Clinical trial NCT02454114: HOME FIRST Pilot: a Study of Early Supported Discharge in Patients With Lower Respiratory Tract Infections
Official title: HOME FIRST (HOME Followed - up With Infection Respiratory Support Team)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Acquired Pneumonia
Hospital Acquired Pneumonia
Lower Respiratory Tract Infection
Keywords: Pneumonia
Community
Hospital
Respiratory
Infection
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Liverpool School of Tropical Medicine
First posted: 2015-05-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: A randomised interventional clinical care pathway study of early supported discharge (termed 'HOME FIRST') versus standard hospital care for patients hospitalised with LRTI.

HOME FIRST will provide co-ordinated multidisciplinary team (MDT) care, provision of 24hr emergency telephone cover, access to fully trained respiratory study nurse(s) and study doctor(s). The HOME FIRST MDT consists of:

* Study doctors (trained respiratory physicians - consultants and senior SpRs)
* Highly trained respiratory specialist nursing staff
* Close links with a physiotherapist (mobility and respiratory)
* Home help provision (temporary assistance with ADLs by carers) which may include occupational therapy or social worker involvement (HOME FIRST has fast access to meals-on-wheels)
* Close links with pharmacy for rapid dispensing of discharge medication.

Patients hospitalised with LRTI at the Royal Liverpool and Broadgreen (RLBUHT) Teaching Hospitals between October 2012 and April 2014 will be approached.

Patients (or the next of kin if the patient is unable to give informed consent) will be offered participation in the study if they fit the strict inclusion/exclusion criteria. They will be then be randomised to receive HOME FIRST or standard hospital care (SHC). The investigators will aim to recruit 25 patients to each arm of the study.

Patients randomised to HOME FIRST care will initially receive up to twice daily respiratory specialist nurse visits for the first 48 hours. After this time period, the frequency and duration of visits will depend on clinical need. The study nurse will establish the need for the involvement of other MDT team members. Laboratory tests will be performed as clinically indicated at the discretion of the study team. Venepuncture will be performed by fully trained research staff for clinical purposes as needed in the HOME FIRST limb: as for those patients in the SHC limb frequency of venepuncture depends on clinical assessment of need by their regular medical team.

Patients randomised to standard hospital care (SHC) - All management and discharge decisions will be made by the patient's usual hospital team. Clinical tests will be performed at the discretion of the medical team. If any significant or concerning clinical issues are noted during study team's visits, the usual medical team will be alerted.

All patients will be discussed at a weekly case-note MDT meeting. All patients will be followed-up on discharge in the 'Respiratory Infection' out-patient clinic (in the patient's own home if necessary) at 6 weeks, with a repeat chest X-ray if needed.

Eligibility criteria: 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

Primary outcomes:
measure: Time to recovery
timeFrame: Six weeks
Secondary outcomes:
measure: 30-day mortality
timeFrame: up to 6 weeks after recruitment
measure: 30-day hospital readmission rates
timeFrame: up to 6 weeks after recruitment
measure: Patient satisfaction using a validated satisfaction questionnaire
timeFrame: at 2 weeks post recruitment
measure: Carer (NOK) satisfaction using a validated satisfaction questionnaire
timeFrame: at 2 weeks post recruitment
measure: Length of stay in hospital
timeFrame: Participants will be followed for the duration of hospital stay, this may be 1 day to 1 year
measure: Functional status as assessed by SF-12 validated questionnaire
timeFrame: up to 6 weeks after recruitment
measure: Pneumonia score as assessed by CAP-SYM validated questionnaire
timeFrame: up to 6 weeks after recruitment
measure: Combined total length of stay (days) - hospital and home first
timeFrame: Participants will be followed for the duration of hospital stay and their HOME FIRST stay, the latter can range from 1 - 5 days
Other outcomes:
measure: Health - economic
timeFrame: One year
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool And Broadgreen University Hospital
state: Merseyside
Study officials:
affiliation: Liverpool School of Tropical Medicine
name: Stephen B Gordon, Professor
role: PRINCIPAL_INVESTIGATOR
References: