Trial Outcomes & Findings for Trusted Messengers: Intervention to Promote COVID-19 Vaccination (NCT NCT04981392)

Last Updated: 2024-11-26

Results Overview

The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).

Recruitment status

COMPLETED

Study phase

Target enrollment

21844 participants

Primary outcome timeframe

3 months

Results posted on

2024-11-26

Participant Flow

14 primary care clinics from three health systems in Central Massachusetts - a tertiary care academic medical center with community practices and two local Federally Qualified Health Centers were included in the study. The 14 participating clinics were matched according to size, practice setting (academic, community, FQHC), availability of COVID-19 vaccines in-clinic, and baseline COVID-19 vaccination rates and block randomized in 4 blocks.

Eligible participants included patients seen at one of the study clinics within 3-years period prior to start of the intervention, age \>= 18 years, who had not been vaccinated against COVID-19 and were Massachusetts residents.

Unit of analysis: Clinic Sites

Participant milestones

Participant milestones
Measure	Intervention Arm Primary care text message outreach to unvaccinated patients and resources to support PCPs Primary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").	Control Arm Patients will receive usual care
Overall Study STARTED	10996 7	10848 7
Overall Study COMPLETED	10996 7	10848 7
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trusted Messengers: Intervention to Promote COVID-19 Vaccination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=10 Participants Primary care text message outreach to unvaccinated patients and resources to support PCPs Primary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").	Control Arm n=10 Participants Patients will receive usual care	Total n=21844 Participants Total of all reporting groups
Age, Categorical <=18 years	79 Participants n=5 Participants	140 Participants n=7 Participants	219 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9649 Participants n=5 Participants	9720 Participants n=7 Participants	19369 Participants n=5 Participants
Age, Categorical >=65 years	1268 Participants n=5 Participants	988 Participants n=7 Participants	2256 Participants n=5 Participants
Sex/Gender, Customized Female	6156 Participants n=5 Participants	6134 Participants n=7 Participants	12290 Participants n=5 Participants
Sex/Gender, Customized Male	4839 Participants n=5 Participants	4714 Participants n=7 Participants	9553 Participants n=5 Participants
Sex/Gender, Customized Unknown/Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3937 Participants n=5 Participants	4466 Participants n=7 Participants	8403 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6676 Participants n=5 Participants	6171 Participants n=7 Participants	12847 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	383 Participants n=5 Participants	211 Participants n=7 Participants	594 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	66 Participants n=5 Participants	31 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) Asian	314 Participants n=5 Participants	153 Participants n=7 Participants	467 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	76 Participants n=5 Participants	53 Participants n=7 Participants	129 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1462 Participants n=5 Participants	705 Participants n=7 Participants	2167 Participants n=5 Participants
Race (NIH/OMB) White	5913 Participants n=5 Participants	6032 Participants n=7 Participants	11945 Participants n=5 Participants
Race (NIH/OMB) More than one race	875 Participants n=5 Participants	2889 Participants n=7 Participants	3764 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2290 Participants n=5 Participants	985 Participants n=7 Participants	3275 Participants n=5 Participants
Region of Enrollment United States	10996 participants n=5 Participants	10848 participants n=7 Participants	21844 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Intention to treat population

Outcome measures

Outcome measures
Measure	Intervention Arm n=10996 Participants Primary care text message outreach to unvaccinated patients and resources to support PCPs Primary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").	Control Arm n=10848 Participants Patients will receive usual care
COVID-19 Vaccination Within 3 Months	137 Participants	98 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Intention to treat population

The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 6 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).

Outcome measures

Outcome measures
Measure	Intervention Arm n=10996 Participants Primary care text message outreach to unvaccinated patients and resources to support PCPs Primary care text message outreach to unvaccinated patients and resources to support PCPs: Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").	Control Arm n=10848 Participants Patients will receive usual care
COVID-19 Vaccination Within 6 Months	235 Participants	162 Participants

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

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

Kimberly Fisher, MD

UMass Chan Medical School

Phone: 5088561975

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place