Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years old)

Patients splenectomized at FPG for whom a vaccination consultation is requested during hospitalization

Patients who provide signed informed consent to participate in the study and for the processing of personal data for research purposes

Disqualifiers

Minor patients

Lack of signed informed consent for participation in the study and for the processing of personal data for research purposes

Patients splenectomized at other healthcare facilities

Trial population

Patients splenectomized at the Fondazione Policlinico Universitario A. Gemelli IRCCS, identified during consultation activities in the requesting wards and/or managed by the hospital outpatient vaccination clinic for frail patients.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Educational intervention for asplenic patients

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change in Infectious Risk Knowledge, Vaccination Attitudes, and Risk Perception Score

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.

Time frame
24 months

Secondary outcomes

1

Patient Experience with Vaccination Prophylaxis Management Score

Patient experience related to the management of vaccination prophylaxis in an intra-hospital outpatient setting, assessed during follow-up outpatient visits. Measure Description: Patient Experience with Vaccination Prophylaxis Questionnaire (validated questionnaire derived from the literature). The total score ranges from 13 to 65, with higher scores indicating a more positive patient experience.

Time frame
24 months
2

Association Between Infectious Risk Knowledge Score and Socio-demographic Characteristics

Correlation between patients' infectious risk knowledge and awareness levels and socio-demographic characteristics (e.g., age, sex, educational level, clinical characteristics), aimed at identifying factors useful for the personalization of educational interventions. Measure Description: Infectious Risk and Vaccination Awareness Questionnaire for Splenectomized Patients. Associations will be evaluated using correlation coefficients and regression parameters.

Time frame
24 months
3

Adherence to the Intra-hospital Vaccination Pathway

Adherence to the intra-hospital vaccination pathway among splenectomized patients managed by the outpatient clinic, including enrollment in the pathway and administration of recommended vaccinations. Measure Description: Proportion (expressed in percentage, %) of patients enrolled in the vaccination pathway and proportion of recommended vaccinations administered per patient. Values range from 0% to 100%, with higher percentages indicating greater adherence.

Time frame
24 months

Other outcomes

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