Clinical trial NCT02538289: Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention
Official title: Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspnea
Keywords: Dyspnea
Palliative Care
Heart Failure
Chronic Pulmonary Disease
Opioids
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2015-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: One month
Secondary outcomes:
measure: Detect the prevalence of dyspnea in patients admitted to our hospital.
timeFrame: One month
measure: Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.
timeFrame: One month
measure: Evaluate the impact on dyspnea intensity associated with an implementation of educational talks addressed to medical staff in the management of dyspnea.
timeFrame: One year
measure: Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
timeFrame: Three months
measure: Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.
timeFrame: One month
measure: Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
timeFrame: Three months
measure: Determine the number of patients that present side effects derived from a chronic opioid treatment that require lowering dose or stopping treatment.
timeFrame: Three months
measure: Determine whether a specific educational talk would be affordable for dyspnea management
timeFrame: One month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gregorio Marañon University Hospital
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: Juan Manuel Nuñez Olarte, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Badia X, Muriel C, Gracia A, Nunez-Olarte JM, Perulero N, Galvez R, Carulla J, Cleeland CS; Grupo Vesbpi. [Validation of the Spanish version of the Brief Pain Inventory in patients with oncological pain]. Med Clin (Barc). 2003 Jan 25;120(2):52-9. doi: 10.1016/s0025-7753(03)73601-x. Spanish.