Health Social DeterminantNCT03973346
Impact of Social Risk Decision Support
A study testing Risk screening tool exposure in people with Health Social Determinant, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of embedding a risk-stratification tool, designed to identify patient needs for services that address social determinant of health related needs, in a commercial electronic health record system (EHR). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Social Determinant
- What is being tested?
- Risk screening tool exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Encounters among patients seeking primary care service at any of the 9 Eskenazi Health FQHC clinics in Indianapolis, IN from January 2017 to May 2020.
- The propensity score matched primary care encounters from non-Eskenazi facilities.
Who cannot join
- Emergency encounters or hospitalizations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Population and Clinical Health With Integrated Services and Advanced Analytics
The purpose of this study is to determine the impact of embedding a risk-stratification tool, designed to identify patient needs for services that address social determinant of health related needs, in a commercial electronic health record system (EHR).
Read the detailed description
Social determinant of health related needs and social risk factors complicate care delivery and drive health and well-being. Social needs are common among undeserved patient populations, but health care providers are often not equipped to routinely identify and address patients in need.
Using a combination of health information exchange, electronic health record, and aggregate datasets the investigators developed predictive algorithms to identify patients a highest risk for a need for a referral to a social worker, dietitian, behavioral health, or other wraparound service provider. Risk scores are available to primary care providers in two ways within the electronic health record system (EHR): 1) a graphical summary of individual risk or 2) a line listing of all scheduled patients.
The investigators are introducing the risk-stratification tool in an urban safety-net primary care provider on a voluntary usage basis.
- Conditions
- Health Social Determinant
- Being tested
- Risk screening tool exposure
- Keywords
- risk prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk screening tool exposureOther
Risk screening tool is available to providers
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Encounters at primary care clinics with the risk screening tool Receives: Other: Risk screening tool exposure |
| Comparison group | No intervention | Propensity score matched comparison encounters |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED utilization rate
Rate of potentially avoidable emergency department utilization as determined by encounters recorded in health information exchange data and categorized using the NYU ED Algorithm.
Measured: 6 months
Missed primary care appointments rate
Rate of no show / cancelled appointments at the intervention site primary care clinics as recorded in the intervention site's electronic health record system
Measured: 6 months
Secondary outcomes (1)
Hospitalization rate
Rate of all cause and potentially preventable hospitalization as determined by encounters recorded in health information exchange data and categorized using AHRQ's prevention quality indicator definitions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: The implementation of the tool has been delayed due to technology governance issues and requests for changes in the end user design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health Social DeterminantStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multiple observation, pre-post with a secondary data source comparison group design, and a difference-in-difference modeling approach.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Joshua R. Vest, PhD, Indiana University
- Investigators
- Joshua R Vest, PhD, Principal investigator, Associte Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973346
- Sponsor's protocol ID
- VEST-RWJF-PHASE2
- Status last verified
- Feb 2021
- First submitted
- 28 May 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kasthurirathne SN, Vest JR, Menachemi N, Halverson PK, Grannis SJ. Assessing the capacity of social determinants of health data to augment predictive models identifying patients in need of wraparound social services. J Am Med Inform Assoc. 2018 Jan 1;25(1):47-53. doi: 10.1093/jamia/ocx130.
PubMed 29177457Vest JR, Grannis SJ, Haut DP, Halverson PK, Menachemi N. Using structured and unstructured data to identify patients' need for services that address the social determinants of health. Int J Med Inform. 2017 Nov;107:101-106. doi: 10.1016/j.ijmedinf.2017.09.008. Epub 2017 Sep 20.
PubMed 29029685Vest JR, Menachemi N, Grannis SJ, Ferrell JL, Kasthurirathne SN, Zhang Y, Tong Y, Halverson PK. Impact of Risk Stratification on Referrals and Uptake of Wraparound Services That Address Social Determinants: A Stepped Wedged Trial. Am J Prev Med. 2019 Apr;56(4):e125-e133. doi: 10.1016/j.amepre.2018.11.009. Epub 2019 Feb 14.
