COVID-19ENSPIRENCT05449418
Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
A study testing Full Intervention in people with COVID-19, run by Kaiser Permanente at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Full Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 988 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not work at an enrolled long-term care facility
- 17 years or younger
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Georgia Center for Research and Evaluation
Atlanta, Georgia, 30311
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: ENSPIRE: Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
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.
- Conditions
- COVID-19
- Being tested
- Full Intervention, Enhanced Usual Care
- Keywords
- vaccine confidence
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full InterventionBehavioural
Also called Co-Design and Peer Advocacy
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.
Enhanced Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Enhanced Usual Care |
| 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. Receives: Behavioral: Full Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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').
Measured: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Secondary outcomes (2)
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.'
Measured: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
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.'
Measured: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Aug 2021
- Primary completion31 Jul 2024
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)
- Responsible party
- Sponsor
- Investigators
- Clarissa Hsu, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449418
- Sponsor's protocol ID
- R221031001
- Acronym
- ENSPIRE
- Status last verified
- Sep 2024
- First submitted
- 22 Jun 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42351054
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENSPIRE: Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
- ClinicalTrials.gov ID
- NCT05449418
- Acronym / sponsor ID
- ENSPIRE / R221031001
- Conditions
- COVID-19
- Keywords
- vaccine confidence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 988 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareDistribution 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 | Behavioral: Full InterventionDevelopment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Does not work at an enrolled long-term care facility
- 17 years or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full InterventionAlso: Co-Design and Peer AdvocacyA 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. | Behavioural | Full Intervention |
| Enhanced Usual CareEmployees 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. | Other | Enhanced Usual Care |
Primary outcome
Change in COVID-19 booster vaccination rate
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.
Change in likelihood of recommending COVID-19 vaccination
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').
2 secondary outcomes
Change in vaccine hesitancy
Time frame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Change in COVID-19 vaccine confidence
Time frame: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42351054Hsu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarissa Hsu, PhD principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Intervention in people with COVID-19, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COVID-19 booster vaccination rate (time frame: Baseline (Time 0); 7 months post-randomization (Time 1); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05449418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.