Plain English Summary
Background and study aims
This study is designed to identify people who may have a lung disease called chronic obstructive pulmonary disease (COPD). COPD affects 5-10% of people worldwide, is rising in prevalence, and is a leading cause of death. In the UK it costs the NHS over £800 million per year. There is however much uncertainty about the natural history of COPD, how to approach early identification of patients, and what treatments are effective in early disease. There is significant under diagnosis of COPD patients and this represents a group of people who could benefit from treatment by their GP. There is increasing interest in finding these patients but no evidence as to which approach to case finding would be most effective or cost-effective. The aims of the study are to determine whether targeted case finding is more effective and cost-effective than current practice, to find out the relative effectiveness and cost-effectiveness of two alternative methods of targeted case finding, and to obtain patients views about the process.
Who can participate?
Potential participants will be identified through GP practice registers and anyone who is potentially eligible will be screened by the GP before being invited to take part. Patients must be aged between 40 and 79 years with no clinical diagnosis of COPD.
What does the study involve?
Participating practices will be randomly allocated to either the targeted group or the routine care group. Patients in the routine care group will not have to do anything. There will be no changes to their care. Patients in the targeted group will fill out a questionnaire either at home or at the surgery (once) and if they say they have respiratory symptoms in the questionnaire they will have a one-time simple lung function test. This lung function test will take about half an hour and will be at their local or nearby surgery. It will require patients to take a standard dose of a salbutamol inhaler prior to taking the test. A few additional questions on their health and personal information will be requested at this point. For all participants, further medical information at the start and end of the study will be sought from their GP, which will be anonymous until they provide consent. Finally, about 80 of the study patients will be invited to be interviewed, either in their own home or in the surgery as preferred. The aim of this is to explore participants' perceptions and understanding of the case finding process and its consequences, any barriers to attendance and participation, and for those who attend the lung function test, what their perceptions are of being either disease free or labelled with a new disease. Patients who have lung function test results which indicate that they may have COPD will be referred back to their GP for management. They will also have the chance to take part in another linked study. Further information from GP records on how they are being managed will also be collected 1 year after their diagnosis.
What are the possible benefits and risks of participating?
The benefits of participating will include additional monitoring of their health status and the possibility of earlier treatment for COPD identified through the study. Patients may also have the chance to take part in a linked study which will provide them with more detailed and more regular monitoring and health assessment. There are no risks from the methods involved. The lung function test may detect previously undiagnosed COPD that requires treatment. With the patients agreement, we will pass these details onto their GP for further consideration.
Where is the study run from?
University of Birmingham (UK).
When is the study starting and how long is it expected to run for?
The study started in August 2012 and end in April 2015.
Who is funding the study?
National Institute of Health Research (NIHR) (UK).
Who is the main contact?
Dr Joanne OBeirne-Elliman
j.l.obeirne@bham.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12825
Study information
Scientific title
TargetCOPD: a randomised controlled trial of targeted case finding for COPD versus routine practice in primary care
Acronym
Study hypothesis
Chronic obstructive pulmonary disease (COPD) places an increasing burden on the NHS, largely due to repeated inpatient admissions as the disease progresses. Although diagnosed COPD is estimated at 1.3% of the population, it is widely accepted that 50-80% of patients with clinically significant disease are not diagnosed and therefore unable to access effective treatments. Within the UK and elsewhere, there is increasing pressure to find these patients, both from patient groups and strategic documents.
TargetCOPD will compare the benefits and cost-effectiveness of two alternative case-finding approaches for identifying undiagnosed COPD in general practice. Using a cluster randomised controlled trial (RCT) design in 56 West Midlands general practices, over the next three years we will assess both approaches (targeted case finding vs usual care).
Patients between 40 and 79 years who are current or ex-smokers will be invited to participate. Using an individual patient RCT nested in the targeted arm, we also plan to compare the effectiveness and cost-effectiveness of active case finding using a postal questionnaire, and opportunistic case finding at usual surgery consultations.
Patients who report positive respiratory symptoms will be invited for further spirometric assessment to ascertain whether they have COPD or not. We will compare which method is the most effective and cost-effective in identifying new patients, possibly allowing earlier treatment. We will also explore patients views on this process by inviting some patients for face to face interviews.
Ethics approval
NRES Committee West Midlands Solihull, 08/03/2012, ref: 11/WM/0403
Study design
Randomised interventiona trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention
Case finding for COPD. Eligible patients in the targeted arm of the study will receive a questionnare in the post about their lung health; if they respond with respiratory symptoms, they are invited for spirometry. Patients in this arm are also flagged in the GP's computer and if they come into practice for any reason, they are given a questionnaire.
Eligible patients in the opportunistic arm are flagged in the GP computer and given the questionnaire if they show up in the GP practice for any reason.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Economic evaluation of case finding for COPD by different methods; Timepoint(s): Cost per case identified
Secondary outcome measures
No secondary outcome measures
Overall trial start date
06/08/2012
Overall trial end date
30/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients that are registered with a GP in the West Midlands area
2. Aged between 40 and 79 years
3. Must have a history of ever smoking
4. Must not have a diagnosis of COPD or asthma
5. They must have the ability to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 76608
Participant exclusion criteria
1. Participants with serious life threatening disease or other condition that could interfere with participation in the study, e.g. patients wih terminal cancer or dementia
2. Diagnosed asthmatics/COPD
Recruitment start date
06/08/2012
Recruitment end date
02/06/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Lung Improvement Studies (BLISS)
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
School of Health and Population Sciences
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR) - Central Commissioning Facility (CCF) ref: RPPG010910061
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Data may be made available on request, we have a process for engagement, collaboration on our website: http://www.birmingham.ac.uk/research/activity/mds/projects/HaPS/PHEB/BLISS/index.aspx
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2014 protocol in http://www.ncbi.nlm.nih.gov/pubmed/25280869
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27444687
Publication citations
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Protocol
Jordan RE, Adab P, Jowett S, Marsh JL, Riley RD, Enocson A, Miller MR, Cooper BG, Turner AM, Ayres JG, Cheng KK, Jolly K, Stockley RA, Greenfield S, Siebert S, Daley A, Fitzmaurice DA, TargetCOPD: a pragmatic randomised controlled trial of targeted case finding for COPD versus routine practice in primary care: protocol., BMC Pulm Med, 2014, 14, 1, 157, doi: 10.1186/1471-2466-14-157.