EmergenciesNCT03834441
Optimized Health-Related Social Needs Screening and Community Linkages
A study testing Oral HRSN screening and Written HRSN screening in people with Emergencies, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The objective of this study is to to understand the most effective method for health-related social need (HRSN) screening in the challenging environment of an emergency department by randomizing patients to oral or written HRSN screening in the ED. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies
- What is being tested?
- Oral HRSN screening and Written HRSN screening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 20 Feb 2020
- 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
- age ≥ 18 years patients and either a parent/guardian of a pediatric/cognitively disabled patient in the MGH ED,
- triaged to the Acute, CDU, Fast Track, Urgent, and Pediatrics areas,
- English- or Spanish-speaking, and
- capable of informed consent.
Who cannot join
- patients unwilling to have the interview audio-recorded,
- medically unstable patients, and
- Section 12, lack of capacity medical hold, sexual assault, child abuse, and emotionally distressed patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The objective of this study is to to understand the most effective method for health-related social need (HRSN) screening in the challenging environment of an emergency department by randomizing patients to oral or written HRSN screening in the ED.
Read the detailed description
Bilingual research assistants (RA) will screen patients for eligibility based on the predetermined criteria and approach eligible patients with a brief description of the study and opportunity for participation. Interested participants will complete a verbal consent process to reduce the barriers to participation, a brief demographic questionnaire, and an assessment of health literacy (Newest Vital Sign) followed by the Partners Healthcare HRSN screener randomized to an oral v. iPad screening strategy.
After completion of the screening tool, participants will complete a secondary questionnaire asking about satisfaction with the process, the presence of additional HRSN not recorded by the Partners HealthCare screener, and their perspectives on screening. At the conclusion, all participants will be provided with standardized, bilingual list of community resources to address each of the screening domains.
- Conditions
- Emergencies
- Being tested
- Oral HRSN screening, Written HRSN screening
- Keywords
- 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.
Oral HRSN screeningOther
Verbal screening delivered by an RA
Written HRSN screeningOther
Patient completes written screen on iPad.
| Study group | Role | What they receive |
|---|---|---|
| Oral screening | Other | Not described Receives: Other: Oral HRSN screening |
| Written screening | Other | Not described Receives: Other: Written HRSN screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Satisfaction With the Screening Process
Satisfaction with screening as measured by:
Please tell us how satisfied you were with the questionnaire you just took:
Extremely Quite a bit Somewhat A little bit Not at all
Measured: Immediately after completing survey
Secondary outcomes (1)
Number of Health Related Social Needs Reported
We will record the number of health related social needs reported
Measured: Immediately after completing survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start7 May 2019
- Primary completion1 Sep 2019
- Study completion20 Feb 2020
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.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Samuels-Kalow, Massachusetts General Hospital
- Investigators
- Margaret Samuels-Kalow, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834441
- Sponsor's protocol ID
- 2019P000128
- Status last verified
- Jan 2023
- First submitted
- 5 Feb 2019
- Last updated
- 9 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Health-Related Social Needs Screening and Community Linkages
- ClinicalTrials.gov ID
- NCT03834441
- Acronym / sponsor ID
- 2019P000128
- Conditions
- Emergencies
- Keywords
- social needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 9 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to to understand the most effective method for health-related social need (HRSN) screening in the challenging environment of an emergency department by randomizing patients to oral or written HRSN screening in the ED.
Detailed description
Bilingual research assistants (RA) will screen patients for eligibility based on the predetermined criteria and approach eligible patients with a brief description of the study and opportunity for participation. Interested participants will complete a verbal consent process to reduce the barriers to participation, a brief demographic questionnaire, and an assessment of health literacy (Newest Vital Sign) followed by the Partners Healthcare HRSN screener randomized to an oral v. iPad screening strategy.
After completion of the screening tool, participants will complete a secondary questionnaire asking about satisfaction with the process, the presence of additional HRSN not recorded by the Partners HealthCare screener, and their perspectives on screening. At the conclusion, all participants will be provided with standardized, bilingual list of community resources to address each of the screening domains.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral screening | Other | Other: Oral HRSN screening |
| Written screening | Other | Other: Written HRSN screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years patients and either a parent/guardian of a pediatric/cognitively disabled patient in the MGH ED,
- triaged to the Acute, CDU, Fast Track, Urgent, and Pediatrics areas,
- English- or Spanish-speaking, and
- capable of informed consent.
Key exclusion criteria (3 listed)
- patients unwilling to have the interview audio-recorded,
- medically unstable patients, and
- Section 12, lack of capacity medical hold, sexual assault, child abuse, and emotionally distressed patients.
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 |
|---|---|---|
| Oral HRSN screeningVerbal screening delivered by an RA | Other | Oral screening |
| Written HRSN screeningPatient completes written screen on iPad. | Other | Written screening |
Primary outcome
Self-reported Satisfaction With the Screening Process
Time frame: Immediately after completing survey
Satisfaction with screening as measured by: Please tell us how satisfied you were with the questionnaire you just took: Extremely Quite a bit Somewhat A little bit Not at all
1 secondary outcome
Number of Health Related Social Needs Reported
Time frame: Immediately after completing survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
Margaret Samuels-Kalow principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral HRSN screening and Written HRSN screening in people with Emergencies, run by Massachusetts General Hospital 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 4 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 9 Feb 2023. 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 9 Feb 2023). 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?
Self-reported Satisfaction With the Screening Process (time frame: Immediately after completing survey). 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 9 Feb 2023.