SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Vaccination Rates Among Utah Community Health Centers

Covid19 Clinical Trial

Official title:

SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Among Utah Community Health Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04939519
• Other study ID #: 00136001_2
• Secondary ID: 3UL1TR002538-03S
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SCALE-UP Utah is a community-academic partnership to address COVID-19 among Utah community health centers. The long-term objective of the project is to increase the reach, acceptance, and uptake of COVID-19 vaccines among Utah's Community Health Center patient population. The study will compare two practical, feasible, scalable interventions to increase COVID-19 vaccine uptake in Utah Community Health Centers:

1. Text Messaging (TM): population health management (PHM) intervention that analyzes EHR data to automatically identify patients eligible for COVID-19 vaccination and uses bi-directional text messaging to help connect patients to a vaccination site;

2. Patient Navigation (PN): PHM intervention to increase vaccination uptake among eligible patients (identified via TM) using patient navigation (e.g., motivating patients, addressing logistics and barriers).

The project will employ a rapid cycle research approach in which interventions are tested on a small scale, using short time frames (e.g., <1 month) and cyclical evaluation cycles. The process will entail implementing interventions in a small number of clinics/patients, evaluating the results, and either adapting the intervention based on results (and retesting), or disseminating the results to other clinics/patients. A critical aspect of these rapid-research cycles is that change can be quickly tested on a small scale, and then disseminated to other clinics/patients. Moreover, we are able to update and adapt the interventions based on changes vaccine regulations, availability, and protocols.

The specific aims are to:

1. Implement and evaluate PHM interventions for increasing the uptake of COVID-19 vaccinations among CHC patients across Utah. Our primary outcome, Uptake-Eligible, is defined as the proportion of patients who receive a COVID-19 vaccination out of those who meet eligibility criteria for vaccination. Our study hypothesis is that patients in the TM+PN cohort will have higher rates of uptake-eligible than those in the TM cohort.

2. Examine implementation effectiveness outcomes, as well as characteristics of both clinics and patients that may influence intervention effects and implementation outcomes.

Description:

SCALE-UP Utah is a patient-level intervention involving 12 Community Health Centers (39 individual clinics) across Utah. The study is designed to utilize Community Health Center patient records to proactively reach patients for COVID-19 vaccinations. This intervention includes a randomization component between two interventions, text messaging (TM) or text messaging with patient navigation (TM+PN). These two intervention paths are occurring simultaneously within the same clinics.

Text messaging (TM) and text messaging with patient navigation (TM+PN)

Overview:

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.

Participants in the TM+PN condition will receive the same text message as the participants in the TM condition. 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 the same information about how and where to receive a vaccine however, they will also receive a message alerting them that a Community Health Worker will contact them to assist with this process, in case they need that. 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.

Step One: Primary Data Extraction To identify the cohort for the TM and TM+PN interventions, a subset of EHR data will be manually extracted from the Community Health Centers as text files generated by EHR reports. The first set of EHR reports will contain all patients seen at each of the Community Health Centers in the last 3 years. Subsequent reports will be obtained weekly, including all encounters in the previous week. Data fields will include risk factors such as age, gender, body mass index, encounter diagnoses for medical co-morbidities, patient demographics (e.g., zip code, insurance status, preferred language, race/ethnicity); as well as cellphone number for text messaging and patient navigation.

Step Two: Randomization & Cohort Selection. Once the data are securely housed, all patients will be assigned to either the TM or TM+PN arm of the intervention. This assignment will remain consistent throughout the study. Cohort selection for the text messages will be based on EHR data considering factors such as age, race/ethnicity, language, relevant medical comorbidities, and residence in low-vaccination areas. These selection criteria are consistent with recommendations from Utah Department of Health and the Centers for Disease Control and Prevention.

Step Three: Implementation. SCALE-UP Utah will send HIPPA-compliant bidirectional texts, which is a communication method routinely used by the Community Health Centers, to patients who are eligible for COVID-19 vaccination. Text messages will be designed by the research team and sent using a HIPPA compliant text messaging service. The text messaging service will retrieve the patient cohort from the study database to send the texts to the patients. The text messages will appear to the patients as having originated from their Community Health Center. As part of their general Community Health Center care, patients have agreed to be contacted by their Community Health Center and text message communication is one of those established contact methods. Text messages will be repeated bi-weekly to continuously prompt vaccination update. This process will repeat until the participant indicates that they have either scheduled or received their vaccination. Every text message will include the option to reply STOP to opt-out of receiving text messages at any time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110163
• Est. completion date: February 28, 2023
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• current patient of a participating community health center

• have a working cellphone,

• have phone number listed in existing electronic medical record at their participating clinic

• speak English or Spanish.

Exclusion Criteria:

• Minors

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute/ University of Utah	Salt Lake City	Utah

Sponsors (5)

Lead Sponsor	Collaborator
University of Utah	Association for Utah Community Health, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Utah Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake-Eligible (vaccination)	Proportion of patients who receive a COVID-19 vaccination out of those who meet eligibility criteria for vaccination	Through study completion, an average of 2 years.
Secondary	Uptake-Total	Proportion of patients who receive a COVID-19 vaccine out of the total patient population	Through study completion, an average of 2 years.
Secondary	Reach-TM Engage	Proportion of patients that respond to the Text Messaging intervention	Through study completion, an average of 2 years.
Secondary	Reach-PN Engage	Proportion of patients that engage with a patient navigator out of those offered patient navigation	Through study completion, an average of 2 years.