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| ID | Type | Description | Link |
|---|---|---|---|
| 75F40120C00174 | Other Grant/Funding Number | FDA |
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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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Based on the outcomes of the initial study (NCT05348603), this optimization study will employ the most effective interventions (letters and messages) and distribute these communications to underrepresented minorities to further promote interest in research. Optimized language will be distributed in English, Spanish, Portuguese, Chinese, Arabic, or Haitian Creole, based on preferred language identified in the patient profile in an electronic medical records system.
The primary objective of the optimization study is to examine the effectiveness on increasing interest in research of an optimized letter versus a generic letter; an optimized message versus a generic message; and an optimized letter and an optimized message versus a generic letter and a generic message.
The secondary objective of the optimization study is to examine the effectiveness on increasing participation in research of an optimized letter versus a generic letter, an optimized message versus a generic message, an optimized letter and an optimized message versus a generic letter and a generic message.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized Letter | Experimental | Participants receive an 'optimized' letter. |
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| Optimized Message | Experimental | Participants receive an 'optimized' message. |
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| Optimized Letter + Optimized Message | Experimental | Participants receive both a 'optimized' letter and a 'optimized' message. |
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| Generic Letter | Active Comparator | Participants receive a 'usual' letter. |
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| Generic Message | Active Comparator | Participants receive a 'usual' message. |
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| Generic Letter + Generic Message | Experimental | Participants receive both a 'usual' letter and a 'usual' message. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Letter | Other | Patients receive a traditional letter. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who create a research profile | The outcome will be assessed by querying the patient's electronic medical record to determine whether the patient has registered in the Yale University Volunteer Database. This database is comprised of patients who agree to be contacted if there is a study at Yale that meets their interests. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who enroll in a research study | The outcome will be assessed by querying our clinical trials management system or electronic health record system to determine if the patient has consented to participate in a research study. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Smith, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Direct to Patient Message | Other | Patients receive a direct to patient message via the portal. |
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| Optimized Letter | Other | Patients receive an optimized letter. |
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| Direct to Patient Message - Optimized | Other | Patients receive an optimized direct to patient message via the portal. |
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