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Management of Patients With Respiratory Symptoms in Sweden

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Person in the case is a male.
Person in the case is a female.
Symptom in the case is breathlessness.
Symptom in the case is pain.
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Breathlessness, Symptom, Opioids, Gender bias

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Respiratory Medicine and Allergology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Man+Breathlessness

Man+Pain

Woman+Breathlessness

Woman+Pain

Arm Description

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 pain.

Person in the case is a female. Symptom in the case is breathlessness.

Person in the case is a female.Symptom in the case is pain.

Outcomes

Primary Outcome Measures

COPD treatment in the Questionnaire
Would there be a difference between the hypothetical case with breathlessness compared to the otherwise identical case with pain instead of breathlessness regarding: Proportion of study participants that consider that the patient in the case is not optimally treated; Proportion of study participants that consider morphine as either primary or secondary treatment option

Secondary Outcome Measures

Gender bias in COPD diagnosis in the Questionnaire
Would there be a difference between the cases with a male respective female patient regarding: Proportion of study participants that consider COPD diagnosis; Proportion of study participants that consider spirometry for further diagnostics
Symptomatic treatment in the Questionnaire
Would there be a difference between the case with breathlessness compared with the case with pain regarding: Chosen treatment options; Reasons not to choose treatment with opioids Chosen treatment options Reasons not to choose treatment with opioids

Full Information

First Posted
March 24, 2016
Last Updated
August 23, 2017
Sponsor
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02728674
Brief Title
Management of Patients With Respiratory Symptoms in Sweden
Official Title
Management of Patients With Respiratory Symptoms in Sweden
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a web-based randomized survey to evaluate management of respiratory symptoms among physicians in Sweden. The aim of this study is to determine if there is a gender bias in the diagnosis of COPD and how often physicians identify that chronic refractory breathlessness requires treatment as compared to refractory pain.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Breathlessness, Symptom, Opioids, Gender bias

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Man+Breathlessness
Arm Type
Other
Arm Description
Person in the case is a male. Symptom in the case is breathlessness.
Arm Title
Man+Pain
Arm Type
Other
Arm Description
Person in the case is a male. Symptom in the case is pain.
Arm Title
Woman+Breathlessness
Arm Type
Other
Arm Description
Person in the case is a female. Symptom in the case is breathlessness.
Arm Title
Woman+Pain
Arm Type
Other
Arm Description
Person in the case is a female.Symptom in the case is pain.
Intervention Type
Other
Intervention Name(s)
Person in the case is a male.
Intervention Description
Person in the case is a male.
Intervention Type
Other
Intervention Name(s)
Person in the case is a female.
Intervention Description
Person in the case is a female.
Intervention Type
Other
Intervention Name(s)
Symptom in the case is breathlessness.
Intervention Description
Symptom in the case is breathlessness.
Intervention Type
Other
Intervention Name(s)
Symptom in the case is pain.
Intervention Description
Symptom in the case is pain.
Primary Outcome Measure Information:
Title
COPD treatment in the Questionnaire
Description
Would there be a difference between the hypothetical case with breathlessness compared to the otherwise identical case with pain instead of breathlessness regarding: Proportion of study participants that consider that the patient in the case is not optimally treated; Proportion of study participants that consider morphine as either primary or secondary treatment option
Time Frame
through study completion, up to 6 months
Secondary Outcome Measure Information:
Title
Gender bias in COPD diagnosis in the Questionnaire
Description
Would there be a difference between the cases with a male respective female patient regarding: Proportion of study participants that consider COPD diagnosis; Proportion of study participants that consider spirometry for further diagnostics
Time Frame
through study completion, up to 6 months
Title
Symptomatic treatment in the Questionnaire
Description
Would there be a difference between the case with breathlessness compared with the case with pain regarding: Chosen treatment options; Reasons not to choose treatment with opioids Chosen treatment options Reasons not to choose treatment with opioids
Time Frame
through study completion, up to 6 months
Other Pre-specified Outcome Measures:
Title
Non-randomized measurements in the Questionnaire
Description
Proportion of study participants that consider the described breathlessness to be refractory
Time Frame
through study completion, up to 6 months
Title
Chosen evidence-grades as non-randomized measurements in the Questionnaire
Description
Chosen evidence-grades for treatment options of refractory breathlessness
Time Frame
through study completion, up to 6 months
Title
Chosen potential risks as non-randomized measurements in the Questionnaire
Description
Chosen potential risks with opioid treatment
Time Frame
through study completion, up to 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Ekström, MD, PhD
Organizational Affiliation
Department of Medicine, Blekinge Hospital, SE-37185 Karlskrona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Respiratory Medicine and Allergology
City
Lund
State/Province
Skane
ZIP/Postal Code
21100
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30002106
Citation
Ahmadi Z, Sandberg J, Shannon-Honson A, Vandersman Z, Currow DC, Ekstrom M. Is chronic breathlessness less recognised and treated compared with chronic pain? A case-based randomised controlled trial. Eur Respir J. 2018 Sep 15;52(3):1800887. doi: 10.1183/13993003.00887-2018. Print 2018 Sep.
Results Reference
derived

Learn more about this trial

Management of Patients With Respiratory Symptoms in Sweden

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