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A Study Into Airways Disease Case Finding and Management (ASSIST)

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ClinicalTrials.gov Identifier: NCT03355677
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University Hospital Southampton NHS Foundation Trust
University of Birmingham
Information provided by (Responsible Party):
University of Southampton

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.


Condition or disease Intervention/treatment Phase
COPD Asthma Procedure: Case finding Clinic Procedure: At Risk Case Clinics Other: Usual Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Clinical Interventional Study Into Airways Disease Case Finding and Complex Case Management
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Case finding clinics
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 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.

Placebo Comparator: Case finding Usual care
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
The control surgeries selected by the HHRA will continue with usual care.

Active Comparator: At Risk Case clinics
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
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.

Placebo Comparator: At Risk Usual Care
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
The control surgeries selected by the HHRA will continue with usual care.




Primary Outcome Measures :
  1. Case finding [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Attendance - Case finding [ Time Frame: 12 months ]
    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

  2. Newly Diagnosed - Case finding [ Time Frame: 12 months ]
    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.

  3. Co Morbidities - case finding [ Time Frame: 12 months ]
    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.

  4. Treatments - case finding [ Time Frame: 12 months ]
    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

  5. Smoking cessation - case finding [ Time Frame: 12 months ]
    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.

  6. secondary care referrals - case finding [ Time Frame: 12 months ]
    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

  7. smoking - [ Time Frame: 12 months ]
    proportion of patients who are referred on to smoking cessation services, and succeed in quitting smoking

  8. Broncholdilator Usage [ Time Frame: 12 months ]
    Number of prescribed short acting bronchodilators administered to patients

  9. Corticosteroids [ Time Frame: 12 months ]
    number of prescribed episodes of oral coticosteroids

  10. Healthcare Usage [ Time Frame: 12 months ]
    Number of episodes of Health care usage utilised by patient

  11. Breathlessness [ Time Frame: 6 and 12 mths ]
    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.

  12. Anxiety [ Time Frame: 6,12 months ]
    anxiety scores recorded by patients using the GAD7 questionnaires

  13. Healthcare status [ Time Frame: 6,12 months ]
    improvements in Healthcare status using EQ 5D questionnaire

  14. Airway disease control [ Time Frame: 6,12 months ]
    improvement in disease control using the COPD Assessment Test

  15. Admission [ Time Frame: 12 months ]
    Proportion of Emergency Department and hospital admissions

  16. Exacerbations [ Time Frame: 12 months ]
    proportion of exacerbations experienced by patients

  17. Depression [ Time Frame: 6,12 months ]
    Depression scores recorded by patients using the PHQ9 questionnaires

  18. Asthma disease control [ Time Frame: 6,12 months ]
    improvement in disease control using Asthma Control Test

  19. COPD Severity [ Time Frame: 6,12 months ]
    improvements in Healthcare status using DOSE

  20. Primary care attendance [ Time Frame: 12 months ]
    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.

  21. Number of respiratory consultations [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355677


Contacts
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Contact: Mal North + 44 (0)7769364198 mcn1f06@soton.ac.uk

Locations
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United Kingdom
University of Southampton Recruiting
Southampton, Hampshire, United Kingdom
Sponsors and Collaborators
University of Southampton
National Institute for Health Research, United Kingdom
University Hospital Southampton NHS Foundation Trust
University of Birmingham
Investigators
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Study Director: Tom Wilkinson University of Southampton

