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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Systematic and standardised assessment of inhalers and implementation of a prescribing guide

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Fribourg, Switzerland, 1700
    • HFR Fribourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control cohort; Participants in the control cohort received standard care.
Active Comparator: Cohort with intervention; Participants included in the intervention cohort receive a systematic and standardised assessment of their inhaler on admission to our department. Their inhalers are adapted in accordance with a prescribing guide.	Other: Systematic and standardised assessment of inhalers and implementation of a prescribing guide; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of inhalers used sub-optimally at 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.	This outcome is assessed within 48 hours prior to hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of inhaler used with a critical error at 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.	This outcome is assessed within 48 hours prior to hospital discharge
Proportion of inhaler used with suboptimal peak inspiratory flow at 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.	This outcome is assessed within 48 hours prior to hospital discharge
Proportion of inhalers that cannot be handled properly despite appropriate teaching at 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.	This outcome is assessed within 48 hours prior to hospital discharge
Proportion of inappropriate inhaler at 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.	This outcome is assessed within 48 hours prior to hospital discharge
Proportion of inhalers used sub-optimally at hospital discharge by type of inhaler.	The proportion of inhalers used sub-optimally at hospital discharge is described by type of inhaler.	This outcome is assessed within 48 hours prior to hospital discharge
Proportion of patients using at least one inhaler sub-optimally	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.	This outcome is assessed within 48 hours prior to hospital discharge
Length of hospital stay	The length of stay in acute care on the internal medicine department will be documented.	This outcome is assessed up to three months

Collaborators and Investigators

• Sponsor: Hôpital Fribourgeois
• Investigators: Principal Investigator: Gaël Grandmaison, Dr, Hôpital Fribourgeois

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 25, 2022
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Hospital; Inhaler; Critical error; Inspiratory peak flow
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 010322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No