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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05785780
Other study ID # 002056
Secondary ID Pro2020002075R00
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date September 30, 2025

Study information

Verified date October 2023
Source Rutgers, The State University of New Jersey
Contact Denalee O'Malley, PhD
Phone 848-319-0004
Email omalledm@rwjms.rutgers.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 74 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States RWJBarnabas Health - Robert Wood Johnson University Hospital New Brunswick New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Participant Acceptability Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants 12 months
Other Implementation Fidelity Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets 12 months
Primary Colonoscopy uptake Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy 12 months
Primary Up-to-date CRC screening Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening 12 months
Secondary 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
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