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

NCT02454114 | Completed

• 1 other identifier: 12/NW/0731
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pneumonia; Community; Hospital; Respiratory; Infection

Outcome Measures

Primary Outcomes (1)

• 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): 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.

  Six weeks

Secondary Outcomes (8)

• 30-day mortality

  up to 6 weeks after recruitment

• 30-day hospital readmission rates

  up to 6 weeks after recruitment

• Patient satisfaction using a validated satisfaction questionnaire

  at 2 weeks post recruitment

• 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

Other Outcomes (1)

• Health - economic

  One year

Study Arms (2)

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.

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.

Other: HOMEFIRST

Interventions

HOMEFIRST 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.

HOMEFIRST

Standard Hospital Care 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.

Standard Hospital Care (SHC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• Liverpool School of Tropical Medicine: collaborator

Study Sites (1)

Royal Liverpool And Broadgreen University Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Healthcare-Associated Pneumonia; Pneumonia; Infections

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Cross Infection; Lung Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen B Gordon, Professor

  Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 27, 2015
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 3, 2022

Record last verified: 2012-10

Locations

GB (1)