A Study Into Airways Disease Case Finding and Management

Asthma Clinical Trial

— ASSIST  

Official title:

A Clinical Interventional Study Into Airways Disease Case Finding and Complex Case Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355677
• Other study ID #: CLAHRC 001
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs which is generally caused by smoking tobacco. It is a largely preventable disease that causes severe and irreversible damage to the lungs. If not detected early, this damage will progress causing significant breathing difficulties, disability and poor survival rates. Patients with COPD can experience exacerbations of their disease which can also lead to can be described as a worsening of the patients symptoms COPD is a global health concern and it is estimated to become the third leading cause of death by 2020. In the United Kingdom, around 900,000 people have a formal diagnosis of COPD. However, it is believed that over 2 million more people may be living with the disease and are unaware that they have it. The cost of treating lung disease in the National Health Service (NHS) is estimated to be approximately £4.7billion per year . The majority of these costs are caused by a small group of COPD patients with severe disease and complex problems , . Late diagnosis has been proven as a contributing factor to the worsening of COPD, disease progression and increased healthcare costs. Indeed, recent research has shown that patients may attend their general practitioner (GP) practice with signs of the disease up to five years before they have the condition diagnosed. A delay in diagnosis is known to hasten the decline in lung function and worsen disease severity making treatment options less useful in the long term. This has led to national guidelines recognising that patients with COPD need to be diagnosed and treated effectively at the earliest opportunity.

The aim of this study is to find the best way to identify or 'case find' patients who have not yet been diagnosed with COPD, and also identify patients with more complex disease using a computerised search programme. The study will examine whether this intervention has saved the NHS money by reducing GP and hospital visits and by decreasing rescue medicine usage for respiratory problems, by comparing this data to similar GP practices where the intervention had not been implemented. Once patients have been identified, they will be invited to attend a clinic appointment at their GP practice to participate in a tailored intervention programme for patients at risk of having COPD and those with existing complex COPD. GP practices will also be offered a training package in order to continue the intervention programme in the future.

Description:

Background Chronic Obstructive Pulmonary Disease (COPD) COPD is a disease of the lungs characterised by airway inflammation leading to airflow obstruction. It is a progressive and largely preventable disease caused by the inhalation of noxious gases generally through cigarette smoking. Patients experience persistent symptoms including breathlessness, reduced exercise tolerance and an increase in the production of mucus in the airways. The impact of the disease to the individual is substantial in terms of physical disability and psycho-social issues.

Patients with COPD can experience an exacerbation of their disease, defined as a sudden worsening of symptoms above and beyond the individual's normal daily variation. COPD exacerbations are the second most common cause of emergency hospital admissions in the UK, with an estimated 94,000 admissions per annum. Indeed, COPD is one of the most expensive inpatient conditions in the UK, costing the National Health Service (NHS) over £800 million in direct healthcare costs. COPD is also set to become the third leading cause of death worldwide by the year 2030, surpassed only by heart disease and stroke. Despite this high level of mortality, public awareness of COPD is low in the United Kingdom (UK): around 89% of the general public have never heard of COPD.

Under-diagnosis of COPD Evidence suggests that 13% of people over 35 have COPD but many are diagnosed late and most are currently undiagnosed. Almost a third of patients admitted to hospital with a COPD exacerbation had not been diagnosed. Opportunities for early diagnosis of COPD are missed in primary care: a recent study demonstrated that 85% of patients had consulted primary care with lower respiratory symptoms in the five years immediately before their diagnosis of COPD. The insidious onset of COPD means undiagnosed patients may unconsciously modify their way of life, and only present to primary care in the later stages of disease. Furthermore, smokers, who constitute a substantial portion of the target population for case finding, have been shown to hold self-exempting beliefs and thus may be less likely to present to primary care. In addition, many patients visit their GP for problems related to COPD, such as chest infections and breathlessness, but the correct diagnosis is not made.

