Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

This work is an implementation science study that examines different aspects of implementing a single intervention. The intervention consists of asking community health centers to implement an outreach strategy to screen patients for colorectal cancer and for social determinants of health in community health centers at the same contact point. These are both clinical targets that the CHCs feel that their patients need and want to offer at a higher rate. The intervention consists of outreach to patients in need of colorectal cancer screening (CRC) to offer fecal immunochemical test (FIT) screening and screening for social determinants of health (SDOH). In this implementation science study, the intervention is an evidence-based intervention being implemented in real-world clinical practice. The intervention is the outreach to offer FIT and SDOH, conducted by clinic staff. Both evidence-based screening activities-FIT and SDOH screening-are used in the practices included in the study but pairing them is intended to increase efficiency and patient-centeredness by addressing health related social needs that may impact patients' ability to engage in cancer screening. The study aims to test the effect of implementing the intervention on clinical and process outcomes. Clinical outcomes are CRC screening and SDOH screening. Analysis of process outcomes includes measuring what organizational factors influence implementation.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Social Determinants of Health
• Intervention / Treatment: Behavioral: Paired Screening Intervention

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02122
      • Harbor Health Services
    • Brockton, Massachusetts, United States, 02301
      • Brockton Neighborhood Health Center
    • Lowell, Massachusetts, United States, 01854
      • Lowell Community Health Center
    • Quincy, Massachusetts, United States, 02171
      • Manet Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Study participants include community health center staff participating in interviews about the implementation of the intervention. Up to four community health center staff members at each of the four community health centers will participate in key informant interviews twice per year. Patients will receive the paired screening intervention as part of their routine care and will not be individually recruited for the study because the intervention is being offered as part of routine care.

Staff Participants

Inclusion Criteria:

• Staff from community health centers who facilitate screening
• Age 18 and older

Exclusion Criteria:

• Have not participated in the implementation of the paired screening intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paired Screening Intervention	Behavioral: Paired Screening Intervention; The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
No Intervention: Usual Care Control; In this stepped wedge design, all sites have a period of being in usual care, and then providing the Paired Screening Intervention. Sites serve as their own controls in this design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care	Colorectal cancer screening completion by any guideline-based method. Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step.	13 pre implementation months, 14 post-implementation months
Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care	Completion of social needs screening (collected as part of routine clinical care). Adjusting for patient socio-demographics, comorbidities, number of healthcare visits, and secular trend. Documented screening in EHR for patients unscreened at the beginning of the step.	13 pre implementation months, 14 post-implementation months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of FIT Kits Mailed	Adoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value.	4 months post-implementation, 8 months post-implementation
Number of Reminders Per FIT Mailing	Adoption measured by number of reminders per FIT mailing to patients. Data were summed to calculate a single value.	4 months post-implementation, 8 months post-implementation
Number of Reminders Per FIT Return	Adoption measured by number of reminders per FIT returned. Data were summed to calculate a single value.	4 months post-implementation, 8 months post-implementation

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Karen Emmons, PhD, Harvard TH Chan School of Public Health

Publications and helpful links

General Publications

• Aschbrenner KA, Kruse G, Emmons KM, Singh D, Barber-Dubois ME, Miller AM, Thomas AN, Bartels SJ. Stakeholder and Equity Data-Driven Implementation: a Mixed Methods Pilot Feasibility Study. Prev Sci. 2022 Oct 4:1-11. doi: 10.1007/s11121-022-01442-9. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 11, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: implementation science; colorectal cancer screening; social determinants of health screening
• 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: 67702115; P50CA244433 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported here, after deidentification (text, tables, figures, and appendices). Upon request and appropriate approvals.
• IPD Sharing Time Frame: 6 months after publication, and for 3 years.
• IPD Sharing Access Criteria: Outside investigators will need an approved concept proposal to analyze study data and spend the requisite time with study staff to learn about the data elements needed to conduct the proposed analysis. With the assistance of our analytic team, s/he will draft a detailed analysis plan and present to the core group of co-investigators. The discussion at this meeting ensures adequate knowledge of the data, and the presenter gains much insight into how the analysis can be most useful and how it relates to previous analyses. Once the plan is approved by this group, it must also be approved by the CHCs that provide the de-identified data. Following approval by the appropriate IRBs and confirmation that it meets HIPAA requirements, s/he may sign a DUA to use a secure, de-identified dataset to complete only the approved analyses and write the manuscript(s) offsite. A formal data analysis plan application and DUA are still in development. Requests should be directed to jdaly@hsph.harvard.edu.

Drug and device information, study documents

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