NCT04585919

Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening

Completed NA Results posted Last updated 1 August 2023

What this trial tests

NA trial testing Paired Screening Intervention in Colorectal Cancer in 26 participants. Completed in 25 January 2022.

Timeline

1 October 2020

Primary endpoint
25 January 2022

25 January 2022

Quick facts

Lead sponsor	Harvard School of Public Health (HSPH)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	screening
Enrollment	26
Start date	1 October 2020
Primary completion	25 January 2022
Estimated completion	25 January 2022
Sites	4 locations across United States

Drugs / interventions tested

• Paired Screening Intervention

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Social Determinants of Health — all drugs for Social Determinants of Health →

Sponsor

Harvard School of Public Health (HSPH)

Who can join

18 and older, any sex, with Colorectal Cancer or Social Determinants of Health. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care Primary · 13 pre implementation months, 14 post-implementation months

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.

Group	Value	95% CI
Paired Screening Intervention	0.068
Usual Care Control	0.028

Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care Primary · 13 pre implementation months, 14 post-implementation months

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.

Group	Value	95% CI
Paired Screening Intervention	0.213
Usual Care Control	0.333

Number of FIT Kits Mailed Secondary · 4 months post-implementation, 8 months post-implementation

Adoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value.

Group	Value	95% CI
Paired Screening Intervention	4404

Number of Reminders Per FIT Mailing Secondary · 4 months post-implementation, 8 months post-implementation

Adoption measured by number of reminders per FIT mailing to patients. Data were summed to calculate a single value.

Group	Value	95% CI
Paired Screening Intervention	0.87

Number of Reminders Per FIT Return Secondary · 4 months post-implementation, 8 months post-implementation

Adoption measured by number of reminders per FIT returned. Data were summed to calculate a single value.

Group	Value	95% CI
Paired Screening Intervention	11.7

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stakeholder and Equity Data-Driven Implementation: a Mixed Methods Pilot Feasibility Study.
   Aschbrenner KA, Kruse G, Emmons KM, Singh D, et al · · 2024 · cited 10× · PMID 36194312 · DOI 10.1007/s11121-022-01442-9
2. Bundling Colorectal Cancer Screening Outreach with Screening for Social Risk in Federally Qualified Health Centers: A Stepped-Wedge Implementation-Effectiveness Study.
   Kruse GR, Percac-Lima S, Barber-Dubois M, Davies ME, et al · · 2024 · cited 5× · PMID 38332440 · DOI 10.1007/s11606-024-08654-5
3. Current Progress in Clinical Research in Secondary Prevention and Early Detection of Colorectal Cancer.
   Partyka O, Pajewska M, Czerw A, Deptała A, et al · · 2025 · cited 2× · PMID 39941735 · DOI 10.3390/cancers17030367