Trial Title:
Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study
NCT ID:
NCT05524428
Condition:
Colo-rectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer
cancer
screening
implementation science
health equity
cancer equity
healthcare access
minority health
early detection
public health
health justice
rapid testing
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
The investigators will use a mixed methods approach involving qualitative focus groups
with health center providers and staff to identify barriers and facilitators to
screening, and implementation science methods to test multilevel implementation
strategies at the health centers.
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Implementation Science Strategy
Description:
The investigators will be conducting focus groups and identifying barriers and
facilitators, and the investigators will be matching identified barriers and facilitators
to implementation strategies at the patient, provider, and system level which the
investigators will be testing using rapid-cycle methods.
Arm group label:
Introduction of Implementation Strategies
Summary:
The investigators will use a mixed methods study i.e. focus groups involving CHC staff as
well as quantitative study which involves analyzing data that is available from the EHR
and DRVS population management platform.
Detailed description:
Aim 1: Describe the demographics of the populations aged 45 - 49, 50-4, and over 55 to
understand baseline screening needs and disparities.
Overview: The investigators will characterize the population in these age groups in order
to understand resources needed to screen patients at age 50 and to expand screening to
the USPSTF's draft guideline if passed.
Setting: The investigators will select 4 CHCs with distinctly diverse populations for Aim
1 and Aim 2.
Approach: The investigators will examine data from the EHR and the DRVS platform to
determine: (1) the size and demographics of the three age groups; (2) the frequency in
which this population presents to the CHC for primary care and other visits; and (3)
current screening initiation patterns. Based on the findings of the investigator's
initial evaluation, the investigators will estimate the additional colorectal cancer
screening tests that will be required to screen this population promptly at age 50 and
the additional resources that will be needed at each health center to meet this need. The
investigators will also estimate the impact of a lower age of screening initiation.
Analysis will be stratified by race/ethnicity, gender, age and insurance status to assess
for any disparities that might be present.
Data Collection and Management: The DRVS population management platform provides the data
needed to evaluate Aim 1. The Implementation Science Center for Cancer Control Equity
(ISCCCE) data management team will pull the data needed for the participating CHCs, once
selected. The investigators have existing data use agreements that will be amended for
this specific project. Data flows and management procedures have already been established
and will serve to expedite this study.
Aim 2: Conduct focus groups with key personnel to identify barriers and facilitators to
screening in 4 different health centers with uniquely diverse populations.
Overview: The investigators will conduct focus groups to understand barriers and
facilitators to colorectal cancer screening including perceptions around the change in
screening age, attitudes about specific strategies to facilitate colorectal cancer
screening (e.g. use of technological-based solutions to prompt screening, task shifting
with integration of medical assistants into the screening process), proposed strategies
to improve screening at the health center, and other likely barriers and facilitators.
Approach: The investigators will conduct focus groups with key personnel at the 4
participating health centers. The investigators will include an administrative leader and
population health managers, data analysts and quality improvement staff, as well as
nurse/practice managers, medical assistants, and providers (MD, NP, and/or PA). Focus
groups will address: (1) barriers and facilitators to timely screening initiation; (2)
perceptions around using technological solutions to prompt colorectal cancer screening;
and (3) perceptions about task-shifting with integration of the medical assistants into
the colorectal cancer screening process. Distinct barriers and facilitators/determinants
will be identified at the patient, provider and system-level. These determinants will be
prioritized (high, medium, low) based on number of times referenced in the interviews.
Data Analysis: Focus group data will be analyzed to identify key themes related to
barriers and facilitators to screening.
Outcomes: The outcome of this aim will be identified barriers and facilitators to
colorectal cancer screening at health centers with a key focus on understanding
perceptions around utilization of technological solutions (e.g. pre-existing text message
platforms at health centers, electronic registries) and integration of the medical
assistants into the CRC screening workflow.
Aim 3: Develop and test intervention components to anticipate and address barriers and
facilitators at the patient, provider and system-level using rapid cycle methods.
Overview: We will identify implementation strategies at patient, provider and
systems-levels and match to identified Aim 2 barriers and facilitators, use design probes
to understand the workflows and preconditions for implementation strategies, and
individually test strategies using rapid cycle methods.
Approach:
- Development of Implementation Strategies: High ranking barriers from Aim 2 will be
matched with implementation strategies that are most likely to influence
implementation outcomes. A minimum of 2 implementation strategies will be developed
at each level. When identifying strategies, we will consider the: (1) implementation
strategy; (2) mechanism in which the strategy impacts the identified determinant (3)
the determinant; (4) moderators that may influence the impact of the strategy; (5)
the preconditions necessary for successful implementation; and (6) implementation
outcomes affected.
- Design Probes: We will conduct design probes to understand the culture, climate and
preconditions to implementation at each health center. We will use design probes to
further understand the day-to-day workings at the health center and workflows. We
will further tailor our implementation strategies based on additional barriers and
facilitators that are identified from design probes.
- Rapid Cycle Testing: Individual strategies will be tested using single case
experimental design (SCED). In SCED each subject serves as their own control, an
intervention is systematically introduced and withdrawn, and the effects of the
intervention are measured. For our study each CHC will serve as a separate subject.
We will conduct a series of single case experiments at each CHC using component
analysis to rapidly test and optimize our strategies. Component analysis allows
researchers to assess several interventions or components of an intervention
individually or as a treatment package in multiple assessments. A minimum of 2
strategies at each level (patient, provider, system) will be tested at each clinic
site. For example, a patient-level strategy might include text messaging to
patients, which is enabled by the DRVS platform. We might test whether single or
multiple text messages around a patient's birthday can prompt screening uptake, or
if messages prior to a health care visit increases uptake of screening offered. An
example at the provider-level might include the impact of a motivational training if
staff identify difficulty motivating patients as a barrier. A systems-level strategy
might include incorporating CRC screening into the workflows of the health center
using the medical assistants, if provider time limitations are identified as a
barrier.
- Post-Implementation Survey: When implementation testing ends, our team will send out
a survey to any CHC staff member (administrative leader and population health
managers, data analysts and quality improvement staff, as well as nurse/practice
manager, medical assistant, and provider [MD, NP, and/or PA]) involved with the
implementation of strategies at the health center level, and the survey information
we will collect will assess perceptions on feasibility, appropriateness, and
acceptability of the implementation strategy used.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Staff members at partnering sites (see locations) who are administrative leaders,
population health managers, data analysts, quality improvement staff, nurses, nurse
managers, practice managers, medical assistants, and providers.
- Staff members at partnering sites ages 18+.
Exclusion Criteria:
- Staff members that are not involved in CRC screening practices at CHCs.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Codman Square Health Center
Address:
City:
Boston
Zip:
02124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephen Tringale, MD
Facility:
Name:
Brockton Neighborhood Health Center
Address:
City:
Brockton
Zip:
02301
Country:
United States
Status:
Recruiting
Contact:
Last name:
Madhur Kuckreja, MD
Facility:
Name:
East Boston Neighborhood Health Center
Address:
City:
East Boston
Zip:
02128
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heidi Emerson, PhD
Facility:
Name:
Duffy Health Center
Address:
City:
Hyannis
Zip:
02601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Jones, MD
Start date:
March 24, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524428
