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Patient Perspective on Climate Impact of Inhalers

Primary Purpose

Asthma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, Inhalers, Environment, Climate impact

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older Followed in the asthma clinic at the Montreal Chest Institute or the Montreal General Hospital. Confirmed diagnosis of asthma presenting for a follow up visit for their asthma (defined as positive methacholine challenge test or confirmed reversibility of lung function 12% increase FEV1 (forced expiratory volume) or 200ml absolute value increase post bronchodilator). On an inhaled steroid for the treatment of asthma for maintenance as well as Ventolin MDI as a rescue inhaler. Stable asthma -not currently being evaluated for an acute asthma exacerbation and no Emergency Room visits for asthma within the last 30 days. Adequate lung function with a FEV1 of at least 50% and, where available, a peak inspiratory flow (PIF) of under 60L/m for use of a DPI and MDI.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Asthma patients

    Arm Description

    Low risk educational intervention. The consented patients will be given an information packet containing an infographic about the climate impact of inhalers, a letter explaining the option of changing inhalers (which clearly outlines that the Bricanyl Turbuhaler will not cost them more money than the Ventolin) and a pre-filled prescription for Bricanyl Turbuhaler. Also 5 selected asthma providers will be asked to fill a questionnaire on their perspectives on the climate impact of inhalers and their approach to inhaler rotation. This may also be supplemented with a phone interview

    Outcomes

    Primary Outcome Measures

    Rotation of Ventolin MDI to Bricanyl Turbuhaler.
    Proportion of participants who changed their inhaler from Ventolin MDI to Bricanyl Turbuhaler within 30 days of study visit.

    Secondary Outcome Measures

    Rate of failure of the intervention
    defined as a rotation back from Bricanyl to Ventolin MDI within 90 days after the clinic
    Proportion of patients who filled Bricanyl Rx change
    Proportion of patients who filled Bricanyl Rx change with pharmacist within 30 days of the clinic but did not possess the medication (30 day medication possession ratio)
    Awareness of patients regarding the climate impact of inhalers
    Awareness of patients regarding the climate impact of inhalers defined by questionnaire data, using a 5 point likert scale (from "not at all aware" to "extremely aware")
    Patients' willingness to change inhalers for environmental reasons
    Patients' willingness to change inhalers for environmental reasons and the importance of different issues (environmental impact, cost, ease of use) for patients, using 3 different 5 point likert scale, one for each sub-category)
    Providers' willingness to change inhalers for environmental reasons
    Providers' willingness to change inhalers for environmental reasons and the importance of different issues (environmental impact, cost, ease of use) for patients. This will be assessed through 5 different 5 points likert scale, as well as with a phone interview.

    Full Information

    First Posted
    October 11, 2023
    Last Updated
    October 18, 2023
    Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06097507
    Brief Title
    Patient Perspective on Climate Impact of Inhalers
    Official Title
    Patient and Prescriber Perspective on Climate Impact of Inhalers in the Treatment of Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The effects of climate change on population health have considerably increased as the planet warms and is thus subjected to more heat waves, extreme weather events and food insecurity. Paradoxically, healthcare systems are major contributors to carbon emissions. Within the field of respirology, choice of inhaler is a low-hanging fruit to address this issue. Metered dose inhalers (MDI) contain potent greenhouse gases and have been shown to have a significantly larger carbon footprint than dry powder inhalers (DPI). The goal of the study is to assess asthma patients' willingness to change inhalers for environmental reasons as well as prescribers' willingness to prescribe a different inhaler for environmental reasons at the patient's request. The study will also be assessing patient awareness of the climate impact of inhalers and the importance that they attribute to this issue as well as other issues (cost and ease of use).
    Detailed Description
    The effects of climate change on population health have considerably increased as the planet warms and is thus subjected to more heat waves, extreme weather events and food insecurity. Paradoxically, healthcare systems are major contributors to carbon emissions. Within the field of respirology, choice of inhaler is a low-hanging fruit to address this issue. Metered dose inhalers (MDI) contain potent greenhouse gases and have been shown to have a significantly larger carbon footprint than dry powder inhalers (DPI). Studies from the United Kingdom have revealed that although patient awareness of the discrepancy in climate impact of inhalers is low, their willingness to change inhalers after being educated on the subject is high. An example of inhaler change is to use the Bricanyl Turbuhaler (terbutaline) instead of Ventolin (salbutamol) as a rescue medication in asthma. They are both short-acting bronchodilators (SABA) and have similar pharmacodynamics. However, use of Bricanyl for one year produces 7,183 kgCO2e or the equivalent of 59.9km by car, whereas use of Ventolin for one year produces 411,720 kgCO2e, the equivalent of 3,431 km by car. The goal of the study is to assess asthma patients' willingness to change inhalers for environmental reasons as well as prescribers' willingness to prescribe a different inhaler for environmental reasons at the patient's request. The study will also be assessing patient awareness of the climate impact of inhalers and the importance that they attribute to this issue as well as other issues (cost and ease of use).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma, Inhalers, Environment, Climate impact

