Pharmacists as Immunizers to Improve Coverage and Provider/Recipient Satisfaction

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)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Meningococcal B; Biological: High-Dose TIV; Biological: Tdap (tetanus-diphtheria-acellular pertussis); Biological: Meningococcal ACWY; Biological: Herpes Zoster; Biological: Travel Health (Hepatitis A, Hepatitis B, Typhoid Fever)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2404
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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).

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.; Other Names: Bexsero; 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.; Other Names: FluZone; 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).; 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.; 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).; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Vaccines Administered by Participating Pharmacies in the Intervention and Non-intervention Communities Before and During the Intervention.	A 2-year demonstration program was conducted in two Canadian provinces (New Brunswick and Nova Scotia). One community in each province served as the intervention community, where pharmacies were allocated to implement various strategies specifically designed for each of the target vaccines. One community in each province also served as the non-intervention community, where immunization practice continued unchanged. Vaccine uptake was compared using pharmacy-generated reports of the number of vaccine doses administered before (from September 2015 to August 2017) and during (September 2017 to November 2019) the intervention and between non-intervention and intervention pharmacies.	At the time of vaccination, 1 day over two years from September 2017 to November 2019.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the Number of Flu Vaccine Recipients Who Were Recruited and Completed the Online AEFI Survey Among Intervention Pharmacies Using Active Recruitment Strategies and the Non-intervention Pharmacies Using Passive Recruitment Strategies.	Recipients of a flu vaccine in the intervention communities were actively recruited to participate in the CANVAS survey by the intervention pharmacists who handed out information sheets and/or pointed to the QR code to sign up for the survey, while flu vaccine recipients in the non-intervention pharmacies were passively recruited through posters with the QR code displayed in waiting areas without telling them about the study. Note: For this secondary outcome, "recruited" means anyone who signed up for the survey but may not have necessarily completed the survey. The number of flu vaccine recipients who were actively recruited in the intervention pharmacies or passively recruited in the non-intervention pharmacies were compared to assess the effectiveness of the active versus passive recruitment approach.	At the time of survey recruitment, 1 day over the 5-month period the surveys remained open during the influenza seasons
Determining the Awareness About Pharmacists as Immunizers and Vaccination Behaviours of the Targeted Public Using Pre-intervention and Post-intervention Knowledge, Attitudes, Beliefs and Behaviours (KABB) Surveys	As part of the pre- and post-KABB surveys, participants were asked questions regarding their awareness about pharmacists as immunizers and their vaccination behaviour. Questions related to their awareness about pharmacists as immunizers were "Are you aware that many pharmacists are trained to administer vaccines? (Yes or No)" and "Which of the following vaccines are currently administered by pharmacists in a pharmacy? (Check all that apply)". Questions related to their vaccination behaviour were "Did you get or have you ever received... (the following vaccines)?" [Note: Those who answered 'Yes' to these yes/no questions are presented below]	At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Determining the Attitudes and Beliefs of the Targeted Public About Pharmacists as Immunizers Using Pre-intervention and Post-intervention Knowledge, Attitudes, Beliefs, and Behaviours (KABB) Surveys	As part of the pre- and post-KABB surveys, participants were asked to indicate how much they agree/disagree with a list of statements about their attitudes and beliefs about pharmacists as immunizers: "Please indicate how much you agree or disagree with the following statements by clicking the box that best fits your opinion". [Note: Those who answered 'agree' are presented below].	At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Determining the Awareness of the National Advisory Committee on Immunization (NACI) Guidelines and the Vaccinating Behaviors of Healthcare Providers Through Pre-intervention and Post-intervention Knowledge, Attitudes, Beliefs and Behaviors (KABB) Surveys	As part of the pre- and post-KABB surveys, healthcare providers were asked about their awareness of NACI recommendations and about their vaccinating behaviour. The questions for their awareness of NACI recommendations were "Are you aware that the Canadian guidelines (NACI) recommends/indicates (the following vaccines)". The questions about their vaccinating behaviour was "Do you offer/discuss/recommend (the following vaccines) according to NACI guidelines?" [Note: Those who answered 'Yes' to these yes/no questions are presented below]	At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Determining the Attitudes and Beliefs of Healthcare Providers Regarding Pharmacists as Immunizers Using Pre-intervention and Post-intervention Knowledge, Attitudes, Beliefs, and Behaviours (KABB) Surveys	As part of the pre- and post-KABB surveys, healthcare providers were asked about their attitudes and beliefs about pharmacists as immunizers. The questions were: "Where do you think vaccines should be administered? (Check all that apply)" [Note: those who selected 'family doctor's office', 'public health clinic', and/or 'pharmacy' as the locations are presented below]; and "Please indicate how much you agree or disagree with the following statements by clicking the box that best fits your opinion?" [Note: Those who answered 'agree' are presented below].	At the time of survey administration, 1 day over the 9-month period each of the surveys remained open

Collaborators and Investigators

• Sponsor: Canadian Immunization Research Network
• Collaborators: GlaxoSmithKline; Dalhousie University; MCM Vaccines B.V.; Canadian Center for Vaccinology
• Investigators: Principal Investigator: Scott A Halperin, MD, Dalhousie

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): July 5, 2021
• Study Completion (Actual): July 5, 2021

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimated): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CT12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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