RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
NCT Number: NCT05785780
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.
Interested in participating?
Request Info50 year–74 year
All sexes
Interventional
Not applicable
New Brunswick, New Jersey, 08903, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 months
Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy
Time frame: 12 months
Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening
Time frame: 12 months
Preliminary Effectiveness: Clinic-level CRC screening by glucose control (controlled vs. uncontrolled)
Time frame: 12 months
Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants
Time frame: 12 months
Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets
Rutgers, The State University of New Jersey
Other
Optimizing Colorectal Cancer Screening Among Patients With Diabetes in Safety-Net Primary Care Settings: Targeting Implementation Approaches
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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