Community Acquired Pneumonia Clinical Trial
— HOMEFIRSTOfficial title:
HOME FIRST (HOME Followed - up With Infection Respiratory Support Team)
NCT number | NCT02454114 |
Other study ID # | 12/NW/0731 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | January 2015 |
Verified date | October 2012 |
Source | Liverpool University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
HOME FIRST (Home Followed - up with Infection Respiratory Support Team) is an early supported discharge scheme. It will enable patients with lower respiratory tract infection (LRTI) to be provided with high quality safe, effective, efficient patient centred care, tailored to their needs in their own home; aiming to improve the overall experience of the service user, improve patient outcomes and reduce hospital length of stay whilst simultaneously reducing admission rates, an area of major strategic importance to the NHS.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Eligibility - Patients with any of the following conditions; - 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 part B of the study. - Pneumonia with concomitant COPD or bronchiectasis - Non-pneumonic lower respiratory tract infection without COPD or bronchiectasis Inclusion Criteria: - Age>18yrs old - All observations must be stable for 12-24hrs - EWS =2 AND SBP>90 (all observations must be stable for 12-24hrs) - Has a telephone - Can manage activities of daily living with current available support (If needed, immediate occupational therapy/physiotherapy/social assessment and care can be arranged prior to discharge and continued at home) - Improving/stable inflammatory markers - Improving/stable U&Es - Fluent English speaker Exclusion Criteria; - Acute exacerbations of COPD - Acute exacerbations of bronchiectasis without consolidation - Patients with CURB-65 >3 admitted <24 hours ago - Patients unable to manage at home even with maximal support from HOME FIRST (This may include intravenous drug users, patients with history of excess alcohol consumption or mental health problems) - Empyema or untapped pleural effusion (If no diagnostic pleural tap performed - discuss with study doctor) - Serious co-morbidities requiring hospital treatment (e.g. CKD, CCF) or deemed unstable (significant AKD) - Suspected MI/raised TnI/T consistent with NSTEMI (Or acute ECG changes) within 5 days of discharge - Empyema or complicated parapneumonic effusion - SBP<90mmHg - Neutropenia - No fixed abode - Tuberculosis suspected - Well enough for discharge without HOME FIRST support - Oxygen saturations <92% on air - for patients without chronic respiratory illness Oxygen saturations <88% on air - for patients with chronic respiratory illness (excluding asthma for which oxygen saturations must be >92% on air). All such cases MUST be discussed as oxygen assessment may be needed |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Liverpool And Broadgreen University Hospital | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Liverpool University Hospitals NHS Foundation Trust | Liverpool School of Tropical Medicine |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health - economic | A formal planned health economic analysis (by an NIHR Research Design Service [RDS] recommended health-economist) will measure costs and resource utilisation, using costs that are sensitive to the different resources used during each care episode, to assess the cost-effectiveness of HOME FIRST. | One year | |
Primary | Time to recovery | Our primary endpoint is time to recovery. This is assessed by our simple 'RECRTI' (functional RECovery from Respiratory Tract Infection) questionnaire (non-validated) which is completed at 6 weeks Patients (or consultees) will be asked at recruitment to define their/the patient's best exercise capacity in the last 3 months e.g chair to bed with 1, unlimited exercise tolerance etc
At the 6 week out-patient appointment they will be asked 4 simple questions: (marked on a likert-type scale in days and weeks): When (if at all) did your sleep return to normal? When (if at all) did your diet/appetite return to normal? When (if at all) did your (pre-defined) exercise capacity return to normal? When (if at all) did your capacity to work or socialise (delete as appropriate) return to normal? With regards to the primary outcome of time to recovery, this is a non-inferiority trial. |
Six weeks | |
Secondary | 30-day mortality | We will assess safety i.e. ensure there is no increase in mortality in the HOME FIRST limb. | up to 6 weeks after recruitment | |
Secondary | 30-day hospital readmission rates | We will assess safety i.e. ensure there is no delayed recovery, no pneumonia (or non-pneumonia) complications resulting in hospital admission in the HOME FIRST arm. | up to 6 weeks after recruitment | |
Secondary | Patient satisfaction using a validated satisfaction questionnaire | A validated patient satisfaction will be conducted at 2 weeks by an independent assessor. | at 2 weeks post recruitment | |
Secondary | Carer (NOK) satisfaction using a validated satisfaction questionnaire | A validated carer/consultee satisfaction will be conducted at 2 weeks by an independent assessor. | at 2 weeks post recruitment | |
Secondary | Length of stay in hospital | Length of hospital stay will be calculated. | Participants will be followed for the duration of hospital stay, this may be 1 day to 1 year | |
Secondary | Functional status as assessed by SF-12 validated questionnaire | Functional status (physical and mental) and quality of life (QOL) questionnaire will be completed to assess recovery / post respiratory infection. | up to 6 weeks after recruitment | |
Secondary | Pneumonia score as assessed by CAP-SYM validated questionnaire | The questionnaire will be completed to assess recovery / post respiratory infection | up to 6 weeks after recruitment | |
Secondary | Combined total length of stay (days) - hospital and home first | Total length of stay - combined will be calculated | Participants will be followed for the duration of hospital stay and their HOME FIRST stay, the latter can range from 1 - 5 days |
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