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

Official title

Intrahospital Vaccination and Active Counseling Versus Active Counseling Alone to Increase Seasonal Influenza immUnization in Patients at High Cardiovascular Risk in Germany: The Randomized Controlled VACC-UP Study

Overview

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).

Interventions

• Biological 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 t
• Behavioral 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.
• Behavioral 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.

Primary outcome measures

• Influenza vaccination rate at the end of the index influenza season [Time frame: From randomization to the end of the index influenza season (March 31), up to approximately 7 months]

Secondary outcome measures (3)

• Influenza vaccination rate at the end of the post-index influenza season [Time frame: From randomization to the end of the post-index influenza season (March 31 of the following year), up to approximately 19 months]
• Association of the individual components of the 7C psychological antecedents of vaccination questionnaire with vaccination status [Time frame: Baseline (prior to counseling and randomization) and end of the index influenza season (March 31), up to approximately 7 months]
• Patient satisfaction with the offer of intrahospital influenza vaccination [Time frame: During the index hospitalization, up to approximately 14 days]

Eligibility criteria

Inclusion criteria

• Age 18 years or older
• Hospitalized due to acute coronary syndrome (ACS) or congestive heart failure (CHF) and fulfilling the criteria for influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO)
• Written informed consent

Exclusion criteria

• Already received seasonal influenza vaccination in the current season, based on self-reported vaccination status and/or vaccination certificate
• Laboratory-confirmed active influenza infection during the index hospitalization
• Contraindication for vaccination (e.g., known allergy)
• Inability to provide written informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Germany · 2 centers

• Clinic III for Internal Medicine, University Hospital of Cologne — Cologne
• Department of Cardiology, University Heart and Vascular Centre Hamburg — Hamburg

Publications

• Frobert O, Gotberg M, Erlinge D, Akhtar Z, Christiansen EH, MacIntyre CR, Oldroyd KG, Motovska Z, Erglis A, Moer R, Hlinomaz O, Jakobsen L, Engstrom T, Jensen LO, Fallesen CO, Jensen SE, Angeras O, Calais F, Karegren A, Lauermann J, Mokhtari A, Nilsson J, Persson J, Stalby P, Islam AKMM, Rahman A, Malik F, Choudhury S, Collier T, Pocock SJ, Pernow J. Influenza Vaccination After Myocardial Infarcti PMID 34459211
• Lawrence DS, Muthoga C, Meya DB, Tugume L, Williams D, Rajasingham R, Boulware DR, Mwandumba HC, Moyo M, Dziwani EN, Maheswaran H, Kanyama C, Hosseinipour MC, Chawinga C, Meintjes G, Schutz C, Comins K, Bango F, Muzoora C, Jjunju S, Nuwagira E, Mosepele M, Leeme T, Ndhlovu CE, Hlupeni A, Shamu S, Boyer-Chammard T, Molloy SF, Youssouf N, Chen T, Shiri T, Jaffar S, Harrison TS, Jarvis JN, Niessen LW PMID 36400090
• Betsch C, Schmid P, Heinemeier D, Korn L, Holtmann C, Bohm R. Beyond confidence: Development of a measure assessing the 5C psychological antecedents of vaccination. PLoS One. 2018 Dec 7;13(12):e0208601. doi: 10.1371/journal.pone.0208601. eCollection 2018. PMID 30532274

Identifiers

NCT: NCT07721649 · 26-1232

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