Colorectal CancerNCT04585919
Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening
A study testing Paired Screening Intervention in people with Colorectal Cancer and Social Determinants of Health, run by Harvard School of Public Health (HSPH) at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Social Determinants of Health
- What is being tested?
- Paired Screening Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2020to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Staff from community health centers who facilitate screening
- Age 18 and older
Who cannot join
- Have not participated in the implementation of the paired screening intervention
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Harbor Health Services
Boston, Massachusetts, 02122
Brockton Neighborhood Health Center
Brockton, Massachusetts, 02301
Lowell Community Health Center
Lowell, Massachusetts, 01854
Manet Community Health Center
Quincy, Massachusetts, 02171
About this study
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.
- Conditions
- Colorectal Cancer, Social Determinants of Health
- Being tested
- Paired Screening Intervention
- Keywords
- implementation science, colorectal cancer screening, social determinants of health screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paired Screening InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Paired Screening Intervention | Experimental | Not described Receives: Behavioral: Paired Screening Intervention |
| Usual Care Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 13 pre implementation months, 14 post-implementation months
Secondary outcomes (3)
Number of FIT Kits Mailed
Adoption measured by number of FIT kits mailed to patients. Data were summed to calculate a single value.
Measured: 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.
Measured: 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.
Measured: 4 months post-implementation, 8 months post-implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Oct 2020
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Karen Emmons, Harvard School of Public Health (HSPH)
- Investigators
- Karen Emmons, PhD, Principal investigator, Harvard TH Chan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585919
- Sponsor's protocol ID
- 67702115
- Other IDs
- P50CA244433
- Status last verified
- Jul 2023
- First submitted
- 30 Sep 2020
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported here, after deidentification (text, tables, figures, and appendices). Upon request and appropriate approvals.
Publications
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.
PubMed 38332440Aschbrenner 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.
PubMed 36194312
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Promotion of Colorectal Cancer and Social Determinants of Health Screening
- ClinicalTrials.gov ID
- NCT04585919
- Acronym / sponsor ID
- 67702115
- Conditions
- Colorectal Cancer, Social Determinants of Health
- Keywords
- implementation science, colorectal cancer screening, social determinants of health screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Paired Screening Intervention | Experimental | Behavioral: Paired Screening Intervention |
| Usual Care Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Staff from community health centers who facilitate screening
- Age 18 and older
Key exclusion criteria (1 listed)
- Have not participated in the implementation of the paired screening intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paired Screening InterventionThe 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. | Behavioural | Paired Screening Intervention |
Primary outcome
Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care
Time frame: 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.
Conditional Odds Ratio of Patients Screened for Social Needs During Intervention Compared to Patients Screened During Usual Care
Time frame: 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.
3 secondary outcomes
Number of FIT Kits Mailed
Time frame: 4 months post-implementation, 8 months post-implementation
Number of Reminders Per FIT Mailing
Time frame: 4 months post-implementation, 8 months post-implementation
Number of Reminders Per FIT Return
Time frame: 4 months post-implementation, 8 months post-implementation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38332440Kruse 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.
- Derived from this study: PubMed 36194312Aschbrenner 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported here, after deidentification (text, tables, figures, and appendices). Upon request and appropriate approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Emmons, PhD principal investigator
Harvard TH Chan School of Public Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paired Screening Intervention in people with Colorectal Cancer and Social Determinants of Health, run by Harvard School of Public Health (HSPH) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditional Odds Ratio of Patients Screened for Colorectal Cancer During Intervention Compared to Patients Screened During Usual Care (time frame: 13 pre implementation months, 14 post-implementation months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.