Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study

Study Overview
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Brief Summary
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Inhalation drugs are essential in the treatment of COPD, in controlling symptoms and preventing exacerbations. The aim of this pilot study is to collect data necessary for the planning of future efficacy trials. We plan to assess the value of providing training in inhalation technique to hospitalized COPD patients. Data on rehospitalizations will be collected from the hospital's medical records and from the National Patient Registry . The inhalation technique of all recruited patients will de assessed at baseline. The patients will then be randomised 1:1 to the intervention or standard care group. The intervention consists of a drug counselling, focusing on inhalation technique. In addition patients in the intervention group will have their medicines personally delivered from the hospital pharmacy at discharge (discharge service). Patients will be asked to fill in questionnaires evaluating the inhalation training and the discharge service

Official Title
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Could Training in Inhalation Technique During the Hospital Stay and Discharge Services From the Pharmacy Reduce the Rate of Readmissions for COPD Patients? - A Pilot Study

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Inhalation technique training and discharge service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to the pulmonary ward, the Medical Department, Oslo University Hospital, Oslo, Norway Exclusion Criteria: Patients previously included to the study usually not administering their inhalation drugs themselves using nebulizer chamber with their drug who are contagious, thus restricting accessibility of personnel who are not able to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients receive an inhalation technique education based on standardized procedure developed by The Norwegian Pharmacy Association. In addition they are offered a discharge service day before or the day of discharge; a second inhalation training and dispensing of their prescribed COPD- medicines. | Other: Inhalation technique training and discharge service<br>* Patient drug counselling one-to-one, focusing on inhalation drugs and technique<br>|
| No Intervention: Standard care<br>Patients receive standard care and follow up of their COPD-treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first readmission | Time to readmission based on data from the national patient registry | One year after discharge of the last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in patient reported symptom score (CAT-score) from baseline to 2 months after discharge | COPD assessment test (CAT) scores at baseline and 2 months after discharge. | 2 months after discharge | 
| Proportion of patients readmitted 3 months after discharge | Based on the hospital records. Preliminary data to be published in a master thesis, as the data on the primary endpoint will be received too late | 3 months |