HOME FIRST (Home Followed-up by the Infection Respiratory Support Team)
| ISRCTN | ISRCTN25542492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25542492 |
| ClinicalTrials.gov number | NCT02454114 |
| Secondary identifying numbers | V1 |
- Submission date
- 21/08/2012
- Registration date
- 16/10/2012
- Last edited
- 13/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
Study information
| Study design | Randomised control feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | HOME FIRST (Home Followed-up by the Infection Respiratory Support Team): a feasibility study |
| Study acronym | HOME FIRST |
| Study objectives | 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(s) | Liverpool NHS Research Ethics Committee, 12/10/2011, ref: 11/NW/0670 |
| Health condition(s) or problem(s) studied | Respiratory infection, including lower respiratory tract infection, pneumonia and bronchiectasis |
| Intervention | HOME FIRST - Early supported hospital discharge or standard hospital care |
| Intervention type | Other |
| 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 study start date | 10/12/2011 |
| Completion date | 05/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Screen 200 or recruit 200 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 10/12/2011 |
| Date of final enrolment | 05/05/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
L3 5QA
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Heather Rogers
Prescot Street
Liverpool
L7 8XP
England
United Kingdom
| Website | http://www.rlbuht.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/009sa0g06 |
Funders
Funder type
Government
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 | 26/02/2014 | Yes | No |
Editorial Notes
13/03/2020: Internal review.
22/05/2019: ClinicalTrials.gov number added.
