Colorectal Cancer ScreeningNCT04683744

Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation

An observational study of Colorectal Cancer Screening, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer Screening
What is being tested?: Semi-structured interviews-Patients and Semi-structured interviews-Health system
How many people: 82 participants
Where: 1 siteUnited States
Study dates: 11 Jan 2021to 31 Jul 2023
Phase: Observational
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
No healthy volunteers
Adult, Older adult

Study population: The participants will be health system primary care patients, and health system leadership, providers, or staff involved in primary care.

Who may be able to join

Health system participants will be eligible if:
they are employed by one of the study team's partner healthcare systems.
Patient participants will be eligible if:
they have had a primary care visit during the past 24 months
they have completed cancer screening during the past 5 years prior to 2020 for breast, cervical or lung cancer as noted in the electronic health record (EHR)
age 50 years or older
speaks English
accessible by phone.

Who cannot join

Patients will be excluded if:
they did not complete any cancer screening for breast, colon, cervical, or lung cancer during the past 5 years prior to 2020
did not complete a primary care visit at a partner healthcare system during the past 2 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University
Indianapolis, Indiana, 462020

Other trials in United States

About this study

The rate of screening for colorectal cancer (CRC) in the U.S. remains low (under 65%), meaning that thousands of people die of colorectal cancer unnecessarily. Colorectal cancer screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). Screening rates go up when patients consider all these tests, not just colonoscopy. Informing patients about their options for CRC screening could produce higher quality decisions, improve the match between patient preferences and tests performed, and increase uptake of CRC screening. Decision aids (DAs) are a promising tool for accomplishing this goal. Also, precision CRC prevention - providing information about an individual's specific risk for CRC - has great promise to increase uptake and improve decision making.

Unfortunately, the COVID-19 pandemic is causing severe challenges to providing CRC screening and other prevention services. Health systems are trying to adapt, but these efforts have only begun and are poorly understood. Moreover, patient perceptions of disease risk and risk from COVID-19 are unknown.

Read the detailed description

The study team will engage with the leadership, staff, and providers in the study team's partner healthcare systems, to identify facilitators and barriers to implementing patient decision aids and provider notifications as well as cancer risk assessment tools, for colorectal cancer screening, and for other evidence-based cancer screening during the COVID pandemic and, potentially, after the conclusion of the pandemic.

At the conclusion of the study, the investigators will have extensive information regarding how best to provide decision aids through an electronic health record (EHR) portal, with or without personalized information, and to deliver provider notifications, which can guide broader implementation.

The study will involve interviews with staff and providers at the study team's partner healthcare systems to identify facilitators and barriers to implementing decision aids and provider notifications for colorectal cancer screening.

Also, the investigators will interview patients to identify perceptions of prevention during the COVID-19 pandemic including risk perception and barriers to screening, perceptions of risk from both the pandemic and disease, and patient cancer screening and risk prevention behaviors engaged in or postponed during the pandemic and patient rationales for their decisions. This part of the study will suggest potentially promising approaches for providing prevention and disease management during the COVID-19 pandemic.

Conditions: Colorectal Cancer Screening
Being tested: Semi-structured interviews-Patients, Semi-structured interviews-Health system
Keywords: decision aid, decision making, COVID-19, risk communication, colorectal neoplasm, electronic health records
Medical subject headings: COVID-19, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Semi-structured interviews-PatientsOther
The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
Semi-structured interviews-Health systemOther
The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.

Study groups in NCT04683744
Study group	Role	What they receive
Healthcare system leadership, providers, and staff		Leadership, providers, and staff at the study team's affiliated health systems. Receives: Other: Semi-structured interviews-Health system
Patients receiving primary care at the study team's affiliated health systems		Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems. Receives: Other: Semi-structured interviews-Patients

What is being measured

The primary outcome is the main question the study is designed to answer.

Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening.
Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening.
Measured: 2 years
Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff.
Semi-structured interviews with health system leadership, providers, and staff from the study team's affiliated health systems about their perceptions of the impact of COVID-19 on primary care and cancer screening.
Measured: 9 months
Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic.
Semi-structured interviews with primary care patients who were due for either breast, cervical, colorectal, or lung cancer screening between April-July 2020 at the study teams affiliate health systems. The interview guide contained questions to explore the patients' understanding, attitudes, and beliefs about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting preventive and other (non-screening) healthcare, and information needed for decision making.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 202131 Jul 2023

First posted24 Dec 2020
Study start11 Jan 2021
Primary completion3 May 2023
Study completion31 Jul 2023

