IMIEPAP: Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Completed

CT.gov ID

NCT01285869

Collaborator

(none)

314

Enrollment

Location

Arms

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia Healthcare-associated Pneumonia	Other: Multidimensional intervention	N/A

Detailed Description

Detailed description published in "Revista Española de Geriatría y Gerontología" (see citation and link)

Study Design

Study Type:

Interventional

Actual Enrollment :

314 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia: a Prospective Randomized Controlled Trial.

Actual Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multidisciplinar intervention Patients that will receive the multidimensional intervention during the ambulatory follow-up.	Other: Multidimensional intervention 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. Other Names: Comprehensive geriatric assesment
No Intervention: Conventional follow up This is an observation only group and outpatient follow up will be indicated in accordance with usual and customary practices.

Arm

Intervention/Treatment

Experimental: Multidisciplinar intervention

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

Other: Multidimensional intervention

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.

Other Names:

Comprehensive geriatric assesment

No Intervention: Conventional follow up

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

Outcome Measures

Primary Outcome Measures

Healthcare resources utilization (readmissions and consultations to hospital and emergency department). [1 year after hospital admission for pneumonia]
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 [1 year after hospital admission for pneumonia]
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 [1 year after hospital admission for pneumonia]
Data will be obtained by review of medical records and telephone interview one year after discharge.
Survival [1 year after hospital admission for pneumonia]
Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025

Sponsors and Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

Principal Investigator: Olga H Torres, Phd, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Chair: Domingo Ruiz, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau