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

NCT ID: NCT05207631

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-01-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Quasi-experimental study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control cohort

Participants in the control cohort received standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Systematic and standardised assessment of inhalers and implementation of a prescribing guide

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hôpital Fribourgeois

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gaël Grandmaison

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gaël Grandmaison, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fribourgeois

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HFR Fribourg

Fribourg, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38579300 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

010322

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

COPD on Primary Care Treatment (COOPT)
NCT00184977 COMPLETED PHASE4
Change of Inspiratory Peak Flow in COPD
NCT00561886 COMPLETED PHASE4
Study in Patients With COPD
NCT00215384 COMPLETED PHASE2