Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients (SPLE-VAC)

Evaluation of an Educational Intervention on Knowledge and Awareness of Infectious Risk in Splenectomized Patients and on Their Satisfaction With Vaccination Management in an Intra-hospital Outpatient Setting.

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.

Study Overview

• Status: Recruiting
• Conditions: Asplenia; Splenectomy; Splenectomy; Status; Splenectomized Patients
• Intervention / Treatment: Other: Educational intervention for asplenic patients

Detailed Description

This is a prospective, observational patient registry conducted at a single academic hospital. Adult patients undergoing splenectomy at the Fondazione Policlinico Universitario A. Gemelli IRCCS are consecutively identified through routine inpatient clinical workflows and enrolled after written informed consent.

Clinical, sociodemographic, and vaccination-related data are collected as part of standard care by the intra-hospital vaccination clinic and recorded in a dedicated database using predefined variables. Patient-reported outcomes are assessed using structured questionnaires administered before and after an educational intervention and, for patients completing the vaccination pathway, at the end of follow-up.

The registry allows longitudinal follow-up to monitor patient education, vaccination uptake, completion of recommended schedules, and post-discharge continuity of care. Follow-up data are collected during outpatient visits or, when necessary, via structured telephone interviews.

Data quality is ensured through standardized data collection procedures, use of validated questionnaires, and cross-verification of vaccination data using independent institutional sources. All data are pseudonymized and managed in compliance with applicable data protection regulations. The study is conducted according to Good Clinical Practice, Good Epidemiological Practice, and the Declaration of Helsinki.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: LAURENTI PATRIZIA, PROFESSOR; Phone Number: 063015.9333; Email: patrizia.laurenti@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Patrizia Laurenti
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Contact: Patrizia Laurenti; Phone Number: +390630155701; Email: patrizia.laurenti@policlinicogemelli.it
      • Principal Investigator: Patrizia Laurenti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
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.	24 months
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.	24 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: LAURENTI PATRIZIA, PROFESSOR, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 13, 2028

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Vaccination; Infection Prevention; splenectomy; OPSI; infection risk; asplenia; Preventive measures; splenectomized patients; post splenectomy infections
• Other Study ID Numbers: 8123 (OHSU IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No