- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02728674
Management of Patients With Respiratory Symptoms in Sweden
Study Overview
Status
Conditions
Detailed Description
BACKGROUND:
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. An American randomized web-based study showed important differences in the diagnosis of COPD among female and male patients.Women were more likely to be misdiagnosed as chronic cough or asthma instead of COPD and physicians were more reluctant to refer further women for spirometry.This is of importance as treatment and follow-up differ between the conditions.
Breathlessness, a subjective experience of breathing discomfort, is the cardinal symptom of cardiac and pulmonary disease. In advanced COPD, 98% of patients experience breathlessness which persists at rest or on minimal exertion, despite optimal treatment of the underlying disease (chronic refractory breathlessness). Dyspnea is linked to reduced physical activity, worsening deconditioning, increased anxiety and depression, impaired quality of life, loss of the will to live near death, increased risk of hospitalization, and earlier death.
The preferred treatment for the relief of chronic refractory breathlessness is a systemic (oral or parenteral) low dose opioid (Level I evidence). In a recent meta-analysis of 16 studies (271 patients in total), low dose opioids reduced chronic refractory breathlessness in advanced COPD, without any reported serious adverse effects. Lower dose opioids were not associated with increased risk of admission to hospital or death in a large register-based Swedish study of 2,249 patients with oxygen-dependent COPD patients treated with lower dose opioids (≤ 30mg of oral morphine/day).
Despite the growing evidence that support the use of opioids, physicians are reluctant to prescribe low dose opioids for breathlessness in COPD. In a review of 2000 random dispensed opioid prescriptions among patients with advanced COPD, most of whom suffered from severe chronic breathlessness, the most common stated indication was pain (97%), with only 2% for breathlessness. In a survey, Dutch chest physicians were reluctant to prescribe opioids for refractory breathlessness in advanced COPD due to perceived resistance from the patient and fear of adverse effects, including respiratory depression. Qualitative studies from Canada has shown that physicians in pulmonary medicine and primary care, families and patients feel that low dose opioids can be helpful for the relief of breathlessness, but that treatment was delayed or avoided due to lack of guidelines, lack of related knowledge and experience about opioids, and fears related to the potential adverse effects and legal censure.
No randomized trial has compared how physicians assess and treat refractory breathlessness versus refractory pain, how often opioids are considered for treatment of breathlessness and what factors affect the choice of treatment in chronic breathlessness as compared to pain in advanced COPD. Furthermore, it remains unknown if there is a gender bias in the diagnosis of COPD among physicians treating COPD patients.
METHOD:
This is a randomized, triple-blind, parallel group-, web-based study based on a survey instrument which is answered by certified physicians who treat patients with respiratory problems in Sweden. The survey is based upon a hypothetical patient case which regards situations and considerations that are part of physicians' daily clinical management and treatment of COPD patients. Two randomizations take place regarding the hypothetical case 1) Sex 2) Symptom. The participant is shown a hypothetical patient case which is randomized (1:1:1:1) regarding sex and symptom to one of four potential case scenarios: man+breathlessness; man+pain; woman+breathlessness; or woman+pain.
AIM:
The aim of the study is to determine if there is a gender bias in the diagnosis of COPD; how often physicians identify that chronic refractory breathlessness requires treatment as compared to refractory pain, which symptomatic treatments are considered with focus on morphine; explore physicians perception regarding the grade of evidence for different treatments for the relief of chronic breathlessness; and examine which factors affect physicians decision to treat refractory breathlessness with opioids.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Skane
-
Lund, Skane, Sweden, 21100
- Department of Respiratory Medicine and Allergology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (all required):
- Certified physician
- Treats patients with respiratory symptoms and reduced physical activity
- Able to read and understand a hypothetical case in Swedish
Exclusion Criteria:
- Knowledge about the aim and/or design of the study, or
- Previous participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Man+Breathlessness
Person in the case is a male.
Symptom in the case is breathlessness.
|
Person in the case is a male.
Symptom in the case is breathlessness.
|
Other: Man+Pain
Person in the case is a male.
Symptom in the case is pain.
|
Person in the case is a male.
Symptom in the case is pain.
|
Other: Woman+Breathlessness
Person in the case is a female.
Symptom in the case is breathlessness.
|
Symptom in the case is breathlessness.
Person in the case is a female.
|
Other: Woman+Pain
Person in the case is a female.Symptom in the case is pain.
|
Symptom in the case is pain.
Person in the case is a female.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COPD treatment in the Questionnaire
Time Frame: through study completion, up to 6 months
|
Would there be a difference between the hypothetical case with breathlessness compared to the otherwise identical case with pain instead of breathlessness regarding:
|
through study completion, up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gender bias in COPD diagnosis in the Questionnaire
Time Frame: through study completion, up to 6 months
|
Would there be a difference between the cases with a male respective female patient regarding:
|
through study completion, up to 6 months
|
Symptomatic treatment in the Questionnaire
Time Frame: through study completion, up to 6 months
|
Would there be a difference between the case with breathlessness compared with the case with pain regarding:
|
through study completion, up to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-randomized measurements in the Questionnaire
Time Frame: through study completion, up to 6 months
|
Proportion of study participants that consider the described breathlessness to be refractory
|
through study completion, up to 6 months
|
Chosen evidence-grades as non-randomized measurements in the Questionnaire
Time Frame: through study completion, up to 6 months
|
Chosen evidence-grades for treatment options of refractory breathlessness
|
through study completion, up to 6 months
|
Chosen potential risks as non-randomized measurements in the Questionnaire
Time Frame: through study completion, up to 6 months
|
Chosen potential risks with opioid treatment
|
through study completion, up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Magnus Ekström, MD, PhD, Department of Medicine, Blekinge Hospital, SE-37185 Karlskrona
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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