Back to resultsEnhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer (CLOVER)
Primary Purpose
Colon Cancer, Lung Cancer, Tobacco Use Cessation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epic Healthy Planet Population Health Module
Sponsored by
About this trial
This is an interventional prevention trial for Colon Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients outside of the age limits or have an established PCP.
Sites / Locations
- UC Davis Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CLOVER arm
Standard of Care arm
Arm Description
This arm will contain clinics that utilize the CLOVER intervention
This arm will contain clinics that do not utilize the CLOVER intervention
Outcomes
Primary Outcome Measures
Overall Adherence to CLOVER Metrics
This is the proportion of patients who appropriately completed screenings and vaccinations that they were eligible for
Secondary Outcome Measures
Colon cancer screening
Proportion of eligible patients who completed colon cancer screening.
Lung cancer screening
Proportion of eligible patients who completed lung cancer screening.
Tobacco cessation counseling
Proportion of eligible patients who completed tobacco cessation counseling.
Obesity counseling
Proportion of eligible patients who completed obesity counseling.
Pneumonia vaccination
Proportion of eligible patients who completed pneumonia vaccination.
Shingles vaccination
Proportion of eligible patients who completed shingles vaccination.
Hepatitis C screening
Proportion of eligible patients who completed hepatitis C screening.
Full Information
NCT ID
NCT04540081
First Posted
August 31, 2020
Last Updated
November 30, 2021
Sponsor
University of California, Davis
Collaborators
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT04540081
Brief Title
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
Acronym
CLOVER
Official Title
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
University of California, Irvine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Lung Cancer, Tobacco Use Cessation, Obesity, Pneumonia, Bacterial, Shingles, Hepatitis C
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CLOVER arm
Arm Type
Experimental
Arm Description
This arm will contain clinics that utilize the CLOVER intervention
Arm Title
Standard of Care arm
Arm Type
No Intervention
Arm Description
This arm will contain clinics that do not utilize the CLOVER intervention
Intervention Type
Other
Intervention Name(s)
Epic Healthy Planet Population Health Module
Intervention Description
Electronic population health module which is tailored to increased adherence to USPSTF and CDC recommendations
Primary Outcome Measure Information:
Title
Overall Adherence to CLOVER Metrics
Description
This is the proportion of patients who appropriately completed screenings and vaccinations that they were eligible for
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Colon cancer screening
Description
Proportion of eligible patients who completed colon cancer screening.
Time Frame
6 months
Title
Lung cancer screening
Description
Proportion of eligible patients who completed lung cancer screening.
Time Frame
6 months
Title
Tobacco cessation counseling
Description
Proportion of eligible patients who completed tobacco cessation counseling.
Time Frame
6 months
Title
Obesity counseling
Description
Proportion of eligible patients who completed obesity counseling.
Time Frame
6 months
Title
Pneumonia vaccination
Description
Proportion of eligible patients who completed pneumonia vaccination.
Time Frame
6 months
Title
Shingles vaccination
Description
Proportion of eligible patients who completed shingles vaccination.
Time Frame
6 months
Title
Hepatitis C screening
Description
Proportion of eligible patients who completed hepatitis C screening.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients outside of the age limits or have an established PCP.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Chak, MD, MPH
Phone
916-734-3751
Email
echak@ucdavis.edu
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Chak, MD, MPH
Phone
916-734-3751
Email
echak@ucdavis.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
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