COVID-19 Vaccine Text Outreach

NCT ID: NCT04834726

Last Updated: 2023-03-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-29

Study Completion Date

2021-07-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Phone Call

Intervention Type BEHAVIORAL

The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging.

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.

Group Type EXPERIMENTAL

Opt-In (Call-Back)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

The message describes that the patient is eligible for the COVID vaccine.

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.

Group Type EXPERIMENTAL

Opt-In (Call-Back)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

The message will describe an endorsement from the provider to get the vaccination.

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.

Group Type EXPERIMENTAL

Scarcity

Intervention Type BEHAVIORAL

The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.

Opt-In (Call-Back)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Opt-Out Framing

Intervention Type BEHAVIORAL

This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.

Opt-In (Call-Back)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Opt-in (In-Bound)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

The message describes that the patient is eligible for the COVID vaccine.

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.

Group Type EXPERIMENTAL

Opt-in (In-Bound)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

The message will describe an endorsement from the provider to get the vaccination.

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.

Group Type EXPERIMENTAL

Scarcity

Intervention Type BEHAVIORAL

The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.

Opt-in (In-Bound)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Opt-Out Framing

Intervention Type BEHAVIORAL

This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.

Opt-in (In-Bound)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scarcity

The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.

Intervention Type BEHAVIORAL

Opt-Out Framing

This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.

Intervention Type BEHAVIORAL

Phone Call

The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Standard Message

The message describes that the patient is eligible for the COVID vaccine.

Intervention Type BEHAVIORAL

Clinician Endorsement

The message will describe an endorsement from the provider to get the vaccination.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shivan J Mehta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shivan Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35696165 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

848696

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

COVID-19 Messaging for Vaccination
NCT05182554 COMPLETED NA