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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05785780
Enrollment
30
Registered
2023-03-27
Start date
2022-11-01
Completion date
2026-09-30
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening, Diabetes Mellitus, Type 2

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).

Interventions

BEHAVIORALTargeted 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.

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The study uses a pilot, pre-post, hybrid effectiveness-implementation design to compare the adapted implementation strategy to usual care on: (1) effectiveness and (2) implementation outcomes.

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes

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.).

Design outcomes

Primary

MeasureTime frameDescription
Colonoscopy uptake12 monthsPreliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy
Up-to-date CRC screening12 monthsPreliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening

Secondary

MeasureTime frameDescription
Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes12 monthsPreliminary Effectiveness: Clinic-level CRC screening by glucose control (controlled vs. uncontrolled)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDenalee O'Malley, PhD

Rutgers Robert Wood Johnson Medical School; Rutgers Cancer Institute of New Jersey

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026