Condition category
Respiratory
Date applied
08/04/2014
Date assigned
02/06/2014
Last edited
15/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease in which patients develop progressive breathlessness, cough and phlegm. Such patients suffer episodes when their symptoms increase, often triggered by infection, called acute exacerbations (AECOPD). AECOPD are the second most common reason for all hospital admissions. There are potential clinical and financial benefits in managing patients at home during exacerbations. Hospital staff with experience of treating unwell patients can deliver most treatments at home that are provided in hospital. It is recommended that patient selection for Hospital at Home (HAH) be based on chance of survival, whilst recognising the lack of a tool for prediction at the time the guideline was written. We then developed a novel, simple clinical scoring system (DECAF) that can predict the survival of patients hospitalised with AECOPD. In this study we aim to find out whether HAH is safe and more cost-effective than hospital admission, whether HAH is the preferred choice for patients and carers, and whether HAH is associated with improvements in health-related quality of life.

Who can participate?
Adults aged 35 or over who are admitted to one of the participating hospitals with an acute exacerbation of COPD and assessed as low risk by the DECAF score can participate. For the qualitative study, patient's carers and healthcare professionals directly involved with caring for patients in the study will be eligible for interview.

What does the study involve?
After obtaining consent, patients will be randomly allocated to be treated for their exacerbation either in the usual way, which involves hospital admission, or to be treated at home. The medical treatment for those patients at home will largely be the same as for those patients in hospital. We will collect clinical information from patients, including their preferred treatment and their health-related quality of life. The costs of the treatment and the costs of social care (including the family carer) will be collected for the economic analysis. This information will be collected from admission up to 90 days. Patients, their carers and healthcare professionals will be approached for interview.

What are the possible benefits and risks of participating?
HAH may foster independence, help maintain usual activities and avoid the complications associated with hospital admission. We do not foresee any risks from participation. Previous studies have shown that home treatment for acute exacerbations of COPD is safe.

Where is the study run from?
1. North Tyneside General Hospital (UK)
2. Wansbeck General Hospital, Ashington (UK)
3. Northumbria Specialist Emergency Care Hospital (UK)

When is the study starting and how long is it expected to run for?
The study started at the end of April 2014 and participants will be recruited over 20 months and followed up for 90 days.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Carlos Echevarria
CarlosEchevarria@doctors.org.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Bourke

ORCID ID

Contact details

Respiratory department
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
-
Stephen.Bourke@nhct.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.10

Study information

Scientific title

Randomised controlled trial of hospital at home compared to standard inpatient management of patients with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD), triaged for hospital admission by Accident and Emergency and with low mortality risk according to the novel DECAF score

Acronym

HOT DECAF

Study hypothesis

1. Managing low risk patients at home for acute exacerbations of COPD (AECOPD) is more cost-effective for health and social costs then inpatient management.
2. Patients treated at home for AECOPD have higher health related quality of life scores, and fewer hospital bed days (up to 90 days) compared to those treated in hospital.
3. Patients with AECOPD (and their carers) prefer home treatment to hospital treatment.

On 22/05/2015 the target number of participants was changed from 140 to 118.

Ethics approval

NRES Committee North East- Sunderland; 22/10/2013; ref. 3/NE/0275

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic Obstructive Pulmonary Disease

Intervention

Patients will be allocated to hospital at home (HAH) or usual care. Whilst receiving hospital at home, the patient will remain under the care of the hospital team, with 24/7 on-call support. Home treatment will comprise of twice daily respiratory specialist nurse visits supervised by a respiratory consultant, with additional input from physiotherapy, occupational therapy and formal social care as required.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Health and social care costs over 90 days: non-inferiority analysis.

Secondary outcome measures

1. Survival
2. All cause and respiratory readmission rates
3. Bed days over: a) acute period of care; b) post-discharge to 90 days
4. Carer and patient preference
5. COPD Exacerbations
6. Unplanned health resource use: emergency hospital visits, unscheduled contact with the respiratory specialist nursing team, community based nurse or GP
7. Hospital anxiety and depression score
8. Quality-of-life: COPD Assessment Tool (CAT) and EQ-5D
9. Zarit Burden Interview (carers)
10. Perceptions of healthcare of patients and their carers and health professionals with regards to the use of the DECAF score for allocation to HAH

Overall trial start date

29/01/2016

Overall trial end date

02/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥35 years
2. Smoking history ≥10 pack years
3. Obstructive spirometry (FEV1/ VC <70%)
4. Primary diagnosis of AECOPD
5. DECAF score 0 or 1

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

118

Participant exclusion criteria

Current exclusion criteria as of 26/09/2014:
1. Other illness likely to limit survival to <1 year
2. Long term ventilation
3. Co-existent secondary diagnosis which necessitates admission
4. Acute confusion precluding discharge
5. Assessment more than one overnight stay after admission
6. Lack of ability to give informed consent

Previous exclusion criteria:
1. Other illness likely to limit survival to <1 year
2. Long term ventilation
3. Co-existent secondary diagnosis which necessitates admission
4. Acute confusion precluding discharge
5. Assessment >24 hours after admission
6. Lack of ability to give informed consent

Recruitment start date

04/06/2014

Recruitment end date

28/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Wansbeck General Hospital
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

Trial participating centre

Northumbria Specialist Emergency Care Hospital
Northumbrian Road
Cramlington
NE23 6NZ
United Kingdom

Sponsor information

Organisation

Northumbria NHS Foundation Trust (UK)

Sponsor details

c/o Caroline Potts
Research and Development Department
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
-
Caroline.Potts@nhct.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit PB-PG-0213-30105

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned submission for publication to Lancet or Respiratory Lancet by January 2017.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Stephen Bourke (Stephen.Bourke@northumbria-healthcare.nhs.uk)

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/11/2016: The overall trial start date has been updated from 28/04/2014 to 296/01/2016. In addition, the publication and dissemination plan and availability of the participant level data have been added. 08/11/2016: The overall trial end date has been updated from 28/04/2016 to 02/12/2016. The recruitment dates have been updated from 28/04/2014 - 28/04/2016 to 04/06/2014 - 28/01/2016