Colon CancerNCT02512835
Understanding the Value of Community Vital Signs in Primary Care
An observational study of Colon Cancer and Breast Cancer, run by Virginia Commonwealth University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Breast Cancer, Cervical Cancer
- What is being tested?
- Community vital signs
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to 1 Nov 2016
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Aims 1a and 1b: Patients outside of the age range
- Aims 2 and 3: Clinicians involved with the design of the research protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fairfax Family Practice Centers
Fairfax, Virginia, 22033
Virginia Ambulatory Care Outcomes Research Network
Richmond, Virginia, 23298
About this study
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.
- Being tested
- Community vital signs
- Keywords
- Primary health care, Public health, Medical Informatics, Social Determinants of Health
- Medical subject headings
- Colonic Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms, Prostatic Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community vital signsOther
We will present clinicians with information about their patients' communities
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Community vital signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The past 5 years
Secondary outcomes (2)
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.
Measured: Past 5 years
Change in care
Physician report on whether they change care in response to knowing a patient lives in a cold spot.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startOct 2015
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
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.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Krist, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512835
- Sponsor's protocol ID
- HM20004050
- Status last verified
- Feb 2018
- First submitted
- 11 Jun 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Value of Community Vital Signs in Primary Care
- ClinicalTrials.gov ID
- NCT02512835
- Acronym / sponsor ID
- HM20004050
- Keywords
- Primary health care, Public health, Medical Informatics, Social Determinants of Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Community vital signsAims 2 and 3: The clinicians in this analysis will include 15 participants recruited from the approximately 100 clinicians at the 12 practices |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Aims 1a and 1b: Patients outside of the age range
- Aims 2 and 3: Clinicians involved with the design of the research protocol.
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 |
|---|---|---|
| Community vital signsWe will present clinicians with information about their patients' communities | Other | Clinicians |
Primary outcome
Quality of care
Time frame: The past 5 years
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.
2 secondary outcomes
ACG morbidity risk score
Time frame: Past 5 years
Change in care
Time frame: Up to one year
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 28 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Alex Krist, M.D. principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Breast Cancer, run by Virginia Commonwealth University at 2 sites 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 2 inclusion and 2 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quality of care (time frame: The past 5 years). 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 28 Feb 2018.