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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Global Alliance to Prevent Prematurity and Stillbirth (GAPPS) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in COVID-19 vaccine attitudes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clarissa Hsu, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Georgia Center for Research and Evaluation | Atlanta | Georgia | 30311 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42351054 | Derived | Hsu C, Piccorelli AV, Green BB, Arthur KC, Becker M, Berry B, Binion B, Derus A, Gachuiri M, Hansen K, Kone A, McCracken C, McDonald B, Nisotel L, Senturia K, Volney J, Wilson KB, Williamson BD. Efficacy of codesigned COVID-19 booster vaccine promotion materials for long-term care staff: a cluster-randomized trial. BMC Public Health. 2026 Jun 25. doi: 10.1186/s12889-026-28069-7. Online ahead of print. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2026 | |
| Reset | Jun 4, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 4, 2026 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
|
| Enhanced Usual Care | Other | 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. |
|
| 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) |
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) |
| Kaiser Permanente Washington Health Research Institute |
| Seattle |
| Washington |
| 98101 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |