Condition category
Respiratory
Date applied
10/08/2008
Date assigned
12/09/2008
Last edited
22/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Bourke

ORCID ID

Contact details

North Tyneside General Hospital
Rake Lane
North Shields
Newcastle-upon-Tyne
NE29 8NH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Survival, quality of life and health resource use following hospitalisation for chronic obstructive pulmonary disease (COPD) exacerbations: a longitudinal, single-centre, observational study

Acronym

Study hypothesis

Acute exacerbations of chronic obstructive pulmonary disease (COPD) account for 10% of hospital admissions and 90-day mortality stands at 15.3%. Mortality increases with frequency of exacerbations, particularly when severe. In patients with severe exacerbations complicated by acute respiratory failure, non-invasive ventilation (NIV) improves survival but is still associated with a one-year mortality of approximately 50%. In these patients with a severe exacerbation, little is known regarding the use of NIV and quality of life and hence there is a lack of clarity regarding whether patients with the most severe exacerbations should be considered for NIV. We therefore intend to assess mortality, quality of life, exacerbation frequency and hospital admissions among survivors of exacerbations of COPD requiring NIV (n = 150) and exacerbations of COPD not requiring NIV (n = 150).

Patients with severe COPD would benefit from input from the palliative care services in addition to optimal medical therapy. Despite evidence that patients with severe COPD have a low quality of life, high levels of disability and high levels of anxiety and depression, current input from palliative care services in this cohort is virtually non-existent. This is largely due to the difficulty in identifying which patients are unlikely to survive more than 6 months and hence should be referred to palliative care services. We therefore intend to identify univariate and independent predictors of in-hospital and six month survival in exacerbations of COPD requiring NIV (n = 150) and exacerbations of COPD not requiring NIV (n = 450).

We also intend to validate a modified Medical Research Council (MRC) Dyspnoea Scale which has previously been shown (in unpublished data) to more accurately predict markers of poor outcome when compared to the original instrument. We will compare the relations of the novel modified MRC Dyspnoea Scale and the standard MRC Dyspnoea Scale with survival, quality of life, readmission rates, length of stay and frequency of hospital admissions.

We therefore intend to recruit 600 patients admitted to Northumbria NHS Foundation Trust with an acute exacerbation of COPD and assess a variety of prognostic indices. A subset of 300 patients will undergo serial assessment of quality of life, health resource utilisation and provision of palliative care services. Provision of palliative care services will be assessed by interviewing the patient and their carers/family, contacting their GP and reviewing their medical notes.

Please note that as of 20/02/2009 this record was updated to include amended trial dates. The initial trial dates at the time of registration were:
Initial anticipated start date: 01/10/2008
Initial anticipated end date: 30/09/2010

Ethics approval

Added 20/02/2009: County Durham and Tees Valley 1 Research Ethics Committee approved on 28th November 2008 (ref: 08/H0905/88)

Study design

Longitudinal, single-centre, observational study

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Acute exacerbations of chronic obstructive pulmonary disease (COPD)

Intervention

All patients admitted who satisfy the above inclusion and exclusion criteria will be invited to participate in the study. We intend to recruit 150 patients requiring non-invasive ventilation (NIV) and 450 who do not require NIV.

A number of prognostic indices will be assessed; age, gender, body mass index (BMI), frequency of exacerbations, frequency of admissions, previous spirometry, smoking history, exercise tolerance, ability to perform ADLs, performance status, previous pulmonary rehabilitation, previous ventilation, previous NIV, a number of physiological indices, chest x-ray (CXR) report, "do not resuscitate" (DNR) order, ability to cough, treatment on discharge, spirometry on discharge, discharge destination.

Mortality data, including cause of death, will be determined in all patients by review of hospital notes and contacting the GP.

All patients requiring NIV and the first 150 patients not requiring NIV will undergo serial assessment of quality of life, oxygen saturations, BMI, spirometry and MRC Dyspnoea Score. These assessments will be performed at discharge, 6 weeks, 3 months and 3 monthly intervals for 1 year.

Total duration of follow-up: 1 year

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. In-hospital and 6 month survival
2. Univariate and independent predictors of in-hospital and 6 month survival

Secondary outcome measures

1. Duration quality of life maintained above baseline
2. Mean improvement in quality of life, assessed in 150 patients not requiring NIV and 150 patients requiring NIV at discharge, 6 weeks, 3 months and then 3 monthly intervals for 1 year. This will be assessed by the following: St. Georges Respiratory Questionnaire, 36-item Short Form health survey (SF-36), Hospital Anxiety and Depression Score, Nottingham Extended Activities of Daily Living Scale
3. Discharge destination
4. Frequency of exacerbations
5. Frequency of hospital admissions and length of stay
6. Provision of palliative care services

Overall trial start date

01/12/2008

Overall trial end date

30/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, age over 40 years
2. Current or former smoker with a smoking history greater than 10 pack years
3. Diagnosis of chronic obstructive pulmonary disease, supported by spirometry
4. Infective exacerbation or pneumonia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Malignancy or other serious life-threatening co-morbidity
2. Severe cognitive impairment/dementia
3. Domiciliary ventilatory support prior to admission

Recruitment start date

01/12/2008

Recruitment end date

30/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Tyneside General Hospital
Newcastle-upon-Tyne
NE29 8NH
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust (UK)

Sponsor details

Rake Lane
North Shields
Newcastle-upon-Tyne
NE29 8NH
United Kingdom
contact.centre@northumbria.nhs.uk

Sponsor type

Government

Website

http://www.northumbria.nhs.uk

Funders

Funder type

Government

Funder name

Northumbria Healthcare NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 dyspnoea and pneumonia results in http://www.ncbi.nlm.nih.gov/pubmed/21896712
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22895999

Publication citations

  1. Dyspnoea and pneumonia results

    Steer J, Norman EM, Afolabi OA, Gibson GJ, Bourke SC, Dyspnoea severity and pneumonia as predictors of in-hospital mortality and early readmission in acute exacerbations of COPD., Thorax, 2012, 67, 2, 117-121, doi: 10.1136/thoraxjnl-2011-200332.

  2. Results

    Steer J, Gibson J, Bourke SC, The DECAF Score: predicting hospital mortality in exacerbations of chronic obstructive pulmonary disease., Thorax, 2012, 67, 11, 970-976, doi: 10.1136/thoraxjnl-2012-202103.

Additional files

Editorial Notes