Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2017

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.

Interventions

  • Behavioral: Teaching talks
    • Two teaching talks specifically addressed to medical staff which concerns the adequate treatment and needs of dyspneic patients, including pharmacological and non-pharmacological treatment.

Arms, Groups and Cohorts

  • Other: Patients admitted before talks
    • Patients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks.
  • Other: Patients admitted after talks
    • Patients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Detect the prevalence of dyspnea in patients admitted to our hospital.
    • Time Frame: One month
    • Number of patients.
  • Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.
    • Time Frame: 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.
    • Time Frame: One year
    • Numerical Rating Scale score.
  • Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
    • Time Frame: 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.
    • Time Frame: One month
    • Dyspnea intensity by Numerical Rating Scale score
  • Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
    • Time Frame: Three months
    • 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.
    • Time Frame: Three months
    • Number of patients that present side effects
  • Determine whether a specific educational talk would be affordable for dyspnea management
    • Time Frame: One month
    • Costs in euros invested in medical staff training

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General Universitario Gregorio Marañon
  • Collaborator
    • Instituto de Salud Carlos III
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Juan Manuel Nuñez Olarte, M.D., Principal Investigator, Hospital General Universitario Gregorio Marañon
  • Overall Contact(s)
    • Juan Manuel Nuñez Olarte, M.D., :+34 915868122, jnunezo@salud.madrid.org

References

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.

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