Clinical trial NCT05207631: Intervention to Reduce Misused Inhaler and Insufficient Peak Inspiratory Flow in Hospitalized COPD Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Inhaler
Critical error
Inspiratory peak flow
Hospital
Lead sponsor: Hôpital Fribourgeois
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Quasi-experimental study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of inhalers used sub-optimally at hospital discharge
timeFrame: This outcome is assessed within 48 hours prior to hospital discharge
Secondary outcomes:
measure: Proportion of inhaler used with a critical error at hospital discharge
timeFrame: This outcome is assessed within 48 hours prior to hospital discharge
measure: Proportion of inhaler used with suboptimal peak inspiratory flow at hospital discharge.
timeFrame: This outcome is assessed within 48 hours prior to hospital discharge
measure: Proportion of inhalers that cannot be handled properly despite appropriate teaching at hospital discharge.
timeFrame: This outcome is assessed within 48 hours prior to hospital discharge
measure: Proportion of inappropriate inhaler at hospital discharge.
timeFrame: This outcome is assessed within 48 hours prior to hospital discharge
measure: Proportion of inhalers used sub-optimally at hospital discharge by type of inhaler.
timeFrame: This outcome is assessed within 48 hours prior to hospital discharge
measure: Proportion of patients using at least one inhaler sub-optimally
timeFrame: This outcome is assessed within 48 hours prior to hospital discharge
measure: Length of hospital stay
timeFrame: This outcome is assessed up to three months
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: HFR Fribourg
Study officials:
affiliation: Hôpital Fribourgeois
name: Gaël Grandmaison, Dr
role: PRINCIPAL_INVESTIGATOR
References: