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临床试验/NCT01944462
NCT01944462已完成4 期

Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center for Adults Aged 65 Years or Older or Those With Defined Risk Factors for Invasive Pneumococcal Disease

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
203
试验地点
2
主要终点
Knowledge and Awareness of Pneumococcal Disease

研究概览

简要总结

The overall goals of this program are to measure the impact of a pharmacist pneumococcal vaccine education program (PPVP) using a senior center model of care and provide the pneumococcal vaccine to eligible participants.

Hypotheses

  1. PPVP will result in improved knowledge and awareness in older minorities in the senior center setting (primary hypothesis);
  2. Participants who are vaccinated through the project will experienced increased trust in receiving vaccines from a pharmacist;
  3. Participants will be satisfied with and trust the PV information provided by pharmacists in the PPVP;
  4. PPVP is an efficient approach to educating patients in the senior center based on its costs;
  5. Participating pharmacists will be activated to implement PPVP learnings in their practice.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A. Inclusions for PPVP:
  • Age ≥ 50 years old
  • Can attend a 1.5-hour session at CIP
  • Cognitively intact based on responses to an Abbreviated Mental Test Score (AMTS) of ≥7 (see Appendix for AMTS instrument)
  • Can speak and read English at ≥4th grade level as evidenced by ability to read a brief passage
  • Access to a telephone
  • B. Inclusions to receive the optional pneumococcal vaccination:
  • Patient meets ≥1 of the following criteria for receiving their first pneumococcal vaccination:
  • All adults age 65 years and older who have not had the vaccine previously
  • Age 50-64 years with any of the following conditions:
  • Cigarette smokers age 19 years and older
  • Chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathies; excluding hypertension)
  • Chronic pulmonary disease (including COPD and emphysema, and for adults ages 19 years and older, asthma)
  • Diabetes mellitus
  • Chronic liver disease, cirrhosis
  • Candidate for or recipient of cochlear implant
  • Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy)
  • Immunocompromising conditions or on immunosuppressive therapy
  • Chronic renal failure or nephrotic syndrome
  • Patient meets ≥1 of the following criteria for receiving a booster dose of the pneumococcal vaccination:
  • Adults age 65 years and older who received their first dose for any indication when they were younger than age 65 years.
  • Adults age 50-64 who have not received the vaccine for ≥5 years and have one of the following conditions:
  • Functional or anatomic asplenia (including persons with sickle cell disease or splenectomy patients);
  • Chronic renal failure (including dialysis patients) or nephrotic syndrome;
  • Immunocompromising conditions or on immunosuppressive therapy

排除标准

  • A. Exclusions to the PPVP program: none
  • B. Exclusions to receiving the optional pneumococcal vaccine:
  • Participant has a history of allergic reaction to pneumococcal vaccine
  • Participant has a history of allergic reaction to any component of any vaccine
  • Participant with moderate or severe illness (these individuals will be advised to speak to their doctor regarding the vaccine)

结局指标

主要结局

Knowledge and Awareness of Pneumococcal Disease

时间窗: Baseline, post-test, 3 months

Change in knowledge and awareness of pneumococcal disease over time were assessed for the following domains: susceptibility to infection, symptoms of disease, severity of illness, and vaccination with an emphasis on vaccine efficacy, safety, and eligibility. Assessments at baseline, post-test (immediately following intervention), and 3 months using the Pneumonia Knowledge Questionnaire, an instrument developed by investigators to assess participants' knowledge and awareness in the domains of interest. Instrument consists of 5 "mark all that apply" items and one "mark the best response" item. Scores range from 0 (no correct responses) to 28 (all responses correct), with a higher score value corresponding to better knowledge and awareness.

次要结局

  • Activation(3 months)
  • Intervention Cost(3 months)
  • Pharmacist Satisfaction(3 months)
  • Satisfaction With PPPP(3 months)
  • Trust in Pharmacists as Vaccine Providers(Baseline, post-test (immediately following intervention), 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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