Pharmacists as Immunizers to Improve Coverage and Provider/Recipient Satisfaction

NCT02868970 | Completed Phase 4 Results

• 1 other identifier: CT12
• Study Type: interventional
• Target: 2,404
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  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

  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

  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

  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

  At the time of survey administration, 1 day over the 9-month period each of the surveys remained open

Study Arms (1)

Community (2 in NB, 2 from NS)

OTHER

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; 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)

Interventions

Meningococcal B 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.

Also known as: Bexsero

Community (2 in NB, 2 from NS)

High-Dose TIV 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.

Also known as: FluZone

Community (2 in NB, 2 from NS)

Tdap (tetanus-diphtheria-acellular pertussis) BIOLOGICAL

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

Community (2 in NB, 2 from NS)

Meningococcal ACWY 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.

Community (2 in NB, 2 from NS)

Herpes Zoster BIOLOGICAL

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

Community (2 in NB, 2 from NS)

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

Community (2 in NB, 2 from NS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Canadian Immunization Research Network: lead
• GlaxoSmithKline: collaborator
• MCM Vaccines B.V.: collaborator
• Canadian Center for Vaccinology: collaborator
• Dalhousie University: collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Interventions

4CMenB vaccine; Influenza Vaccines; Herpes Zoster Vaccine; Hepatitis A Vaccines; Hepatitis B Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chickenpox Vaccine; Herpesvirus Vaccines; Viral Hepatitis Vaccines

Limitations and Caveats

The demonstration program was not able to separate which of the various outreach strategies had the most impact on vaccination uptake (e.g., unable to separate simulated public funding from other outreach strategies such as posters, targeted outreach for the Tdap vaccine). This may be an indication that pharmacies focused on the Tdap vaccine because it was "funded" (simulated public funding).

Results Point of Contact

• Title: Dr. Jennifer Isenor
• Organization: Canadian Center for Vaccinology, Dalhousie University

jennifer.isenor@dal.ca

902-494-2378

Study Officials

• Scott A Halperin, MD

  Dalhousie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: August 16, 2016
• Study Start: February 15, 2017
• Primary Completion: July 5, 2021
• Study Completion: July 5, 2021
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)