Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Not Applicable

• Conditions: Dyspnea
• Interventions: Behavioral: Teaching talks

• Registration Number: NCT02538289
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-02
• Status Verified: 2016-02
• Study Start: 2016-04
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients admitted after talks	Teaching talks	Patients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks.
Patients admitted before talks	Teaching talks	Patients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks.

Primary Outcome Measures

Name	Time	Method
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.	One month	Decrease the number of patients admitted to Cardiology or Respiratory Medicine departments who present chronic respiratory dyspnea or irruptive dyspnea.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gregorio Marañon University Hospital; 🇪🇸 Madrid, Spain