Social Determinants of HealthNCT04630041
Social Needs Screenings in ED
A study testing 211 Referral in people with Social Determinants of Health, run by Andrea Wallace at 1 site in United States.
Trial summary
This study will determine whether existing Health Information Technology can be leveraged to 1) implement a universal, patient-centered social needs assessment and referral process during routine Emergency Department care; 2) understand whether linking social needs assessment, community based referral, and health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health
- What is being tested?
- 211 Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,081 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- seen in the UHealth University hospital ED
- ability to use touchpad technology
- ability to communicate via telephone for 211 follow-up
Who cannot join
- Non-English and non-Spanish speaking (English nor Spanish need not be the 1st language)
- unable to communicate verbally
- admitted to an inpatient unit or to a skilled nursing facility (vs discharged to a community-based setting where participants are responsible for their own self-care)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation Barriers to Social Needs Screenings in Routine Emergency Care
This study will determine whether existing Health Information Technology can be leveraged to 1) implement a universal, patient-centered social needs assessment and referral process during routine Emergency Department care; 2) understand whether linking social needs assessment, community based referral, and health outcomes data may facilitate an understanding of population health; and 3) address the needs and wishes of patients and clinicians.
Hypothesis: Results of this study will provide much needed information to already overburdened hospital systems regarding whether systematically incorporating social needs information and referrals into emergency discharge processes allows for a better understanding of factors placing patients at risk for poor outcomes post-discharge, and whether doing so has potential for enhancing discharge support for a larger patient population seen in emergency departments.
- Conditions
- Social Determinants of Health
- Being tested
- 211 Referral
- Keywords
- Emergencies, Social needs
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
211 ReferralBehavioural
Patients with one or more reported social need will be referred to 211 for community based services. 211 will reach out and contact patients for follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Social Needs Assessment | Experimental | Patients in the Emergency Department will complete a social needs assessment screener that may refer them to 211 services Receives: Behavioral: 211 Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Utilization Outcome questionnaire
The variable will be created by combining primary care utilization (yes/no), ED revisit (yes/no), and hospitalization (yes/no) within 60 days of original ED visit. Scores range from 0 to 3. Higher scores indicate worse health utilization outcomes.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 May 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Determinants of HealthStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Wallace
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor-investigator, Andrea Wallace, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630041
- Sponsor's protocol ID
- 00125877
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wallace AS, Luther BL, Sisler SM, Wong B, Guo JW. Integrating social determinants of health screening and referral during routine emergency department care: evaluation of reach and implementation challenges. Implement Sci Commun. 2021 Oct 7;2(1):114. doi: 10.1186/s43058-021-00212-y.
PubMed 34620248
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Barriers to Social Needs Screenings in Routine Emergency Care
- ClinicalTrials.gov ID
- NCT04630041
- Acronym / sponsor ID
- 00125877
- Conditions
- Social Determinants of Health
- Keywords
- Emergencies, Social needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,081 participants (actual)
- Lead sponsor
- Andrea WallaceUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 16 Nov 2020 (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.
This study will determine whether existing Health Information Technology can be leveraged to 1) implement a universal, patient-centered social needs assessment and referral process during routine Emergency Department care; 2) understand whether linking social needs assessment, community based referral, and health outcomes data may facilitate an understanding of population health; and 3) address the needs and wishes of patients and clinicians.
Hypothesis: Results of this study will provide much needed information to already overburdened hospital systems regarding whether systematically incorporating social needs information and referrals into emergency discharge processes allows for a better understanding of factors placing patients at risk for poor outcomes post-discharge, and whether doing so has potential for enhancing discharge support for a larger patient population seen in emergency departments.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Needs Assessment | Experimental | Behavioral: 211 ReferralPatients in the Emergency Department will complete a social needs assessment screener that may refer them to 211 services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- seen in the UHealth University hospital ED
- ability to use touchpad technology
- ability to communicate via telephone for 211 follow-up
Key exclusion criteria (3 listed)
- Non-English and non-Spanish speaking (English nor Spanish need not be the 1st language)
- unable to communicate verbally
- admitted to an inpatient unit or to a skilled nursing facility (vs discharged to a community-based setting where participants are responsible for their own self-care)
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 |
|---|---|---|
| 211 ReferralPatients with one or more reported social need will be referred to 211 for community based services. 211 will reach out and contact patients for follow-up. | Behavioural | Social Needs Assessment |
Primary outcome
Health Utilization Outcome questionnaire
Time frame: 60 days
The variable will be created by combining primary care utilization (yes/no), ED revisit (yes/no), and hospitalization (yes/no) within 60 days of original ED visit. Scores range from 0 to 3. Higher scores indicate worse health utilization outcomes.
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 16 Nov 2020.
- Derived from this study: PubMed 34620248Wallace AS, Luther BL, Sisler SM, Wong B, Guo JW. Integrating social determinants of health screening and referral during routine emergency department care: evaluation of reach and implementation challenges. Implement Sci Commun. 2021 Oct 7;2(1):114. doi: 10.1186/s43058-021-00212-y.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 211 Referral in people with Social Determinants of Health, run by Andrea Wallace 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 3 inclusion and 3 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 16 Nov 2020. 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 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?
Health Utilization Outcome questionnaire (time frame: 60 days). 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 NCT04630041, 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 16 Nov 2020.