Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)

Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)

This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Multi-level intervention to increase CRC screening

• Study Type: Interventional
• Enrollment (Estimated): 6240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark B Dignan, PhD; Phone Number: 859-323-4708; Email: mark.dignan@uky.edu
• Study Contact Backup: Name: Mark Cromo, BS; Phone Number: 859-257-3833; Email: mark.cromo@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • Markey Cancer Center
      • Contact: Mark Cromo, BS; Phone Number: 859-257-3833; Email: mark.cromo@uky.edu
      • Contact: Mark Dignan, Ph.D., MPH; Phone Number: 859-323-4708; Email: mbdign2@email.uky.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: Electra Paskett, PhD; Phone Number: 614-293-3917; Email: electra.paskett@osumc.edu
      • Contact: Jill Oliveri, DrPH; Phone Number: 614-293-8174; Email: jill.oliveri@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age 50-74
• all races, sexes and genders
• resident of the study area

Exclusion Criteria:

.no exclusions based on gender, race or ethnicity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-level Intervention; Receives the project intervention first	Behavioral: Multi-level intervention to increase CRC screening; Intervention for the community, providers, patients, clinics and systems
No Intervention: Delayed Multi-level Intervention; Offered the intervention later in the project

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC screening - clinic level	Change in clinic-level screening rate from baseline to the end of the 12-month active intervention period, assessed through clinic electronic health record data	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC screening - community level	Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys	12 months

Collaborators and Investigators

• Sponsor: University of Kentucky
• Collaborators: National Cancer Institute (NCI); Ohio State University
• Investigators: Principal Investigator: Mark B Dignan, PhD, University of Kentucky

Publications and helpful links

General Publications

• Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Katz ML, Reiter PL, Gray DM 2nd, Pennell ML, Young GS, Huang B, Fickle D, Cromo M, Rogers M, Gross D, Gibson A, Jellison J, Sarap MD, Bivens TA, McGuire TD, McAlearney AS, Huerta TR, Rahurkar S, Paskett ED, Dignan M. Development of a multilevel intervention to increase colorectal cancer screening in Appalachia. Implement Sci Commun. 2021 May 19;2(1):51. doi: 10.1186/s43058-021-00151-8.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2018C0166; UH3CA233282 (U.S. NIH Grant/Contract); 832127323 (Other Identifier: DUNS - The Ohio State University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium.

Dataset Items in the LDS are defined by the Common Data Elements.

There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers.

In addition, all data that underlie results in publications will be available per Notice of Award.

• IPD Sharing Time Frame: Baseline data available beginning 10/2020, follow-up data available 12/2023
• IPD Sharing Access Criteria: There are 2 classes of dataset requests: 1) public use and 2) special. Requestors submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use data set containing common data elements will be made available to external researchers by application. IMS responds to public use dataset application by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must first submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive review by NCI and Research Triangle Institute (RTI) before being forwarded to the SC for review and approval. Requestors report every 6 months on published articles or conference presentations to RTI. Requestors also are encouraged to make articles available through PubMed Central website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No