search
Back to results

COVID-19 Vaccine Text Outreach

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opt-In (Call-Back)
Opt-in (In-Bound)
Standard Message
Clinician Endorsement
Scarcity
Opt-Out Framing
Phone Call
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19 focused on measuring Vaccination Uptake, Text Messaging, Outreach

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Dose 1 Completion
Percentage of patients who complete the first dose of the COVID vaccine within 1 month of initial outreach

Secondary Outcome Measures

Dose 1 Completion
Percentage of patients who complete the first dose of the COVID vaccine within 2 months of initial outreach
Vaccine Completion
Percentage of patients who complete the vaccination process within 2 months of initial outreach

Full Information

First Posted
April 6, 2021
Last Updated
March 23, 2023
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT04834726
Brief Title
COVID-19 Vaccine Text Outreach
Official Title
Pragmatic Trial of COVID Vaccine Text Outreach Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
July 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Vaccination Uptake, Text Messaging, Outreach

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2A: Call Back + Standard Msg
Arm Type
Experimental
Arm Description
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.
Arm Title
2B: Call Back + Clinician Endorsement
Arm Type
Experimental
Arm Description
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.
Arm Title
2C: Call Back + Scarcity
Arm Type
Experimental
Arm Description
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.
Arm Title
2D: Call Back + Opt-Out Framing
Arm Type
Experimental
Arm Description
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.
Arm Title
3A: In-Bound Call + Standard Msg
Arm Type
Experimental
Arm Description
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.
Arm Title
3B: In-Bound Call + Clinician Endorsement
Arm Type
Experimental
Arm Description
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.
Arm Title
3C: In-Bound Call + Scarcity
Arm Type
Experimental
Arm Description
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.
Arm Title
3D: In-Bound Call + Opt-Out Framing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Opt-In (Call-Back)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Opt-in (In-Bound)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Message
Intervention Description
The message describes that the patient is eligible for the COVID vaccine.
Intervention Type
Behavioral
Intervention Name(s)
Clinician Endorsement
Intervention Description
The message will describe an endorsement from the provider to get the vaccination.
Intervention Type
Behavioral
Intervention Name(s)
Scarcity
Intervention Description
The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.
Intervention Type
Behavioral
Intervention Name(s)
Opt-Out Framing
Intervention Description
This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.
Intervention Type
Behavioral
Intervention Name(s)
Phone Call
Intervention Description
The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging.
Primary Outcome Measure Information:
Title
Dose 1 Completion
Description
Percentage of patients who complete the first dose of the COVID vaccine within 1 month of initial outreach
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Dose 1 Completion
Description
Percentage of patients who complete the first dose of the COVID vaccine within 2 months of initial outreach
Time Frame
2 months
Title
Vaccine Completion
Description
Percentage of patients who complete the vaccination process within 2 months of initial outreach
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35696165
Citation
Mehta SJ, Mallozzi C, Shaw PA, Reitz C, McDonald C, Vandertuyn M, Balachandran M, Kopinsky M, Sevinc C, Johnson A, Ward R, Park SH, Snider CK, Rosin R, Asch DA. Effect of Text Messaging and Behavioral Interventions on COVID-19 Vaccination Uptake: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2216649. doi: 10.1001/jamanetworkopen.2022.16649.
Results Reference
derived

Learn more about this trial

COVID-19 Vaccine Text Outreach

We'll reach out to this number within 24 hrs