Condition category
Respiratory
Date applied
09/05/2016
Date assigned
04/07/2016
Last edited
04/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name given to a collection of diseases which affect the lungs. It is characterised by breathlessness, cough and excess mucus production and is often caused by smoking. COPD is frequently complicated by episodes of sudden worsening of respiratory symptoms, termed ‘exacerbations’. Sometimes during an exacerbation waste gases rise to a dangerous level. In this setting additional breathing support may be required. This ‘assisted ventilation’can be in the form of a tube placed directly into the patient’s lungs or much more commonly in the form of a tight fitting facial mask. This technique is called non-invasive ventilation (NIV) and can be lifesaving. Determining which patients should receive NIV is a complex decision that requires an assessment of an individual’s chances of survival should NIV be provided. However even specialist clinicians are overly pessimistic about the results of NIV treatment, which may lead to patients being inappropriately denied treatment. A simple, reliable tool to accurately identify patients likely to benefit and enhance clinical decision making has tremendous potential to further increase appropriate use of NIV. The study team has developed a score (tool) to predict the chance of successful treatment if NIV is started. For this score to be used in day to day practice it needs to be tested to ensure it works as expected. Therefore data will be collected about the health of a group of patients who experience assisted ventilation over a year. The aim of this study is to assess whether this tool is able to predict the outcome of assisted ventilation. In a second part of the study, a group of patients that have previously received assisted ventilation will be followed up over one year and data about their quality of life and the impact of COPD on their day to day activities will be collected. This data will allow clinicians to better understand what a patient experiences after ventilation. From this information particular markers of poor quality of life may be identified.

Who can participate?
Adults aged 35 and over with COPD who smoke a pack of cigarettes a day for 10 years and need treatment with a breathing machine.

What does the study involve?
In the first part of the study, information about patient’s health is collected by their usual care team over the course of one year and stored in a database. The tool is then applied to the data in order to find out if it would have accurately predicted the outcome of the patient, had the tool been applied to the patient at the time that they received ventilation. In the second part of the study, at baseline (immediately prior to discharge) and then again after three, six and twelve months, patients complete a number of questionnaires about their state of health as well as simple physical test such as their oxygen levels and weight, in order to assess their quality of life, the impact of COPD on their lives and whether they would wish to have ventilation again in the future should the need arise.

What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants taking part in this study.

Where is the study run from?
1. North Tyneside General Hospital (UK)
2. Guy's Hospital, London (UK)
3. St Thomas' Hospital, London (UK)
4. Queen's Medical Centre, Nottingham (UK)
5. St James's University Hospital, Leeds (UK)

When is the study starting and how long is it expected to run for?
May 2015 to February 2019

Who is funding the study?
1. Philips Respironics (UK)
2. Pfizer OpenAir (UK)

Who is the main contact?
1. Ms Victoria Ferguson (public)
2. Dr Tom Hartley (scientific)

Trial website

Contact information

Type

Public

Primary contact

Ms Victoria Ferguson

ORCID ID

Contact details

Research and Development Department
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom

Type

Scientific

Additional contact

Dr Tom Hartley

ORCID ID

Contact details

Research and Development Department
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V2.3

Study information

Scientific title

Validation of a novel scoring system to predict inpatient mortality in exacerbations of Chronic Obstructive Pulmonary Disease requiring assisted ventilation with supplementary longitudinal assessment of quality of life and other patient-centred outcomes over one year

Acronym

NIVO

Study hypothesis

There are no existing tools in use routinely in clinical practice to predict outcomes following an exacerbation of chronic obstructive pulmonary disease (COPD) requiring assisted ventilation. We are developing a tool to predict in-hospital mortality (ISRCTN16977236). Among patients who survive to discharge, little is known about patient-centred outcomes including quality of life, functional status and survival; a better understanding of such outcomes would help inform appropriate future care planning, including palliative care.

The principal aims of this study are:
1. To prospectively validate the tool to predict in-hospital mortality in multiple centres
2. Among patients who survive to discharge, to identify predictors of six month mortality and perform longitudinal assessment of patient-centred outcomes including quality of life and functional status. Patients' views regarding their recent experience of assisted ventilation and willingness to undergo such treatment again will also be captured.

Ethics approval

Not provided at time of registration

Study design

Cross-sectional observation study with longitudinal follow up

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

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 (COPD)

Intervention

Validation study
Each patient meeting selection criteria has a dataset collected by their usual care team. This data comprises descriptive indices, the components of our derived tool and other comparative tools, other clinical indices and mortality and readmissions to one year. Anonymised data is entered onto a centralised database. Following completion performance of the tool will be assessed by AUROC curve analysis.

