Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Educational intervention for asplenic patients: an educational intervention aimed at informing patients about the condition of asplenia, the associated infectious risks, and the main preventive measures, with particular emphasis on vaccination prophylaxis. To support the intervention, educational materials will be distributed, including an informational brochure and the "Recommended Vaccinations for Asplenic Patients" schedule.

Study summary

The absence or dysfunction of the spleen is associated with a substantially increased risk of invasive infections that may rapidly progress to fulminant sepsis, including overwhelming post-splenectomy infection (OPSI), a medical emergency with high mortality. Although the risk is greatest in the first two years after splenectomy, it persists lifelong. Preventing infections in patients with anatomical or functional asplenia requires an integrated strategy that includes patient education, early recognition of symptoms, behavioral measures, antibiotic prophylaxis when indicated, and vaccination.

Post-splenectomy immunization has been shown to reduce OPSI incidence. Regional and international guidelines recommend vaccination against pneumococcus, Haemophilus influenzae type b, meningococcus (B and ACWY), herpes zoster, diphtheria-tetanus-pertussis, measles-mumps-rubella-varicella, and annual influenza. However, adherence to these recommendations is frequently suboptimal, often due to limited awareness among patients and healthcare professionals.

This study involves the intra-hospital vaccination team providing structured vaccination consultations to splenectomized patients hospitalized at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS. During ward consultations, patients receive an educational intervention on asplenia-related infectious risks and preventive measures, supported by standardized informational materials. Effectiveness is evaluated using a pre-post questionnaire assessing knowledge and awareness. Patients completing the vaccination pathway at the outpatient clinic also complete a questionnaire assessing their experience with vaccination management in an intra-hospital setting.

Eligibility

Primary outcome measure(s)

• Change in Infectious Risk Knowledge, Vaccination Attitudes, and Risk Perception Score — 24 months
  Change from baseline to post-intervention in patients' knowledge of infectious risk, attitudes toward vaccination, and perception of infectious risk following an educational and counseling intervention. The outcome is assessed in splenectomized patients identified and/or managed by the intra-hospital outpatient clinic of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS (FPG). Measure Description: Infectious Risk and Vaccination Awareness Questionnaire for Splenectomized Patients (specifically developed and validated questionnaire). The total score ranges from 16 to 80, with higher scores indicating greater knowledge, more favorable attitudes toward vaccination, and higher perceived infectious risk.

Trial sites (2)

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