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

NCT ID: NCT02454114

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard Hospital Care

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

HOMEFIRST

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool School of Tropical Medicine

OTHER

Sponsor Role: collaborator

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen B Gordon, Professor

Role: PRINCIPAL_INVESTIGATOR

Liverpool School of Tropical Medicine

Locations

Royal Liverpool And Broadgreen University Hospital

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Other Identifiers

12/NW/0731

Identifier Type: -

Identifier Source: org_study_id