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

NCT05449418 | Active Not Recruiting

• 1 other identifier: R221031001
• Study Type: interventional
• Target: 988
• Locations: 1 country
• Sites: 2

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

Keywords

vaccine confidence

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• Change in vaccine hesitancy

  Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)

• Change in COVID-19 vaccine confidence

  Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)

Other Outcomes (2)

• Change in COVID-19 vaccine knowledge

  Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)

• Change in COVID-19 vaccine attitudes

  Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)

Study Arms (2)

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.

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.

Behavioral: Full Intervention

Interventions

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.

Also known as: Co-Design and Peer Advocacy

Full Intervention

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years or older

You may not qualify if:

• Does not work at an enrolled long-term care facility
• years or younger

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Global Alliance to Prevent Prematurity and Stillbirth (GAPPS): collaborator

Study Sites (2)

Kaiser Permanente Georgia Center for Research and Evaluation

Atlanta, Georgia, 30311, United States

Location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clarissa Hsu, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 8, 2022
• Study Start: August 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)