NCT02512835

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

June 11, 2015

Last Update Submit

February 26, 2018

Conditions

Keywords

Primary health carePublic healthMedical InformaticsSocial Determinants of Health

Outcome Measures

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.

    The past 5 years

Secondary Outcomes (2)

  • ACG morbidity risk score

    Past 5 years

  • Change in care

    Up to one year

Study Arms (2)

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

We will present clinicians with information about their patients' communities

Clinicians

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Aims 1a and 1b: Patients outside of the age range
  • Aims 2 and 3: Clinicians involved with the design of the research protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fairfax Family Practice Centers

Fairfax, Virginia, 22033, United States

Location

Virginia Ambulatory Care Outcomes Research Network

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsBreast NeoplasmsUterine Cervical NeoplasmsProstatic NeoplasmsCardiovascular Diseases

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Alex Krist, M.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

July 31, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 28, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations