Clinical trial NCT06489964: Addressing Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies
Official title: Addressing the Problem of Recommended But Unfunded Vaccines Through a Transitional Stepped Co-payment Mechanism in Pharmacies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preventable Disease, Vaccine
Lead sponsor: Canadian Immunization Research Network
Sponsor class: NETWORK
Collaborators: name: Dalhousie University
name: Canadian Center for Vaccinology
First posted: 2024-07-08
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot demonstration and evaluation project is to increase the accessibility and uptake of recommended immunizations in the general public by implementing a transitional stepped co-payment model in community pharmacies in Nova Scotia and Ontario for the delivery of recommended but unfunded vaccines until full public funding is available. The main question it aims to answer is:

* Can a transitional stepped co-payment model through pharmacies for the delivery of recommended but unfunded vaccines (e.g., Shingrix, FluMist) increase the accessibility and uptake of recommended immunizations among various stakeholders until full public funding is available?

Participants will:

* Receive a reduced cost of the vaccine (if eligible) through this transitional stepped co-payment funding model, as part of routine care (following standard pharmacy practice).
* Complete a feedback and satisfaction survey exploring their thoughts on the transitional stepped co-payment model, their satisfaction with the co-payment model, their perception on vaccinations in general and specifically about recommended but unfunded vaccines, and their demographics (such as gender, age, education, race/ethnicity).

Detailed description: While the National Advisory Committee on Immunization (NACI) provides vaccine recommendations, it is the responsibility of provinces and territories in Canada to decide which vaccine programs they will support and implement publicly. Some vaccines recommended by NACI are not publicly funded in Canada and require out-of-pocket pay or private health insurance plans. This lack of public funding may be a factor contributing to low vaccine uptake. Cost-related barriers are also important concerns among prescribers who tend to be hesitant in recommending vaccines that are not publicly funded due to issues with patient affordability. Pharmacy professionals across Canada are increasingly taking a dominant role in administering certain publicly funded vaccines such as influenza and COVID-19, but administration of other publicly funded immunizations have been limited in many jurisdictions, and pharmacy services providing unfunded vaccines are underutilized.

Publicly funded immunization programs have demonstrated their cost-effectiveness for the healthcare system; however, evaluating the economic impact of introducing new vaccines into these programs is a time-consuming process, resulting in delays in making them available for public funding. The significant upfront costs of introducing a new vaccine program can be financially prohibitive, acting as a major barrier to having vaccinations covered through public funding. As a result, introducing a co-payment system for recommended but unfunded vaccines may help mitigate the perception that these vaccines are of lesser importance, especially if the government is covering a portion of the vaccine and administration fees. A flexible transitional stepped co-payment model, where the costs are shared between the patient or their private insurance and the government, until full funding becomes available, could potentially offer a solution to enhance immunization rates for these vaccines.

In this Pilot Demonstration and Evaluation Project, the investigators propose to better understand potential solutions to cost-related barriers that limit uptake of recommended but unfunded vaccines. Implementation of a transitional stepped co-payment funding model within community pharmacies will be piloted at select community pharmacies in Nova Scotia and Ontario where pharmacists will prescribe and administer recommended but unfunded vaccines. Electronic surveys will assess public and provider satisfaction with the model and vaccination rates before and after implementation will be compared.

Eligibility criteria: Inclusion Criteria:

* The selection of the community pharmacies will be based on population size, stable pharmacy patients, availability and interest of community pharmacies and community pharmacy professionals, sufficient numbers of pharmacy professionals 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 centres. Communities will be geographically separated to minimize potential spill over.
* The selection of the community pharmacy sites is still in progress. We will aim to recruit pharmacies in different locations around the province(s) and ensure the locations are comparable in terms of socioeconomic status and separated sufficiently to reduce shopping around for the best deal.
* The participating pilot pharmacies will recruit individuals who are currently eligible for the vaccine as per NACI guidance for each product as part of routine care.

Exclusion Criteria:

* Patients of the participating pharmacies in Nova Scotia and Ontario who already have private insurance coverage to cover all (or most) of the vaccine will be excluded from taking part in this pilot project.

Primary outcomes:
measure: Evaluating Acceptability of Implementing of a Transitional Stepped Co-Payment Model within Community Pharmacies through Surveys with Members of the Public and Community Pharmacists
timeFrame: 6 months
measure: Evaluating Feasibility of Implementing a Transitional Stepped Co-Payment Model within Community Pharmacies through Surveys with Members of the Public and Community Pharmacists
timeFrame: 6 months
Secondary outcomes:
measure: Number of vaccines administered at participating community pharmacy sites
timeFrame: 30 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Emily Black, PharmD
role: PRINCIPAL_INVESTIGATOR
References: