Community Acquired PneumoniaHOMEFIRSTNCT02454114
HOME FIRST Pilot: a Study of Early Supported Discharge in Patients With Lower Respiratory Tract Infections
A study testing HOMEFIRST and Standard Hospital Care in people with Community Acquired Pneumonia and Hospital Acquired Pneumonia, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia, Hospital Acquired Pneumonia, Lower Respiratory Tract Infection
- What is being tested?
- HOMEFIRST and Standard Hospital Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool And Broadgreen University Hospital
Liverpool, Merseyside, L7 8XP
About this study
Official title: HOME FIRST (HOME Followed - up With Infection Respiratory Support Team)
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.
Read the 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.
- Conditions
- Community Acquired Pneumonia, Hospital Acquired Pneumonia, Lower Respiratory Tract Infection
- Being tested
- HOMEFIRST, Standard Hospital Care
- Keywords
- Pneumonia, Community, Hospital, Respiratory, Infection
- Medical subject headings
- Community-Acquired Pneumonia, Healthcare-Associated Pneumonia, Pneumonia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMEFIRSTOther
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.
Standard Hospital CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Hospital Care (SHC) | Active comparator | 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. Receives: Other: Standard Hospital Care |
| HOMEFIRST | Active comparator | 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. Receives: Other: HOMEFIRST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks
Secondary outcomes (8)
30-day mortality
We will assess safety i.e. ensure there is no increase in mortality in the HOME FIRST limb.
Measured: up to 6 weeks after recruitment
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.
Measured: up to 6 weeks after recruitment
Patient satisfaction using a validated satisfaction questionnaire
A validated patient satisfaction will be conducted at 2 weeks by an independent assessor.
Measured: at 2 weeks post recruitment
Carer (NOK) satisfaction using a validated satisfaction questionnaire
A validated carer/consultee satisfaction will be conducted at 2 weeks by an independent assessor.
Measured: at 2 weeks post recruitment
Length of stay in hospital
Length of hospital stay will be calculated.
Measured: 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
Functional status (physical and mental) and quality of life (QOL) questionnaire will be completed to assess recovery / post respiratory infection.
Measured: up to 6 weeks after recruitment
Pneumonia score as assessed by CAP-SYM validated questionnaire
The questionnaire will be completed to assess recovery / post respiratory infection
Measured: up to 6 weeks after recruitment
Combined total length of stay (days) - hospital and home first
Total length of stay - combined will be calculated
Measured: Participants will be followed for the duration of hospital stay and their HOME FIRST stay, the latter can range from 1 - 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Liverpool School of Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Stephen B Gordon, Professor, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454114
- Sponsor's protocol ID
- 12/NW/0731
- Acronym
- HOMEFIRST
- Status last verified
- Oct 2012
- First submitted
- 8 May 2015
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOME FIRST (HOME Followed - up With Infection Respiratory Support Team)
- ClinicalTrials.gov ID
- NCT02454114
- Acronym / sponsor ID
- HOMEFIRST / 12/NW/0731
- Conditions
- Community Acquired Pneumonia, Hospital Acquired Pneumonia, Lower Respiratory Tract Infection
- Keywords
- Pneumonia, Community, Hospital, Respiratory, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- Liverpool School of Tropical Medicine
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Hospital Care (SHC) | Active comparator | Other: Standard Hospital CareAll 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. |
| HOMEFIRST | Active comparator | Other: HOMEFIRSTPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOMEFIRSTHOMEFIRST 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. | Other | HOMEFIRST |
| Standard Hospital CareNo 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. | Other | Standard Hospital Care (SHC) |
Primary outcome
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.
8 secondary outcomes
30-day mortality
Time frame: up to 6 weeks after recruitment
30-day hospital readmission rates
Time frame: up to 6 weeks after recruitment
Patient satisfaction using a validated satisfaction questionnaire
Time frame: at 2 weeks post recruitment
Carer (NOK) satisfaction using a validated satisfaction questionnaire
Time frame: at 2 weeks post recruitment
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
Functional status as assessed by SF-12 validated questionnaire
Time frame: up to 6 weeks after recruitment
Pneumonia score as assessed by CAP-SYM validated questionnaire
Time frame: up to 6 weeks after recruitment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen B Gordon, Professor principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOMEFIRST and Standard Hospital Care in people with Community Acquired Pneumonia and Hospital Acquired Pneumonia, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.