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Pharmacists as Immunizers to Improve Coverage and Provider/Recipient Satisfaction

NCT ID: NCT02868970

Last Updated: 2024-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2021-07-05

Brief Summary

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This project proposes to implement and compare new community pharmacy-based strategies for improving vaccine coverage.

Detailed Description

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Although there are many safe and effective vaccines for adults, the Public Health Agency of Canada has noted that public perception of vaccination is that it is primarily for infants and children. The National Advisory Committee on Immunization (NACI) recommends adults and adolescents receive the influenza vaccine, tetanus-diphtheria-acellular pertussis vaccine (Tdap), and meningococcal vaccines (MenACWY, 4CMenB). As well, NACI recommends that people 60 years or older receive the herpes zoster vaccine and that Canadians who travel to high-risk areas should consider getting vaccinated to protect themselves against travel-related illnesses, such as Hepatitis A and Typhoid Fever. While NACI makes recommendations, provinces and territories (P/Ts) determine if they will fund and implement vaccine programs. Unlike the childhood immunization programs which tend to be funded by P/Ts, many adult vaccines are unfunded, resulting in poor population uptake. In this project,the investigators propose to implement and compare new community pharmacy-based strategies for improving vaccine coverage.

Patients are typically educated about preventative health care during face-to-face visits with physicians in office settings. The ability to educate and deliver preventative health care is limited by the available provider time during office visits - providers often focus on acute needs and current disease management. New delivery models and a means of extending preventative health care delivery outside of traditional face-to-face office visits are needed.

Pharmacists are in a unique position of being among the most accessible of health professionals. Given their extended operating hours, accessibility, and established trust with patients, pharmacists are well-positioned to improve vaccination rates and health system efficacy through injection administration.

Vaccine coverage rates will be measured using the following:

1. pharmacy database analysis,
2. public health vaccine reports by physicians,
3. number of vaccine doses delivered to pharmacies in all four regions, and
4. public survey within the study communities to determine immunization status.

Intervention communities include Saint John, New Brunswick and New Glasgow/Pictou/Antigonish, Nova Scotia area, which include the smaller towns of Stellarton and Westville, Nova Scotia. Control communities include Moncton, New Brunswick and Kentville/New Minas/Wolfville, Nova Scotia, which include the smaller towns of Canning and Coldbrook, Nova Scotia.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Community (2 in NB, 2 from NS)

There are four communities involved in the study, two in New Brunswick and two in Nova Scotia. All pharmacies in each community will be allocated to one intervention. Interventions include: High-Dose TIV, Meningococcal B Vaccine, Meningococcal ACWY vaccine, Tdap, Herpes Zoster vaccine and Travel Health vaccines (Hepatitis A, Hepatitis B, Typhoid Fever).

Group Type OTHER

Meningococcal B

Intervention Type BIOLOGICAL

Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.

High-Dose TIV

Intervention Type BIOLOGICAL

Fluzone High-Dose is an injectable influenza vaccine made to protect against the flu strains most likely to cause illness for that particular flu season.

Tdap (tetanus-diphtheria-acellular pertussis)

Intervention Type BIOLOGICAL

Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).

Meningococcal ACWY

Intervention Type BIOLOGICAL

Meningococcal ACWY vaccine is indicated for active immunization of individuals up to 55 years of age against invasive meningococcal diseases caused by Neisseria meningitides serogroups A, C, W-135 and Y.

Herpes Zoster

Intervention Type BIOLOGICAL

Herpes zoster vaccine is indicated for the immunization of individuals 50 years of age or older for the prevention of herpes zoster (shingles).

Travel Health (Hepatitis A, Hepatitis B, Typhoid Fever)

Intervention Type BIOLOGICAL

Hepatitis A vaccine is indicated for immunization against infections caused by hepatitis A virus; Hepatitis B vaccine is indicated for immunization against infection caused by hepatitis B virus; and typhoid fever vaccine is indicated for active immunization against Salmonella typhi, the organism which causes typhoid fever.

Interventions

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Meningococcal B

Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.

Intervention Type BIOLOGICAL

High-Dose TIV

Fluzone High-Dose is an injectable influenza vaccine made to protect against the flu strains most likely to cause illness for that particular flu season.

Intervention Type BIOLOGICAL

Tdap (tetanus-diphtheria-acellular pertussis)

Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).

Intervention Type BIOLOGICAL

Meningococcal ACWY

Meningococcal ACWY vaccine is indicated for active immunization of individuals up to 55 years of age against invasive meningococcal diseases caused by Neisseria meningitides serogroups A, C, W-135 and Y.

Intervention Type BIOLOGICAL

Herpes Zoster

Herpes zoster vaccine is indicated for the immunization of individuals 50 years of age or older for the prevention of herpes zoster (shingles).

Intervention Type BIOLOGICAL

Travel Health (Hepatitis A, Hepatitis B, Typhoid Fever)

Hepatitis A vaccine is indicated for immunization against infections caused by hepatitis A virus; Hepatitis B vaccine is indicated for immunization against infection caused by hepatitis B virus; and typhoid fever vaccine is indicated for active immunization against Salmonella typhi, the organism which causes typhoid fever.

Intervention Type BIOLOGICAL

Other Intervention Names

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Bexsero FluZone

Eligibility Criteria

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Inclusion Criteria

* For the selection of the four communities include population size (approximately 30,000 adults \>18 years of age), stable population, service by a centralized regional hospital and local community hospitals, availability of community pharmacies, interest of community pharmacists (sufficient numbers of pharmacists qualified to provide vaccinations), and lack of substantial health care spill over to adjacent communities.
* Spill over is defined as a pattern of health-care utilization where patients regularly receive care at different regional health centers.
* Intervention communities include Saint John, New Brunswick and New Glasgow/Pictou/Antigonish, Nova Scotia area, which include the smaller towns of Stellarton and Westville, Nova Scotia.
* Control communities include Moncton, New Brunswick and Kentville/New Minas/Wolfville, Nova Scotia, which include the smaller towns of Canning and Coldbrook, Nova Scotia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

MCM Vaccines B.V.

INDUSTRY

Sponsor Role collaborator

Canadian Center for Vaccinology

OTHER

Sponsor Role collaborator

Dalhousie University

OTHER

Sponsor Role collaborator

Canadian Immunization Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Jennifer Isenor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott A Halperin, MD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CT12

Identifier Type: -

Identifier Source: org_study_id