[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05785780":3,"trial-entities:NCT05785780":83,"trial-summary:NCT05785780":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":58,"locations":61,"central_contacts":71,"overall_officials":72,"references":77,"see_also_links":82},"NCT05785780","002056","Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings","Optimizing Colorectal Cancer Screening Among Patients With Diabetes in Safety-Net Primary Care Settings: Targeting Implementation Approaches","ENROLLING_BY_INVITATION","2026-08-31","2026-07","2026-07-10","2022-11-01","Rutgers, The State University of New Jersey","OTHER",true,"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.","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\u002Fclinical 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).",[19,20],"Colorectal Cancer Screening","Diabetes Mellitus, Type 2",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[25],"NA",{"count":27,"type":28},30,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"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.",[32],[36,40],{"measure":37,"description":38,"timeFrame":39},"Colonoscopy uptake","Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy","12 months",{"measure":41,"description":42,"timeFrame":39},"Up-to-date CRC screening","Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening",[44],{"measure":45,"description":46,"timeFrame":39},"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)","ALL","50 Years","74 Years",{"inclusion":51,"exclusion":56,"raw_text":57},[52,53,54,55],"Diagnosis of diabetes mellitus;","Participants not up-to-date with CRC screening based on electronic health record (e.g. FOBT\u002FFIT 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\u002FFOBT incomplete test ordered for more than six months or a sigmoidoscopy or colonoscopy referral not completed for greater than one year.",[],"Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus;\n* Participants not up-to-date with CRC screening based on electronic health record (e.g. FOBT\u002FFIT in last year; flexible sigmoidoscopy within four years; or colonoscopy within nine years);\n* Age-eligible for CRC screening (50-74 years of age);\n* Participants in process of undergoing screening are eligible for participation if they have a FIT\u002FFOBT incomplete test ordered for more than six months or a sigmoidoscopy or colonoscopy referral not completed for greater than one year.\n\nExclusion Criteria:\n\n• Medical conditions not concordant with standard CRC screening intervals (e.g. prior CRC diagnosis, inflammatory bowel disease, renal failure, etc.).",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"geoPoint":68},"RWJBarnabas Health - Robert Wood Johnson University Hospital","New Brunswick","New Jersey","08903","United States",{"lat":69,"lon":70},40.48622,-74.45182,[],[73],{"name":74,"affiliation":75,"role":76},"Denalee O'Malley, PhD","Rutgers Robert Wood Johnson Medical School; Rutgers Cancer Institute of New Jersey","PRINCIPAL_INVESTIGATOR",[78],{"pmid":79,"type":80,"citation":81},"38969987","DERIVED","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\u002Fs12875-024-02496-0.",[],{"nct_id":4,"conditions":84,"biomarkers":87},[85,86],"Colorectal Carcinoma","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":89,"summary":90,"prompt_version":90},false,null]