HealthyPhase 4NCT02868970
Pharmacists as Immunizers to Improve Coverage and Provider/Recipient Satisfaction
A Phase 4 study testing Meningococcal B, High-Dose TIV and Tdap (tetanus-diphtheria-acellular pertussis) in people with Healthy, run by Canadian Immunization Research Network at 1 site in Canada.
Trial summary
This project proposes to implement and compare new community pharmacy-based strategies for improving vaccine coverage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meningococcal B, High-Dose TIV and Tdap (tetanus-diphtheria-acellular pertussis)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,404 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2017to 5 Jul 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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)
This project proposes to implement and compare new community pharmacy-based strategies for improving vaccine coverage.
Read the 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:
- pharmacy database analysis,
- public health vaccine reports by physicians,
- number of vaccine doses delivered to pharmacies in all four regions, and
- 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
- Healthy
- Being tested
- Meningococcal B, High-Dose TIV, Tdap (tetanus-diphtheria-acellular pertussis), Meningococcal ACWY, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal BBiological
Also called Bexsero
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 TIVBiological
Also called FluZone
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)Biological
Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).
Meningococcal ACWYBiological
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 ZosterBiological
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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]
Measured: 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].
Measured: 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]
Measured: 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].
Measured: At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start15 Feb 2017
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Immunization Research Network
- Sponsor type
- Research network
- Collaborators
- GlaxoSmithKline, MCM Vaccines B.V., Canadian Center for Vaccinology, Dalhousie University
- Responsible party
- Principal investigator, Jennifer Isenor, Canadian Immunization Research Network
- Investigators
- Scott A Halperin, MD, Principal investigator, Dalhousie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868970
- Sponsor's protocol ID
- CT12
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2016
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02868970
- Acronym / sponsor ID
- CT12
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,404 participants (actual)
- Lead sponsor
- Canadian Immunization Research NetworkResearch network
- Collaborators
- GlaxoSmithKline, MCM Vaccines B.V., Canadian Center for Vaccinology, Dalhousie University
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project proposes to implement and compare new community pharmacy-based strategies for improving vaccine coverage.
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:
- pharmacy database analysis,
- public health vaccine reports by physicians,
- number of vaccine doses delivered to pharmacies in all four regions, and
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community (2 in NB, 2 from NS) | Other | 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)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcal BAlso: BexseroBexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B. | Biological | Community (2 in NB, 2 from NS) |
| High-Dose TIVAlso: FluZoneFluzone High-Dose is an injectable influenza vaccine made to protect against the flu strains most likely to cause illness for that particular flu season. | Biological | Community (2 in NB, 2 from NS) |
| 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 | Community (2 in NB, 2 from NS) |
| Meningococcal ACWYMeningococcal 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 | Community (2 in NB, 2 from NS) |
| Herpes ZosterHerpes zoster vaccine is indicated for the immunization of individuals 50 years of age or older for the prevention of herpes zoster (shingles). | Biological | Community (2 in NB, 2 from NS) |
| 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. | Biological | Community (2 in NB, 2 from NS) |
Primary outcome
Number of Vaccines Administered by Participating Pharmacies in the Intervention and Non-intervention Communities Before and During the Intervention.
Time frame: At the time of vaccination, 1 day over two years from September 2017 to November 2019.
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.
5 secondary outcomes
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the time of survey administration, 1 day over the 9-month period each of the surveys remained open
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott A Halperin, MD principal investigator
Dalhousie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meningococcal B, High-Dose TIV and Tdap (tetanus-diphtheria-acellular pertussis) in people with Healthy, run by Canadian Immunization Research Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Vaccines Administered by Participating Pharmacies in the Intervention and Non-intervention Communities Before and During the Intervention. (time frame: At the time of vaccination, 1 day over two years from September 2017 to November 2019.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024; AzTrials last refreshed its copy on 3 Nov 2026.