Covid19
Conditions
Keywords
Vaccination Uptake, Text Messaging, Outreach
Brief summary
This project aims to evaluate different approaches to increase COVID-19 vaccine uptake among at-risk patients at Penn Medicine in an equitable and systematic manner through a centralized outreach program. The investigators will evaluate different text-based scheduling and messaging approaches informed by behavioral science to increase uptake among eligible patients, including the use of clinician endorsement, opt-out framing, and scarcity.
Detailed description
This project will evaluate a centralized approach to increasing COVID through direct outreach to eligible patients via text messaging. This pragmatic randomized controlled trial has the following aims: Aim 1: To conduct systematic large scale text message outreach for vaccine delivery among a defined group of Penn Medicine in a way that advances equity. Aim 2: To offer different scheduling workflows through text messaging that might increase uptake and reduce disparities. Aim 3: To compare the equity and efficiency of different messages informed by behavioral science, including PCP endorsement, opt-out framing, and scarcity.
Interventions
BEHAVIORALOpt-In (Call-Back)
Messaging will include a prompt to agree to scheduling. If patient agrees, the access center will call these patients back to schedule, calling up to 3 times.
BEHAVIORALOpt-in (In-Bound)
Messaging will include a prompt to agree to scheduling followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
BEHAVIORALStandard Message
The message describes that the patient is eligible for the COVID vaccine.
BEHAVIORALClinician Endorsement
The message will describe an endorsement from the provider to get the vaccination.
BEHAVIORALScarcity
The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.
BEHAVIORALOpt-Out Framing
This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.
BEHAVIORALPhone Call
The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients of Penn Medicine aged 18+ who reside in Philadelphia and who have had at least 1 visit in the past 5 years with a Penn Medicine primary care provider (PCP)
Exclusion criteria
* Patients who have completed any dose of the vaccine at Penn Medicine, are currently scheduled to receive the vaccine, have externally documented vaccination records, or have previously received text-message based vaccine outreach.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose 1 Completion | 1 month | Percentage of patients who complete the first dose of the COVID vaccine within 1 month of initial outreach |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose 1 Completion | 2 months | Percentage of patients who complete the first dose of the COVID vaccine within 2 months of initial outreach |
| Vaccine Completion | 2 months | Percentage of patients who complete the vaccination process within 2 months of initial outreach |
Countries
United States
Participant flow
Recruitment details
Waiver of informed consent obtained. 19,554 patients randomized.
Participants by arm
| Arm | Count |
|---|---|
| 1: Usual Care Patients will receive a phone call to schedule their appointment from an Access Center representative. Access Center representatives will make up to 3 attempts to schedule an appointment with the patient. Patients randomized to this arm will not receive any text messaging.
Phone Call: The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging. | 390 |
| 2A: Call Back + Standard Msg The message describes that the patient is eligible for the COVID vaccine. Will include a prompt to agree to scheduling. The access center will call these patients back to schedule, calling up to 3 times.
Opt-In (Call-Back): Messaging will include a prompt to agree to scheduling. If patient agrees, the access center will call these patients back to schedule, calling up to 3 times.
Standard Message: The message describes that the patient is eligible for the COVID vaccine. | 1,971 |
| 2B: Call Back + Clinician Endorsement The message will describe an endorsement from the provider to get the vaccination. Will include a prompt to agree to scheduling. The access center will call these patients back to schedule, calling up to 3 times.
Opt-In (Call-Back): Messaging will include a prompt to agree to scheduling. If patient agrees, the access center will call these patients back to schedule, calling up to 3 times.
Clinician Endorsement: The message will describe an endorsement from the provider to get the vaccination. | 1,985 |
| 2C: Call Back + Scarcity The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine. Will include a prompt to agree to scheduling. The access center will call these patients back to schedule, calling up to 3 times.
Opt-In (Call-Back): Messaging will include a prompt to agree to scheduling. If patient agrees, the access center will call these patients back to schedule, calling up to 3 times.
Scarcity: The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine. | 1,977 |
| 2D: Call Back + Opt-Out Framing The message will highlight that a vaccine is reserved for the patient, implying that they need to opt-outWill include a prompt to agree to scheduling. The access center will call these patients back to schedule, calling up to 3 times.
Opt-In (Call-Back): Messaging will include a prompt to agree to scheduling. If patient agrees, the access center will call these patients back to schedule, calling up to 3 times.
