Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

NCT ID: NCT04585919

Last Updated: 2023-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-01-25

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Social Determinants of Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This trial uses a randomized stepped wedge study design. This pragmatic design involves a sequential, randomized roll-out of the intervention across the four participating clinical sites or "clusters" over 8 week intervals or "steps." The intervention is the paired outreach to patients in need of CRC screening to offer FIT screening and screening for SDOH. The participants who will be enrolled are CHC staff who will provide input on the implementation processes and outcomes.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Paired Screening Intervention

Group Type EXPERIMENTAL

Paired Screening Intervention

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Karen Emmons

Professor of Social and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Emmons, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard TH Chan School of Public Health

Locations

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Harbor Health Services

Boston, Massachusetts, United States

Site Status

Brockton Neighborhood Health Center

Brockton, Massachusetts, United States

Site Status

Lowell Community Health Center

Lowell, Massachusetts, United States

Site Status

Manet Community Health Center

Quincy, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38332440 (View on PubMed)

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. 2024 Apr;25(Suppl 1):136-146. doi: 10.1007/s11121-022-01442-9. Epub 2022 Oct 4.

Reference Type DERIVED
PMID: 36194312 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P50CA244433

Identifier Type: NIH

Identifier Source: secondary_id

View Link

67702115

Identifier Type: -

Identifier Source: org_study_id

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