Clinical trial NCT06571747: Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement
Official title: Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Influenza
Behavior, Social
Keywords: Vaccination
Nudges
Behavioral Science
Cardiovascular Disease
Myocardial Infarction
Heart Failure
Implementation Science
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 3668428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with documented influenza vaccine receipt
timeFrame: up to 8 months
Secondary outcomes:
measure: Time to influenza vaccine receipt
timeFrame: up to 8 months
Other outcomes:
measure: Laboratory-confirmed influenza infection
timeFrame: Up to 12 months
measure: Hospitalization for influenza or pneumonia.
timeFrame: Up to 12 months
measure: All Cause Resource Utilization
timeFrame: Up to 12 months
measure: Total inpatient days
timeFrame: Up to 12 months
measure: All-cause intensive care unit (ICU) days
timeFrame: Up to 12 months
measure: Major Adverse Cardiovascular Events
timeFrame: Up to 12 months
measure: All-cause death
timeFrame: Up to 12 months
measure: Composite of major adverse CV events and all cause death
timeFrame: Up to 12 months
Locations:
city: Pleasanton
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Bethesda
country: United States
facility: Kaiser Permanente Mid Atlantic States
state: Maryland
Study officials:
affiliation: The Permanente Medical Group
name: Ankeet Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mid-Atlantic Permanente Medical Group
name: Benjamin Galper, MD
role: PRINCIPAL_INVESTIGATOR
References: