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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Colorectal Cancer Screening, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Targeted CRC Screening Toolkit


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted CRC Screening Toolkit<br>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. | Behavioral: Targeted CRC Screening Toolkit<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonoscopy uptake | Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy | 12 months | 
| Up-to-date CRC screening | Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |