Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening
2 other identifiers
interventional
26
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Oct 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2022
CompletedResults Posted
Study results publicly available
August 1, 2023
CompletedAugust 1, 2023
July 1, 2023
1.3 years
September 30, 2020
April 4, 2023
July 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Number of FIT Kits Mailed
4 months post-implementation, 8 months post-implementation
Number of Reminders Per FIT Mailing
4 months post-implementation, 8 months post-implementation
Number of Reminders Per FIT Return
4 months post-implementation, 8 months post-implementation
Study Arms (2)
Paired Screening Intervention
EXPERIMENTALUsual Care Control
NO INTERVENTIONIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Staff from community health centers who facilitate screening
- Age 18 and older
You may not qualify if:
- Have not participated in the implementation of the paired screening intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard School of Public Health (HSPH)lead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (4)
Harbor Health Services
Boston, Massachusetts, 02122, United States
Brockton Neighborhood Health Center
Brockton, Massachusetts, 02301, United States
Lowell Community Health Center
Lowell, Massachusetts, 01854, United States
Manet Community Health Center
Quincy, Massachusetts, 02171, United States
Related Publications (2)
Kruse GR, Percac-Lima S, Barber-Dubois M, Davies ME, Gundersen DA, Ho O, Mascioli L, Munshi M, Perry S, Singh D, Thomas A, Emmons KM, Haas JS. Bundling Colorectal Cancer Screening Outreach with Screening for Social Risk in Federally Qualified Health Centers: A Stepped-Wedge Implementation-Effectiveness Study. J Gen Intern Med. 2024 May;39(7):1188-1195. doi: 10.1007/s11606-024-08654-5. Epub 2024 Feb 8.
PMID: 38332440DERIVEDAschbrenner 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. 2024 Apr;25(Suppl 1):136-146. doi: 10.1007/s11121-022-01442-9. Epub 2022 Oct 4.
PMID: 36194312DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Daly
- Organization
- Harvard TH Chan School of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Emmons, PhD
Harvard TH Chan School of Public Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Social and Behavioral Sciences
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 14, 2020
Study Start
October 1, 2020
Primary Completion
January 25, 2022
Study Completion
January 25, 2022
Last Updated
August 1, 2023
Results First Posted
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication, and for 3 years.
- 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.
Individual participant data that underlie the results reported here, after deidentification (text, tables, figures, and appendices). Upon request and appropriate approvals.