A Study Into Airways Disease Case Finding and Management

NCT03355677 | Completed DMC

• 1 other identifier: CLAHRC 001
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Asthma

Keywords

Case finding; complex case management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Attendance - Case finding

  12 months

• Newly Diagnosed - Case finding

  12 months

• Co Morbidities - case finding

  12 months

• Treatments - case finding

  12 months

• Smoking cessation - case finding

  12 months

Study Arms (4)

Case finding clinics

ACTIVE COMPARATOR

The visit will be a minimum 90 minutes long at the participants own GP surgery. This will include a respiratory assessment including spirometry will performed by a RT Respiratory Nurse Specialist (RNS) and where possible a Practice Nurse or Nurse Practitioner will attend. The visit will consist of objective measurements, investigations and questionnaires

Procedure: Case finding Clinic

Case finding Usual care

PLACEBO COMPARATOR

In the control arm of the study, practices will continue with usual care according to national guidance for case finding for COPD (NICE, 2010). Matched practices will have their eligible population identified through electronic searches based on data routinely recorded in primary care run in the HHRa. Case finding yield will be measured as the percentage of patients from the eligible population identified with a respiratory diagnosis in the 12 months from study beginning to study end.

Other: Usual Care

At Risk Case clinics

ACTIVE COMPARATOR

The complex case clinic will be a minimum 120 minute appointment at the participants own GP surgery. The intervention will include an initial assessment by a RT Respiratory Nurse Specialist (RNS) and followed by a joint assessment by a respiratory physician (RP) working alongside a practice clinician (GP and/or Practice Nurse/Nurse Practitioner). The visit will consist of objective measurements, investigations and questionnaires as outlined in section 3 below. A personalised disease management and action plan will be agreed jointly between the RT, practice clinician and participant. The practice clinician will undertake the necessary tasks required for the agreed management plan. The clinical responsibility for the participant will remain with the GP practice.

Procedure: At Risk Case Clinics

At Risk Usual Care

PLACEBO COMPARATOR

In the control arm of the study, practices will continue with usual care according to national guidance for the management of COPD and asthma . A cohort of patients matched for practice and for age, sex, disease condition and, where possible, disease control will be identified. This cohort will be monitored against markers of sub-optimal disease (medication usage, exacerbations, unscheduled visits to the practice, attendance or admission to hospital).

Other: Usual Care

Interventions

Case finding Clinic PROCEDURE

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.

Case finding clinics

At Risk Case Clinics PROCEDURE

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.

At Risk Case clinics

Usual Care OTHER

The control surgeries selected by the HHRA will continue with usual care.

At Risk Usual Care; Case finding Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Registered with one of the participating GP practices as at 1st January 2015
• On the practice COPD or asthma registers
• 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

Sponsors & Collaborators

• University of Southampton: lead
• National Institute for Health Research, United Kingdom: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• University of Birmingham: collaborator

Study Sites (1)

University of Southampton

Southampton, Hampshire, United Kingdom

Location

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tom Wilkinson

  University of Southampton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patient identified by an electronic algorithm as at risk of having possible COPD were invited to attend a case finding clinic at their local GP practice for lung function testing. The algorithm was applied to control group practices and the number of new cases of COPD in the records was compared. 'At risk' patients with existing asthma and COPD were also invited to attend, and have their health status reviewed. We were unable to complete control group comparisons on this group of patients.

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: November 28, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)