Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities

COVID-19 Clinical Trial

— ENSPIRE  

Official title:

ENSPIRE: Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05449418
• Other study ID #: R221031001
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ENSPIRE study is a cluster-randomized comparative effectiveness trial being conducted within long-term care and residential facilities that will test a communication and engagement strategy for increasing COVID-19 booster vaccination rates against an enhanced usual care comparator (Centers for Disease Control and Prevention or other national organization vaccine education and communication materials) among facility staff. The communication and engagement strategy being tested includes (1) the development of materials co-designed with and tailored to facility staff whose primary language is a language other than English or who are from certain cultural affinity groups and (2) the distribution of the developed materials by members of the language/cultural affinity groups with peer advocacy activities (full intervention). The study is being conducted in Washington state and Georgia.

Long-term care/residential facilities will be asked to furnish their staff booster rate at 4 timepoints: pre-intervention, and one month (timepoint 1), 3 months (timepoint 2), and 6 months (timepoint 3) post-intervention. Staff at participating long-term care facilities will be invited to complete three online surveys at 3 timepoints: pre-intervention, 3 months post-intervention and 6 months post-intervention. Long-term care facilities will be randomized to a trial arm following the pre-intervention data collection.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 988
• Est. completion date: November 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Works at a participating long-term care facility that has more than 50 staff members, has a staff COVID-19 booster vaccination rate of =60% as of December 1, 2021, and is located in Washington state or Georgia.

• 18 years or older

Exclusion Criteria:

• Does not work at an enrolled long-term care facility

• 17 years or younger

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Full Intervention
A small group of employees who work at facilities randomized to this arm will be invited to develop tailored COVID-19 vaccination promotion materials in teams with other long-term care staff sharing the same or similar language and/or cultural affinity. These employees will also help promote these materials to all of the employees who work at their facilities.

Other:
• Enhanced Usual Care
Employees who work at facilities randomized to this arm will see COVID-19 vaccine promotion materials from the Centers for Disease Control and Prevention [CDC] or other national organization.

Locations

Country	Name	City	State
United States	Kaiser Permanente Georgia Center for Research and Evaluation	Atlanta	Georgia
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	Global Alliance to Prevent Prematurity and Stillbirth (GAPPS), Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in COVID-19 vaccine knowledge	Change in COVID-19 vaccine knowledge using 6 COVID-19 vaccine knowledge true/false questions adapted from information on the CDC's COVID-19 Myths and Facts webpage.	Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Other	Change in COVID-19 vaccine attitudes	Change in COVID-19 vaccine attitudes using 10 questions assessed on a 5-point Likert scale adapted from existing surveys and polls assessing COVID-19 vaccine perceptions.	Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Primary	Change in COVID-19 booster vaccination rate	Change in percentage of staff at long-term care centers that have received a booster vaccine over time.	Baseline (Time 0); 7 months post-randomization (Time 1); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Primary	Change in likelihood of recommending COVID-19 vaccination	Change in likelihood of recommending COVID-19 vaccination to others (coworkers, family, friends) assessed using a 6-item Net Promoter Score scale. The scale is assessed on an 11-point scale ranging from 0 ('Least Likely') to 10 ('Most Likely').	Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Secondary	Change in vaccine hesitancy	Change in vaccine hesitancy assessed using a modified Vaccine Hesitancy Scale with 11 items. The scale is assessed on a 5-point Likert scale with answer choices ranging from 'Strongly Disagree' to 'Strongly Agree.'	Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Secondary	Change in COVID-19 vaccine confidence	Change in vaccine confidence using a modified 3-item Vaccine Confidence Scale. The answer choices are on a Likert-scale: 'strongly agree', 'tend to agree', 'tend to disagree', 'strongly disagree', and 'I don't know.'	Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)