The importance of early diagnosis of COPD National health policy initiatives in the UK underscore improved diagnosis as a priority Early diagnosis of COPD followed by optimisation of treatment has potential cost savings for the NHS of more than £1 billion over 10 years . Prevention strategies (smoking cessation, dietary, exercise promotion, self-management and vaccination) can be targeted on this group of patients to maintain and improve health, and appropriate pharmacologic therapies (that can improve symptoms, exercise tolerance and quality of life and reduce the risk of exacerbations) commenced in newly identified people if appropriate. A recent systematic review of the literature concluded that a combination of a screening questionnaire and micro-spirometry seems to demonstrate the best overall screening test accuracy, but there has been little uptake of this strategy in UK primary care and doubts remain as to its feasibility and cost-effectiveness. However, whilst a variety of approaches to case finding have been trialled world-wide published studies have been variable in quality and the most effective, economical method of screening has yet to be identified. The National Institute for Health and Clinical Excellence (NICE) and the Department of Health (DoH) in the UK have recommended both systematic and opportunistic case finding to diagnose symptomatic patients . The UK National Screening Committee concurs, explicitly recommending case finding (defined as targeting patients with symptoms suggestive of COPD) rather than screening (defined as identifying apparently healthy people who may be at increased risk of COPD). A recent All Party Parliamentary Group report on Respiratory Deaths (APPG RD) concluded that tools to aid health care professionals to case find for COPD need to be developed in order to prioritise for use at national level.

Case-finding: identifying symptomatic but not yet diagnosed patients 'TargetCOPD' is an ongoing NIHR funded randomised controlled trial comparing the cost-effectiveness of two alternative case-finding approaches for identifying undiagnosed COPD. Both approaches rely on patient self-reported questionnaires to identify symptoms; one opportunistically administered, the other systematically administered. 'TargetCOPD' should provide some useful information on case-finding using questionnaires. However, evidence suggests that alternative approaches to case finding such as electronic searches based on routine primary care data may be a valuable tool for identifying symptomatic patients with as yet undiagnosed COPD. However, further validation of electronic case-finding strategies is required.

In early 2015 the Wessex CLAHRC, WAHSN and West Hampshire CCG ran a service development project in two surgeries in West Hampshire using notes review and a different electronic case finding instrument, GRASP-COPD. The project identified a need for further investigation into the efficiency of case-finding strategies.

The investigators propose to use an electronic case-finding algorithm developed and validated in Birmingham, UK as part of a NIHR funded programme grant centred on case finding for COPD.

'Complex' patients: identification and management Over the past two decades, there has been a shift in the locus of care for the majority of patients with chronic respiratory diseases in the UK towards the community. Respiratory diseases are amongst the most common causes of primary care consultations, accounting for 24 million consultations annually. Increasing numbers of complex respiratory patients are being managed in the primary care setting by generalist teams, with a focus on avoidance of admissions to hospital. Specialist secondary care is restricted to those patients admitted to hospital in a crisis or referred because of uncontrolled disease.

There is evidence of significant and unwarranted variability in the standards of respiratory management in both the primary and secondary care sectors. Marked variations in outcomes for patients with respiratory disease have also been shown, both regionally and between individual General Practitioner (GP) practices. There is evidence linking the quality of care provided in general practice with unplanned admissions to secondary care , and decreased admission rates have been reported in a number of long-term conditions (including COPD and asthma) where GPs were financially incentivised to provide high-quality care . Moreover, higher levels of professional education, nurse staffing and clinical recording in primary care are all associated with an improvement in the quality of clinical care for patients with COPD. However, a 'skills gap' may exist in some primary care settings, where GPs and other health care professionals lack advanced training in the management of these common conditions, particularly in the case of patients with multi-morbidity, uncertain diagnosis or complex problems .

