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

NCT05207631 | Completed

• 1 other identifier: 010322
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Inhaler; Critical error; Inspiratory peak flow; Hospital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of inhaler used with a critical error at hospital discharge

  This outcome is assessed within 48 hours prior to hospital discharge

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

  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.

  This outcome is assessed within 48 hours prior to hospital discharge

• Proportion of inappropriate inhaler at hospital discharge.

  This outcome is assessed within 48 hours prior to hospital discharge

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

  This outcome is assessed within 48 hours prior to hospital discharge

Study Arms (2)

Control cohort

NO INTERVENTION

Participants in the control cohort received standard care.

Cohort with intervention

ACTIVE COMPARATOR

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

Interventions

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.

Cohort with intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Fribourgeois: lead

Study Sites (1)

HFR Fribourg

Fribourg, 1700, Switzerland

Location

Related Publications (1)

• Grandmaison G, Grobety T, Dumont P, Vaucher J, Hayoz D, Suter P. An in-hospital intervention to reduce the proportion of misused inhalers at hospital discharge among patients with COPD: a non-randomised intervention study. Swiss Med Wkly. 2024 Apr 4;154:3394. doi: 10.57187/s.3394.

  PMID: 38579300 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Gaël Grandmaison, Dr

  Hôpital Fribourgeois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Quasi-experimental study

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 26, 2022
• Study Start: March 1, 2022
• Primary Completion: December 25, 2022
• Study Completion: January 24, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)