Acute Coronary Syndrome, Cardiovascular Diseases, Heart Failure, Influenza, Human, Vaccination Refusal
Conditions
Keywords
Influenza vaccination, Vaccination rate, Intrahospital vaccination, Acute coronary syndrome, Congestive heart failure, Health services research, Vaccine hesitancy, 7C psychological antecedents of vaccination, Cardiovascular prevention
Brief 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).
Interventions
BIOLOGICALIntrahospital 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.
BEHAVIORALStandardized 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.
BEHAVIORALStandard 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.
Sponsors
Stephan Baldus
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Two-arm parallel group design. All patients receive standardized active influenza vaccination counseling. Patients are randomized 1:1 to an additional offer of intrahospital influenza vaccination (intervention) or to the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control). Fixed block randomization is stratified by study site (Cologne/Hamburg) and vaccination indication (ACS/CHF).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influenza vaccination rate at the end of the post-index influenza season | From randomization to the end of the post-index influenza season (March 31 of the following year), up to approximately 19 months | Proportion of patients vaccinated against seasonal influenza at the end of the post-index season. For all patients, self-reported vaccination status is assessed by telephone interview beginning April 1 of the post-index season and cross-validated with data from the treating general practitioner. |
| Association of the individual components of the 7C psychological antecedents of vaccination questionnaire with vaccination status | Baseline (prior to counseling and randomization) and end of the index influenza season (March 31), up to approximately 7 months | Association of the individual components of the 7C psychological antecedents of vaccination questionnaire (7-point scale, long version), assessed at baseline prior to active counseling, with vaccination status at the end of the index season. Assessed using univariate and multivariable regression models reporting odds ratios with 95% confidence intervals. |
| Patient satisfaction with the offer of intrahospital influenza vaccination | During the index hospitalization, up to approximately 14 days | Descriptive assessment of patient satisfaction with the intrahospital vaccination offer, based on a study-specific patient satisfaction questionnaire completed by patients in the intervention group. |
Countries
Germany
Contacts
CONTACTSebastian Heyne, Dr. med.
CONTACTStephan Baldus, Prof. Dr. med.
PRINCIPAL_INVESTIGATORStephan Baldus, Prof. Dr. med.
Clinic III for Internal Medicine, University Hospital of Cologne
STUDY_DIRECTORSebastian Heyne, Dr. med.
Clinic III for Internal Medicine, University Hospital of Cologne
Outcome results
None listed