The investigators have performed pilot studies which have identified widespread variability in practice level competencies for the diagnosis and management of respiratory conditions in primary care; in particular quality assured spirometry is only performed in a minority. No practices currently deliver FeNO measurements central to draft NICE Asthma guidelines. Knowledge of inhaled therapy options and techniques is highly variable. Patients with more severe or complicated disease may receive suboptimal care, which may in turn lead to poor outcomes. Such patients may fail to reach a specialist assessment that could potentially improve outcomes, either because they are not offered referral to a specialist clinic or because they decline going to a hospital clinic for such an assessment. Therefore, a community-based integrated care approach with joint specialist-generalist "mentorship" clinics in the community which utilise both specialist skills and the overall holistic perspective of the generalist primary care teams may be a promising solution. We have piloted a series of such 'mentorship' clinics as part of a service improvement programme of work with West Hampshire Clinical Commissioning Group (WHCCG) and the Wessex Academic Health Sciences Network (WAHSN). Pilot data suggest significant impacts on suboptimal outcomes including a reduction in inappropriate inhaled medication, exacerbations, unscheduled visits to primary care and attendance and admission to hospital. Furthermore, attendance rates and feedback from patients and care-givers suggest such clinics have high levels of acceptability to patients and their families.

Further potential benefits of 'mentorship' clinics in the community include not only improvement in quality of care for each of the individual patients seen, but also on-site education for the primary care teams, leaving a legacy of improved skills and greater confidence in managing complex disease. Such clinics have the potential to increase patient and staff satisfaction, reduce secondary care use and consequently reduce the financial burden of respiratory disease on the local health economy.

Up to 20 GP practices throughout Wessex will be recruited to the intervention arm. Practices in the intervention arm will be recruited pragmatically through the relevant CCG or local clinical and academic networks. Practices will be supported by the clinical research team from study set up to study end. The study team will directly engage with each practice in order to ensure that study processes align with administrative and clinical arrangements in each specific practice. A briefing/debriefing session will be held with each practice prior to the study commencing and at study conclusion.

Practices in the control arm will be matched if possible by size, demographic profile, socio-economic status profile and rural/urban setting. Control practices will be identified through the Hampshire Health Record Analytic Database (HHRA). The HHRA is a separate electronic database created for research, analysis and commissioning support within the local NHS. It currently includes data from 133 practices across Hampshire which is linked to the GP patient database system. The Governance body is the Hampshire Health Record Advisory Group (HHRAG), which ensures the security and confidentiality of the HHRA and HHR (Hampshire Health Records) and considers issues of data integration, data sharing and data extraction/analysis. The HHRA receives data monthly from the HHR, but in a pseudonymised format,. Although the HHRA can be viewed in a pseudonymised format by analysts working directly with the database, all data used for research purposes is extracted in an anonymised format.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Case Finding

• • Registered with one of the participating GP practices as at 1st January 2015

• =40 years old

• Ex or current smoker

• No COPD diagnosis

• Willing and able to give written informed consent.

Exclusion Criteria:

• • Unable to give informed consent

• Suffering from a terminal illness

• Patients whom the GP or clinical investigator deem inappropriate to participate

• Existing COPD diagnosis

• Obvious contraindications to spirometry (e.g. unstable abdominal aortic aneurysm)

• Under secondary care for investigation of breathlessness

• Pregnant

• Housebound

Inclusion Criteria - Complex Case Management

• Registered with one of the participating GP practices as at 1st January 2015

• On the practice COPD or asthma registers

• Identified by the electronic search Exclusion Criteria

• Unable to give informed consent

• Suffering from a terminal illness

• Patients whom the GP or clinical investigator deem inappropriate to participate

• No existing respiratory diagnosis

• Under secondary care for respiratory issues

• Housebound

Related Conditions & MeSH terms

• Asthma
• COPD
• Signs and Symptoms

Intervention

Procedure:
• Case finding Clinic
Case finding clinic - participants will be reviewed by a respiratory specialist team. Full respiratory history will be taken and physical examination will be preformed. The participant will then complete 3 quality of life and functionality questionnaires the MRC dyspnoea score and the COPD diagnostic questionnaire. They will then be asked to perform FeNO CO and spirometry measurements.
• At Risk Case Clinics
Complex Case Clinic participants will be reviewed by a respiratory specialist team. Full respiratory history will be taken and physical examination will be preformed. The participant will then complete 6 quality of life and functionality questionnaires . They will then be asked to perform FeNO CO and spirometry measurements. Participants inhaler technique will be checked and any errors corrected. Smoking cessation advice and support will be given if necessary. Each participant will be given an individualised self management plan.

