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A Study of Overcoming Social Determinants of Health

Social and Relational Capital to Overcome Social Determinants of Health.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05773313
Enrollment
12
Registered
2023-03-17
Start date
2023-06-15
Completion date
2024-07-17
Last updated
2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Determinants of Health (SDOH)

Brief summary

This study is being done to determine if assistance in accessing community resources can improve health outcomes. Social determinants of health are the conditions in which individuals are born, work and live that can impact health. These can include access to healthcare, healthy food, education, safe neighborhoods, transportation, political and social environments that are safe and fair.

Interventions

BEHAVIORALThe Open Table

An organization that connects community volunteers to individuals in need to help overcome life's challenges.

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Identified social determinants of health (SDOH). need that impacts healthcare outcomes (identified by the healthcare team)

Exclusion criteria

* Non-english speaking patients * Patients who are pregnant

Design outcomes

Primary

MeasureTime frameDescription
Change in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentBaseline and 12 monthsEvaluated using the CMS Accountable Health SDOH Screening Tool used to assess patient needs across the following domains: house instability, food insecurity, transportation problems, utility help needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disabilities that community services can help with. If the participant chose the underlined option, they might have an unmet health-related social need. Only domains where an unmet health-related social need was identified was included in the analysis.
Change in ResilienceBaseline and 12 monthsEvaluated using the 6-item Brief Resilience Scale (BRS) questionnaire assessing the participants ability to bounce back on a 1-5 scale range. Total questions scores are divided by total number of questions answered for a final score range from 1.00-2.99 = low resilience; 3.00-4.30 = normal resilience; 4.31-5.00 = high resilience.

Secondary

MeasureTime frameDescription
HospitalizationsBaseline and 12 monthsDifference in total number of hospitalizations in the 12 months before intervention and 12 months during intervention.
Emergency Room VisitsBaseline and 12 monthsDifference in total number of emergency room visits in the 12 months before intervention and 12 months during intervention.
Primary Care VisitsBaseline and 12 monthsDifference in total number of primary care visits in the 12 months before intervention and 12 months during intervention.

Countries

United States

Participant flow

Participants by arm

ArmCount
The Open Table Model
Subjects identified as having their health negatively impacted by Social Determinants of Health (SDOH) met with The Open Table members to determine their specific needs, decide on a plan for overcoming this need and following up to ensure resolution. The Open Table: An organization that connects community volunteers to individuals in need to help overcome life's challenges.
12
Total12

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up3

Baseline characteristics

CharacteristicThe Open Table Model
Age, Continuous46.0 years
STANDARD_DEVIATION 18.01
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
7 Participants
Region of Enrollment
United States
12 participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 12
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

Primary

Change in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening Assessment

Evaluated using the CMS Accountable Health SDOH Screening Tool used to assess patient needs across the following domains: house instability, food insecurity, transportation problems, utility help needs, interpersonal safety, financial strain, employment, family and community support, education, physical activity, substance use, mental health, and disabilities that community services can help with. If the participant chose the underlined option, they might have an unmet health-related social need. Only domains where an unmet health-related social need was identified was included in the analysis.

Time frame: Baseline and 12 months

Population: 3 participants did not complete the CMS accountable health SDOH screening assessment at 12 months.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentFood Insecurity-Baseline6 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentFood Insecurity-12 Months5 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentFinancial Strain-Baseline9 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentFinancial Strain-12 Months5 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentFamily and Community Support-Baseline10 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentFamily and Community Support-12 Months7 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentPhysical Activity-Baseline9 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentPhysical Activity-12 Months7 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentDisability-Baseline12 Participants
The Open Table ModelChange in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening AssessmentDisability-12 Months8 Participants
Comparison: Food Insecurityp-value: >0.999Wilcoxon (Mann-Whitney)
Comparison: Financial Insecurityp-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: Social Isolationp-value: >0.999Wilcoxon (Mann-Whitney)
Comparison: Physical Inactivityp-value: >0.999Wilcoxon (Mann-Whitney)
Comparison: Disabilityp-value: >0.999Wilcoxon (Mann-Whitney)
Primary

Change in Resilience

Evaluated using the 6-item Brief Resilience Scale (BRS) questionnaire assessing the participants ability to bounce back on a 1-5 scale range. Total questions scores are divided by total number of questions answered for a final score range from 1.00-2.99 = low resilience; 3.00-4.30 = normal resilience; 4.31-5.00 = high resilience.

Time frame: Baseline and 12 months

Population: 3 participants did not complete the BRS questionnaire at 12 months.

ArmMeasureGroupValue (MEAN)Dispersion
The Open Table ModelChange in ResilienceBaseline3.0 score on a scaleStandard Deviation 0.94
The Open Table ModelChange in Resilience12 Months3.3 score on a scaleStandard Deviation 0.98
p-value: 0.461Wilcoxon (Mann-Whitney)
Secondary

Emergency Room Visits

Difference in total number of emergency room visits in the 12 months before intervention and 12 months during intervention.

Time frame: Baseline and 12 months

ArmMeasureGroupValue (MEAN)Dispersion
The Open Table ModelEmergency Room VisitsBaseline1.7 VisitsStandard Deviation 1.5
The Open Table ModelEmergency Room Visits12 Months1.2 VisitsStandard Deviation 1.85
p-value: 0.438Wilcoxon (Mann-Whitney)
Secondary

Hospitalizations

Difference in total number of hospitalizations in the 12 months before intervention and 12 months during intervention.

Time frame: Baseline and 12 months

ArmMeasureGroupValue (MEAN)Dispersion
The Open Table ModelHospitalizationsBaseline0.3 HospitalizationsStandard Deviation 0.62
The Open Table ModelHospitalizations12 Months0.3 HospitalizationsStandard Deviation 0.89
p-value: >0.999Wilcoxon (Mann-Whitney)
Secondary

Primary Care Visits

Difference in total number of primary care visits in the 12 months before intervention and 12 months during intervention.

Time frame: Baseline and 12 months

ArmMeasureGroupValue (MEAN)Dispersion
The Open Table ModelPrimary Care VisitsBaseline8.3 VisitsStandard Deviation 6.94
The Open Table ModelPrimary Care Visits12 Months5.5 VisitsStandard Deviation 5.32
p-value: 0.08Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026