Covid19, Vaccination
Conditions
Keywords
Covid-19, Vaccine Hesitancy, Vaccine Confidence
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPrimary 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).
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients seen by a PCP at a participating clinic site within 3-years prior to study start * Age \> / = 18 years
Exclusion criteria
* Patients who have received at least one dose of a COVID-19 vaccine series prior to the start of the intervention * Non-Massachusetts residents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Vaccination Within 3 Months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Vaccination Within 6 Months | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 10 |
| Control Arm Patients will receive usual care | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 79 Participants | 140 Participants | 219 Participants |
| Age, Categorical >=65 years | 1268 Participants | 988 Participants | 2256 Participants |
| Age, Categorical Between 18 and 65 years | 9649 Participants | 9720 Participants | 19369 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3937 Participants | 4466 Participants | 8403 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6676 Participants | 6171 Participants | 12847 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 383 Participants | 211 Participants | 594 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 66 Participants | 31 Participants | 97 Participants |
| Race (NIH/OMB) Asian | 314 Participants | 153 Participants | 467 Participants |
| Race (NIH/OMB) Black or African American | 1462 Participants | 705 Participants | 2167 Participants |
| Race (NIH/OMB) More than one race | 875 Participants | 2889 Participants | 3764 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 76 Participants | 53 Participants | 129 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2290 Participants | 985 Participants | 3275 Participants |
| Race (NIH/OMB) White | 5913 Participants | 6032 Participants | 11945 Participants |
| Region of Enrollment United States | 10996 participants | 10848 participants | 21844 participants |
| Sex/Gender, Customized Female | 6156 Participants | 6134 Participants | 12290 Participants |
| Sex/Gender, Customized Male | 4839 Participants | 4714 Participants | 9553 Participants |
| Sex/Gender, Customized Unknown/Missing | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: 3 months
Population: Intention to treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | COVID-19 Vaccination Within 3 Months | 137 Participants |
| Control Arm | COVID-19 Vaccination Within 3 Months | 98 Participants |
p-value: 0.0066Difference in adjusted % vaccinated
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).
Time frame: 6 months
Population: Intention to treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | COVID-19 Vaccination Within 6 Months | 235 Participants |
| Control Arm | COVID-19 Vaccination Within 6 Months | 162 Participants |
p-value: 0.0058Difference in adjusted % vaccinated