Publications:
Foundation BL. Lung disease in the UK - big picture statistics 2016 [Available from: https://statistics.blf.org.uk/lung-disease-uk-big-picture.
Foundation BL. Asthma Statistics 2016 [Available from: https://statistics.blf.org.uk/asthma.
Foundation BL. Chronic obstructive pulmonary disease (COPD) Statistics 2016 [Available from: https://statistics.blf.org.uk/copd.
Department of Health. A Outcomes Strategy for people with Chronic Obstructive Pulmonary Disease and Asthma in England. 2011.
Asthma UK. Living on a Knife Edge. 2003
Chung KF BE, Wenzel ES, . Difficult-to-treat severe asthma. 2011 ed. Sheffield: ERS. p. 120-9.
Global Initiative for Chronic Obstructive Lung Disease. Global starergy for the diagnosis, management and prevention of chronic obstructive pulmonary disease, 2015 [Available from: http://www.goldcopd.it/materiale/2015/GOLD_Pocket_2015.pdf.
National Institute for Health Care and Excellence. Chronic obstructive pulmonary disease in over 16s: diagnosis and management, NICE guidelines [CG101]: NICE; 2010 [updated 11/07/2016. Available from: https://www.nice.org.uk/guidance/CG101.
All Party Palimentary Group on Respiratory Health. Report on the Inquiry into Respiratory Deaths 2014. Available from: https://www.blf.org.uk/take-action/campaign-with-us/appg-on-respiratory-health.
World Health Organisation. Chronic obstructive pulmonary disease (COPD) 2004 [Available from: http://www.who.int/respiratory/copd/en/.
British Lung Foundation. Invisible Lives. Chronic obstructive pulmonary disease (COPD) finding the missing millions 2007 [Available from: www.blf.org.uk/publications/detail/Invisible-Lives-report.
Department of Health. An outcomes strategy for people with chronic obstructive pulmonary disease (COPD) and asthma in England 2011 [Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213840/dh_113279.pdf.
Kotz D, Nelemans P, van Schayck CP, Wesseling GJ. External validation of a COPD diagnostic questionnaire. The European respiratory journal. 2008;31(2):298-303. 35. Price D. Spirometry and questionnaire use for early diagnosis of chronic obstructive pulmonary disease. . Hot Topics in Respiratory Medicine. 2010;5(14):13-8.
Service TUNS. The UK NSC recommendation on Chronic Obstructive Pulmonary Disease 2013 [Available from: http://legacy.screening.nhs.uk/copd.
Smith J HH, Edwards N, Maybin J, Parker H, Rosen R, Walsh N, . Securing the future of general practice: new models of primary care Nuffield Trust and King's Fund 2013 [updated 11/07/2016. Available from: http://www.nuffieldtrust.org.uk/sites/files/nuffield/publication/130718_securing_the_future_revised.pdf.
Robertson et al. Specialist in out of hospital setting 2014 [updated http://www.kingsfund.org.uk/publications/specialists-out-hospital-settings.
Excellence NIfHCa. Asthma: diagnosis and monitoring of asthma in adults, children and young people 2015 [Available from: https://www.nice.org.uk/guidance/dg12/resources/asthma-diagnosis-and-monitoring-draft-nice-guideline2
Evaluation of case finding for COPD/asthma and management of poorly controlled asthma/COPD project [Available from: http://wessexahsn.org.uk/img/projects/WHCCGWAHSNevaluation300415final%20(4).pdf
Professor David Greenway. Shape of Training, Securing the future of excellent patient care 2013. Available from: http://www.shapeoftraining.co.uk/static/documents/content/Shape_of_training_FINAL_Report.pdf_53977887.pdf.
Fletcher CM. Standardised questionniare on respiratory symptoms: a statement prepared and approved by the MRC commitee on the aetiology of chronic bronchitis (MRC breathlessness score) BMJ (Clinical research ed). 1960;2:1665.
Baker SEE, R. . How many qualitative interviews is enough? Expert voices and early career reflections on sampling and cases in qualitative research. National Centre for Research Methods. 2012.
Joffe HaY, L., . Content and thematic analysis. Research methods for clinical and health psychology. California:. Sage. 2004:56-68.
Ritchie J LJ, McNaughton Nicholls C, Ormston R. . Qualitative research practice: a guide for social science students and researchers. Sage. 2013.

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Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT03355677     History of Changes
Other Study ID Numbers: CLAHRC 001
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Southampton:
Case finding
complex case management