Condition category
Respiratory
Date applied
21/08/2012
Date assigned
16/10/2012
Last edited
18/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Stephen Gordon

ORCID ID

Contact details

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

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 measures

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

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

http://www.rlbuht.nhs.uk/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24571705

Publication citations

  1. 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.

Additional files

Editorial Notes