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| Name | Class |
|---|---|
| Adelante Healthcare | UNKNOWN |
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This study will deploy a multimodal pragmatic intervention to improve vaccine uptake in priority populations and address vaccine hesitancy to improve access by using a proactive organized population-based outreach leveraging health information technology with tailored navigation support to address mistrust and social barriers.
This study will deploy a multimodal pragmatic intervention to improve vaccine uptake in priority populations through a proactive organized population-based outreach approach. It will leverage health information technology with tailored navigation support to address mistrust and social barriers. Study key objectives are to:
conduct a survey of patients to assess and track barriers, intent, and sources of information on COVID vaccine over time.
Determine whether a primary care physician (PCP) endorsement with or without interactive digital communication plus navigation is more effective in promoting uptake of COVID-19 vaccine than general messages from the clinic. Patients will be randomized to one of three arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short message service (SMS) | Active Comparator | Subjects will receive vaccine availability and appointment information via SMS. |
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| Personalized text message | Experimental | Subjects will receive vaccine availability and appointment information via a personalized message text from the primary care provider (PCP). |
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| Interactive or 2-way SMS | Experimental | Subjects will receive vaccine availability and appointment information via interactive 2-way SMS options. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS delivery of information | Behavioral | Patients are informed via SMS that COVID-19 vaccine doses are available and advised to schedule an appointment. Links to information or phone for scheduling will be provided. Messages mimic the clinic's usual practice of information delivery to patients |
| Measure | Description | Time Frame |
|---|---|---|
| Dose 1 COVID-19 Vaccine | Primary outcome will be the receipt of the first dose of any of the COVID-19 vaccines with FDA emergency use authorization | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dose 2 COVID-19 Vaccine | Examine receipt of all doses as recommended by the manufacturer (for most vaccine2 doses). | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement | We will assess engagement with the 2-way SMS options as well as use of online appointment scheduling | 30 days |
Inclusion Criteria: 18 years and older, receiving care at Adelante Healthcare and not vaccinated or already scheduled for vaccination through the health center's appointment system Exclusion Criteria: Patient younger than 18 or who have been previously or are selected for vaccination during or prior to the week of study enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Chyke Doubeni, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004347 | Drug Interactions |
| ID | Term |
|---|---|
| D000069437 | Pharmacological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
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Arm 1: Patient is informed via SMS of vaccine availability and advised to schedule an appointment.
Arm 2: Same as Arm 1 but delivered as a personalized message text from the PCP. Arm 3: Patients assigned to Arm 3 will receive the same message in the Arm 2 intervention. In addition, they will be given interactive or 2-way SMS options to obtain additional information about COVID vaccine.
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| Personalized text message delivery of information | Behavioral | Patients are informed via SMS that COVID-19 vaccine doses are available and advised to schedule an appointment. The SMS message is personalized as a recommendation from the primary care clinician |
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| Interactive or 2-way SMS delivery of information | Behavioral | This intervention is same as in the Arm 2 using personalized messaging from the PCP. In addition, patients are given interactive or 2-way SMS options to obtain additional information about COVID vaccine and answers to frequently asked questions. |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |