Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients

NCT07354893 | Recruiting

• 1 other identifier: 8123
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Splenectomized Patients; Splenectomy; Splenectomy; Status; Asplenia

Keywords

OPSI; infection risk; Infection Prevention; Preventive measures; Vaccination; asplenia; splenectomy; splenectomized patients; post splenectomy infections

Outcome Measures

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.

  24 months

Secondary Outcomes (3)

• Patient Experience with Vaccination Prophylaxis Management Score

  24 months

• Association Between Infectious Risk Knowledge Score and Socio-demographic Characteristics

  24 months

• Adherence to the Intra-hospital Vaccination Pathway

  24 months

Interventions

Educational intervention for asplenic patients OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Study Officials

• LAURENTI PATRIZIA, PROFESSOR

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LAURENTI PATRIZIA, PROFESSOR

CONTACT

063015.9333; patrizia.laurenti@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 13, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

IT (2)