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Trial Title:
Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings
NCT ID:
NCT05785780
Condition:
Colorectal Cancer Screening
Diabetes Mellitus, Type 2
Conditions: Official terms:
Colorectal Neoplasms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The study uses a pilot, pre-post, hybrid effectiveness-implementation design to compare
the adapted implementation strategy to usual care on: (1) effectiveness and (2)
implementation outcomes.
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Targeted CRC Screening Toolkit
Description:
Strategies in the toolkit include but are not limited to: identification of patient and
practice-level barriers, routine tailored patient reminders, provider reminders, & clinic
staff feedback.
Arm group label:
Targeted CRC Screening Toolkit
Summary:
This mixed methods study evaluates the effectiveness and feasibility of a multi-level
(patient, team, organizations) intervention to optimize CRC screening for patients with
diabetes in primary care safety-net settings.
Detailed description:
Aim 3 is a hybrid type 2 effectiveness-implementation pilot study in six primary care
safety net clinics. This single-arm study uses a pre-post design to evaluate the targeted
implementation strategies impact on: (1) preliminary effectiveness and (2) implementation
(i.e., feasibility and acceptability) and a mixed-method comparative case study learning
evaluation for safety-net primary care adoption and implementation. Implementation
strategies that will be tested were developed through a stakeholder engaged,
community-based participatory implementation planning approach. This study uses a
tailored combination of implementation strategies that include but are not limited to:
identification of patient and practice-level barriers, patient education matierals,
patient reminders provider/clinical team education, clinical champions, and audit and
feedback. The impact of this evaluation will be measure using mixed methods to assess
Exploration, Preparation, Implementation factors related to how organizational and
contextual variables affect adoption and implementation for targeting CRC screening among
patients with diabetes in safety net clinics at 12 months post intervention. Aim 3
surveys 20 clinicians and staff from 6 clinics (n=120) and conducts key-informant
interviews with 8 clinic and staff members at pre- and post-implementation (who have
participated in the survey; n=96) and evaluates aggregate data for 30 patients across six
clinics (n=180).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of diabetes mellitus;
- Participants not up-to-date with CRC screening based on electronic health record
(e.g. FOBT/FIT in last year; flexible sigmoidoscopy within four years; or
colonoscopy within nine years);
- Age-eligible for CRC screening (50-74 years of age);
- Participants in process of undergoing screening are eligible for participation if
they have a FIT/FOBT incomplete test ordered for more than six months or a
sigmoidoscopy or colonoscopy referral not completed for greater than one year.
Exclusion Criteria:
• Medical conditions not concordant with standard CRC screening intervals (e.g. prior CRC
diagnosis, inflammatory bowel disease, renal failure, etc.).
Gender:
All
Minimum age:
50 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
RWJBarnabas Health - Robert Wood Johnson University Hospital
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Denalee O'Malley, PhD
Email:
omalledm@rwjms.rutgers.edu
Contact backup:
Last name:
Cigil Abraham
Email:
cma182@rwjms.rutgers.edu
Start date:
November 1, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Rutgers, The State University of New Jersey
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Rutgers, The State University of New Jersey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785780
