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HOME FIRST Pilot: a Study of Early Supported Discharge in Patients With Lower Respiratory Tract Infections (HOMEFIRST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02454114
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Liverpool School of Tropical Medicine
Information provided by (Responsible Party):
Royal Liverpool and Broadgreen University Hospitals NHS Trust

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.

Condition or disease Intervention/treatment
Community Acquired Pneumonia Hospital Acquired Pneumonia Lower Respiratory Tract Infection Other: HOMEFIRST Other: Standard Hospital Care

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: HOME FIRST (HOME Followed - up With Infection Respiratory Support Team)
Study Start Date : October 2013
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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. Patients receiving SHC will be discussed at weekly case note MDT meeting and 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.
Other: Standard Hospital Care

No research investigations will occur except for questionnaires; as part of usual clinical practice patients will have bloods and radiology requested as desired by their usual clinical team.

SF-12 (physical and mental function) [performed twice in total] - at recruitment (day 0) and 6 weeks

CAP-SYM [performed 3 times in total] - at recruitment day 0 (twice including day minus 30) and 6 weeks

Patient (and carer/consultee) satisfaction - conducted over the telephone at 2 wks by an independent assessor.

Active Comparator: HOMEFIRST

Patients randomised to HOMEFIRST care will initially receive up to twice daily visits for the first 48 hours. After this, the frequency and duration of visits will depend on clinical need but not exceed 5 days. The study nurse will establish the need for the involvement of other MDT members. Laboratory tests will be performed as clinically indicated. Venepuncture will be performed for clinical purposes as needed.

Patients will be discussed at a weekly case-note MDT meeting and 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.

Patients are either discharged from HOMEFIRST, readmitted or handed over to their community care team at the end of the intervention.

Other: HOMEFIRST
HOMEFIRST patients receive monitoring and review of; vital signs, symptoms, mental state, nutrition and hydration, urine output, skin turgor and integrity, mobility, coping ability, medication concordance, smoking and nutrition and hydration. Individualised verbal and written self-management plans, a list of symptoms (including red flag symptoms) to prompt contact with the study team and a 24hr emergency contact number are provided. Clinical bloods and other investigations will be taken/requested as necessary. Questionnaires will be completed as follows; SF-12 - at recruitment and 6 weeks, CAP-SYM - at recruitment and 6 weeks. Satisfaction questionnaires are conducted over the telephone at 2 wks by an independent assessor. As part of usual clinical practice patients will have bloods and radiology requested as required.



Primary Outcome Measures :
  1. Time to recovery [ Time Frame: 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.



Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: up to 6 weeks after recruitment ]
    We will assess safety i.e. ensure there is no increase in mortality in the HOME FIRST limb.

  2. 30-day hospital readmission rates [ Time Frame: up to 6 weeks after recruitment ]
    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.

  3. Patient satisfaction using a validated satisfaction questionnaire [ Time Frame: at 2 weeks post recruitment ]
    A validated patient satisfaction will be conducted at 2 weeks by an independent assessor.

  4. Carer (NOK) satisfaction using a validated satisfaction questionnaire [ Time Frame: at 2 weeks post recruitment ]
    A validated carer/consultee satisfaction will be conducted at 2 weeks by an independent assessor.

  5. Length of stay in hospital [ Time Frame: Participants will be followed for the duration of hospital stay, this may be 1 day to 1 year ]
    Length of hospital stay will be calculated.

  6. Functional status as assessed by SF-12 validated questionnaire [ Time Frame: up to 6 weeks after recruitment ]
    Functional status (physical and mental) and quality of life (QOL) questionnaire will be completed to assess recovery / post respiratory infection.

  7. Pneumonia score as assessed by CAP-SYM validated questionnaire [ Time Frame: up to 6 weeks after recruitment ]
    The questionnaire will be completed to assess recovery / post respiratory infection

  8. Combined total length of stay (days) - hospital and home first [ Time Frame: Participants will be followed for the duration of hospital stay and their HOME FIRST stay, the latter can range from 1 - 5 days ]
    Total length of stay - combined will be calculated


Other Outcome Measures:
  1. Health - economic [ Time Frame: One year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454114


Locations
United Kingdom
Royal Liverpool And Broadgreen University Hospital
Liverpool, Merseyside, United Kingdom, L7 8XP
Sponsors and Collaborators
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool School of Tropical Medicine
Investigators
Principal Investigator: Stephen B Gordon, Professor Liverpool School of Tropical Medicine

Responsible Party: Royal Liverpool and Broadgreen University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02454114     History of Changes
Other Study ID Numbers: 12/NW/0731
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: October 2012

Keywords provided by Royal Liverpool and Broadgreen University Hospitals NHS Trust:
Pneumonia
Community
Hospital
Respiratory
Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases