Colon CancerCLOVERNCT04540081
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
A study testing Epic Healthy Planet Population Health Module in people with Colon Cancer and Lung Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Colon Cancer, Lung Cancer, Tobacco Use Cessation
- What is being tested?
- Epic Healthy Planet Population Health Module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient who has a UC Davis or UC Irvine primary care provider (PCP) and is deficient in any of the following: colon cancer screening, lung cancer screening, tobacco cessation counseling, obesity counseling, pneumonia vaccination, shingles vaccine, and hepatitis C screening.
Who cannot join
- Patients outside of the age limits or have an established PCP.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older.
- Conditions
- Colon Cancer, Lung Cancer, Tobacco Use Cessation, Obesity, Pneumonia, Bacterial, Shingles
- Being tested
- Epic Healthy Planet Population Health Module
- Medical subject headings
- Colonic Neoplasms, Lung Neoplasms, Tobacco Use Cessation, Obesity, Pneumonia, Bacterial, Herpes Zoster, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epic Healthy Planet Population Health ModuleOther
Electronic population health module which is tailored to increased adherence to USPSTF and CDC recommendations
| Study group | Role | What they receive |
|---|---|---|
| CLOVER arm | Experimental | This arm will contain clinics that utilize the CLOVER intervention Receives: Other: Epic Healthy Planet Population Health Module |
| Standard of Care arm | No intervention | This arm will contain clinics that do not utilize the CLOVER intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Adherence to CLOVER Metrics
This is the proportion of patients who appropriately completed screenings and vaccinations that they were eligible for
Measured: 6 months
Secondary outcomes (7)
Colon cancer screening
Proportion of eligible patients who completed colon cancer screening.
Measured: 6 months
Lung cancer screening
Proportion of eligible patients who completed lung cancer screening.
Measured: 6 months
Tobacco cessation counseling
Proportion of eligible patients who completed tobacco cessation counseling.
Measured: 6 months
Obesity counseling
Proportion of eligible patients who completed obesity counseling.
Measured: 6 months
Pneumonia vaccination
Proportion of eligible patients who completed pneumonia vaccination.
Measured: 6 months
Shingles vaccination
Proportion of eligible patients who completed shingles vaccination.
Measured: 6 months
Hepatitis C screening
Proportion of eligible patients who completed hepatitis C screening.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start5 Oct 2020
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540081
- Sponsor's protocol ID
- 1624888
- Acronym
- CLOVER
- Status last verified
- Nov 2021
- First submitted
- 31 Aug 2020
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
- ClinicalTrials.gov ID
- NCT04540081
- Acronym / sponsor ID
- CLOVER / 1624888
- Conditions
- Colon Cancer, Lung Cancer, Tobacco Use Cessation, Obesity, Pneumonia, Bacterial, Shingles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLOVER arm | Experimental | Other: Epic Healthy Planet Population Health ModuleThis arm will contain clinics that utilize the CLOVER intervention |
| Standard of Care arm | No intervention | –This arm will contain clinics that do not utilize the CLOVER intervention |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who has a UC Davis or UC Irvine primary care provider (PCP) and is deficient in any of the following: colon cancer screening, lung cancer screening, tobacco cessation counseling, obesity counseling, pneumonia vaccination, shingles vaccine, and hepatitis C screening.
Key exclusion criteria (1 listed)
- Patients outside of the age limits or have an established PCP.
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 |
|---|---|---|
| Epic Healthy Planet Population Health ModuleElectronic population health module which is tailored to increased adherence to USPSTF and CDC recommendations | Other | CLOVER arm |
Primary outcome
Overall Adherence to CLOVER Metrics
Time frame: 6 months
This is the proportion of patients who appropriately completed screenings and vaccinations that they were eligible for
7 secondary outcomes
Colon cancer screening
Time frame: 6 months
Lung cancer screening
Time frame: 6 months
Tobacco cessation counseling
Time frame: 6 months
Obesity counseling
Time frame: 6 months
Pneumonia vaccination
Time frame: 6 months
Shingles vaccination
Time frame: 6 months
Hepatitis C screening
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Biopsy-Resection Agreement of Peritoneal Histopathological Growth Patterns in Colorectal Peritoneal Metastases: A Prospective Observational Pilot Study
Peritoneal (Metastatic) Cancer, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epic Healthy Planet Population Health Module in people with Colon Cancer and Lung Cancer, run by University of California, Davis 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 1 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 27 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Adherence to CLOVER Metrics (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2023.