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

NCT ID: NCT05449418

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 988 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2026-02-28

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Full Intervention

Intervention Type: 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.

Interventions

Full Intervention

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.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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.

Intervention Type: OTHER

Other Intervention Names

Co-Design and Peer Advocacy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)

UNKNOWN

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clarissa Hsu, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Georgia Center for Research and Evaluation

Atlanta, Georgia, United States

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States

Countries

United States

Other Identifiers

R221031001

Identifier Type: -

Identifier Source: org_study_id