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Enrolling by Invitation

NCT Number: NCT05785780

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

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.

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Targeted CRC Screening Toolkit

Behavioral

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.

Primary outcomes

  1. Colonoscopy uptake

    Time frame: 12 months

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

  2. Up-to-date CRC screening

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

    Preliminary Effectiveness: Clinic-level CRC screening by glucose control (controlled vs. uncontrolled)

Other outcomes

  1. Participant Acceptability

    Time frame: 12 months

    Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants

  2. Implementation Fidelity

    Time frame: 12 months

    Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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