Trial Outcomes & Findings for COVID-19 Vaccine Text Outreach (NCT NCT04834726)

NCT ID: NCT04834726

Last Updated: 2023-03-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

19554 participants

Primary outcome timeframe

1 month

Results posted on

2023-03-27

Participant Flow

Waiver of informed consent obtained. 19,554 patients randomized.

Participant milestones

Participant milestones
Measure	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. Phone Call: 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. 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. Standard Message: 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. 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. Clinician Endorsement: 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. 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. Scarcity: The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.	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. 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. Opt-Out Framing: This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.	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. 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. Standard Message: 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. 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. Clinician Endorsement: 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. 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. Scarcity: The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.	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. 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. Opt-Out Framing: This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.
Overall Study STARTED	472	2393	2389	2392	2385	2380	2382	2383	2378
Overall Study COMPLETED	390	1971	1985	1977	1957	1918	1935	1934	1978
Overall Study NOT COMPLETED	82	422	404	415	428	462	447	449	400

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Phone Call: 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. 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. Standard Message: 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. 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. Clinician Endorsement: 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. 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. Scarcity: The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.	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. 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. Opt-Out Framing: This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.	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. 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. Standard Message: 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. 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. Clinician Endorsement: 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. 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. Scarcity: The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.	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. 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. Opt-Out Framing: This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.
Overall Study Excluded for receiving one or more vaccine doses prior to outreach	82	422	404	415	428	462	447	449	400

Baseline Characteristics

COVID-19 Vaccine Text Outreach

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1: Usual Care n=390 Participants 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. Phone Call: The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging.	2A: Call Back + Standard Msg n=1971 Participants 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. 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. Standard Message: The message describes that the patient is eligible for the COVID vaccine.	2B: Call Back + Clinician Endorsement n=1985 Participants 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. 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. Clinician Endorsement: The message will describe an endorsement from the provider to get the vaccination.	2C: Call Back + Scarcity n=1977 Participants 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. 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. Scarcity: The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.	2D: Call Back + Opt-Out Framing n=1957 Participants 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. 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. Opt-Out Framing: This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.	3A: In-Bound Call + Standard Msg n=1918 Participants 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. 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. Standard Message: The message describes that the patient is eligible for the COVID vaccine.	3B: In-Bound Call + Clinician Endorsement n=1935 Participants 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. 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. Clinician Endorsement: The message will describe an endorsement from the provider to get the vaccination.	3C: In-Bound Call + Scarcity n=1934 Participants 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. 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. Scarcity: The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.	3D: In-Bound Call + Opt-Out Framing n=1978 Participants 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. 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. Opt-Out Framing: This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.	Total n=16045 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 11.6 • n=5 Participants	36.7 years STANDARD_DEVIATION 10.9 • n=7 Participants	36.9 years STANDARD_DEVIATION 10.6 • n=5 Participants	36.9 years STANDARD_DEVIATION 11.2 • n=4 Participants	37.4 years STANDARD_DEVIATION 11.6 • n=21 Participants	36.7 years STANDARD_DEVIATION 11.0 • n=8 Participants	37.3 years STANDARD_DEVIATION 11.2 • n=8 Participants	36.7 years STANDARD_DEVIATION 11.3 • n=24 Participants	36.6 years STANDARD_DEVIATION 10.9 • n=42 Participants	36.9 years STANDARD_DEVIATION 11.1 • n=42 Participants
Sex: Female, Male Female	235 Participants n=5 Participants	1162 Participants n=7 Participants	1193 Participants n=5 Participants	1183 Participants n=4 Participants	1115 Participants n=21 Participants	1116 Participants n=8 Participants	1105 Participants n=8 Participants	1153 Participants n=24 Participants	1156 Participants n=42 Participants	9418 Participants n=42 Participants
Sex: Female, Male Male	155 Participants n=5 Participants	809 Participants n=7 Participants	792 Participants n=5 Participants	794 Participants n=4 Participants	842 Participants n=21 Participants	802 Participants n=8 Participants	830 Participants n=8 Participants	781 Participants n=24 Participants	822 Participants n=42 Participants	6627 Participants n=42 Participants
Race/Ethnicity, Customized White	189 Participants n=5 Participants	1040 Participants n=7 Participants	1024 Participants n=5 Participants	1023 Participants n=4 Participants	1030 Participants n=21 Participants	991 Participants n=8 Participants	1017 Participants n=8 Participants	1009 Participants n=24 Participants	1022 Participants n=42 Participants	8345 Participants n=42 Participants
Race/Ethnicity, Customized Black	127 Participants n=5 Participants	568 Participants n=7 Participants	597 Participants n=5 Participants	598 Participants n=4 Participants	575 Participants n=21 Participants	563 Participants n=8 Participants	550 Participants n=8 Participants	553 Participants n=24 Participants	575 Participants n=42 Participants	4706 Participants n=42 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	26 Participants n=5 Participants	143 Participants n=7 Participants	161 Participants n=5 Participants	139 Participants n=4 Participants	157 Participants n=21 Participants	152 Participants n=8 Participants	153 Participants n=8 Participants	159 Participants n=24 Participants	150 Participants n=42 Participants	1240 Participants n=42 Participants
Race/Ethnicity, Customized More Than One Race	3 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	9 Participants n=4 Participants	14 Participants n=21 Participants	15 Participants n=8 Participants	15 Participants n=8 Participants	8 Participants n=24 Participants	13 Participants n=42 Participants	104 Participants n=42 Participants
Race/Ethnicity, Customized Other Race	45 Participants n=5 Participants	207 Participants n=7 Participants	189 Participants n=5 Participants	208 Participants n=4 Participants	181 Participants n=21 Participants	197 Participants n=8 Participants	200 Participants n=8 Participants	205 Participants n=24 Participants	218 Participants n=42 Participants	1650 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic/Latino	26 Participants n=5 Participants	131 Participants n=7 Participants	114 Participants n=5 Participants	115 Participants n=4 Participants	126 Participants n=21 Participants	103 Participants n=8 Participants	131 Participants n=8 Participants	114 Participants n=24 Participants	107 Participants n=42 Participants	967 Participants n=42 Participants
Race/Ethnicity, Customized Non-Hispanic/Latino	352 Participants n=5 Participants	1785 Participants n=7 Participants	1824 Participants n=5 Participants	1829 Participants n=4 Participants	1800 Participants n=21 Participants	1781 Participants n=8 Participants	1761 Participants n=8 Participants	1779 Participants n=24 Participants	1815 Participants n=42 Participants	14726 Participants n=42 Participants
Race/Ethnicity, Customized Other Ethnicity	12 Participants n=5 Participants	55 Participants n=7 Participants	47 Participants n=5 Participants	33 Participants n=4 Participants	31 Participants n=21 Participants	34 Participants n=8 Participants	43 Participants n=8 Participants	41 Participants n=24 Participants	56 Participants n=42 Participants	352 Participants n=42 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 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.