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 (20)Papers the sponsor has linked to this study.
Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
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: Observational
Observational model: Other
Time perspective: Other
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04683744
Sponsor's protocol ID: 2012926551
Other IDs: CDR-2018C3-14715
Status last verified: Jan 2025
First submitted: 20 Dec 2020
Last updated: 31 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kaufman HW, Chen Z, Niles J, Fesko Y. Changes in the Number of US Patients With Newly Identified Cancer Before and During the Coronavirus Disease 2019 (COVID-19) Pandemic. JAMA Netw Open. 2020 Aug 3;3(8):e2017267. doi: 10.1001/jamanetworkopen.2020.17267.
PubMed 32749465
Castanon A, Rebolj M, Pesola F, Sasieni P. Recovery strategies following COVID-19 disruption to cervical cancer screening and their impact on excess diagnoses. Br J Cancer. 2021 Apr;124(8):1361-1365. doi: 10.1038/s41416-021-01275-3. Epub 2021 Feb 9.
PubMed 33558708
Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of Cancer Screening Deficit in the United States With the COVID-19 Pandemic. JAMA Oncol. 2021 Jun 1;7(6):878-884. doi: 10.1001/jamaoncol.2021.0884.
PubMed 33914015
Alkatout I, Biebl M, Momenimovahed Z, Giovannucci E, Hadavandsiri F, Salehiniya H, Allahqoli L. Has COVID-19 Affected Cancer Screening Programs? A Systematic Review. Front Oncol. 2021 May 17;11:675038. doi: 10.3389/fonc.2021.675038. eCollection 2021.
PubMed 34079764
Czeisler ME, Marynak K, Clarke KEN, Salah Z, Shakya I, Thierry JM, Ali N, McMillan H, Wiley JF, Weaver MD, Czeisler CA, Rajaratnam SMW, Howard ME. Delay or Avoidance of Medical Care Because of COVID-19-Related Concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020 Sep 11;69(36):1250-1257. doi: 10.15585/mmwr.mm6936a4.
PubMed 32915166
Findling MG, Blendon RJ, Benson JM. Delayed Care with Harmful Health Consequences-Reported Experiences from National Surveys During Coronavirus Disease 2019. JAMA Health Forum. 2020 Dec 1;1(12):e201463. doi: 10.1001/jamahealthforum.2020.1463. No abstract available.
PubMed 36218479
Park S, Stimpson JP. Trends in Self-reported Forgone Medical Care Among Medicare Beneficiaries During the COVID-19 Pandemic. JAMA Health Forum. 2021 Dec 30;2(12):e214299. doi: 10.1001/jamahealthforum.2021.4299. eCollection 2021 Dec.
PubMed 35977302
Lieneck C, Herzog B, Krips R. Analysis of Facilitators and Barriers to the Delivery of Routine Care during the COVID-19 Global Pandemic: A Systematic Review. Healthcare (Basel). 2021 May 1;9(5):528. doi: 10.3390/healthcare9050528.
PubMed 34062813
Aitken M, Kleinrock M. Shifts in Healthcare Demand, Delivery and Care During the COVID-19 Era. Published online 2020. https://www.iqvia.com/insights/the-iqvia-institute/covid-19/shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era
Powell RE, Henstenburg JM, Cooper G, Hollander JE, Rising KL. Patient Perceptions of Telehealth Primary Care Video Visits. Ann Fam Med. 2017 May;15(3):225-229. doi: 10.1370/afm.2095.
PubMed 28483887
Price ST, Mainous AG, Rooks BJ. Survey of cancer screening practices and telehealth services among primary care physicians during the COVID-19 pandemic. Prev Med Rep. 2022 Mar 17;27:101769. doi: 10.1016/j.pmedr.2022.101769. eCollection 2022 Jun.
PubMed 35313453
Basu P, Alhomoud S, Taghavi K, Carvalho AL, Lucas E, Baussano I. Cancer Screening in the Coronavirus Pandemic Era: Adjusting to a New Situation. JCO Glob Oncol. 2021 Mar;7:416-424. doi: 10.1200/GO.21.00033.
PubMed 33784177
Cancino RS, Su Z, Mesa R, Tomlinson GE, Wang J. The Impact of COVID-19 on Cancer Screening: Challenges and Opportunities. JMIR Cancer. 2020 Oct 29;6(2):e21697. doi: 10.2196/21697.
PubMed 33027039
Horn DM, Haas JS. Expanded Lung and Colorectal Cancer Screening - Ensuring Equity and Safety under New Guidelines. N Engl J Med. 2022 Jan 13;386(2):100-102. doi: 10.1056/NEJMp2113332. Epub 2022 Jan 8. No abstract available.
PubMed 34995027
Gorin SNS, Jimbo M, Heizelman R, Harmes KM, Harper DM. The future of cancer screening after COVID-19 may be at home. Cancer. 2021 Feb 15;127(4):498-503. doi: 10.1002/cncr.33274. Epub 2020 Nov 10.
PubMed 33170520

