search
Back to results

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

Primary Purpose

Community Acquired Pneumonia, Hospital Acquired Pneumonia, Lower Respiratory Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HOMEFIRST
Standard Hospital Care
Sponsored by
Liverpool University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Community Acquired Pneumonia focused on measuring Pneumonia, Community, Hospital, Respiratory, Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Liverpool And Broadgreen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard Hospital Care (SHC)

HOMEFIRST

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

30-day mortality
We will assess safety i.e. ensure there is no increase in mortality in the HOME FIRST limb.
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.
Patient satisfaction using a validated satisfaction questionnaire
A validated patient satisfaction will be conducted at 2 weeks by an independent assessor.
Carer (NOK) satisfaction using a validated satisfaction questionnaire
A validated carer/consultee satisfaction will be conducted at 2 weeks by an independent assessor.
Length of stay in hospital
Length of hospital stay will be calculated.
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.
Pneumonia score as assessed by CAP-SYM validated questionnaire
The questionnaire will be completed to assess recovery / post respiratory infection
Combined total length of stay (days) - hospital and home first
Total length of stay - combined will be calculated

Full Information

First Posted
May 8, 2015
Last Updated
June 1, 2022
Sponsor
Liverpool University Hospitals NHS Foundation Trust
Collaborators
Liverpool School of Tropical Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02454114
Brief Title
HOME FIRST Pilot: a Study of Early Supported Discharge in Patients With Lower Respiratory Tract Infections
Acronym
HOMEFIRST
Official Title
HOME FIRST (HOME Followed - up With Infection Respiratory Support Team)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool University Hospitals NHS Foundation Trust
Collaborators
Liverpool School of Tropical Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia, Hospital Acquired Pneumonia, Lower Respiratory Tract Infection
Keywords
Pneumonia, Community, Hospital, Respiratory, Infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Hospital Care (SHC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HOMEFIRST
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HOMEFIRST
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Hospital Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to recovery
Description
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.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
30-day mortality
Description
We will assess safety i.e. ensure there is no increase in mortality in the HOME FIRST limb.
Time Frame
up to 6 weeks after recruitment
Title
30-day hospital readmission rates
Description
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.
Time Frame
up to 6 weeks after recruitment
Title
Patient satisfaction using a validated satisfaction questionnaire
Description
A validated patient satisfaction will be conducted at 2 weeks by an independent assessor.
Time Frame
at 2 weeks post recruitment
Title
Carer (NOK) satisfaction using a validated satisfaction questionnaire
Description
A validated carer/consultee satisfaction will be conducted at 2 weeks by an independent assessor.
Time Frame
at 2 weeks post recruitment
Title
Length of stay in hospital
Description
Length of hospital stay will be calculated.
Time Frame
Participants will be followed for the duration of hospital stay, this may be 1 day to 1 year
Title
Functional status as assessed by SF-12 validated questionnaire
Description
Functional status (physical and mental) and quality of life (QOL) questionnaire will be completed to assess recovery / post respiratory infection.
Time Frame
up to 6 weeks after recruitment
Title
Pneumonia score as assessed by CAP-SYM validated questionnaire
Description
The questionnaire will be completed to assess recovery / post respiratory infection
Time Frame
up to 6 weeks after recruitment
Title
Combined total length of stay (days) - hospital and home first
Description
Total length of stay - combined will be calculated
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
Other Pre-specified Outcome Measures:
Title
Health - economic
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B Gordon, Professor
Organizational Affiliation
Liverpool School of Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Liverpool And Broadgreen University Hospital
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs