Effect of Text Messaging and Behavioral Interventions on COVID-19 Vaccination Uptake: A Randomized Clinical Trial.

Importance: COVID-19 vaccine uptake among urban populations remains low. Objective: To evaluate whether text messaging with outbound or inbound scheduling and behaviorally informed content might increase COVID-19 vaccine uptake. Design, Setting, and Participants: This randomized clinical trial with a factorial design was conducted from April 29 to July 6, 2021, in an urban academic health system. The trial comprised 16 045 patients at least 18 years of age in Philadelphia, Pennsylvania, with at least 1 primary care visit in the past 5 years, or a future scheduled primary care visit within the next 3 months, who were unresponsive to prior outreach. The study was prespecified in the trial protocol, and data were obtained from the intent-to-treat population. Interventions: Eligible patients were randomly assigned in a 1:20:20 ratio to (1) outbound telephone call only by call center, (2) text message and outbound telephone call by call center to those who respond, or (3) text message, with patients instructed to make an inbound telephone call to a hotline. Patients in groups 2 and 3 were concurrently randomly assigned in a 1:1:1:1 ratio to receive different content: standard messaging, clinician endorsement (eg, "Dr. XXX recommends"), scarcity ("limited supply available"), or endowment framing ("We have reserved a COVID-19 vaccine appointment for you"). Main Outcomes and Measures: The primary outcome was the proportion of patients who completed the first dose of the COVID-19 vaccine within 1 month, according to the electronic health record. Secondary outcomes were the completion of the first dose within 2 months and completion of the vaccination series within 2 months of initial outreach. Additional outcomes included the percentage of patients with invalid cell phone numbers (wrong number or nontextable), no response to text messaging, the percentage of patients scheduled for the vaccine, text message responses, and the number of telephone calls made by the access center. Analysis was on an intention-to-treat basis. Results: Among the 16 045 patients included, the mean (SD) age was 36.9 (11.1) years; 9418 (58.7%) were women; 12 869 (80.2%) had commercial insurance, and 2283 (14.2%) were insured by Medicaid; 8345 (52.0%) were White, 4706 (29.3%) were Black, and 967 (6.0%) were Hispanic or Latino. At 1 month, 14 of 390 patients (3.6% [95% CI, 1.7%-5.4%]) in the outbound telephone call-only group completed 1 vaccine dose, as did 243 of 7890 patients (3.1% [95% CI, 2.7%-3.5%]) in the text plus outbound call group (absolute difference, -0.5% [95% CI, -2.4% to 1.4%]; P = .57) and 253 of 7765 patients (3.3% [95% CI, 2.9%-3.7%]) in the text plus inbound call group (absolute difference, -0.3% [95% CI, -2.2% to 1.6%]; P = .72). Among the 15 655 patients receiving text messaging, 118 of 3889 patients (3.0% [95% CI, 2.5%-3.6%]) in the standard messaging group completed 1 vaccine dose, as did 135 of 3920 patients (3.4% [95% CI, 2.9%-4.0%]) in the clinician endorsement group (absolute difference, 0.4% [95% CI, -0.4% to 1.2%]; P = .31), 100 of 3911 patients (2.6% [95% CI, 2.1%-3.1%]) in the scarcity group (absolute difference, -0.5% [95% CI, -1.2% to 0.3%]; P = .20), and 143 of 3935 patients (3.6% [95% CI, 3.0%-4.2%]) in the endowment group (absolute difference, 0.6% [95% CI, -0.2% to 1.4%]; P = .14). Conclusions and Relevance: There was no detectable increase in vaccination uptake among patients receiving text messaging compared with telephone calls only or behaviorally informed message content. Trial Registration: ClinicalTrials.gov Identifier: NCT04834726.

Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists.

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.