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
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Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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Brain Cancer, Breast Cancer

All Colorectal Cancer Screening trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation
ClinicalTrials.gov ID: NCT04683744
Acronym / sponsor ID: 2012926551
Conditions: Colorectal Cancer Screening
Keywords: decision aid, decision making, COVID-19, risk communication, colorectal neoplasm, electronic health records
Study type: Observational
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 11 Jan 2021 (actual)
Primary completion: 3 May 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 24 Dec 2020 (actual)
Results: Posted 31 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
Healthcare system leadership, providers, and staff	–	Other: Semi-structured interviews-Health systemLeadership, providers, and staff at the study team's affiliated health systems.
Patients receiving primary care at the study team's affiliated health systems	–	Other: Semi-structured interviews-PatientsPatients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The participants will be health system primary care patients, and health system leadership, providers, or staff involved in primary care.

Key inclusion criteria (8 listed)

they are employed by one of the study team's partner healthcare systems.
they have had a primary care visit during the past 24 months
they have completed cancer screening during the past 5 years prior to 2020 for breast, cervical or lung cancer as noted in the electronic health record (EHR)
age 50 years or older
speaks English

Key exclusion criteria (3 listed)

they did not complete any cancer screening for breast, colon, cervical, or lung cancer during the past 5 years prior to 2020
did not complete a primary care visit at a partner healthcare system during the past 2 years.

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
Semi-structured interviews-PatientsThe interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.	Other	Patients receiving primary care at the study team's affiliated health systems
Semi-structured interviews-Health systemThe interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.	Other	Healthcare system leadership, providers, and staff

Primary outcome

Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening.
Time frame: 2 years
Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening.
Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff.
Time frame: 9 months
Semi-structured interviews with health system leadership, providers, and staff from the study team's affiliated health systems about their perceptions of the impact of COVID-19 on primary care and cancer screening.
Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic.
Time frame: 6 months
Semi-structured interviews with primary care patients who were due for either breast, cervical, colorectal, or lung cancer screening between April-July 2020 at the study teams affiliate health systems. The interview guide contained questions to explore the patients' understanding, attitudes, and beliefs about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting preventive and other (non-screening) healthcare, and information needed for decision making.

Results and safety

Results posted to the registry on 31 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthcare System Leadership, Providers, and Staff	20	20
Not Screened Patients	29	29
Screened Patients	33	32

Primary outcome: Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening.

Time frame: 2 years. Number. Unit: Themes

Measure	Healthcare System Leadership, Providers, and Staff n = 20
Themes: Barriers identified	8
Themes: Facilitators identified	6

Population analysed: The initial sample of 8 interviewees identified 12 additional stakeholders, allowing us to "snowball" our sample to complete interviews with 20 participants including primary care providers, nurses, medical assistants, quality and clinic managers, and cancer screening program managers.

Primary outcome: Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff.

Time frame: 9 months. Number. Unit: Themes

Measure	Healthcare System Leadership, Providers, and Staff n = 20
Value	5

Population analysed: 20 leaders, managers, and providers were interviewed in January-July 2021, and 11 were re-interviewed in January-March 2022. We identified five emergent, overarching themes of the impact of COVID-19 pandemic on cancer screening and preventive care services across two healthcare organizations and across the time frame of the COVID-19 pandemic (2020-2022).

Primary outcome: Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic.

Time frame: 6 months. Number. Unit: Themes

Measure	Not Screened Patients n = 29	Screened Patients n = 32
Cancer Screening	3	3
Other Healthcare Services (non-screening)	4	4
Health Information	3	3

Population analysed: We interviewed 32 patients who completed screening in 2020 and 29 patients who did not complete the relevant screening test from April 2020 to the date of the interview.

