Condition category
Not Applicable
Date applied
22/05/2009
Date assigned
10/07/2009
Last edited
03/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.puc.cl

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

Publication citations

Additional files

Editorial Notes