Longitudinal study:
At baseline (immediately prior to discharge), 3, 6 and 12 months questionnaires and physical tests (spirometry, weight, oxygen saturation) are measured in a face to face interview either in hospital or patient's home. In addition, at baseline and 3 months future ventilation questions are asked. Every month throughout the study (i.e. months 1-12) the patient complete the following questionnaires which will be given out and collected at researcher visits: COPD assessment test (CAT), extended medical research council dyspnoea score (eMRCD), Nottingham extended activity of daily living scale (NEADL), EQ-5D-5L and hospital anxiety and depression score (HADS).

Intervention type

Other

Phase

Drug names

Primary outcome measures

Prediction of in-hospital mortality within the validation cohort assessed by the area under the receiver operating characteristic (AUROC) curve for tools developed using:
1. Indices available on admission
2. All indices up to and including the time of deterioration

Secondary outcome measures

In the admitted population:
1. Comparison of the AUROC curves for both novel tools
2. Comparison of the AUROC curves for both novel tools to CAPS, APACHE II and Confalonieri risk chart

Among patients surviving to discharge:
1. Mortality to 1 year by review of electronic record, contacting GP or review of patient notes
2. Readmission rates at 30, 90 and 365 days by review of electronic record, contacting GP, review of patient notes
3. Comparison of mortality and clinically significant change in quality of life in patients with, and without pre-defined characteristics:
3.1. Late failure of NIV (recurrent respiratory acidaemia, despite on-going ventilatory support; in-patient mortality will also be captured).
3.2. Persistent hypercapnia.
3.3. Long-term oxygen therapy.
3.4. Long-term ventilation on discharge.
3.5. Eosinopenia (<0.05 109/L) at discharge
4. Longitudinal changes in patient reported outcomes (CAT, eQ-5D-5L, NEADL, HADS) post discharge, quantified by calculating: mean change (relative to the minimum clinically important difference (MCID)); duration maintained above baseline and time taken to reach peak
5. Predictors of a) 6 month mortality and b) poor baseline QoL with a subsequent clinically significant deterioration (poor recovery)
6. Relation between clinically significant anxiety and depression on discharge and: survival, QoL, functional status and readmission rate
7. Examination of patient willingness to undergo ventilation again in the future by direct questioning at baseline and 3 months

Overall trial start date

05/05/2015

Overall trial end date

04/02/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 35 years or older
2. Smoking history greater than or equal to 10 pack years (1 pack per day for 10 years)
3. Obstructive spirometry (FEV1/FVC < 0.7)
4. Acute exacerbation of COPD (AECOPD) primary diagnosis
5. Respiratory acidosis treated with NIV or IPPV (arterial blood gas pH <7.35, pCO2 > 6.5)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

425 (minimum)

Participant exclusion criteria

1. Previous inclusion in the study
2. Other illness likely to limit survival to less than 1 year

Recruitment start date

18/10/2016

Recruitment end date

04/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

St Thomas' Hospital
Westminster Bridge Road
SE1 7EH
LS9 7TF
United Kingdom

Trial participating centre

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

Research and Development Department
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Philips Respironics

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer OpenAir

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. The findings will be disseminated to a broad regional, national and international audience, including respiratory specialists, general physicians and intensive care physicians, through presentations at local, national and international conferences, and publication in high ranking, peer-reviewed, journals. Open access publication fees are included in our application.
2. Locally, we will keep patients, carers, primary and secondary care clinicians, healthcare managers, commissioners and neighbouring healthcare providers informed by publications in existing newsletters and presentations at local and regional meetings, conducted within both NHS organisations and the University. Through established links with the British Lung Foundation (BLF), we will seek to disseminate the results of the study through BLF electronic and published media. We will establish a patient/public group of service users and encourage them to publish the results from the perspective of patients and carers, facilitated by the research team and the BLF.
3. The research team and co-applicants include members (and the chair) of the UK NIV Research Network. We will keep the network and British Thoracic Society COPD Speciality Advisory Group (SAG) and clinical guideline groups informed about the progress and outcome of the study.
4. We will liaise with NHS Improving Quality; the scores developed could be implemented as part of a national service improvement project. A previous study conducted by our group describing the DECAF prognostic score was published in Thorax, awarded several international prizes recognising its importance and impact, and its use in clinical practice has been recommended by the recent National UK COPD Audit report. We expect similar success in the dissemination and clinical implementation of the results of the proposed study.

Intention to publish date

01/08/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/11/2016: The recruitment start date has been updated from 01/08/2016 to 18/10/2016.