Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia

NCT04427527 | Completed Results

• 3 other identifiers: 2018C0166UH3CA233282832127323
• Study Type: interventional
• Target: 29,772
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• CRC Screening - Clinic Level

  This is the Y1 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).

  Y1 Follow-up

• CRC Screening - Clinic Level

  This is the Y2 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).

  Y2 Follow-up

• CRC Screening - Clinic Level

  This is the baseline clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).

  Y0 Baseline

Secondary Outcomes (3)

• CRC Screening - Community (County) Level

  Y0 Baseline

• CRC Screening - Community Level

  Y2 Follow-up

• CRC Screening - Community Level

  Y1 Follow-up

Study Arms (2)

Multi-level Intervention

EXPERIMENTAL

Receives the project intervention first

Behavioral: Multi-level intervention to increase CRC screening

Delayed Multi-level Intervention

NO INTERVENTION

Offered the intervention later in the project

Interventions

Multi-level intervention to increase CRC screening BEHAVIORAL

Intervention for the community, providers, patients, clinics and systems

Multi-level Intervention

Eligibility Criteria

• Age: 50 Years - 74 Years
• Gender Eligibility Details: Self-report of gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Ohio State University: collaborator
• Mark Dignan, PhD: lead

Study Sites (2)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Paskett ED, Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Gray DM, Pennell ML, Huang B, Young GS, Fickle D, Cromo M, Katz ML, Reiter PL, Rogers M, Gross DA, Fairchild V, Xu W, Carman A, Walunis JM, McAlearney AS, Huerta TR, Rahurkar S, Biederman E, Dignan M. Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) in Appalachia: protocol for a group randomized, delayed intervention trial. Transl Behav Med. 2023 Sep 28;13(10):748-756. doi: 10.1093/tbm/ibad017.

  PMID: 37202831 DERIVED

• 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.

  PMID: 34011410 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

The original intention of this study was to calculate the clinic-level CRC screening rate before and after the MLI based on individual patient-level electronic health record data from participating clinics in each county (primary outcome). However, due to difficulties in retrieving patient-level electronic health record data from clinics, clinics were asked to provide aggregated self-reported annual CRC screening data that was ultimately used to calculate CRC screening rate.

Results Point of Contact

• Title: Mark Dignan, PhD, MPH
• Organization: University of Kentucky

mark.dignan@uky.edu

859-323-4708

Study Officials

• Mark B Dignan, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Primary care clinics randomized to usual care do not receive intervention materials or attention
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Primary care clinics randomized to intervention or usual care

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: August 19, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: September 4, 2026
• Results First Posted: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Baseline data available beginning 10/2020, follow-up data available 12/2023
• 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.

Locations

US (2)