Opt-Out Framing: This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out. | 1,957 |
| 3A: In-Bound Call + Standard Msg The message describes that the patient is eligible for the COVID vaccine. Will include a prompt to agree to scheduling, which will be followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
Opt-in (In-Bound): Messaging will include a prompt to agree to scheduling followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
Standard Message: The message describes that the patient is eligible for the COVID vaccine. | 1,918 |
| 3B: In-Bound Call + Clinician Endorsement The message will describe an endorsement from the provider to get the vaccination. Will include a prompt to agree to scheduling, which will be followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
Opt-in (In-Bound): Messaging will include a prompt to agree to scheduling followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
Clinician Endorsement: The message will describe an endorsement from the provider to get the vaccination. | 1,935 |
| 3C: In-Bound Call + Scarcity The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine. Will include a prompt to agree to scheduling, which will be followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
Opt-in (In-Bound): Messaging will include a prompt to agree to scheduling followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
Scarcity: The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine. | 1,934 |
| 3D: In-Bound Call + Opt-Out Framing The message will highlight that a vaccine is reserved for the patient, implying that they need to opt-out. Will include a prompt to agree to scheduling, which will be followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
Opt-in (In-Bound): Messaging will include a prompt to agree to scheduling followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
Opt-Out Framing: This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out. | 1,978 |
| Total | 16,045 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Excluded for receiving one or more vaccine doses prior to outreach | 82 | 422 | 404 | 415 | 428 | 462 | 447 | 449 | 400 |
Baseline characteristics
| Characteristic | 1: Usual Care | 2A: Call Back + Standard Msg | 2B: Call Back + Clinician Endorsement | 2C: Call Back + Scarcity | 2D: Call Back + Opt-Out Framing | 3A: In-Bound Call + Standard Msg | 3B: In-Bound Call + Clinician Endorsement | 3C: In-Bound Call + Scarcity | 3D: In-Bound Call + Opt-Out Framing | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 11.6 | 36.7 years STANDARD_DEVIATION 10.9 | 36.9 years STANDARD_DEVIATION 10.6 | 36.9 years STANDARD_DEVIATION 11.2 | 37.4 years STANDARD_DEVIATION 11.6 | 36.7 years STANDARD_DEVIATION 11 | 37.3 years STANDARD_DEVIATION 11.2 | 36.7 years STANDARD_DEVIATION 11.3 | 36.6 years STANDARD_DEVIATION 10.9 | 36.9 years STANDARD_DEVIATION 11.1 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 26 Participants | 143 Participants | 161 Participants | 139 Participants | 157 Participants | 152 Participants | 153 Participants | 159 Participants | 150 Participants | 1240 Participants |
| Race/Ethnicity, Customized Black | 127 Participants | 568 Participants | 597 Participants | 598 Participants | 575 Participants | 563 Participants | 550 Participants | 553 Participants | 575 Participants | 4706 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 26 Participants | 131 Participants | 114 Participants | 115 Participants | 126 Participants | 103 Participants | 131 Participants | 114 Participants | 107 Participants | 967 Participants |
| Race/Ethnicity, Customized More Than One Race | 3 Participants | 13 Participants | 14 Participants | 9 Participants | 14 Participants | 15 Participants | 15 Participants | 8 Participants | 13 Participants | 104 Participants |
| Race/Ethnicity, Customized Non-Hispanic/Latino | 352 Participants | 1785 Participants | 1824 Participants | 1829 Participants | 1800 Participants | 1781 Participants | 1761 Participants | 1779 Participants | 1815 Participants | 14726 Participants |
| Race/Ethnicity, Customized Other Ethnicity | 12 Participants | 55 Participants | 47 Participants | 33 Participants | 31 Participants | 34 Participants | 43 Participants | 41 Participants | 56 Participants | 352 Participants |
| Race/Ethnicity, Customized Other Race | 45 Participants | 207 Participants | 189 Participants | 208 Participants | 181 Participants | 197 Participants | 200 Participants | 205 Participants | 218 Participants | 1650 Participants |
| Race/Ethnicity, Customized White | 189 Participants | 1040 Participants | 1024 Participants | 1023 Participants | 1030 Participants | 991 Participants | 1017 Participants | 1009 Participants | 1022 Participants | 8345 Participants |
| Sex: Female, Male Female | 235 Participants | 1162 Participants | 1193 Participants | 1183 Participants | 1115 Participants | 1116 Participants | 1105 Participants | 1153 Participants | 1156 Participants | 9418 Participants |
| Sex: Female, Male Male | 155 Participants | 809 Participants | 792 Participants | 794 Participants | 842 Participants | 802 Participants | 830 Participants | 781 Participants | 822 Participants | 6627 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Dose 1 Completion
Percentage of patients who complete the first dose of the COVID vaccine within 1 month of initial outreach
Time frame: 1 month
Population: All randomized patients who were not excluded from analyses for receiving one or more vaccine doses prior to outreach.Comparisons were made between all patients assigned to a texting + outbound call arm (arms 2A+2B+2C+2D) and the outbound phone call only arm (arm 1), and between texting + inbound call arm (arms 3A+3B+3C+3D) and the outbound phone call only arm (arm 1). This was the original analysis as outlined in the protocol, which is why results are reported in this fashion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Outbound Phone Only | Dose 1 Completion | 14 Participants |
| Arm 2: Text + Outbound Call | Dose 1 Completion | 243 Participants |
| Arm 3: Text + Inbound Call | Dose 1 Completion | 253 Participants |
Secondary
Dose 1 Completion
Percentage of patients who complete the first dose of the COVID vaccine within 2 months of initial outreach
Time frame: 2 months
Population: All randomized patients who were not excluded from analyses for receiving one or more vaccine doses prior to outreach. Comparisons were made between all patients assigned to a texting + outbound call arm (arms 2A+2B+2C+2D) and the outbound phone call only arm (arm 1), and between texting + inbound call arm (arms 3A+3B+3C+3D) and the outbound phone call only arm (arm 1). This was the original analysis as outlined in the protocol, which is why results are reported in this fashion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Outbound Phone Only | Dose 1 Completion | 16 Participants |
| Arm 2: Text + Outbound Call | Dose 1 Completion | 315 Participants |
| Arm 3: Text + Inbound Call | Dose 1 Completion | 342 Participants |
Secondary
Vaccine Completion
Percentage of patients who complete the vaccination process within 2 months of initial outreach
Time frame: 2 months
Population: All randomized patients who were not excluded from analyses for receiving one or more vaccine doses prior to outreach. Comparisons were made between all patients assigned to a texting + outbound call arm (arms 2A+2B+2C+2D) and the outbound phone call only arm (arm 1), and between texting + inbound call arm (arms 3A+3B+3C+3D) and the outbound phone call only arm (arm 1). This was the original analysis as outlined in the protocol, which is why results are reported in this fashion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Outbound Phone Only | Vaccine Completion | 13 Participants |
| Arm 2: Text + Outbound Call | Vaccine Completion | 222 Participants |
| Arm 3: Text + Inbound Call | Vaccine Completion | 231 Participants |