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

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2; Colorectal Cancer Screening

Treatments: Behavioral: Targeted CRC Screening Toolkit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05785780

Pro2020002075 (Other Identifier)

002056

R00CA256043 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Targeted CRC Screening Toolkit

Experimental group

Description:

Based on national survey data and a community engagement participatory implemention planning group, a tailored combination of widely accepted implementation strategies will be adapted for targeting CRC screening for patients with diabetes. These strategies include but are not limited to: identification of patient and practice-level barriers, patient education, provider reminders, and audit and feedback.

Treatment:

Behavioral: Targeted CRC Screening Toolkit