Clinical trial NCT05449418: Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
Official title: ENSPIRE: Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: vaccine confidence
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)
First posted: 2022-07-08
Enrollment: 988
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in COVID-19 booster vaccination rate
timeFrame: Baseline (Time 0); 7 months post-randomization (Time 1); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
measure: Change in likelihood of recommending COVID-19 vaccination
timeFrame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Secondary outcomes:
measure: Change in vaccine hesitancy
timeFrame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
measure: Change in COVID-19 vaccine confidence
timeFrame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Other outcomes:
measure: Change in COVID-19 vaccine knowledge
timeFrame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
measure: Change in COVID-19 vaccine attitudes
timeFrame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia Center for Research and Evaluation
state: Georgia
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Clarissa Hsu, PhD
role: PRINCIPAL_INVESTIGATOR
References: