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

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Systematic and standardised assessment of inhalers and implementation of a prescribing guide
Sponsored by
Hôpital Fribourgeois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Inhaler, Critical error, Inspiratory peak flow, Hospital

Eligibility Criteria

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

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

Sites / Locations

  • HFR Fribourg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control cohort

Cohort with intervention

Arm Description

Participants in the control cohort received standard care.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 29, 2021
Last Updated
January 24, 2023
Sponsor
Hôpital Fribourgeois
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1. Study Identification

Unique Protocol Identification Number
NCT05207631
Brief Title
Intervention to Reduce Misused Inhaler and Insufficient Peak Inspiratory Flow in Hospitalized COPD Patients
Acronym
MIPIF
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 25, 2022 (Actual)
Study Completion Date
January 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Fribourgeois

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Inhaler, Critical error, Inspiratory peak flow, Hospital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Quasi-experimental study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control cohort
Arm Type
No Intervention
Arm Description
Participants in the control cohort received standard care.
Arm Title
Cohort with intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Systematic and standardised assessment of inhalers and implementation of a prescribing guide
Intervention Description
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 Outcome Measure Information:
Title
Proportion of inhalers used sub-optimally at hospital discharge
Description
An inhaler used sub-optimally is defined as an inhaler used with at least one critical error and/or with insufficient inspiratory flow.
Time Frame
This outcome is assessed within 48 hours prior to hospital discharge
Secondary Outcome Measure Information:
Title
Proportion of inhaler used with a critical error at hospital discharge
Description
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.
Time Frame
This outcome is assessed within 48 hours prior to hospital discharge
Title
Proportion of inhaler used with suboptimal peak inspiratory flow at hospital discharge.
Description
The peak inspiratory flow values considered sub-optimal for inhaler use are defined in the literature and are specific to each inhaler type.
Time Frame
This outcome is assessed within 48 hours prior to hospital discharge
Title
Proportion of inhalers that cannot be handled properly despite appropriate teaching at hospital discharge.
Description
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.
Time Frame
This outcome is assessed within 48 hours prior to hospital discharge
Title
Proportion of inappropriate inhaler at hospital discharge.
Description
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.
Time Frame
This outcome is assessed within 48 hours prior to hospital discharge
Title
Proportion of inhalers used sub-optimally at hospital discharge by type of inhaler.
Description
The proportion of inhalers used sub-optimally at hospital discharge is described by type of inhaler.
Time Frame
This outcome is assessed within 48 hours prior to hospital discharge
Title
Proportion of patients using at least one inhaler sub-optimally
Description
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.
Time Frame
This outcome is assessed within 48 hours prior to hospital discharge
Title
Length of hospital stay
Description
The length of stay in acute care on the internal medicine department will be documented.
Time Frame
This outcome is assessed up to three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaël Grandmaison, Dr
Organizational Affiliation
Hôpital Fribourgeois
Official's Role
Principal Investigator
Facility Information:
Facility Name
HFR Fribourg
City
Fribourg
ZIP/Postal Code
1700
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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