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

Primary Purpose

Colorectal Cancer Screening, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted CRC Screening Toolkit
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer Screening

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.).

Sites / Locations

  • RWJBarnabas Health - Robert Wood Johnson University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Targeted CRC Screening Toolkit

Arm Description

Based on national survey data and a community engagement participatory implemention planning group, a tailored combination of widely accepted implementation strategies will be adapted for targeting CRC screening for patients with diabetes. These strategies include but are not limited to: identification of patient and practice-level barriers, patient education, provider reminders, and audit and feedback.

Outcomes

Primary Outcome Measures

Colonoscopy uptake
Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy
Up-to-date CRC screening
Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening

Secondary Outcome Measures

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)

Full Information

First Posted
March 14, 2023
Last Updated
October 19, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05785780
Brief Title
Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings
Official Title
Optimizing Colorectal Cancer Screening Among Patients With Diabetes in Safety-Net Primary Care Settings: Targeting Implementation Approaches
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted CRC Screening Toolkit
Arm Type
Experimental
Arm Description
Based on national survey data and a community engagement participatory implemention planning group, a tailored combination of widely accepted implementation strategies will be adapted for targeting CRC screening for patients with diabetes. These strategies include but are not limited to: identification of patient and practice-level barriers, patient education, provider reminders, and audit and feedback.
Intervention Type
Behavioral
Intervention Name(s)
Targeted CRC Screening Toolkit
Intervention Description
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 Outcome Measure Information:
Title
Colonoscopy uptake
Description
Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy
Time Frame
12 months
Title
Up-to-date CRC screening
Description
Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes
Description
Preliminary Effectiveness: Clinic-level CRC screening by glucose control (controlled vs. uncontrolled)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Participant Acceptability
Description
Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants
Time Frame
12 months
Title
Implementation Fidelity
Description
Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denalee O'Malley, PhD
Phone
848-319-0004
Email
omalledm@rwjms.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cilgy Abraham
Phone
732-235-5965
Email
cma182@rwjms.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denalee O'Malley, PhD
Organizational Affiliation
Rutgers Robert Wood Johnson Medical School; Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
RWJBarnabas Health - Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denalee O'Malley, PhD
Email
omalledm@rwjms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Cigil Abraham
Email
cma182@rwjms.rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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