Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Targeted CRC Screening Toolkit.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Screening, Diabetes Mellitus, Type 2. Basic parameters: 50 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Colorectal Cancer Screening Among Patients With Diabetes in Safety-Net Primary Care Settings: Targeting Implementation Approaches
Overview
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
- 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.
Primary outcome measures
- Colonoscopy uptake [Time frame: 12 months]
- Up-to-date CRC screening [Time frame: 12 months]
Secondary outcome measures (1)
- Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes [Time frame: 12 months]
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- RWJBarnabas Health - Robert Wood Johnson University Hospital — New Brunswick
Publications
- O'Malley DM, Crabtree BF, Kaloth S, Ohman-Strickland P, Ferrante J, Hudson SV, Kinney AY. Strategic use of resources to enhance colorectal cancer screening for patients with diabetes (SURE: CRC4D) in federally qualified health centers: a protocol for hybrid type ii effectiveness-implementation trial. BMC Prim Care. 2024 Jul 5;25(1):242. doi: 10.1186/s12875-024-02496-0. PMID 38969987
Identifiers
NCT: NCT05785780 · 002056 · Pro2020002075 · R00CA256043