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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD016883-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The study aims to assess the impact of a multicomponent intervention to support Primary Care Provider (PCP) outreach to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA via a pragmatic, cluster randomized trial.
The goal of this study is to increase uptake of the COVID-19 vaccine among vulnerable populations through systematic primary care (PCP or clinic) text message outreach to unvaccinated patients, information provision via a study website, and resources to support PCPs.
The clinical trial will randomize 14 primary care clinics from three health systems in the Worcester, Massachusetts area to intervention or control. Eligible patients seen at a study clinic randomized to the intervention will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.
Providers at a study clinic randomized to the intervention will be provided resources to support their conversations with unvaccinated patients during the intervention. Resources will include access to the study website, factsheets to share with vaccine hesitant patients, prescription pads to be used to "prescribe' the website, and an electronic "smartphrase" that can automatically add information about the study website and how to schedule a COVID-19 vaccination to patients' After Visit Summary and/or clinic note.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Primary care text message outreach to unvaccinated patients and resources to support PCPs |
|
| Control Arm | No Intervention | Patients will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary care text message outreach to unvaccinated patients and resources to support PCPs | Behavioral | Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase"). |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Vaccination Within 3 Months | The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Vaccination Within 6 Months | The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 6 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly A Fisher, M.D | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01655 | United States |
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Eligible participants included patients seen at one of the study clinics within 3-years period prior to start of the intervention, age >= 18 years, who had not been vaccinated against COVID-19 and were Massachusetts residents.
14 primary care clinics from three health systems in Central Massachusetts - a tertiary care academic medical center with community practices and two local Federally Qualified Health Centers were included in the study. The 14 participating clinics were matched according to size, practice setting (academic, community, FQHC), availability of COVID-19 vaccines in-clinic, and baseline COVID-19 vaccination rates and block randomized in 4 blocks.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Primary care text message outreach to unvaccinated patients and resources to support PCPs Primary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase"). |
| FG001 | Control Arm | Patients will receive usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients that are ≥18, unvaccinated, visit at study clinic in past 3 years, alive at time of data pull, MA residents.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Primary care text message outreach to unvaccinated patients and resources to support PCPs Primary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase"). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | COVID-19 Vaccination Within 3 Months | The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR). | Intention to treat population | Posted | Count of Participants | Participants | 3 months |
|
Deaths and Adverse Events were not collected
Deaths and Adverse Events were not collected
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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 | Intervention Arm | Primary care text message outreach to unvaccinated patients and resources to support PCPs Primary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase"). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Fisher, MD | UMass Chan Medical School | 5088561975 | kimberly.fisher2@umassmed.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 | Aug 1, 2022 | Oct 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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The intervention will be tested using a pragmatic, cluster randomized clinical trial. Randomization will occur at the clinic level. Clinics will be matched by practice setting (Academic, Community, Federally Qualified Health Center) and other characteristics as possible. Within each pair, clinics will be randomly allocated to either the intervention or usual care Arm.
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|
| BG001 | Control Arm | Patients will receive usual care |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | 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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| Region of Enrollment | Number | participants |
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| OG001 | Control Arm | Patients will receive usual care |
|
|
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| Secondary | COVID-19 Vaccination Within 6 Months | The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 6 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR). | Intention to treat population | Posted | Count of Participants | Participants | 6 months |
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|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Arm | Patients will receive usual care | 0 | 0 | 0 | 0 | 0 | 0 |
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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 |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |