COVID-19 Vaccine Text Outreach

NCT04834726 | Completed Results

• 1 other identifier: 848696
• Study Type: interventional
• Target: 19,554
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Vaccination Uptake; Text Messaging; Outreach

Outcome Measures

Primary Outcomes (1)

• Dose 1 Completion

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

  1 month

Secondary Outcomes (2)

• Dose 1 Completion

  2 months

• Vaccine Completion

  2 months

Study Arms (9)

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.

Behavioral: Phone Call

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.

Behavioral: Opt-In (Call-Back); Behavioral: Standard Message

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.

Behavioral: Opt-In (Call-Back); Behavioral: Clinician Endorsement

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.

Behavioral: Opt-In (Call-Back); Behavioral: Scarcity

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.

Behavioral: Opt-In (Call-Back); Behavioral: Opt-Out Framing

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.

Behavioral: Opt-in (In-Bound); Behavioral: Standard Message

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.

Behavioral: Opt-in (In-Bound); Behavioral: Clinician Endorsement

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.

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

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.

Behavioral: Opt-in (In-Bound); Behavioral: Opt-Out Framing

Interventions

Opt-In (Call-Back) 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.

2A: Call Back + Standard Msg; 2B: Call Back + Clinician Endorsement; 2C: Call Back + Scarcity; 2D: Call Back + Opt-Out Framing

Opt-in (In-Bound) 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.

3A: In-Bound Call + Standard Msg; 3B: In-Bound Call + Clinician Endorsement; 3C: In-Bound Call + Scarcity; 3D: In-Bound Call + Opt-Out Framing

Standard Message BEHAVIORAL

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

2A: Call Back + Standard Msg; 3A: In-Bound Call + Standard Msg

Clinician Endorsement BEHAVIORAL

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

2B: Call Back + Clinician Endorsement; 3B: In-Bound Call + Clinician Endorsement

Scarcity BEHAVIORAL

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

2C: Call Back + Scarcity; 3C: In-Bound Call + Scarcity

Opt-Out Framing BEHAVIORAL

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

2D: Call Back + Opt-Out Framing; 3D: In-Bound Call + Opt-Out Framing

Phone Call BEHAVIORAL

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

1: Usual Care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 35696165 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Water Insecurity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drinking Water; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Shivan Mehta
• Organization: University of Pennsylvania

shivan.mehta@pennmedicine.upenn.edu

215-898-6027

Study Officials

• Shivan Mehta, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 29, 2021
• Primary Completion: June 4, 2021
• Study Completion: July 6, 2021
• Last Updated: March 27, 2023
• Results First Posted: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)