- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02512835
Understanding the Value of Community Vital Signs in Primary Care
Study Overview
Status
Intervention / Treatment
Detailed Description
The investigators will integrate community vital signs into clinical data, identify cold spots, and determine prospectively how clinicians use these community data at the point of care and for populations of patients. The investigators hypothesize that (1) the patients in a primary care practice live in a range of communities with different social determinants of health, including cold spots that lack health-promoting resources, (2) community vital signs are associated with patient health outcomes (e.g., being up-to-date with preventive care, control of chronic conditions, morbidity), and (3) knowing that a patient resides in a cold spot will help clinicians improve patient care.
Aim 1a: Determine community vital sign cold spots in the catchment area of 12 primary care practices.
Aim 1b: Determine whether patients residing in cold spots experience worse outcomes, such as receiving inadequate care, worse chronic disease control, or higher morbidity.
Aim 2: Determine whether knowing a patient's community vital signs and social needs at the point of care will change clinical management; and explore how practices could use community vital signs for population care.
Aim 3: Identify other community vital signs that practices would find useful for managing patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Virginia
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Fairfax, Virginia, United States, 22033
- Fairfax Family Practice Centers
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Richmond, Virginia, United States, 23298
- Virginia Ambulatory Care Outcomes Research Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aims 1a and 1b: Patients seen at one of the 12 study practices
- Aims 2 and 3: Clinicians at one of the 12 study practices
Exclusion Criteria:
- Aims 1a and 1b: Patients outside of the age range
- Aims 2 and 3: Clinicians involved with the design of the research protocol.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clinic patients
Aims 1a and 1b: The participants include all unique patients seen at the 12 study practices (approximately 170,000 patients over the past two years).
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Clinicians
Aims 2 and 3: The clinicians in this analysis will include 15 participants recruited from the approximately 100 clinicians at the 12 practices
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We will present clinicians with information about their patients' communities
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of care
Time Frame: The past 5 years
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Likelihood patient living in a cold spot received recommended cancer screening and cardiovascular preventive care based on National Committee for Quality Assurance (NCQA) quality measures.
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The past 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACG morbidity risk score
Time Frame: Past 5 years
|
Likelihood a patient living in a cold spot has a higher Adjusted Clinical Group (ACG) risk score than patient not living in a cold spot.
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Past 5 years
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Change in care
Time Frame: Up to one year
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Physician report on whether they change care in response to knowing a patient lives in a cold spot.
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Up to one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alex Krist, M.D., Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20004050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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