Impact of an Educational Program in the Management of Community-Acquired Pneumonia

ISRCTN	ISRCTN39531840
DOI	https://doi.org/10.1186/ISRCTN39531840
Secondary identifying numbers	EDU001NEUM

Submission date: 21/08/2009
Registration date: 18/09/2009
Last edited: 16/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
We are carrying out an educational program before hospital discharge in patients hospitalised with community-acquired pneumonia. Our goal is decrease additional healthcare visits and rehospitalisation within 30 days of hospital discharge. We also want to look at the time to return to activities of daily living, degree of satisfaction and achievement of the objectives of the educational program.

Who can participate?
Adult patients aged 18 years and over, diagnosed with community-acquired pneumonia and requiring hospitalisation.

What does the study involve?
Participants will be randomly allocated to receive either conventional health information or the new educational program before hospital discharge. Patient and family or caregiver receive the educational program in two sessions each about 30-45 minutes long and receive an information leaflet about self-management. Prior to hospital discharge and 30 and 90 days after hospitalisation we will invite participants to answer a survey about their use of healthcare services and the educational program or conventional health information.

What are the possible benefits and risks of participating?
Patients in the conventional health information group receive health information according to standard clinical practice. Patients in the educational program group will have an opportunity to receive individual discharge planning to improve knowledge, skills and attitudes about self-management of community-acquired pneumonia. Information obtained from this study may help improve health education in patients hospitalized with community-acquired pneumonia. By taking part in this study there are no risks of physical injury or harm.

Where is the study run from?
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain).

When is the study starting and how long is it expected to run for?
The study started in November 2011 and will run until October 2014.

Who is funding the study?
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain).

Who is the main contact?
Mr Jordi Adamuz Tomás
Jordi.Adamuz@gmail.com

Contact information

Mr Jordi Adamuz Tomás
Scientific

Servei de Malalties Infeccioses (Pl.12)
C/Feixa Llarga s/n
Barcelona
08907
Spain

Phone	+34 (0) 610 32 92 37
Email	Jordi.Adamuz@gmail.com

Study information

Study design	Prospective randomised multicenter controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Impact of an EDUcational program in the management of Community-Acquired Pneumonia: a prospective randomised controlled trial
Study acronym	EDUCAP
Study objectives	1. Patients admitted with diagnosis of community-acquired pneumonia who receive the health education program will have a significantly decreased healthcare resource utilisation during the month after discharge: readmissions and consultations to primary care and emergency department 2. The satisfaction degree with the information to discharge in the intervention group will be higher than the control group 3. Patients who receive the educational program will have a decreased time to return to normal activities than the control group 4. Patients receiving the education program will achieve the objectives of the program On 05/09/2014 the following changes were made to the trial record: 1. The acronym was changed from IEPMCAP to EDUCAP 2. The study design was changed from 'Prospective randomised controlled trial' to 'Prospective randomised multicenter controlled trial' 3. The anticipated start date was changed from 05/10/2009 to 01/01/2011 4. The anticipated end date was changed from 29/07/2011 to 31/10/2014 5. The target number of participants was changed from '182 participants in each group (total = 364)' to '102 participants in each group (total = 204)'
Ethics approval(s)	Clinical Research Ethics Committee of Hospital Universitari de Bellvitge, 08/10/2009, ref: AC064/09
Health condition(s) or problem(s) studied	Community-acquired pneumonia
Intervention	Patients will be randomly assigned to receive the educational program during hospitalisation to improve their own understanding of the disease and self-care management at home. The control group will receive the conventional health education. The educative program is based in the planning model of health educational program (PRECEDE). The nurse will carry out the educational program to the intervention group. The patient and family or caregiver will receive the educational program. The duration is approximately 30 - 45 minutes and the patient will receive the information leaflet. The objectives of the educational program are: improve the hydration of the patient, maintain a good disease control and improve the treatment adherence, balanced diet, progressive physical activity and smoking and alcohol gradual decline.
Intervention type	Other
Primary outcome measure	1. Epidemiological, clinical and evolutive characteristics during the admission 2. Healthcare resources utilisation (readmissions and consultations to primary care and emergency department) within 30 days subsequent to discharge We will conduct a complete medical history to obtain epidemiological, clinical and evolutionary variables during the hospitalisation. To achieve the variables related to the healthcare resource utilisation, all patients will be followed up a month after discharge. All variables will be collected in a Statistical Package for the Social Sciences (SPSS) database.
Secondary outcome measures	1. Patient satisfaction 2. Time to return to normal activities 3. Intermediate objectives of the educational program To achieve the variables all patients will be followed up a month after discharge. At 3 months, we also will assess the educational program through a telephone call. All variables will be collected in a Statistical Package for the Social Sciences (SPSS) database.
Overall study start date	01/11/2011
Completion date	31/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	102 participants in each group (total = 204)
Key inclusion criteria	1. Adult patients (aged 18 years and over), either sex 2. Diagnosed with community-acquired pneumonia 3. Requiring hospitalisation in the Infectious Diseases and Respiratory Departments of Hospital Universitari de Bellvitge Updated 05/09/2014: 3. Requiring hospitalisation in the Infectious Disease or Respiratory Disease Departments of Hospital Universitari de Bellvitge, Respiratory Disease Department or Home-care Service of Hospital Clínic de Barcelona and Respiratory Disease or Internal Medicine Departments of Hospital Universitari Arnau de Vilanova de Lleida
Key exclusion criteria	1. Derived from a nursing home or extended care facility 2. Cognitive deficit 3. Do not understand Spanish or Catalan languages 4. No signed informed consent Added 05/09/2014: 5. Immunocompromised patients
Date of first enrolment	01/11/2011
Date of final enrolment	31/10/2014

Locations

Countries of recruitment

Spain

Study participating centre

Servei de Malalties Infeccioses (Pl.12)

Barcelona
08907
Spain

Sponsor information

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)
Hospital/treatment centre

c/o Jordi Adamuz Tomás
Servei de Malalties Infeccioses (Pl.12)
C/Feixa Llarga s/n
Barcelona
08907
Spain

Phone	+34 (0) 610 32 92 37
Email	jadamuz@bellvitgehospital.cat
Website	http://www.bellvitgehospital.cat/
"ROR"	https://ror.org/0008xqs48

Funders

Funder type

Hospital/treatment centre

Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/10/2015		Yes	No

Editorial Notes

16/10/2015: Added publication reference.