Covid19NCT04834726

COVID-19 Vaccine Text Outreach

A study testing Opt-In (Call-Back), Opt-in (In-Bound) and Standard Message in people with Covid19, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Covid19
What is being tested?: Opt-In (Call-Back), Opt-in (In-Bound) and Standard Message
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19,554 participants
Where: 1 siteUnited States
Study dates: 29 Apr 2021to 6 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Pragmatic Trial of COVID Vaccine Text Outreach Interventions

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.

Read the 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.

Conditions: Covid19
Being tested: Opt-In (Call-Back), Opt-in (In-Bound), Standard Message, Clinician Endorsement, Scarcity
Keywords: Vaccination Uptake, Text Messaging, Outreach
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opt-In (Call-Back)Behavioural
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-in (In-Bound)Behavioural
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 MessageBehavioural
The message describes that the patient is eligible for the COVID vaccine.
Clinician EndorsementBehavioural
The message will describe an endorsement from the provider to get the vaccination.
ScarcityBehavioural
The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.
Opt-Out FramingBehavioural
This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.
Phone CallBehavioural
The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging.

Study groups in NCT04834726
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Opt-in (In-Bound); Behavioral: Opt-Out Framing

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 20216 Jul 2021

First posted8 Apr 2021
Study start29 Apr 2021
Primary completion4 Jun 2021
Study completion6 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 19,554 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04834726
Sponsor's protocol ID: 848696
Status last verified: Mar 2023
First submitted: 6 Apr 2021
Last updated: 27 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35696165

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV

All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pragmatic Trial of COVID Vaccine Text Outreach Interventions
ClinicalTrials.gov ID: NCT04834726
Acronym / sponsor ID: 848696
Conditions: Covid19
Keywords: Vaccination Uptake, Text Messaging, Outreach
Study type: Interventional
Recruitment status: Completed
Enrolment: 19,554 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 29 Apr 2021 (actual)
Primary completion: 4 Jun 2021 (actual)
Study completion: 6 Jul 2021 (actual)
First posted: 8 Apr 2021 (actual)
Results: Posted 24 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
1: Usual Care	Active comparator	Behavioral: Phone CallPatients 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.
2A: Call Back + Standard Msg	Experimental	Behavioral: Opt-In (Call-Back), Behavioral: Standard MessageThe 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.
2B: Call Back + Clinician Endorsement	Experimental	Behavioral: Opt-In (Call-Back), Behavioral: Clinician EndorsementThe 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.
2C: Call Back + Scarcity	Experimental	Behavioral: Opt-In (Call-Back), Behavioral: ScarcityThe 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.
2D: Call Back + Opt-Out Framing	Experimental	Behavioral: Opt-In (Call-Back), Behavioral: Opt-Out FramingThe 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.
3A: In-Bound Call + Standard Msg	Experimental	Behavioral: Opt-in (In-Bound), Behavioral: Standard MessageThe 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.
3B: In-Bound Call + Clinician Endorsement	Experimental	Behavioral: Opt-in (In-Bound), Behavioral: Clinician EndorsementThe 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.
3C: In-Bound Call + Scarcity	Experimental	Behavioral: Opt-in (In-Bound), Behavioral: ScarcityThe 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.
3D: In-Bound Call + Opt-Out Framing	Experimental	Behavioral: Opt-in (In-Bound), Behavioral: Opt-Out FramingThe 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	2A: Call Back + Standard Msg, 2B: Call Back + Clinician Endorsement, 2C: Call Back + Scarcity, 2D: Call Back + Opt-Out Framing
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.	Behavioural	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 MessageThe message describes that the patient is eligible for the COVID vaccine.	Behavioural	2A: Call Back + Standard Msg, 3A: In-Bound Call + Standard Msg
Clinician EndorsementThe message will describe an endorsement from the provider to get the vaccination.	Behavioural	2B: Call Back + Clinician Endorsement, 3B: In-Bound Call + Clinician Endorsement
ScarcityThe message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.	Behavioural	2C: Call Back + Scarcity, 3C: In-Bound Call + Scarcity
Opt-Out FramingThis will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.	Behavioural	2D: Call Back + Opt-Out Framing, 3D: In-Bound Call + Opt-Out Framing
Phone CallThe access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging.	Behavioural	1: Usual Care

Primary outcome

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

2 secondary outcomes

Dose 1 Completion
Time frame: 2 months
Vaccine Completion
Time frame: 2 months

Results and safety

Results posted to the registry on 24 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1: Usual Care	472	390
2A: Call Back + Standard Msg	2,393	1,971
2B: Call Back + Clinician Endorsement	2,389	1,985
2C: Call Back + Scarcity	2,392	1,977
2D: Call Back + Opt-Out Framing	2,385	1,957
3A: In-Bound Call + Standard Msg	2,380	1,918
3B: In-Bound Call + Clinician Endorsement	2,382	1,935
3C: In-Bound Call + Scarcity	2,383	1,934
3D: In-Bound Call + Opt-Out Framing	2,378	1,978

Primary outcome: Dose 1 Completion

Time frame: 1 month. Count of participants. Unit: Participants

Measure	Arm 1: Outbound Phone Only n = 390	Arm 2: Text + Outbound Call n = 7890	Arm 3: Text + Inbound Call n = 7765
Value	14	243	253

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
1: Usual Care	0 of 0	0 of 0
2A: Call Back + Standard Msg	0 of 0	0 of 0
2B: Call Back + Clinician Endorsement	0 of 0	0 of 0
2C: Call Back + Scarcity	0 of 0	0 of 0
2D: Call Back + Opt-Out Framing	0 of 0	0 of 0
3A: In-Bound Call + Standard Msg	0 of 0	0 of 0
3B: In-Bound Call + Clinician Endorsement	0 of 0	0 of 0
3C: In-Bound Call + Scarcity	0 of 0	0 of 0
3D: In-Bound Call + Opt-Out Framing	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35696165Mehta 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.
Individual participant dataSharing planned: No

Related trials for Covid19

Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shivan Mehta, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Opt-In (Call-Back), Opt-in (In-Bound) and Standard Message in people with Covid19, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose 1 Completion (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04834726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.