Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Study Overview
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Brief Summary
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Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are becoming more frequent. Patients suffering from dyspnea have a significant disabling due to chronic refractory dyspnea and crisis of irruptive dyspnea. Although there are several tools that may produce an improvement of symptom intensity, they are underused.

Detailed Description
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We sought to investigate whether if teaching interventions specifically addressed to medical staff improve the well-being of dyspneic patients. The MAIN GOAL of this study is to evaluate the effect of two talks (conveyed to doctors and nurses of Cardiology and Respiratory Medicine Departments) on the patient-perceived dyspnea. The contents of these talks will be prepared and supervised by Palliative Care specialists. This is a four-staged study that includes a first observational phase (prevalence study of dyspnea) followed by intervention and a third phase that will determine the effect of this teaching intervention. The fourth phase consists in the elaboration of specific protocols for management of dyspnea. A pharmacovigilance study of opioids will also take place.

Official Title
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Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Conditions
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Dyspnea

Intervention / Treatment
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* Behavioral: Teaching talks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospital admission with dyspnea as main symptom Acceptance of participation in the study Diagnosis of Chronic Respiratory Disease Diagnosis of Chronic Heart Failure Chronic Refractory Dyspnea higher than 1/10 and Irruptive Dyspnea higher than 2/10 degree by Rating Numerical Scale Exclusion Criteria: Cognitive Impairment Voluntary dropout.

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients admitted before talks<br>Patients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks. | Behavioral: Teaching talks<br>* Two teaching talks specifically addressed to medical staff which concerns the adequate treatment and needs of dyspneic patients, including pharmacological and non-pharmacological treatment.<br>|
| Other: Patients admitted after talks<br>Patients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks. | Behavioral: Teaching talks<br>* Two teaching talks specifically addressed to medical staff which concerns the adequate treatment and needs of dyspneic patients, including pharmacological and non-pharmacological treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the number of patients with advanced heart or chronic respiratory diseases who present chronic refractory dyspnea or irruptive dyspnea and do not receive adequate treatment. | Decrease the number of patients admitted to Cardiology or Respiratory Medicine departments who present chronic respiratory dyspnea or irruptive dyspnea. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect the prevalence of dyspnea in patients admitted to our hospital. | Number of patients. | One month | 
| Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea. | Frequency of methods usage for dyspnea relief. | One month | 
| Evaluate the impact on dyspnea intensity associated with an implementation of educational talks addressed to medical staff in the management of dyspnea. | Numerical Rating Scale score. | One year | 
| Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea. | Number of patients that receive opioid treatment at three months of inclusion | Three months | 
| Determine the intensity and functional impact of dyspnea in patients admitted to our hospital. | Dyspnea intensity by Numerical Rating Scale score | One month | 
| Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea. | Dyspnea intensity by Numerical Rating Scale score | Three months | 
| Determine the number of patients that present side effects derived from a chronic opioid treatment that require lowering dose or stopping treatment. | Number of patients that present side effects | Three months | 
| Determine whether a specific educational talk would be affordable for dyspnea management | Costs in euros invested in medical staff training | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyspnea, Palliative Care, Heart Failure, Chronic Pulmonary Disease, Opioids