HOME FIRST (HOME Followed - up With Infection Respiratory Support Team)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Time to recovery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Time to recovery
时间窗: Six weeks
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): 1. When (if at all) did your sleep return to normal? 2. When (if at all) did your diet/appetite return to normal? 3. When (if at all) did your (pre-defined) exercise capacity return to normal? 4. 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.
次要结局
- 30-day mortality(up to 6 weeks after recruitment)
- 30-day hospital readmission rates(up to 6 weeks after recruitment)
- Pneumonia score as assessed by CAP-SYM validated questionnaire(up to 6 weeks after recruitment)
- Combined total length of stay (days) - hospital and home first(Participants will be followed for the duration of hospital stay and their HOME FIRST stay, the latter can range from 1 - 5 days)
- Carer (NOK) satisfaction using a validated satisfaction questionnaire(at 2 weeks post recruitment)
- Length of stay in hospital(Participants will be followed for the duration of hospital stay, this may be 1 day to 1 year)
- Functional status as assessed by SF-12 validated questionnaire(up to 6 weeks after recruitment)
- Patient satisfaction using a validated satisfaction questionnaire(at 2 weeks post recruitment)