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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34MH120790-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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There is compelling evidence that longer duration of untreated psychosis independently predicts negative outcomes. The proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State. Results from this initiative will be critical to informing the subsequent design and conduct of larger, focused, and proactive digital media campaigns targeting patient with First Episode Psychosis and their caregivers online, intended to accelerate linkage to care and reduce the duration of untreated psychosis throughout the U.S.
Approximately 100,000 individuals in the Unites States experience a first episode of psychosis (FEP) each year. Psychotic symptoms typically emerge during formative years of adolescence and young adult development and interfere with the establishment of healthy educational, vocational, and social foundations. Despite the severity of symptoms and significant decline in functioning, the time between symptom onset and receiving appropriate care in the U.S. is alarmingly lengthy. Longer Duration of Untreated Psychosis (DUP) has been shown to independently predict negative outcomes, including poorer response to treatment, worse global, vocational, social, and cognitive functioning, greater risk of relapse, higher symptom severity, and poorer quality of life. Prior successful DUP reduction initiatives have utilized various marketing strategies to educate the community about early intervention services, however these strategies are expensive, inefficient, and outdated. Targeted online outreach, supported by technological innovation, offers the prospect of proactively reaching individuals earlier in the course of illness development, as well as individuals who might not otherwise come into contact with traditional referral sources. In response to this challenge, Northwell Health's early psychosis research team is collaborating with Strong365, a nonprofit initiative dedicated to raising early psychosis intervention awareness, to develop and test a proactive and targeted comprehensive digital media marketing campaign designed to facilitate help-seeking and encourage treatment initiation in prospective patients with FEP and their caregivers. Investigators will take advantage of search engine advertisements, which allow advertisers (researchers) to select keywords/phrases and create linked ads appearing as a strategically placed search result. Dedicated ads will appear in response to online search queries conducted by prospective patients and their caregivers throughout New York State (NYS) that align with the campaign's pre-selected keywords/phrases. Individuals who click on the ads will be immediately directed to a landing page/website, and offered a variety of innovative and interactive online engagement tools intended to instantly connect users with specialty care staff and to facilitate earlier treatment initiation. Campaign referrals will be centralized and individuals with FEP will be enrolled into OnTrackNY (OTNY), a network of 21 dedicated early psychosis intervention programs throughout NYS. The campaign will target individuals as well as their caregivers, searching for psychosis-related terms or information online. Investigators will measure the DUP of individuals enrolled into OTNY before and after campaign activation and track the impact of the campaign on the number of FEP referrals and number of patients admitted to OTNY in NYS. Furthermore, investigators aim to identify the campaign target audience most effective at promoting treatment initiation as well as the online tools and resources most effective at encouraging treatment initiation for individuals with FEP. Investigators will additionally explore the online trajectories to care of individuals with FEP engaging with the campaign.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Campaign | No Intervention | Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation. | |
| Active Campaign | Active Comparator | Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| search engine advertisement campaign | Behavioral | This proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State. |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing the Duration of Untreated Psychosis | Evaluate the effectiveness of a search engine ad campaign on reducing the duration of untreated psychosis (DUP) by directly comparing DUP pre-campaign to DUP during the campaign. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Referrals | Evaluate the effectiveness of a search engine ad campaign on rates of referrals by directly comparing referrals pre-campaign to referrals during the campaign. | 2 years |
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Inclusion Criteria: All individuals searching online for information related to mental health
Exclusion Criteria: none
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Birnbaum, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell | Glen Oaks | New York | 11004 | United States | ||
| Northwell |
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A stepped-wedge cluster randomization design was implemented. OTNY sites were grouped into 6 clusters/regions based on geolocation and the total number of referrals received at each clinic. The six clusters/regions were; 1) Bronx, 2) Manhattan, 3) Queens, 4) Brooklyn, 5) Hudson River/Central NY, 6) Staten Island/Long-Island/Western NY. There was a total of four 6-month time periods, including the baseline period where all 6 clusters receive the control treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Manhattan and Queens | 6 months control: 18 months campaign. After the initial 6-month baseline period, the campaign began running in 2 regions in NYS including Manhattan (4 sites) and Queens (3 sites). The campaign remained active for the entire 18 months. All other regions/sites remained in the control condition (no campaign). |
| FG001 | Brooklyn and Hudson Valley/Central NY/Westchester/Middleton | 12 months control; 12 months campaign. After 12 months in the control condition, the campaign expanded to another 2 regions including Brooklyn (3 sites), Hudson Valley/Central NY/Westchester/Middleton (6 sites). All other regions/sites remained in the control condition (no campaign). |
| FG002 | Bronx and Staten Island/Long Island/Western NY | 18 months control; 6 months active campaign. After 18 months in the control condition, the campaign expanded to the final 2 regions including the Bronx (2 sites) and Staten Island/Long Island/Western NY (4 sites). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Pre-Campaign Activation |
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| Phase 1 (Active in 2 Regions) |
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| Phase 2 (Active in 4 Regions) |
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| Phase 3 (Active in All 6 Regions) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Campaign | Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation. |
| BG001 | Active Campaign |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Reducing the Duration of Untreated Psychosis | Evaluate the effectiveness of a search engine ad campaign on reducing the duration of untreated psychosis (DUP) by directly comparing DUP pre-campaign to DUP during the campaign. | Posted | Least Squares Mean | Standard Error | Days | 2 years |
|
2 years and 6 months
Definition did not differ.
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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 | Pre-Campaign | Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States prior to campaign initiation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Birnbaum | northwell | 718-470-8305 | mbirnbaum@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2022 | Aug 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Queens |
| New York |
| 11004 |
| United States |
| NOT COMPLETED |
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Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation.
Search engine advertisement campaign: This proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Rates of Referrals | Evaluate the effectiveness of a search engine ad campaign on rates of referrals by directly comparing referrals pre-campaign to referrals during the campaign. | Posted | Mean | Standard Deviation | number of new referrals | 2 years |
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|
| 0 |
| 356 |
| 0 |
| 356 |
| 0 |
| 356 |
| EG001 | Active Campaign | Investigators will measure the duration of untreated psychosis and rates of referrals to OnTrackNY programs throughout New York States during the active campaign initiation. | 0 | 342 | 0 | 342 | 0 | 342 |
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