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Asthma patients
    Arm Type
    Experimental
    Arm Description
    Low risk educational intervention. The consented patients will be given an information packet containing an infographic about the climate impact of inhalers, a letter explaining the option of changing inhalers (which clearly outlines that the Bricanyl Turbuhaler will not cost them more money than the Ventolin) and a pre-filled prescription for Bricanyl Turbuhaler. Also 5 selected asthma providers will be asked to fill a questionnaire on their perspectives on the climate impact of inhalers and their approach to inhaler rotation. This may also be supplemented with a phone interview
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational intervention
    Intervention Description
    The consented patients will be given an information packet containing an infographic about the climate impact of inhalers, a letter explaining the option of changing inhalers (which clearly outlines that the Bricanyl Turbuhaler will not cost them more money than the Ventolin) and a pre-filled prescription for Bricanyl Turbuhaler.
    Primary Outcome Measure Information:
    Title
    Rotation of Ventolin MDI to Bricanyl Turbuhaler.
    Description
    Proportion of participants who changed their inhaler from Ventolin MDI to Bricanyl Turbuhaler within 30 days of study visit.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Rate of failure of the intervention
    Description
    defined as a rotation back from Bricanyl to Ventolin MDI within 90 days after the clinic
    Time Frame
    90 days
    Title
    Proportion of patients who filled Bricanyl Rx change
    Description
    Proportion of patients who filled Bricanyl Rx change with pharmacist within 30 days of the clinic but did not possess the medication (30 day medication possession ratio)
    Time Frame
    30 days
    Title
    Awareness of patients regarding the climate impact of inhalers
    Description
    Awareness of patients regarding the climate impact of inhalers defined by questionnaire data, using a 5 point likert scale (from "not at all aware" to "extremely aware")
    Time Frame
    Baseline
    Title
    Patients' willingness to change inhalers for environmental reasons
    Description
    Patients' willingness to change inhalers for environmental reasons and the importance of different issues (environmental impact, cost, ease of use) for patients, using 3 different 5 point likert scale, one for each sub-category)
    Time Frame
    Baseline
    Title
    Providers' willingness to change inhalers for environmental reasons
    Description
    Providers' willingness to change inhalers for environmental reasons and the importance of different issues (environmental impact, cost, ease of use) for patients. This will be assessed through 5 different 5 points likert scale, as well as with a phone interview.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Followed in the asthma clinic at the Montreal Chest Institute or the Montreal General Hospital. Confirmed diagnosis of asthma presenting for a follow up visit for their asthma (defined as positive methacholine challenge test or confirmed reversibility of lung function 12% increase FEV1 (forced expiratory volume) or 200ml absolute value increase post bronchodilator). On an inhaled steroid for the treatment of asthma for maintenance as well as Ventolin MDI as a rescue inhaler. Stable asthma -not currently being evaluated for an acute asthma exacerbation and no Emergency Room visits for asthma within the last 30 days. Adequate lung function with a FEV1 of at least 50% and, where available, a peak inspiratory flow (PIF) of under 60L/m for use of a DPI and MDI.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicole EZER, MD
    Phone
    (514)-934-1934
    Ext
    76192
    Email
    nicole.ezer@mcgill.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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