Behavior, Social, Cardiovascular Diseases, Influenza
Conditions
Keywords
Vaccination, Nudges, Behavioral Science, Cardiovascular Disease, Myocardial Infarction, Heart Failure, Implementation Science
Brief summary
In randomized clinical trials and observational studies, influenza vaccination is effective in reducing influenza-related illness and hospitalizations and potentially cardiovascular (CV) events and mortality in select populations. However, the potential population-level benefit of influenza vaccination is limited by its uptake. Novel implementation strategies to improve vaccination uptake are needed. KP VACCINATE is a multicenter, sequential, individual-level randomized controlled implementation trial examining the effectiveness of a CV-focused nudging communication vs. usual care communication on influenza vaccination uptake among Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Mid Atlantic States (KPMAS) eligible members during the 2024-2025 influenza season.
Detailed description
In randomized clinical trials and observational studies, influenza vaccination is effective in reducing influenza-related illness and hospitalizations and potentially cardiovascular events and mortality in select populations. However, the potential population level benefit of influenza vaccination is limited by its uptake. Novel implementation strategies to improve vaccination uptake are needed. KP VACCINATE is a multicenter, sequential, individual-level randomized controlled implementation trial examining the effectiveness of a CV-focused nudging communication vs. usual care communication on influenza vaccination uptake among Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Mid Atlantic States (KPMAS) eligible members during the 2024-2025 influenza season. The study will evaluate an operational directive at KPNC and KPMAS. Eligible participants will be randomized into 4 study arms, corresponding to the messaging received at two different vaccine communication touchpoints (Touchpoint 1/Touchpoint 2) during the 2024-2025 influenza season: 1. CV-focused nudge communication/CV-focused nudge communication 2. CV-focused nudge communication/Usual care communication 3. Usual care communication/CV-focused nudge communication 4. Usual care communication/Usual care communication
Interventions
BEHAVIORALCardiovascular-Focused Nudge Communication
Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years 2. Active KPNC or KPMAS member 3. ≥6 months of continuous health plan coverage and prescription drug benefit before September 1, 2024 4. Evidence of member access to the KP HealthConnect® Portal and/or a listed registered email address 5. No documented influenza vaccination during the 2024-2025 influenza season prior to randomization
Exclusion criteria
1. Unable to receive or opted out of receiving health system messaging 2. Other exclusion that prevents messaging outreach. 3. Unknown service area or medical center affiliation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with documented influenza vaccine receipt | up to 8 months | Proportion of participants with documented influenza vaccine receipt after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to influenza vaccine receipt | up to 8 months | Time from randomization to influenza vaccine receipt. |
Other
| Measure | Time frame | Description |
|---|---|---|
| All Cause Resource Utilization | Up to 12 months | Composite and individual components of: All-cause hospitalization, emergency department (ED) visits, and observation stays |
| Total inpatient days | Up to 12 months | Total inpatient days |
| All-cause intensive care unit (ICU) days | Up to 12 months | All-cause intensive care unit (ICU) days |
| Laboratory-confirmed influenza infection | Up to 12 months | Incidence of laboratory-confirmed influenza infection. |
| All-cause death | Up to 12 months | All-cause death, ascertained through a combination of Social Security Administration files, state death certificate files, electronic health records, and member proxy reporting. |
| Composite of major adverse CV events and all cause death | Up to 12 months | Composite of major adverse CV events (incident or worsening heart failure events, hospitalization for acute myocardial infarction, atrial fibrillation, venous thromboembolism and hospitalization or acute stroke) and all-cause death. |
| Major Adverse Cardiovascular Events | Up to 12 months | Composite and individual components of major adverse CV events: incident or worsening heart failure events, hospitalization for acute myocardial infarction, atrial fibrillation, venous thromboembolism and hospitalization for acute stroke |
| Hospitalization for influenza or pneumonia. | Up to 12 months | Hospitalization for influenza or pneumonia. |
Countries
United States
Outcome results
None listed