Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Optimizing Colorectal Cancer Screening Among Patients With Diabetes in Safety-Net Primary Care Settings: Targeting Implementation Approaches

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785780
• Other study ID #: 002056
• Secondary ID: Pro2020002075R00
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Denalee O'Malley, PhD
• Phone: 848-319-0004
• Email: omalledm[@]rwjms.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Targeted CRC Screening Toolkit
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.

Locations

Country	Name	City	State
United States	RWJBarnabas Health - Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant Acceptability	Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants	12 months
Other	Implementation Fidelity	Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets	12 months
Primary	Colonoscopy uptake	Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy	12 months
Primary	Up-to-date CRC screening	Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening	12 months
Secondary	Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes	Preliminary Effectiveness: Clinic-level CRC screening by glucose control (controlled vs. uncontrolled)	12 months