Plain English Summary
Background and study aims
Lower respiratory tract infections (LRTIs) are infections that affect the airways and lungs. Many patients with LRTIs could be treated as outpatients rather than stay in hospital. HOME FIRST is a new scheme that will enable patients with LRTIs to be discharged from hospital early and receive care in their own home. This study will investigate patient uptake to such a scheme, and compare HOME FIRST to current standard hospital care with regards to factors such as safety, death rates, readmission rates, rate of recovery, and care satisfaction.
Who can participate?
Patients aged 18 or over with lower respiratory tract infections.
What does the study involve?
Participants are randomly allocated to either HOME FIRST or standard hospital care. They are followed up by telephone at 2 weeks and at an outpatient clinic at 1 and 6 months.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Liverpool School of Tropical Medicine (UK).
When is study starting and how long is it expected to run for?
December 2011 to May 2012.
Who is funding the study?
NIHR Biomedical Research Centres (BRC).
Who is the main contact?
Prof Stephen Gordon
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02454114
Protocol/serial number
V1
Study information
Scientific title
HOME FIRST (Home Followed-up by the Infection Respiratory Support Team): a feasibility study
Acronym
HOME FIRST
Study hypothesis
That HOME FIRST (Home Followed-up with Infection Respiratory Support Team) is an early supported discharge scheme feasibility study where patients are randomised to HOME FIRST or standard hospital care is acceptable to patients.
More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12493
Ethics approval
Liverpool NHS Research Ethics Committee, 12/10/2011, ref: 11/NW/0670
Study design
Randomised control feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Respiratory infection - Lower respiratory tract infection, pneumonia and bronchiectasis
Hospital at home schemes
Intervention
HOME FIRST - Early supported hospital discharge or standard hospital care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Patient acceptability
Secondary outcome measures
1. Safety/mortality
2. Readmission rate
3. Length of stay
4. Total days of care
5. Functional and symptom improvement
Overall trial start date
10/12/2011
Overall trial end date
05/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with any of the following conditions:
1. Pneumonia - community-acquired (CAP) or hospital-acquired (HAP) - pneumonia definition - a series of clinical symptoms with radiological consolidation
N.B. All pneumonia CURB-65 scores will be considered but patients with CURB-65 ≥3 MUST have had at least 24hrs of in-patient observation before recruitment into the study.
2. Acute tracheo-bronchitis & acute bronchitis
3. Non-pneumonic lower respiratory tract infection
4. Influenza with respiratory manifestations
5. Infective exacerbation of bronchiectasis
6. Lung abscess
7. Pneumonia with concomitant COPD (if this service is not provided elsewhere)
Patient Suitability:
1. Simple pleural effusions only (if no diagnostic pleural tap performed please discuss)
2. Can manage ADLs with current support (immediate OT/physio/social assessment/care can be arranged prior to discharge (if needed) and continued at home)
3. Able to give fully informed consent
4. Has a phone
5. Age>18yrs old
6. EWS ≤2 AND SBP>90 (all observations must be stable for 12-24hrs) AND mild confusion only (defined as an 10-point AMTS ≥7)
7. All observations must be stable for 12-24hrs
8. Improving inflammatory markers (WCC/CRP)
9. Stable or improving U&Es
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Screen 200 or recruit 200
Participant exclusion criteria
1. Acute exacerbations of COPD - infective & non-infective (other services already provided)
2. Patients with CURB-65 >3 admitted<24hrs ago
3. Patients unable to manage at home even with maximal support from HOME FIRST (this may include some patients IV drug users, with ETOH excess or mental health problems)
4. Serious co-morbidities requiring hospital treatment (eg: CKD, CCF) or deemed unstable (significant AKD)
5. Suspected MI/raised TnI/T consistent with NSTEMI (Or acute ECG changes) within 5 days of discharge
6. Empyema or complicated parapneumonic effusion
7. SBP<90mmHg
8. Neutropenia
9. No fixed abode
10. Tuberculosis suspected
11. Well enough for discharge without HOME FIRST homecare support
12. Sats <92% on air - for patients without chronic respiratory illness
13. Sats <88% on air [except asthma sats must be >92%] - for patients with chronic respiratory illness. All such cases MUST be discussed as oxygen assessment may be needed.
Recruitment start date
10/12/2011
Recruitment end date
05/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
Sponsor information
Organisation
Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)
Sponsor details
c/o Heather Rogers
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Biomedical Research Centres (BRC) - PASS (Pneumonia Aetiology and severity)
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24571705
Publication citations
-
Results
Collins AM, Eneje OJ, Hancock CA, Wootton DG, Gordon SB, Feasibility study for early supported discharge in adults with respiratory infection in the UK., BMC Pulm Med, 2014, 14, 25, doi: 10.1186/1471-2466-14-25.