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

Not Applicable

Active, not recruiting

• Conditions: COVID-19
• Interventions: Other: Enhanced Usual Care; Behavioral: Full Intervention

• Registration Number: NCT05449418
• Lead Sponsor: Kaiser Permanente

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2024-07-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 988

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Usual Care	Enhanced Usual Care	Distribution of COVID-19 vaccine promotion materials from the Centers for Disease Control and Prevention \[CDC\] or other national organization with limited distribution support at long-term care centers.
Full Intervention	Full Intervention	Development of materials co-designed with and tailored to language/cultural affinity groups and distributed with assistance from co-design participants who will serve as peer advocates.

Primary Outcome Measures

Name	Time	Method
Change in likelihood of recommending COVID-19 vaccination	Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)	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').
Change in COVID-19 booster vaccination rate	Baseline (Time 0); 7 months post-randomization (Time 1); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)	Change in percentage of staff at long-term care centers that have received a booster vaccine over time.

Secondary Outcome Measures

Name	Time	Method
Change in vaccine hesitancy	Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)	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.'
Change in COVID-19 vaccine confidence	Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)	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.'

Trial Locations

Locations (2)

Kaiser Permanente Washington Health Research Institute; 🇺🇸 Seattle, Washington, United States

Kaiser Permanente Georgia Center for Research and Evaluation; 🇺🇸 Atlanta, Georgia, United States