Social Determinants of Health (SDOH)NCT05773313
A Study of Overcoming Social Determinants of Health
A study testing The Open Table in people with Social Determinants of Health (SDOH), run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health (SDOH)
- What is being tested?
- The Open Table
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identified social determinants of health (SDOH). need that impacts healthcare outcomes (identified by the healthcare team)
Who cannot join
- Non-english speaking patients
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social and Relational Capital to Overcome Social Determinants of Health.
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.
- Conditions
- Social Determinants of Health (SDOH)
- Being tested
- The Open Table
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Open TableBehavioural
An organization that connects community volunteers to individuals in need to help overcome life's challenges.
| Study group | Role | What they receive |
|---|---|---|
| The Open Table Model | Experimental | Subjects identified as having their health negatively impacted by Social Determinants of Health (SDOH) will meet with The Open Table members to determine their specific needs, decide on a plan for overcoming this need and following up to ensure resolution. Receives: Behavioral: The Open Table |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
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.
Measured: Baseline and 12 months
Secondary outcomes (3)
Hospitalizations
Difference in total number of hospitalizations in the 12 months before intervention and 12 months during intervention.
Measured: Baseline and 12 months
Emergency Room Visits
Difference in total number of emergency room visits in the 12 months before intervention and 12 months during intervention.
Measured: Baseline and 12 months
Primary Care Visits
Difference in total number of primary care visits in the 12 months before intervention and 12 months during intervention.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start15 Jun 2023
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of Health (SDOH)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Nathan L. Delafield, Mayo Clinic
- Investigators
- Nathan Delafield, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773313
- Sponsor's protocol ID
- 22-012939
- Other IDs
- UL1TR002377
- Status last verified
- Jun 2025
- First submitted
- 10 Mar 2023
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delafield NL, Havanur A, Bonner TJ, Horsley R, Mead-Harvey C, Bersoux S, White K, Ali N, Milam AJ. A Community-Based Intervention to Address Social Determinants of Health: A Pilot Study. Jt Comm J Qual Patient Saf. 2025 Nov;51(11):727-732. doi: 10.1016/j.jcjq.2025.08.002. Epub 2025 Aug 7.
PubMed 40912931
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Relational Capital to Overcome Social Determinants of Health.
- ClinicalTrials.gov ID
- NCT05773313
- Acronym / sponsor ID
- 22-012939
- Conditions
- Social Determinants of Health (SDOH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Open Table Model | Experimental | Behavioral: The Open TableSubjects identified as having their health negatively impacted by Social Determinants of Health (SDOH) will meet with The Open Table members to determine their specific needs, decide on a plan for overcoming this need and following up to ensure resolution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Identified social determinants of health (SDOH). need that impacts healthcare outcomes (identified by the healthcare team)
Key exclusion criteria (2 listed)
- Non-english speaking patients
- Patients who are pregnant
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 |
|---|---|---|
| The Open TableAn organization that connects community volunteers to individuals in need to help overcome life's challenges. | Behavioural | The Open Table Model |
Primary outcome
Change in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening Assessment
Time frame: Baseline and 12 months
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.
Change in Resilience
Time frame: Baseline and 12 months
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.
3 secondary outcomes
Hospitalizations
Time frame: Baseline and 12 months
Emergency Room Visits
Time frame: Baseline and 12 months
Primary Care Visits
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40912931Delafield NL, Havanur A, Bonner TJ, Horsley R, Mead-Harvey C, Bersoux S, White K, Ali N, Milam AJ. A Community-Based Intervention to Address Social Determinants of Health: A Pilot Study. Jt Comm J Qual Patient Saf. 2025 Nov;51(11):727-732. doi: 10.1016/j.jcjq.2025.08.002. Epub 2025 Aug 7.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Nathan Delafield, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Open Table in people with Social Determinants of Health (SDOH), run by Mayo Clinic 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 1 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 17 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Participant Center for Medicare and Medicaid Services (CMS) Accountable Health Social Determinants of Health (SDOH) Screening Assessment (time frame: Baseline and 12 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 NCT05773313, which also lists 1 linked publication.
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 17 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.