CARD for Community Pharmacy Vaccinations

Sponsor

University of Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06098703

Collaborator

Public Health Agency of Canada (PHAC) (Other), Wholehealth Pharmacy Partners (Other)

2,000

Enrollment

Location

Arms

Anticipated Duration (Months)

142.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.

Condition or Disease	Intervention/Treatment	Phase
Vaccination Reaction Vaccination Pain Community Pharmacy	Behavioral: CARD (Comfort Ask Relax Distract)	N/A

Detailed Description

It is estimated that 1 out of 5 children and adults are not vaccinated because of concerns about pain and fear. The CARD (Comfort Ask Relax Distract) system is a new vaccine delivery system proven to reduce pain, fear and immunization stress-related responses. Improving the vaccination experiences of patients can improve attitudes about vaccination and increase vaccine acceptance.

The objective of this cluster randomized trial is to evaluate scaling of CARD across community pharmacies on patients vaccination symptoms, beliefs and attitudes and pharmacy staff beliefs and attitudes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster trial involving at least 24 community pharmacies allocated to CARD or control (standard care) in a 1:1 ratio. Eligible pharmacies belonging to Wholehealth Pharmacy Partners from across Ontario, Canada, will be included.Cluster trial involving at least 24 community pharmacies allocated to CARD or control (standard care) in a 1:1 ratio. Eligible pharmacies belonging to Wholehealth Pharmacy Partners from across Ontario, Canada, will be included.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Vaccine recipients will not be aware of whether they are in the intervention or control group or the objective of the trial. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are in the intervention pharmacies will not deliver care to participants in the control pharmacies and care providers in the control pharmacies will not deliver care in the intervention pharmacies. Vaccine recipients are rating the primary outcome.

Primary Purpose:

Treatment

Official Title:

CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CARD (multi-faceted intervention) CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback).	Behavioral: CARD (Comfort Ask Relax Distract) CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations
No Intervention: Control (standard care) There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies.

Arm

Intervention/Treatment

Experimental: CARD (multi-faceted intervention)

CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback).

Behavioral: CARD (Comfort Ask Relax Distract)

CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations

No Intervention: Control (standard care)

There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies.

Outcome Measures

Primary Outcome Measures

Experience with vaccination [within 15 minutes after vaccination]
Vaccine client self-reported experience with vaccination (better or not)

Secondary Outcome Measures

Fear [within 15 minutes after vaccination]
Vaccine client self-reported fear during vaccination (0-10)
Pain [within 15 minutes after vaccination]
Vaccine client self-reported pain during vaccination (0-10)
Dizziness [within 15 minutes after vaccination]
Vaccine client self-reported dizziness during vaccination (0-10)
Fainting [within 15 minutes after vaccination]
Fainting during/after vaccination (yes/no)
Utilization of coping strategies during vaccination [within 5 minutes of vaccination]
Use of individual coping strategies during vaccination (e.g., distraction, support person) (yes/no)
CARD satisfaction survey [within 15 minutes of vaccination]
Vaccine client self-reported satisfaction with CARD (e.g., helpfulness, willingness to use again, willingness to return for next vaccination, vaccination decision-making, as applicable), responses reported for individual items
Implementation success of CARD [within 3 months of vaccination clinics]
Perceptions of implementation success of CARD program delivery as reported by CARD implementers (primary targets) using CARD Global Impression Checklist, individual questions (5-point Likert Scale higher number represents better outcome); responses reported for individual items. This information is supplemented with focus group information and study notes.
Attitudes about vaccination [within 3 months of vaccination clinics]
Perceptions of CARD and non-CARD implementers using CARD Attitudes survey, individual questions (5-point Likert Scale higher number represents better outcome); responses reported for individual items. This information is supplemented with focus group information and study notes.
Vaccination behaviours [within 3 months of vaccination clinics]
Self-reported vaccine behaviours of immunizers using CARD Behaviour Survey, individual questions (rank as whether behaviours are done or not); responses reported for individual items. Includes CARD and non-CARD implementers.
Vaccine interaction survey [within 5 minutes of vaccination]
Perceptions of CARD and non-CARD immunizers about vaccination interaction [duration, satisfaction, CARD usefulness (intervention group only)]; responses reported for individual items.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

vaccine clients being vaccinated in community pharmacies participating in the project
pharmacy staff in community pharmacies participating in the project

Exclusion Criteria:

unable to understand and read English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anna Taddio	Toronto	Ontario	Canada	M5S 3M2

Sponsors and Collaborators

University of Toronto
Public Health Agency of Canada (PHAC)
Wholehealth Pharmacy Partners

Investigators

Principal Investigator: Anna Taddio, PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Taddio, Professor, University of Toronto

ClinicalTrials.gov Identifier:

NCT06098703

Other Study ID Numbers:

43097

First Posted:

Oct 24, 2023

Last Update Posted:

Oct 25, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Anna Taddio, Professor, University of Toronto

Vaccination reaction

Vaccination experience

Study Results

No Results Posted as of Oct 25, 2023