Other:
• Usual Care
The control surgeries selected by the HHRA will continue with usual care.

Locations

Country	Name	City	State
United Kingdom	University of Southampton	Southampton	Hampshire

Sponsors (4)

Lead Sponsor	Collaborator
University of Southampton	National Institute for Health Research, United Kingdom, University Hospital Southampton NHS Foundation Trust, University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

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* Note: There are 70 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Case finding	The proportion of those patients identified by the case-finding algorithm at the chosen threshold who are diagnosed with COPD within 12 months following assessment at a case-finding clinic (for the intervention group practices) or following the practice-matched index date (for the control group practices). For the intervention group this will be the proportion of those invited to attend. For the control group this will be the proportion of those patients who would have been invited to attend, based on identical case-finding algorithm criteria.	12 months
Secondary	Attendance - Case finding	The proportion of all patients identified by Read code algorithm in intervention practices compared to matched practices in the control group who attend case finding clinics	12 months
Secondary	Newly Diagnosed - Case finding	The proportion of all patients identified by Read code algorithm in intervention practices compared to matched practices in the control group who • Are newly diagnosed with asthma, COPD or other respiratory disorder or have a change in diagnosis made.	12 months
Secondary	Co Morbidities - case finding	The proportion of all patients identified by Read code algorithm in intervention practices compared to matched practices in the control group who• Have additional co-morbidities identified.	12 months
Secondary	Treatments - case finding	The proportion of all patients identified by Read code algorithm in intervention practices compared to matched practices in the control group who • Have new treatment commenced, including changes to prescribed medication and non-pharmacological interventions initiated	12 months
Secondary	Smoking cessation - case finding	The proportion of all patients identified by Read code algorithm in intervention practices compared to matched practices in the control group who • Are referred on to smoking cessation services, and succeed in quitting smoking.	12 months
Secondary	secondary care referrals - case finding	The proportion of all patients identified by Read code algorithm in intervention practices compared to matched practices in the control group who require referral on to secondary care	12 months
Secondary	smoking -	proportion of patients who are referred on to smoking cessation services, and succeed in quitting smoking	12 months
Secondary	Broncholdilator Usage	Number of prescribed short acting bronchodilators administered to patients	12 months
Secondary	Corticosteroids	number of prescribed episodes of oral coticosteroids	12 months
Secondary	Healthcare Usage	Number of episodes of Health care usage utilised by patient	12 months
Secondary	Breathlessness	improvement in Breathlessness scores recorded by patients using the Medical Research Council breathlessness score. Grading from 1-5 to establish clinical grade of breathlessness on daily activity. Higher values are considered to mean greater impact on functionality.	6 and 12 mths
Secondary	Anxiety	anxiety scores recorded by patients using the GAD7 questionnaires	6,12 months
Secondary	Healthcare status	improvements in Healthcare status using EQ 5D questionnaire	6,12 months
Secondary	Airway disease control	improvement in disease control using the COPD Assessment Test	6,12 months
Secondary	Admission	Proportion of Emergency Department and hospital admissions	12 months
Secondary	Exacerbations	proportion of exacerbations experienced by patients	12 months
Secondary	Depression	Depression scores recorded by patients using the PHQ9 questionnaires	6,12 months
Secondary	Asthma disease control	improvement in disease control using Asthma Control Test	6,12 months
Secondary	COPD Severity	improvements in Healthcare status using DOSE	6,12 months
Secondary	Primary care attendance	Comparison of the primary care attendance rate among the group of patients attending the 'at risk' in the year before clinic attendance with the year after.	12 months
Secondary	Number of respiratory consultations	Comparison of the respiratory consultation rate in primary care among the cohort of patients invited for a complex case review (i.e. attendance at the 'at risk' clinic) with a comparator cohort of patients identified as being 'at risk' within a group of practices matched to the 'at risk' intervention group of practices.	12 months