Impact of Pharmacist-led Educational Intervention on Pneumococcal Vaccination Rates in Cancer Patients

Impact of Pharmacist-led Educational Intervention on Pneumococcal Vaccination Rates in Cancer Patients: A Randomized Controlled Study

According to the World Health Organization (WHO), immunization; is defined as making a person immune or resistant to an infectious disease by applying a vaccine (1). The primary indicator of an effective immunization is that adequate vaccination rates have been achieved. The risk of cancer and chronic diseases increases with advancing age, which increases the importance of immunization in adults.

Cancer patients, one of the patient groups for whom adult immunization is a priority and crucial, are subjected to immunosuppressive medications, making them vulnerable to infections. In cancer patients, infections are severe, antimicrobial treatments are sometimes insufficient, leading to morbidity and mortality. One of these infections is pneumococcal disease caused by Streptococcus pneumonia, with high morbidity and mortality in cancer patients. Invasive pneumococcal disease is seen 23-48 times more frequently in cancer patients compared to healthy individuals. In many countries worldwide, the 13-valent pneumococcal conjugate vaccine and the 23-valent polysaccharide pneumococcal vaccine, both developed to prevent pneumonia caused by Streptococcus pneumonia, are successfully used in childhood vaccination programs within the framework of WHO's immunization policies. However, in Turkey, like in the rest of the world, the required adult immunization rates have not been achieved yet. Immunization rates among cancer patients, one of the patient groups for whom adult vaccination is required, remain below the targeted levels. Pharmacists, one of the health professionals, have significant contributions to increasing vaccination rates in adults. According to studies, pharmacists can help raise immunization rates by providing education and information. In Turkey, no study has been conducted to assess the impact of vaccination education on cancer patients' attitudes and actions about the pneumococcal vaccine. This study aimed to determine the impact of pharmacist-led pneumonia and pneumococcal vaccine education on cancer patients' vaccination attitudes, knowledge, and vaccination rates.

Study Overview

• Status: Completed
• Conditions: Cancer; Pneumococcal Infections; Pneumonia, Bacterial
• Intervention / Treatment: Behavioral: vaccine education

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Faculty of Medicine Department of Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:The study will involve patients who have all of the following features simultaneously.

• patients who visit medical oncology outpatient clinics,
• patients who are over 18 years old,
• patients who have been diagnosed with cancer for less than two years,
• patients who are in remission stage (as determined by a medical oncologist),
• patients who have never had the pneumococcal vaccine.

Exclusion Criteria:

• patients who could not communicate in Turkish,
• patients who were illiterate,
• patients who had visual/auditory/cognitive impairments,
• patients who had previously received a pneumococcal vaccine recommendation,
• patients who did not know their pneumococcal immunization status
• patients who want to leave the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vaccine education; The intervention arm refers to the arm in which the pharmacist gives vaccination education.	Behavioral: vaccine education; The educational content was developed based on research and expert perspectives and included general information about immunization, pneumonia, and pneumococcal vaccines, as well as vaccine myths. This information was first conveyed to the patients verbally, and then booklets with the same material were handed to them. The Pneumococcal Conjugate Vaccine 13 (PCV13) vaccination was recommended based on Infectious Disease Society of America (IDSA), Advisory Committee on Immunization Practices (ACIP), and national adult immunization guidelines.
No Intervention: Standard of Care; The control arm refers to the arm that includes patients who receive routine health care services without vaccination education provided by the pharmacist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccination attitude	changes in the patients' Vaccination Attitudes Examination (VAX )Scale scores (This scale consists of 12 items and four subgroups (mistrust of vaccine benefit, worries about unforeseen future effects, concerns about commercial profiteering, and preference for natural immunity) to be responded on a 6-point Likert scale, and the total score ranges between 12-72. The higher scores indicate the anti-vaccination attitudes of the patients.)	3 months after education provision
Knowledge about pneumonia and the pneumococcal vaccine	changes in the patients' Vaccination Knowledge Questionnaire (VKQ) (that consists of 13 questions to be answered as 'yes/no/unknown')	3 months after education provision
Vaccination behavior	changes in the patients' vaccination rates (The vaccination status of patients with the pneumococcal vaccine will be asked.)	3 months after education provision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the relationship between demographic characteristics and pneumococcal vaccination behavior	determining factors affecting pneumococcal vaccination behavior in patients. Parameters (age, gender, educational status, etc.) that differ statistically between vaccinated and unvaccinated patients will be determined, and then logistic regression will be made for these parameters to determine the factors affecting vaccinating behavior.	3 months after education provision

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Aygin Bayraktar-Ekincioglu, Hacettepe University Faculty of Pharmacy Department of Clinical Pharmacy/Ankara/Turkey

Publications and helpful links

General Publications

• Wong A, Marrie TJ, Garg S, Kellner JD, Tyrrell GJ; SPAT Group. Increased risk of invasive pneumococcal disease in haematological and solid-organ malignancies. Epidemiol Infect. 2010 Dec;138(12):1804-10. doi: 10.1017/S0950268810000919. Epub 2010 Apr 30.
• Chiou WY, Hung SK, Lin HY, Chen LC, Hsu FC, Tsai SJ, Yu BH, Lee MS, Li CY. Effectiveness of 23-valent pneumococcal polysaccharide vaccine on elderly patients with colorectal cancer: A population-based propensity score-matched cohort study. Medicine (Baltimore). 2019 Dec;98(50):e18380. doi: 10.1097/MD.0000000000018380.
• Urun Y, Akbulut H, Demirkazik A, Cay Senler F, Utkan G, Onur H, Icli F. Perception about influenza and pneumococcal vaccines and vaccination coverage among patients with malignancies and their family members. J BUON. 2013 Apr-Jun;18(2):511-5.
• Klassing HM, Ruisinger JF, Prohaska ES, Melton BL. Evaluation of Pharmacist-Initiated Interventions on Vaccination Rates in Patients with Asthma or COPD. J Community Health. 2018 Apr;43(2):297-303. doi: 10.1007/s10900-017-0421-9.
• Otsuka SH, Tayal NH, Porter K, Embi PJ, Beatty SJ. Improving herpes zoster vaccination rates through use of a clinical pharmacist and a personal health record. Am J Med. 2013 Sep;126(9):832.e1-6. doi: 10.1016/j.amjmed.2013.02.018. Epub 2013 Jul 3.

Helpful Links

• Immunization

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Pneumonia, Bacterial
• Other Study ID Numbers: Oz2214836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study protocol and results
• IPD Sharing Time Frame: Starting in January 2023
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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