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CompletedNCT02512835Updated Feb 28, 2018

Understanding the Value of Community Vital Signs in Primary Care

An observational study in Colon Cancer, Breast Cancer and Cervical Cancer, sponsored by Virginia Commonwealth University. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Virginia Commonwealth University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Other
Enrollment
120
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Social determinants of health (e.g. the income, education, and environment of patients) may exert greater influence on health outcomes than traditional clinical factors (e.g. lab results, diagnoses, and family history). Calls for integrating primary care and public health are therefore increasing, but merging these domains of care is logistically difficult. Research is lacking on the incremental benefit of adding public health data at the practice level-- in improving either health outcomes or care delivery. This proof of concept pilot will merge data from electronic health records (EHRs) with community vital signs, a set of metrics that describes key community resources that affect health. The investigators will identify resource poor communities, or cold spots, based on four variables (education, poverty, life expectancy, and access to healthy foods) at the census tract level - referred to as a community vital sign. The hypothesis is that patients coming from cold spots are more likely to have worse health outcomes and that clinicians will deliver better care if they know a patient's community context and his/her specific social needs. This study will involve 12 primary care practices in Northern Virginia that care for more than 170,000 patients. Patient addresses will be geocoded for each practice and determine which patients reside in cold spots for each community vital sign. The variation for each community vital sign for each practice's patients will be calculated and a bivariate and regression analyses will be used to determine whether coming from a cold spot is associated with worse clinical quality metrics. 15 clinicians will be alerted when they see a patient from a cold spot, patients will complete a social needs survey, and clinicians will prospectively document through surveys whether such knowledge affects interpersonal interactions (such as time spent with patients and the use of clearer language) or clinical management (such as referrals to care coordination or community resources). By pragmatically integrating community vital signs into care, this innovative proposal will seek to understand which community data clinicians value, how these data might influence care, and how best to incorporate these data into clinical and population care.

Read the 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.

02

Conditions studied

  • Colon Cancer
  • Breast Cancer
  • Cervical Cancer
  • Prostate Cancer
  • Cardiovascular Disease

Keywords

  • Primary health care
  • Public health
  • Medical Informatics
  • Social Determinants of Health
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 120 is below the median of 573 across 1,483 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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). Aims 2 and 3: The clinicians in this analysis will include 15 participants recruited from the approximately 100 clinicians at the 12 practices - ideally 1-2 clinicians from each office. Because the study will characterize the upper bounds, or ideal outcomes, in the use of community vital signs, clinicians who are willing to participate and provide feedback will be selectively recruited.

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

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.
05

Study design

Observational model
Ecologic or community
Time perspective
Other
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

  • Clinicians

    Aims 2 and 3: The clinicians in this analysis will include 15 participants recruited from the approximately 100 clinicians at the 12 practices

    Other: Community vital signs

Interventions

  • OtherCommunity vital signs

    We will present clinicians with information about their patients' communities

06

What researchers measure

Primary outcomes

  1. Quality of care

    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.

    Time frame: The past 5 years

Secondary outcomes

  1. ACG morbidity risk score

    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.

    Time frame: Past 5 years

  2. Change in care

    Physician report on whether they change care in response to knowing a patient lives in a cold spot.

    Time frame: Up to one year

07

Study locations

2 sites
  • Fairfax Family Practice Centers
    Fairfax, Virginia 22033, United States
  • Virginia Ambulatory Care Outcomes Research Network
    Richmond, Virginia 23298, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02512835
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Jul 31, 2015
Start date
Oct 2015
Primary completion
Nov 1, 2016
Completion
Nov 1, 2016
Last update
Feb 28, 2018

Study contacts

Alex Krist, M.D.
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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