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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: Targeted CRC Screening Toolkit

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denalee O'Malley, PhD; Phone Number: 848-319-0004; Email: omalledm@rwjms.rutgers.edu
• Study Contact Backup: Name: Cilgy Abraham; Phone Number: 732-235-5965; Email: cma182@rwjms.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • RWJBarnabas Health - Robert Wood Johnson University Hospital
      • Contact: Denalee O'Malley, PhD; Email: omalledm@rwjms.rutgers.edu
      • Contact: Cigil Abraham; Email: cma182@rwjms.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Targeted CRC Screening Toolkit; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonoscopy uptake	Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy	12 months
Up-to-date CRC screening	Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Acceptability	Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants	12 months
Implementation Fidelity	Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets	12 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Denalee O'Malley, PhD, Rutgers Robert Wood Johnson Medical School; Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Colorectal Neoplasms
• Other Study ID Numbers: 002056; Pro2020002075 (Other Identifier: Rutgers, The State University of New Jersey); R00CA256043 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No