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Clinical Trials/NCT04834726
NCT04834726CompletedNot Applicable

Pragmatic Trial of COVID Vaccine Text Outreach Interventions

University of Pennsylvania1 site in 1 country19,554 target enrollmentStarted: April 29, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19,554
Locations
1
Primary Endpoint
Dose 1 Completion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Health Services Research
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

1: Usual Care

Active Comparator

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.

Intervention: Phone Call (Behavioral)

2A: Call Back + Standard Msg

Experimental

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.

Intervention: Opt-In (Call-Back) (Behavioral)

2D: Call Back + Opt-Out Framing

Experimental

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.

Intervention: Opt-In (Call-Back) (Behavioral)

2A: Call Back + Standard Msg

Experimental

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.

Intervention: Standard Message (Behavioral)

2B: Call Back + Clinician Endorsement

Experimental

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.

Intervention: Opt-In (Call-Back) (Behavioral)

2B: Call Back + Clinician Endorsement

Experimental

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.

Intervention: Clinician Endorsement (Behavioral)

2C: Call Back + Scarcity

Experimental

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.

Intervention: Opt-In (Call-Back) (Behavioral)

2C: Call Back + Scarcity

Experimental

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.

Intervention: Scarcity (Behavioral)

2D: Call Back + Opt-Out Framing

Experimental

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.

Intervention: Opt-Out Framing (Behavioral)

3A: In-Bound Call + Standard Msg

Experimental

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.

Intervention: Opt-in (In-Bound) (Behavioral)

3A: In-Bound Call + Standard Msg

Experimental

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.

Intervention: Standard Message (Behavioral)

3B: In-Bound Call + Clinician Endorsement

Experimental

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.

Intervention: Opt-in (In-Bound) (Behavioral)

3B: In-Bound Call + Clinician Endorsement

Experimental

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.

Intervention: Clinician Endorsement (Behavioral)

3C: In-Bound Call + Scarcity

Experimental

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.

Intervention: Opt-in (In-Bound) (Behavioral)

3C: In-Bound Call + Scarcity

Experimental

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.

Intervention: Scarcity (Behavioral)

3D: In-Bound Call + Opt-Out Framing

Experimental

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: Opt-in (In-Bound) (Behavioral)

3D: In-Bound Call + Opt-Out Framing

Experimental

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: Opt-Out Framing (Behavioral)

Outcomes

Primary Outcomes

Dose 1 Completion

Time Frame: 1 month

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

Secondary Outcomes

  • Vaccine Completion(2 months)
  • Dose 1 Completion(2 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shivan J Mehta

Principal Investigator

University of Pennsylvania

Study Sites (1)

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