NCT Number: NCT05449418
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Kaiser Permanente Georgia Center for Research and Evaluation, Atlanta, Georgia, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Co-Design and Peer Advocacy
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.
Time frame: 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.
Time frame: 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').
Time frame: 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.'
Time frame: 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.'
Time frame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
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.
Time frame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
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.
Kaiser Permanente
Other
ENSPIRE: Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
Acronym: ENSPIRE
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