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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral screening | Other |
| |
| Written screening | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral HRSN screening | Other | Verbal screening delivered by an RA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately after completing survey |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Health Related Social Needs Reported | We will record the number of health related social needs reported | Immediately after completing survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Samuels-Kalow | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
There is no plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Screening | Oral HRSN screening: Verbal screening delivered by an RA |
| FG001 | Written Screening | Written HRSN screening: Patient completes written screen on iPad. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocation |
| |||||||||||||
| Analysis |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Screening | Oral HRSN screening: Verbal screening delivered by an RA |
| BG001 | Written Screening | Written HRSN screening: Patient completes written screen on iPad. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Immediately after completing survey |
|
Through study completion (no more than 1 day).
Participants were enrolled in the study and completed the outcome measurement on the same day. There was no further contact with participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Screening | Oral HRSN screening: Verbal screening delivered by an RA | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Samuels-Kalow | MGH | 617-726-8340 | msamuels-kalow@partners.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2019 | Apr 19, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Written HRSN screening |
| Other |
Patient completes written screen on iPad. |
|
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Health literacy | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Health Related Social Needs Reported | We will record the number of health related social needs reported | Would you like any information about any of the HRSN topics? | Posted | Count of Participants | Participants | Immediately after completing survey |
|
|
|
| 115 |
| 0 |
| 115 |
| 0 |
| 115 |
| EG001 | Written Screening | Written HRSN screening: Patient completes written screen on iPad. | 0 | 121 | 0 | 121 | 0 | 121 |
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