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Clinical Trials/NCT05785780
NCT05785780
Recruiting
Not Applicable

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

Rutgers, The State University of New Jersey1 site in 1 country30 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer Screening
Sponsor
Rutgers, The State University of New Jersey
Enrollment
30
Locations
1
Primary Endpoint
Up-to-date CRC screening
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
September 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Denalee O'Malley

Assistant Professor

Rutgers, The State University of New Jersey

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.).

Outcomes

Primary Outcomes

Up-to-date CRC screening

Time Frame: 12 months

Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening

Colonoscopy uptake

Time Frame: 12 months

Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy

Secondary Outcomes

  • Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes(12 months)

Study Sites (1)

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