Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)

Condition(s) studied

Investigational drug(s) / intervention(s)

Intrahospital seasonal influenza vaccination offer: Offer of bedside vaccination against seasonal influenza during the index hospitalization, administered in a standardized manner by trained treating physicians according to the latest STIKO recommendations and the respective product information. The appropriate vaccine is selected according to current recommendations (e.g., high-dose quadrivalent vaccine for patients aged 60 years and older, standard-dose quadrivalent vaccine otherwise). Vaccination is offered from September 1 to February 28 of the respective influenza season.

Standardized active influenza vaccination counseling: Standardized active counseling on influenza vaccination using a cardiovascular gain-framed information sheet, including the recommendation to be vaccinated and the opportunity to discuss vaccination with the treating physician. Counseling is provided to all patients in both arms after completion of the baseline 7C questionnaire and prior to randomization.

Standard of care discharge recommendation for ambulatory vaccination: Current standard of care in Germany: the recommendation to obtain ambulatory influenza vaccination from the primary care physician, stated in the discharge papers.

Study summary

The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk.

Patients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).

Eligibility

Primary outcome measure(s)

• Influenza vaccination rate at the end of the index influenza season — From randomization to the end of the index influenza season (March 31), up to approximately 7 months
  Proportion of patients vaccinated against seasonal influenza at the end of the index season (defined as March 31). For intervention group patients vaccinated during the index hospitalization, vaccination status is documented from inpatient medical records. For control group patients and intervention group patients who declined intrahospital vaccination, self-reported vaccination status is assessed by telephone interview beginning April 1 and cross-validated with data from the treating general practitioner.

Trial sites (2)

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