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Completed

NCT Number: NCT05207631

Intervention to Reduce Misused Inhaler and Insufficient Peak Inspiratory Flow in Hospitalized COPD Patients

The drug treatment of chronic obstructive pulmonary disease (COPD) is mainly based on inhaled therapy. This route of administration is limited by inhaler handling errors, insufficient inspiratory flow or inappropriate inhalers. According to the scientific literature, these limitations are extremely common in both outpatients and inpatients.

Our hypothesis is that the implementation of a standardised and systematic assessment of inhalers combined with a prescribing guide to help select a suitable inhaler will decrease the proportion of suboptimally used inhalers at discharge in patients hospitalised with a diagnosis of COPD.

To assess the effectiveness of our intervention, the investigators will compare the proportion of inhalers used suboptimally at hospital discharge between a control cohort before the implementation of our intervention and a cohort after the implementation of our intervention. Secondary outcomes include reasons for sub-optimal use of inhalers, i.e. inhaler handling errors, insufficient peak inspiratory flow or inappropriate inhaler. Secondary outcomes will also include length of hospital stay and 30-day readmission rate.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HFR Fribourg

Fribourg, 1700, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission to the HFR Fribourg internal medicine department
  • Age greater than or equal to 18 years
  • Diagnosis of COPD
  • Use of an inhaler device for the treatment of COPD before admission

Exclusion criteria

  • Inability to complete initial assessment due to language problems
  • Inability to complete initial assessment due to physical or mental conditions
  • Patient who has already received the intervention during a previous hospitalization.
  • Length of hospitalization of less than 72 hours
  • Patient already included in the control period

Treatment and study plan

Systematic and standardised assessment of inhalers and implementation of a prescribing guide

Other

Participants included in the intervention cohort receive a systematic and standardised assessment of their inhalers on admission to our department. The assessment is carried out by a physiotherapist and aims to assess inhalation technique, peak inspiratory flow and ability to use the inhaler after targeted teaching. Based on this information and a prescription guide provided, the patient's doctor can select the most appropriate inhaler.

Primary outcomes

  1. Proportion of inhalers used sub-optimally at hospital discharge

    Time frame: This outcome is assessed within 48 hours prior to hospital discharge

    An inhaler used sub-optimally is defined as an inhaler used with at least one critical error and/or with insufficient inspiratory flow.

Secondary outcomes

  1. Proportion of inhaler used with a critical error at hospital discharge

    Time frame: This outcome is assessed within 48 hours prior to hospital discharge

    In accordance with the literature, the investigators define critical error as an action or an inaction that in itself would have a detrimental impact of the delivery of the drug to the distal airways.

  2. Proportion of inhaler used with suboptimal peak inspiratory flow at hospital discharge.

    Time frame: This outcome is assessed within 48 hours prior to hospital discharge

    The peak inspiratory flow values considered sub-optimal for inhaler use are defined in the literature and are specific to each inhaler type.

  3. Proportion of inhalers that cannot be handled properly despite appropriate teaching at hospital discharge.

    Time frame: This outcome is assessed within 48 hours prior to hospital discharge

    If critical errors are identified in the handling of the inhaler, the physiotherapist provides targeted instruction to correct these errors. After each instruction, a new assessment of the inhaler technique is performed and the instruction is repeated if a critical error persists. If handling critical errors persist despite appropriate instruction, it's considered that the inhaler cannot be handled by the patient.

  4. Proportion of inappropriate inhaler at hospital discharge.

    Time frame: This outcome is assessed within 48 hours prior to hospital discharge

    An inhaler is considered unsuitable if the patient is unable to handle it properly after appropriate instruction and/or if the patient does not have sufficient inspiratory flow for optimal use of the inhaler.

  5. Proportion of inhalers used sub-optimally at hospital discharge by type of inhaler.

    Time frame: This outcome is assessed within 48 hours prior to hospital discharge

    The proportion of inhalers used sub-optimally at hospital discharge is described by type of inhaler.

  6. Proportion of patients using at least one inhaler sub-optimally

    Time frame: This outcome is assessed within 48 hours prior to hospital discharge

    A participant is considered to have suboptimal device use if making a critical error when using an inhaler or if their peak inspiratory flow rate is insufficient for optimal device use.

  7. Length of hospital stay

    Time frame: This outcome is assessed up to three months

    The length of stay in acute care on the internal medicine department will be documented.

Sponsors and collaborators

Lead sponsor

Hôpital Fribourgeois

Other

Registry information

Official study title

Misused Inhaler and Insufficient Peak Inspiratory Flow in Hospitalized COPD Patients Before and After Implementation of a Systematic Assessment and a Prescription Guide - a Quasi Experimental Study - MIPIF

Acronym: MIPIF

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 26, 2022
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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