clinic leaders to
evaluate: 1) current CRC screening workflow, 2) CRC data capturing and validation process,
and 3) capacity and resources available to support the implementation. Also, we will conduct
a readiness survey with clinical providers and support staff to assess organizational climate
and culture. Our 29 survey items were adapted and modified from validated instruments65-68
that measured CFIR constructs using a Delphi method.
Effective strategies to support the implementation process is critical. Implementation
strategies are actions taken to enhance the adoption, implementation, and sustainability of
evidence-based interventions. We will use different implementation strategies to implement
our multilevel intervention. Finally, we will implement our multilevel, multicomponent
intervention in three phases along the CRC screening continuum. In Phase 1, we will collect
baseline data and implement provider and staff education sessions. In Phase 2, we will add
provider reminders, patient reminders, and provider assessment and feedback. We will add
patient navigation during the last phase.
C4. Study Design
This study is a multilevel, three-phase, stepped wedge cluster randomized trial with four
clusters of clinics from four different FQHCs. Our FQHC partners together have 40 primary
care clinics and 130 primary care providers. During Phase 1, there will be a 3-month waiting
period during which no intervention components will be implemented. After the 3-month waiting
period, we will randomize two clusters of clinics to cross from the control to the
intervention and the remaining two clusters to follow three months later. All clusters of
clinics will stay at the same phase for nine months, followed by a 3-month transition period,
and then cross over to the next phase. In Phase 1, we will implement provider and staff
education sessions. In Phase 2, we will add provider reminders, patient reminders, and
provider assessment and feedback. We will add patient navigation during the last phase.
C5. Study Sites
We will partner with four FQHCs, two in Illinois and two in Indiana. Together, our FQHC
partners have 40 primary care clinics and 130 primary care providers and served 162,000
individual patients in 2018. Of the 162,000 patients, 78% were racial minorities, 93% live at
or below 200% poverty, and 17% were uninsured. The CRC screening rates among our partners
range from 25% to 43%.
C6. Process Evaluation
We will assess the potential causal and contextual factors that may be associated with
observed outcomes at the provider and clinic levels. After completion of each phase, we will
send all providers at our partner clinics a survey to assess their exposure to and experience
with the intervention component. Furthermore, we will evaluate the changes in organizational
culture and climate that may ascertain potential mechanisms of impact using the 29 survey
items we developed based on the CFIR.
C7. Data Analysis Plan
We will conduct descriptive analyses, as well as within-group and between-group changes over
time. Furthermore, to evaluate the four-component intervention effects, we will take a
step-by-step approach. First, each intervention effect at each time phase will be estimated
separately using linear-mixed effects models. The estimate of intervention effect in each
model will be used to test if additional intervention component significantly affects outcome
measures. Next, we will develop a grand model, including all intervention components
simultaneously, in addition to the models described above.
