COPDMIPIFNCT05207631
Intervention to Reduce Misused Inhaler and Insufficient Peak Inspiratory Flow in Hospitalized COPD Patients
A study testing Systematic and standardised assessment of inhalers and implementation of a prescribing guide in people with COPD, run by Hôpital Fribourgeois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Systematic and standardised assessment of inhalers and implementation of a prescribing guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2022to 24 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Systematic and standardised assessment of inhalers and implementation of a prescribing guide
- Keywords
- Inhaler, Critical error, Inspiratory peak flow, Hospital
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic and standardised assessment of inhalers and implementation of a prescribing guideOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Systematic and standardised assessment of inhalers and implementation of a prescribing guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This outcome is assessed up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Mar 2022
- Primary completion25 Dec 2022
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaël Grandmaison, Hôpital Fribourgeois
- Investigators
- Gaël Grandmaison, Dr, Principal investigator, Hôpital Fribourgeois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207631
- Sponsor's protocol ID
- 010322
- Acronym
- MIPIF
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38579300
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05207631
- Acronym / sponsor ID
- MIPIF / 010322
- Conditions
- COPD
- Keywords
- Inhaler, Critical error, Inspiratory peak flow, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| Control cohort | No intervention | –Participants in the control cohort received standard care. |
| Cohort with intervention | Active comparator | Other: Systematic and standardised assessment of inhalers and implementation of a prescribing guideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic and standardised assessment of inhalers and implementation of a prescribing guideParticipants 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. | Other | Cohort with intervention |
Primary outcome
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.
7 secondary outcomes
Proportion of inhaler used with a critical error at hospital discharge
Time frame: This outcome is assessed within 48 hours prior to hospital discharge
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
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
Proportion of inappropriate inhaler at hospital discharge.
Time frame: This outcome is assessed within 48 hours prior to hospital discharge
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
Proportion of patients using at least one inhaler sub-optimally
Time frame: This outcome is assessed within 48 hours prior to hospital discharge
Length of hospital stay
Time frame: This outcome is assessed up to three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 38579300Grandmaison 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaël Grandmaison, Dr principal investigator
Hôpital Fribourgeois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic and standardised assessment of inhalers and implementation of a prescribing guide in people with COPD, run by Hôpital Fribourgeois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of inhalers used sub-optimally at hospital discharge (time frame: This outcome is assessed within 48 hours prior to hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.