Pharmacists as Immunizers to Improve Coverage and Provider/Recipient Satisfaction

Healthy Clinical Trial

Official title:

Pharmacists as Immunizers to Improve Coverage and Provider/Recipient Satisfaction: A Prospective, Controlled Community Embedded Study With Vaccines With Low Coverage Rates (The Improve ACCESS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868970
• Other study ID #: CT12
• Status: Completed
• Phase: Phase 4
• Start date: February 15, 2017
• Est. completion date: July 5, 2021

Study information

• Verified date: March 2022
• Source: Canadian Immunization Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2747
• Est. completion date: July 5, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion criteria: Not meeting inclusion criteria

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• 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.
• 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.
• 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).
• 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.
• 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).
• 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.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (5)

Lead Sponsor	Collaborator
Canadian Immunization Research Network	Canadian Center for Vaccinology, Dalhousie University, GlaxoSmithKline, MCM Vaccines B.V.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of targeted patient interventions by pharmacists on vaccine coverage measured using de-identified pharmacy database information, public health vaccine reports by physicians, and vaccine doses delivered.	A demonstration program implementation and evaluation project will be conducted in two New Brunswick and two Nova Scotia communities. Communities will be allocated to one of two different two-year program implementation strategies specifically designed for each of the target vaccines. One of the communities will serve as the non-intervention control arm where immunization practice will continue unchanged. Uptake of targeted vaccines in intervention communities will be compared to the same information in the control communities.	Two years
Secondary	Frequency of patient-reported adverse events following pharmacist-delivered immunizations.	The methodology used by the Canadian National Vaccine Safety Network (CANVAS) to conduct active surveillance during the first two weeks of the seasonal influenza vaccine campaign will be employed in this study. Patients in all intervention communities receiving high-dose TIV at the pharmacy or participating physicians' offices will be invited to participate in a specific survey of adverse events experienced during the 7 days following immunization.	7 days following immunization
Secondary	Pre- and post-intervention knowledge, attitudes, beliefs and behaviours (KABB) of target adults, pharmacists, physicians, and public health practitioners.	Surveys will be distributed before and after the intervention regarding knowledge, attitudes, beliefs, and behaviours of targeted vaccines and their delivery by pharmacists.	Two years