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

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

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.

Study Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia; Healthcare-associated Pneumonia
• Intervention / Treatment: Other: Multidimensional intervention

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year after hospital admission for pneumonia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year after hospital admission for pneumonia
Institutionalization	Data will be obtained by review of medical records and telephone interview one year after discharge.	1 year after hospital admission for pneumonia
Survival	Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge.	1 year after hospital admission for pneumonia

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Link to the article with description of the study is provided

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 28, 2011

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pneumonia; Intervention Studies; Aged; Geriatric Assessment; Aged, 80 and over
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia
• Other Study ID Numbers: IIBSP-INT-2010-13