Contact information
Type
Scientific
Primary contact
Dr Gabriel Rada
ORCID ID
Contact details
Módulo Universidad Católica
Hospital Dr Sótero del Río
Av. Concha y Toro 3459
Puente
Alto
Santiago
-
Chile
gabriel@rada.cl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SA08I20007
Study information
Scientific title
Efficacy, costs and user satisfaction of hospital at home as a model of early discharge from hospital in patients with low and moderate risk [Eficacia, costos y satisfacción usuaria de la hospitalización en domicilio como modelo de alta precoz desde el hospital, en pacientes de riesgo bajo y moderado]
Acronym
Study hypothesis
1. Hospital at home is as safe and effective as traditional hospitalisation, in terms of morbidity and mortality
2. Hospital at home does not increase significantly the length of hospitalisation when compared to traditional hospitalisation
3. Hospital at home may decrease the risk of some outcomes associated with traditional hospitalisation (i.e. risk of falls, delirium). Functional recovery and capacity to perform daily activities would be restored in less time and with greater success.
4. Sending patient to hospital at home would release some hospital beds, without increasing the costs
5. User's satisfaction would be higher with hospital at home than with traditional hospitalisation
Ethics approval
Ethics committee of the Dr. Sótero del Río Hospital, SSMSO, Santiago, Chile, gave approval on the 5th January 2009
Study design
Single centre randomised masked open study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Adult inpatients with moderate risk diseases
Intervention
Arm 1 (intervention) - Hospital at home:
Subjects assigned to this group will be cared by the hospital at home team (intervention). They will be responsible for providing care (as described under 'intervention characteristics'), deciding on further health care provision (including rehospitalisation) and coordinating future ambulatory treatment. The provision of the intervention will go on until a definitive discharge is decided (this date is considered for the measurement of length of hospitalisation).
Arm 2 (control):
Subjects assigned to the control group will receive standard care in the hospital. No additional intervention (with the exception of outcome measurements) is considered for this group.
Hospital at home team description:
The project is based in the Dr. Sótero del Río Hospital, which is the public facility for the nation's most populous districts in Santiago, Chile. The team is composed by gerontologists, nurses, paramedics, kinesiologists and a social assistant. The services provided include: blood tests (all tests available in the hospital, transportation included), X-Ray, intravenous treatment administration, oxygen therapy, nurse care (wound care, catheter management, drainage tubes), secretion aspiration, motor and respiratory rehabilitation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Length of hospitalisation, measured at discharge (considering both treatments modalities as hospitalisation)
Secondary outcome measures
1. Barthel's Index of Activities of Daily Living, measured at days 0 and 28
2. Confusion Assessment Method for Delirium, measured at days 0 and 7
3. Katz Activities of Daily Living Scale, measured at days 0 and 28
4. Zarit Caregiver Burden Scale, measured at days 0 and 28
5. Pressure ulcers, measured at days 0 and 7
6. Falls, measured at discharge
7. User's satisfaction, measured at discharge
8. Rehospitalisation, measured on day 28, month 3, month 6
9. Emergency department consultations after discharge, measured on day 28, month 3, month 6
10. Mortality, measured on day 28, month 3, month 6
Overall trial start date
01/06/2009
Overall trial end date
01/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult inpatients requiring interventions usually provided in the hospital, as health care professionals supervision, intravenous drug administration, oxygen therapy, intensive nursing care or rehabilitation
2. One of the following conditions as the main cause of hospitalisation or as complication of the hospitalisation:
2.1. Surgical procedure
2.2. Pneumonia (community acquired and health-care related)
2.3. Upper urinary tract infection (community acquired and health-care related)
2.4. Septic arthritis
2.5. Acute complications of diabetes
2.6. Decompensated chronic obstructive pulmonary disease
2.7. Decompensated heart failure
2.8. End-stage kidney disease waiting for the initiation of dialysis
2.9. Acute renal failure
2.10. Decompensated liver disease
2.11. Deep vein thrombosis requiring hospitalisation
3. Predicted hospital stay over two days
4. Treating physician agreement with the possibility of the patient being managed under hospital at home modality
5. Responsible caregiver agreement with the possibility of the patient being managed under hospital at home modality
6. Home meeting basic characteristics (space, safety conditions, basic service availability, hygiene in general)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
102
Participant exclusion criteria
1. Terminal disease or palliative care
2. Patients requiring intravenous treatments more than twice a day
3. Domestic violence, drug addiction, criminal behaviour, extreme poverty or any other factor that may hamper the normal recovery of patients
Recruitment start date
01/06/2009
Recruitment end date
01/02/2010
Locations
Countries of recruitment
Chile
Trial participating centre
Módulo Universidad Católica
Santiago
-
Chile
Sponsor information
Organisation
Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile)
Sponsor details
Avenue Libertador Bernardo O'Higgins 340
Santiago
-
Chile
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Commission of Scientific Research and Technology, Ministry of Health (Chile) - Fifth National Contest of Projects of Investigation and Development in Health (FONIS 2008) (ref: SA08I20007)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary