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AzTrials

COPDNCT03096509

Participatory Action Research to Evaluate the Delivery of the MISSION ABC Service Model and Assess Health Service and Clinical Outcomes

An observational study of COPD and Asthma, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Innovations aimed at improving new patient identification, diagnosis, nonpharmacological treatment, supported self-management, and remote monitoring, together with new methods of clinical support could improve outcomes in patients with respiratory disease. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
COPD, Asthma, Breathlessness
What is being tested?
MISSION ABC Integrated Care clinic
How many people
342 participants
Where
1 siteUnited Kingdom
Study dates
19 Jan 2017to 31 Mar 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients invited to a MISSION ABC clinic, all Healthcare Professionals attending.

Who may be able to join

  • Attendance at a MISSION ABC clinic or training session as a patient, carer or Healthcare Professional

Who cannot join

  • Unable to give informed consent
  • Level of literacy precludes inclusion in questionnaire-based study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Portsmouth Hospitals NHS Trust

    Portsmouth, PO6 3LY

Other trials in United Kingdom

About this study

Official title: MISSION ABC: Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and COPD - Participatory Action Research to Evaluate the Delivery of the MISSION ABC Service Model and Assess Health Service and Clinical Outcomes

Innovations aimed at improving new patient identification, diagnosis, nonpharmacological treatment, supported self-management, and remote monitoring, together with new methods of clinical support could improve outcomes in patients with respiratory disease. The Investigators have developed a model of care incorporating key innovations for patients with asthma, COPD and undifferentiated breathlessness. This service is being implemented within Wessex CCGs. The investigators will assess whether the implementation of the service is effective, and how it can be adjusted, in addition to introducing innovations to assess whether the expected benefits for patients are realised.

Read the detailed description

A combination of study designs are required to evaluate all aspects of the service:

  • Participatory action research approach, involving real-time evaluation at each clinic to inform subsequent clinics
  • Before-and-after study for patient outcomes pre-clinic attendance and post-clinic attendance.
  • Qualitative methods (interviews, focus groups)

Evaluation of the clinic cycles will include consideration of qualitative data from patients, carers and healthcare professionals, in addition to quantitative outcomes for service implementation and patient factors (i.e. uptake of the service and benefits realised in-session), including those in the following areas:

  • Clinic process
  • Education and supported self-management
  • Added value of diagnostic tools (new diagnoses)
  • Applicability and use of treatment tools and treatment tailoring
  • Self-monitoring appropriateness and uptake
  • Balance measures (e.g. increased secondary care traffic)

The longer-term impact of the service will be evaluated using clinical and health service outcomes such as:

  • Hospitalisations for airways disease
  • perceived disease control (symptom scores etc)
  • exacerbation frequency
  • health-related quality of life
  • Patient Activation Measures (PAM)
  • Treatments used
  • Healthcare resource use (primary and secondary care)
Being tested
MISSION ABC Integrated Care clinic
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Asthma, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MISSION ABC Integrated Care clinicOther

    The Investigators have developed a model of care incorporating key innovations for patients with asthma, COPD and undifferentiated breathlessness. This service is being implemented within Wessex CCGs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of clinic process measured through the collection of qualitative feedback.

    Qualitative feedback forms collected at ever clinical encounter, qualitative interviews at 3 months post clinic and HCP focus groups will generate qualitative data. This will be evaluated cyclically to inform changes in the clinic structure.

    Measured: up to 18 months

Secondary outcomes (15)

  1. Number of changes in primary diagnosis or classification of disease severity resulting from a MISSION clinic appointment.

    The number of new or changed diagnoses made as a result of a MISSION clinical encounter will be recorded.

    Measured: 18 months

  2. Number of additional co-morbid medical conditions identified from a MISSION clinical encounter.

    The number of co-morbid medical conditions identified by the medical team at a MISSION clinic will be recorded

    Measured: 18 months

  3. Frequency of uptake and attendance at the enhanced asthma education programme ESMENA

    The number of patients invited to attend ESMENA who accept the invitation will be recorded. Attendance rates over each 3 sessions will be recorded.

    Measured: 18 months

  4. Changes in patients' perceived confidence in self-management before and after MISSION clinics and education sessions measured through questionnaire feedback

    Patients will be asked to fill out a baseline questionnaire exploring their confidence in managing their disease and their health behaviours. They will be asked to rate confidence using a Liekrt scale that will be repeated at 3 and 6 months following their clinical or educational encounters.

    Measured: 18 months

  5. Uptake and acceptability of HCP education through the MISSION process

    The numbers and grade of HCP who attend MISSION clinics and dedicated education sessions will be recorded. 10% attendees will be asked to participate in focus group interviews which will explore their beliefs around the value and acceptability of these educational opportunities.

    Measured: 18 months

  6. Number of patients where inhaler technique is improved at the first MISSION clinical encounter

    Each patient will undergo an assessment of inhaler technique at their first appointment. Where education is required, it will be recorded if that intervention results in improvement.

    Measured: 18 months

  7. Number of referrals to the smoking cessation service embedded in the MISSION clinics that results in a quit attempt

    Data will be extracted from the GP record to indicate if a quit attempt is made

    Measured: 18 months

  8. Any change in medication recorded

    The number of new, changed or stopped prescriptions will be recorded.

    Measured: 18 months

  9. Number of triggers on remote monitoring that can be managed remotely

    The number of patients using the Message Dynamics or Clinitouch remote monitoring systems who trigger a positive response on symptoms or observations where they can be managed via a supported call rather than a GP attendance will be recorded. Any suspected delay in reporting disease deterioration due to the presence of the remote monitoring systems will also be recorded.

    Measured: 18 months

  10. Number of additional secondary care referrals made as a result of the MISSION ABC process.

    As a balancing measure, any secondary care referrals made will be recorded and additional costs to the healthcare system calculated.

    Measured: 18 months

  11. Change in disease-specific symptom control questionnaires from baseline to 3 and 6 months

    CAT or ACQ will be measured at baseline and then 3 and 6 months to assess changes in symptom control

    Measured: 6 months

  12. Change in the productivity measure WPA from baseline to 3 and 6 months

    Each patient will be asked to fill in the WPA at baseline, 3 and 6 months and the answers compared

    Measured: 6 months

  13. Change in the patient activation measure from baseline to 3 and 6 months.

    Each patient will be asked to fill in the PAM at baseline, 3 and 6 months and the answers compared

    Measured: 6 months

  14. Changes in unscheduled health care usage per patient in the 12 months before and after MISSION ABC

    For each patient the investigators will record their number of exacerbations, unscheduled GP visits, out-of-hours service calls, ED attendances and admissions in the 12 months before and 12 months after the MISSION clinic.

    Measured: 24 months

  15. Acceptability of each innovation measured

    MISSION ABC incorporates several innovative diagnosis and treatment solutions: Thorasys oscillometry, Flo-Tone devices, Airsonett laminar airflow, my mHealth online education, Message Dynamics Remote Monitoring, Clinitouch remote monitoring. For each device patients will be asked to give qualitative feedback.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start19 Jan 2017
  3. Primary completion31 Mar 2018
  4. Study completion31 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096509
Sponsor's protocol ID
PHT/2016/84
Status last verified
Apr 2023
First submitted
1 Mar 2017
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Heiden E, Longstaff J, Chauhan MJA, DeVos R, Lanning E, Neville D, Jones TL, Begum S, Amos M, Mottershaw M, Micklam J, Holdsworth B, Rupani H, Brown T, Chauhan AJ; Mission ABC Collaborators. MISSION ABC: transforming respiratory care through one-stop multidisciplinary clinics - an observational study. BMJ Open. 2024 Jan 8;14(1):e078947. doi: 10.1136/bmjopen-2023-078947.

    PubMed 38191248

  • Fox L, Heiden E, Chauhan MAJ, Longstaff JM, Balls L, De Vos R, Neville DM, Jones TL, Leung AW, Morrison L, Rupani H, Brown TP, Stores R, Chauhan AJ. Evaluation of telehealth support in an integrated respiratory clinic. NPJ Prim Care Respir Med. 2022 Nov 11;32(1):51. doi: 10.1038/s41533-022-00304-9.

    PubMed 36369507

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Asthma, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of clinic process measured through the collection of qualitative feedback. (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03096509, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.

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