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Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia (IMIEPAP)

Primary Purpose

Community-acquired Pneumonia, Healthcare-associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidimensional intervention
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Community-acquired Pneumonia focused on measuring Pneumonia, Intervention Studies, Aged, Aged, 80 and over, Geriatric Assessment

Eligibility Criteria

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

Inclusion Criteria:

  • Elderly patients (aged 65 years and over), of either sex, not dependent for basic activities of daily living (Barthel index ≥60 points).
  • Diagnosed with community-acquired pneumonia at the Emergency Department or Day Hospitals at "Hospital de la Santa Creu I Santa Pau"
  • Admitted to hospital.

Exclusion Criteria:

  • Derived from other acute care hospitals.
  • Patients with HIV infection.
  • Neutrophil counter<1000/mm3
  • Transplanted patients.
  • Barthel index<60 points.
  • Terminal disease.
  • No signed informed consent.

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multidisciplinar intervention

Conventional follow up

Arm Description

Patients that will receive the multidimensional intervention during the ambulatory follow-up.

This is an observation only group and outpatient follow up will be indicated in accordance with usual and customary practices.

Outcomes

Primary Outcome Measures

Healthcare resources utilization (readmissions and consultations to hospital and emergency department).
To achieve the variables related to the healthcare resource utilization, computarized medical records will be reviewed and all patients will be followed up by telephone interview one year after discharge.The cause for readmission will be recorded.

Secondary Outcome Measures

Functional status
Data will be obtained by review of medical records and telephone interview one year after discharge. Dependency in basic activities of daily living will be scored using the Barthel Index (Mahoney & Barthel. Maryland State Med J 14; 61-65) which measures the capacity to perform ten basic activities and gives a quantitative estimation of the patient level of dependency, scoring to 0 (totally dependent) to 100 (totally independent).
Institutionalization
Data will be obtained by review of medical records and telephone interview one year after discharge.
Survival
Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge.

Full Information

First Posted
January 27, 2011
Last Updated
February 24, 2019
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT01285869
Brief Title
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia
Acronym
IMIEPAP
Official Title
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia: a Prospective Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The hypothesis of this study is that long-term outcome in elderly patients admitted with the diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) would improve with a multidimensional intervention including assessment of co-morbidities, nutritional, functional and cognitive status and immunization.
Detailed Description
Detailed description published in "Revista Española de Geriatría y Gerontología" (see citation and link)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, Healthcare-associated Pneumonia
Keywords
Pneumonia, Intervention Studies, Aged, Aged, 80 and over, Geriatric Assessment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinar intervention
Arm Type
Experimental
Arm Description
Patients that will receive the multidimensional intervention during the ambulatory follow-up.
Arm Title
Conventional follow up
Arm Type
No Intervention
Arm Description
This is an observation only group and outpatient follow up will be indicated in accordance with usual and customary practices.
Intervention Type
Other
Intervention Name(s)
Multidimensional intervention
Other Intervention Name(s)
Comprehensive geriatric assesment
Intervention Description
The patient will be cited 2 months after hospital discharge for a geriatric evaluation carried out by a geriatric nurse and an internist with geriatric training. The duration of the first visit is 45-60 minutes. The visit consists of: 1. Assessment of the pneumonia resolution, co-morbidities, aspiration risk, risk of multiresistant infections, and the immunization, functional and cognitive status. 2. An individualized intervention plan. The patient and family or caregiver will receive an educational intervention, a written report with the planned intervention and an educational leaflet. Those patients who require further assessment or follow up of the intervention will receive 1 or 2 more visits and all the patients will be cited one year after the first visit.
Primary Outcome Measure Information:
Title
Healthcare resources utilization (readmissions and consultations to hospital and emergency department).
Description
To achieve the variables related to the healthcare resource utilization, computarized medical records will be reviewed and all patients will be followed up by telephone interview one year after discharge.The cause for readmission will be recorded.
Time Frame
1 year after hospital admission for pneumonia
Secondary Outcome Measure Information:
Title
Functional status
Description
Data will be obtained by review of medical records and telephone interview one year after discharge. Dependency in basic activities of daily living will be scored using the Barthel Index (Mahoney & Barthel. Maryland State Med J 14; 61-65) which measures the capacity to perform ten basic activities and gives a quantitative estimation of the patient level of dependency, scoring to 0 (totally dependent) to 100 (totally independent).
Time Frame
1 year after hospital admission for pneumonia
Title
Institutionalization
Description
Data will be obtained by review of medical records and telephone interview one year after discharge.
Time Frame
1 year after hospital admission for pneumonia
Title
Survival
Description
Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge.
Time Frame
1 year after hospital admission for pneumonia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elderly patients (aged 65 years and over), of either sex, not dependent for basic activities of daily living (Barthel index ≥60 points). Diagnosed with community-acquired pneumonia at the Emergency Department or Day Hospitals at "Hospital de la Santa Creu I Santa Pau" Admitted to hospital. Exclusion Criteria: Derived from other acute care hospitals. Patients with HIV infection. Neutrophil counter<1000/mm3 Transplanted patients. Barthel index<60 points. Terminal disease. No signed informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga H Torres, Phd
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Domingo Ruiz, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26526565
Citation
Torres OH, Gil E, Comas MT, Saez ME, Clotet S, Ramirez HD, Mateo M, Ruiz D. [Impact of a multidimensional intervention in elderly patients with community-acquired pneumonia: IMIEPCAP clinical trial]. Rev Esp Geriatr Gerontol. 2016 Jan-Feb;51(1):37-43. doi: 10.1016/j.regg.2015.09.004. Epub 2015 Oct 30. Spanish.
Results Reference
background
Links:
URL
http://www.elsevier.es/es-revista-revista-espanola-geriatria-gerontologia-124-linkresolver-impacto-una-intervencion-multidimensional-pacientes-S0211139X15001808
Description
Link to the article with description of the study is provided

Learn more about this trial

Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia

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