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NCT05785780 | RECRUITING | Colorectal Cancer Screening

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

Rutgers, The State University of New Jersey

Information provided by (Responsible Party):

Denalee O'Malley

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.

Condition or disease

Colorectal Cancer Screening

Diabetes Mellitus, Type 2

Intervention/treatment

Targeted CRC Screening Toolkit

Phase

NA

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
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Optimizing Colorectal Cancer Screening Among Patients With Diabetes in Safety-Net Primary Care Settings: Targeting Implementation Approaches
Actual Study Start Date : 2022-11-01
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 74 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.).
Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings

Location Details

NCT05785780

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08903