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

Outcome measures

Outcome measures
Measure	Arm 1: Outbound Phone Only n=390 Participants Patients in this arm received a call from the patient vaccine access center to schedule a vaccine appointment.	Arm 2: Text + Outbound Call n=7890 Participants Patients in this arm received a text message asking if they would like to receive a call from the patient vaccine access center. Includes Arms 2A+2B+2C+2D	Arm 3: Text + Inbound Call n=7765 Participants Patients in this arm received a text asking if they would like to receive the phone number to call the patient access center to schedule their vaccine appointment. This arm includes 3A+3B+3C+3D.
Dose 1 Completion	14 Participants	243 Participants	253 Participants

SECONDARY outcome

Timeframe: 2 months

Population: 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.

Percentage of patients who complete the first dose of the COVID vaccine within 2 months of initial outreach

Outcome measures

Outcome measures
Measure	Arm 1: Outbound Phone Only n=390 Participants Patients in this arm received a call from the patient vaccine access center to schedule a vaccine appointment.	Arm 2: Text + Outbound Call n=7890 Participants Patients in this arm received a text message asking if they would like to receive a call from the patient vaccine access center. Includes Arms 2A+2B+2C+2D	Arm 3: Text + Inbound Call n=7765 Participants Patients in this arm received a text asking if they would like to receive the phone number to call the patient access center to schedule their vaccine appointment. This arm includes 3A+3B+3C+3D.
Dose 1 Completion	16 Participants	315 Participants	342 Participants

SECONDARY outcome

Timeframe: 2 months

Population: 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.

Percentage of patients who complete the vaccination process within 2 months of initial outreach

Outcome measures

Outcome measures
Measure	Arm 1: Outbound Phone Only n=390 Participants Patients in this arm received a call from the patient vaccine access center to schedule a vaccine appointment.	Arm 2: Text + Outbound Call n=7890 Participants Patients in this arm received a text message asking if they would like to receive a call from the patient vaccine access center. Includes Arms 2A+2B+2C+2D	Arm 3: Text + Inbound Call n=7765 Participants Patients in this arm received a text asking if they would like to receive the phone number to call the patient access center to schedule their vaccine appointment. This arm includes 3A+3B+3C+3D.
Vaccine Completion	13 Participants	222 Participants	231 Participants

Additional Information

Dr. Shivan Mehta

University of Pennsylvania

Phone: 215-898-6027

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place