PubMed 30772150
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Population and Clinical Health With Integrated Services and Advanced Analytics
- ClinicalTrials.gov ID
- NCT03973346
- Acronym / sponsor ID
- VEST-RWJF-PHASE2
- Conditions
- Health Social Determinant
- Keywords
- risk prediction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The implementation of the tool has been delayed due to technology governance issues and requests for changes in the end user design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- 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.
The purpose of this study is to determine the impact of embedding a risk-stratification tool, designed to identify patient needs for services that address social determinant of health related needs, in a commercial electronic health record system (EHR).
Detailed description
Social determinant of health related needs and social risk factors complicate care delivery and drive health and well-being. Social needs are common among undeserved patient populations, but health care providers are often not equipped to routinely identify and address patients in need.
Using a combination of health information exchange, electronic health record, and aggregate datasets the investigators developed predictive algorithms to identify patients a highest risk for a need for a referral to a social worker, dietitian, behavioral health, or other wraparound service provider. Risk scores are available to primary care providers in two ways within the electronic health record system (EHR): 1) a graphical summary of individual risk or 2) a line listing of all scheduled patients.
The investigators are introducing the risk-stratification tool in an urban safety-net primary care provider on a voluntary usage basis.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple observation, pre-post with a secondary data source comparison group design, and a difference-in-difference modeling approach.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Risk screening tool exposureEncounters at primary care clinics with the risk screening tool |
| Comparison group | No intervention | –Propensity score matched comparison encounters |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Encounters among patients seeking primary care service at any of the 9 Eskenazi Health FQHC clinics in Indianapolis, IN from January 2017 to May 2020.
- The propensity score matched primary care encounters from non-Eskenazi facilities.
Key exclusion criteria (1 listed)
- Emergency encounters or hospitalizations
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 |
|---|---|---|
| Risk screening tool exposureRisk screening tool is available to providers | Other | Intervention group |
Primary outcome
ED utilization rate
Time frame: 6 months
Rate of potentially avoidable emergency department utilization as determined by encounters recorded in health information exchange data and categorized using the NYU ED Algorithm.
Missed primary care appointments rate
Time frame: 6 months
Rate of no show / cancelled appointments at the intervention site primary care clinics as recorded in the intervention site's electronic health record system
1 secondary outcome
Hospitalization rate
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 29177457Kasthurirathne SN, Vest JR, Menachemi N, Halverson PK, Grannis SJ. Assessing the capacity of social determinants of health data to augment predictive models identifying patients in need of wraparound social services. J Am Med Inform Assoc. 2018 Jan 1;25(1):47-53. doi: 10.1093/jamia/ocx130.
- Background: PubMed 29029685Vest JR, Grannis SJ, Haut DP, Halverson PK, Menachemi N. Using structured and unstructured data to identify patients' need for services that address the social determinants of health. Int J Med Inform. 2017 Nov;107:101-106. doi: 10.1016/j.ijmedinf.2017.09.008. Epub 2017 Sep 20.
- Background: PubMed 30772150Vest JR, Menachemi N, Grannis SJ, Ferrell JL, Kasthurirathne SN, Zhang Y, Tong Y, Halverson PK. Impact of Risk Stratification on Referrals and Uptake of Wraparound Services That Address Social Determinants: A Stepped Wedged Trial. Am J Prev Med. 2019 Apr;56(4):e125-e133. doi: 10.1016/j.amepre.2018.11.009. Epub 2019 Feb 14.
- 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.
Joshua R Vest, PhD principal investigator
Associte Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk screening tool exposure in people with Health Social Determinant, run by Indiana University at 1 site 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 1 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: withdrawn, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
ED utilization rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973346, which also lists 3 linked publications.
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 10 Feb 2021.