Adverse events

Time frame: Adverse events were monitored during the interviews. The time frame for patient participants was a one-time phone interview that lasted about 30 minutes. The interviews for health system participants lasted about 30-60 minutes.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthcare System Leadership, Providers, and Staff	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Not Screened Patients	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Screened Patients	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Limitations and caveats (from the sponsor): We involved just two healthcare systems in one Midwestern city. Our sample of interviewed leaders, providers, and staff may not have been representative of the entire organizations. Our method for identifying patients to interview did not include all patients at these health systems who were due for screening early in the pandemic, so we may have failed to include important perspectives or experiences.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32749465Kaufman HW, Chen Z, Niles J, Fesko Y. Changes in the Number of US Patients With Newly Identified Cancer Before and During the Coronavirus Disease 2019 (COVID-19) Pandemic. JAMA Netw Open. 2020 Aug 3;3(8):e2017267. doi: 10.1001/jamanetworkopen.2020.17267.
Background: PubMed 33558708Castanon A, Rebolj M, Pesola F, Sasieni P. Recovery strategies following COVID-19 disruption to cervical cancer screening and their impact on excess diagnoses. Br J Cancer. 2021 Apr;124(8):1361-1365. doi: 10.1038/s41416-021-01275-3. Epub 2021 Feb 9.
Background: PubMed 33914015Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of Cancer Screening Deficit in the United States With the COVID-19 Pandemic. JAMA Oncol. 2021 Jun 1;7(6):878-884. doi: 10.1001/jamaoncol.2021.0884.
Background: PubMed 34079764Alkatout I, Biebl M, Momenimovahed Z, Giovannucci E, Hadavandsiri F, Salehiniya H, Allahqoli L. Has COVID-19 Affected Cancer Screening Programs? A Systematic Review. Front Oncol. 2021 May 17;11:675038. doi: 10.3389/fonc.2021.675038. eCollection 2021.
Background: PubMed 32915166Czeisler ME, Marynak K, Clarke KEN, Salah Z, Shakya I, Thierry JM, Ali N, McMillan H, Wiley JF, Weaver MD, Czeisler CA, Rajaratnam SMW, Howard ME. Delay or Avoidance of Medical Care Because of COVID-19-Related Concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020 Sep 11;69(36):1250-1257. doi: 10.15585/mmwr.mm6936a4.
Background: PubMed 36218479Findling MG, Blendon RJ, Benson JM. Delayed Care with Harmful Health Consequences-Reported Experiences from National Surveys During Coronavirus Disease 2019. JAMA Health Forum. 2020 Dec 1;1(12):e201463. doi: 10.1001/jamahealthforum.2020.1463. No abstract available.
Background: PubMed 35977302Park S, Stimpson JP. Trends in Self-reported Forgone Medical Care Among Medicare Beneficiaries During the COVID-19 Pandemic. JAMA Health Forum. 2021 Dec 30;2(12):e214299. doi: 10.1001/jamahealthforum.2021.4299. eCollection 2021 Dec.
Background: PubMed 34062813Lieneck C, Herzog B, Krips R. Analysis of Facilitators and Barriers to the Delivery of Routine Care during the COVID-19 Global Pandemic: A Systematic Review. Healthcare (Basel). 2021 May 1;9(5):528. doi: 10.3390/healthcare9050528.
BackgroundAitken M, Kleinrock M. Shifts in Healthcare Demand, Delivery and Care During the COVID-19 Era. Published online 2020. https://www.iqvia.com/insights/the-iqvia-institute/covid-19/shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era
Background: PubMed 28483887Powell RE, Henstenburg JM, Cooper G, Hollander JE, Rising KL. Patient Perceptions of Telehealth Primary Care Video Visits. Ann Fam Med. 2017 May;15(3):225-229. doi: 10.1370/afm.2095.
Background: PubMed 35313453Price ST, Mainous AG, Rooks BJ. Survey of cancer screening practices and telehealth services among primary care physicians during the COVID-19 pandemic. Prev Med Rep. 2022 Mar 17;27:101769. doi: 10.1016/j.pmedr.2022.101769. eCollection 2022 Jun.
Background: PubMed 33784177Basu P, Alhomoud S, Taghavi K, Carvalho AL, Lucas E, Baussano I. Cancer Screening in the Coronavirus Pandemic Era: Adjusting to a New Situation. JCO Glob Oncol. 2021 Mar;7:416-424. doi: 10.1200/GO.21.00033.
Epic Health Research Network. Preventive Cancer Screenings during COVID-19 Pandemic.Link provided by the sponsor.
Centers for Medicare and Medicaid Centers for Medicare and Medicaid Services (CMS). Medicare telemedicine snapshot: Medicare claims and encounter data: March 1, 2020 to February 28, 2021. Received by September 9, 2021.Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Peter Schwartz, MD, PhD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer Screening, run by Indiana University at 1 site 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 8 inclusion and 3 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 31 Jan 2025). 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?

Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening. (time frame: 2 years). The study lists 3 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 NCT04683744, which also lists 20 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 31 Jan 2025.