Trial Outcomes & Findings for SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Vaccination Rates Among Utah Community Health Centers (NCT NCT04939519)
NCT ID: NCT04939519
Last Updated: 2025-12-12
Results Overview
Proportion of patients who receive a COVID-19 vaccine out of the total patient population
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65300 participants
Primary outcome timeframe
12 months
Results posted on
2025-12-12
Participant Flow
Participant milestones
| Measure |
Text-Messaging (TM)
Population health management intervention that analyzes electronic health record data to automatically identify participants who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
|
Text-Messaging Plus Patient Navigation
Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Patient Navigation (PN): Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
|
|---|---|---|
|
Overall Study
STARTED
|
32594
|
32706
|
|
Overall Study
COMPLETED
|
32594
|
32706
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Vaccination Rates Among Utah Community Health Centers
Baseline characteristics by cohort
| Measure |
Text-Messaging (TM)
n=32594 Participants
Population health management intervention that analyzes electronic health record data to automatically identify participants who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
|
Text-Messaging Plus Patient Navigation
n=32706 Participants
Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Patient Navigation (PN): Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
|
Total
n=65300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-29 years old
|
9210 Participants
n=26 Participants
|
9096 Participants
n=24 Participants
|
18306 Participants
n=50 Participants
|
|
Age, Customized
30-64 years old
|
19902 Participants
n=26 Participants
|
20033 Participants
n=24 Participants
|
39935 Participants
n=50 Participants
|
|
Age, Customized
65 and older
|
3482 Participants
n=26 Participants
|
3577 Participants
n=24 Participants
|
7059 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Female
|
17535 Participants
n=26 Participants
|
17376 Participants
n=24 Participants
|
34911 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Male
|
13387 Participants
n=26 Participants
|
13687 Participants
n=24 Participants
|
27074 Participants
n=50 Participants
|
|
Sex/Gender, Customized
Other or unknown
|
1672 Participants
n=26 Participants
|
1643 Participants
n=24 Participants
|
3315 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12792 Participants
n=26 Participants
|
12820 Participants
n=24 Participants
|
25612 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16201 Participants
n=26 Participants
|
16324 Participants
n=24 Participants
|
32525 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3601 Participants
n=26 Participants
|
3562 Participants
n=24 Participants
|
7163 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native White
|
728 Participants
n=26 Participants
|
763 Participants
n=24 Participants
|
1491 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Asian
|
206 Participants
n=26 Participants
|
241 Participants
n=24 Participants
|
447 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
380 Participants
n=26 Participants
|
330 Participants
n=24 Participants
|
710 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
226 Participants
n=26 Participants
|
217 Participants
n=24 Participants
|
443 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
444 Participants
n=26 Participants
|
445 Participants
n=24 Participants
|
889 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
3602 Participants
n=26 Participants
|
3561 Participants
n=24 Participants
|
7163 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
White
|
21888 Participants
n=26 Participants
|
22002 Participants
n=24 Participants
|
43890 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
5120 Participants
n=26 Participants
|
5147 Participants
n=24 Participants
|
10267 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Proportion of patients who receive a COVID-19 vaccine out of the total patient population
Proportion of patients who receive a COVID-19 vaccine out of the total patient population
Outcome measures
| Measure |
Text-Messaging (TM)
n=32594 Participants
Population health management intervention that analyzes electronic health record data to automatically identify participants who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
|
Text-Messaging Plus Patient Navigation
n=32706 Participants
Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Patient Navigation (PN): Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
|
|---|---|---|
|
Uptake-Total
|
14308 Participants
|
14381 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Proportion of patients that respond to the Text Messaging intervention
Proportion of patients that respond to the Text Messaging intervention
Outcome measures
| Measure |
Text-Messaging (TM)
n=32594 Participants
Population health management intervention that analyzes electronic health record data to automatically identify participants who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
|
Text-Messaging Plus Patient Navigation
n=32706 Participants
Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Patient Navigation (PN): Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
|
|---|---|---|
|
Reach-TM Engage
|
5538 Participants
|
5587 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Proportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN
Proportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN
Outcome measures
| Measure |
Text-Messaging (TM)
Population health management intervention that analyzes electronic health record data to automatically identify participants who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
|
Text-Messaging Plus Patient Navigation
n=1469 Participants
Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Patient Navigation (PN): Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
|
|---|---|---|
|
Reach-PN Engage- Logistics Assistance
|
0 Participants
|
592 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Proportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN
Proportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN
Outcome measures
| Measure |
Text-Messaging (TM)
Population health management intervention that analyzes electronic health record data to automatically identify participants who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
|
Text-Messaging Plus Patient Navigation
n=175 Participants
Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Patient Navigation (PN): Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
|
|---|---|---|
|
Reach-PN Engage- Requested Navigation
|
0 Participants
|
122 Participants
|
Adverse Events
Text-Messaging (TM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text-Messaging Plus Patient Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Wetter
Huntsman Cancer Institute at University of Utah
Phone: 801-213-6178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place