Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities (ENSPIRE)
Primary Purpose
COVID-19
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full Intervention
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional other trial for COVID-19 focused on measuring vaccine confidence
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
Sites / Locations
- Kaiser Permanente Georgia Center for Research and EvaluationRecruiting
- Kaiser Permanente Washington Health Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Enhanced Usual Care
Full Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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').
Secondary Outcome Measures
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.'
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.'
Full Information
NCT ID
NCT05449418
First Posted
June 22, 2022
Last Updated
January 17, 2023
Sponsor
Kaiser Permanente
Collaborators
Patient-Centered Outcomes Research Institute, Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)
1. Study Identification
Unique Protocol Identification Number
NCT05449418
Brief Title
Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
Acronym
ENSPIRE
Official Title
ENSPIRE: Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Patient-Centered Outcomes Research Institute, Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
vaccine confidence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Full Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Full Intervention
Other Intervention Name(s)
Co-Design and Peer Advocacy
Intervention Description
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
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in COVID-19 booster vaccination rate
Description
Change in percentage of staff at long-term care centers that have received a booster vaccine over time.
Time Frame
Baseline (Time 0); 7 months post-randomization (Time 1); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
Title
Change in likelihood of recommending COVID-19 vaccination
Description
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)
Secondary Outcome Measure Information:
Title
Change in vaccine hesitancy
Description
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)
Title
Change in COVID-19 vaccine confidence
Description
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)
Other Pre-specified Outcome Measures:
Title
Change in COVID-19 vaccine knowledge
Description
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)
Title
Change in COVID-19 vaccine attitudes
Description
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.
Time Frame
Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Fraser
Phone
206-287-4640
Email
james.r.fraser@kp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney McCracken, PhD
Phone
470-676-2991
Email
Courtney.E.McCracken@kp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarissa Hsu, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Georgia Center for Research and Evaluation
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30311
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney McCracken, PhD
Phone
470-676-2991
Email
Courtney.E.McCracken@kp.org
First Name & Middle Initial & Last Name & Degree
Courtney McCracken, PhD
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Fraser
Phone
206-287-4640
Email
james.r.fraser@kp.org
First Name & Middle Initial & Last Name & Degree
Clarissa Hsu, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
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