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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Infectious Risk Knowledge, Vaccination Attitudes, and Risk Perception Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Infectious Risk Knowledge, Vaccination Attitudes, and Risk Perception Score
时间窗: 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.
次要结局
- 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)
研究者
Laurenti Patrizia
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS