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

NCT ID: NCT05785780

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-09-30

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).

Conditions

Colorectal Cancer Screening; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Targeted CRC Screening Toolkit

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.

Group Type: EXPERIMENTAL

Targeted CRC Screening Toolkit

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Denalee O'Malley

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denalee O'Malley, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Robert Wood Johnson Medical School; Rutgers Cancer Institute of New Jersey

Locations

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Denalee O'Malley, PhD

Role: CONTACT

omalledm@rwjms.rutgers.edu

848-319-0004

Cilgy Abraham

Role: CONTACT

cma182@rwjms.rutgers.edu

732-235-5965

Facility Contacts

Denalee O'Malley, PhD

Role: primary

omalledm@rwjms.rutgers.edu

Cigil Abraham

Role: backup

cma182@rwjms.rutgers.edu

References

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.

Reference Type: DERIVED

PMID: 38969987 (View on PubMed)

Other Identifiers

Pro2020002075

Identifier Type: OTHER

Identifier Source: secondary_id

R00CA256043

Identifier Type: NIH

Identifier Source: secondary_id

View Link

002056

Identifier Type: -

Identifier Source: org_study_id