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Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Primary Purpose

Dyspnea

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Teaching talks
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyspnea focused on measuring Dyspnea, Palliative Care, Heart Failure, Chronic Pulmonary Disease, Opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gregorio Marañon University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients admitted before talks

Patients admitted after talks

Arm Description

Patients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks.

Patients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks.

Outcomes

Primary Outcome 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.
Decrease the number of patients admitted to Cardiology or Respiratory Medicine departments who present chronic respiratory dyspnea or irruptive dyspnea.

Secondary Outcome Measures

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

Full Information

First Posted
August 31, 2015
Last Updated
February 23, 2017
Sponsor
Hospital General Universitario Gregorio Marañon
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT02538289
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General Universitario Gregorio Marañon
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Dyspnea, Palliative Care, Heart Failure, Chronic Pulmonary Disease, Opioids

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients admitted before talks
Arm Type
Other
Arm Description
Patients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks.
Arm Title
Patients admitted after talks
Arm Type
Other
Arm Description
Patients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks.
Intervention Type
Behavioral
Intervention Name(s)
Teaching talks
Intervention Description
Two teaching talks specifically addressed to medical staff which concerns the adequate treatment and needs of dyspneic patients, including pharmacological and non-pharmacological treatment.
Primary Outcome Measure Information:
Title
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.
Description
Decrease the number of patients admitted to Cardiology or Respiratory Medicine departments who present chronic respiratory dyspnea or irruptive dyspnea.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Detect the prevalence of dyspnea in patients admitted to our hospital.
Description
Number of patients.
Time Frame
One month
Title
Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.
Description
Frequency of methods usage for dyspnea relief.
Time Frame
One month
Title
Evaluate the impact on dyspnea intensity associated with an implementation of educational talks addressed to medical staff in the management of dyspnea.
Description
Numerical Rating Scale score.
Time Frame
One year
Title
Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
Description
Number of patients that receive opioid treatment at three months of inclusion
Time Frame
Three months
Title
Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.
Description
Dyspnea intensity by Numerical Rating Scale score
Time Frame
One month
Title
Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
Description
Dyspnea intensity by Numerical Rating Scale score
Time Frame
Three months
Title
Determine the number of patients that present side effects derived from a chronic opioid treatment that require lowering dose or stopping treatment.
Description
Number of patients that present side effects
Time Frame
Three months
Title
Determine whether a specific educational talk would be affordable for dyspnea management
Description
Costs in euros invested in medical staff training
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Manuel Nuñez Olarte, M.D.
Phone
:+34 915868122
Email
jnunezo@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Martínez-Sellés
Phone
+34 915868286
Email
mmselles@secardiologia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Manuel Nuñez Olarte, M.D.
Organizational Affiliation
Hospital General Universitario Gregorio Marañon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gregorio Marañon University Hospital
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Martínez-Sellés, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12570914
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.
Results Reference
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Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

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