Clinical trial NCT03096509: Participatory Action Research to Evaluate the Delivery of the MISSION ABC Service Model and Assess Health Service and Clinical Outcomes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Asthma
Breathlessness
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Wessex Academic Health Science Network
name: East Hampshire Better Local Care Fund
name: Pfizer
name: The Health Foundation
First posted: 2017-03-30
Enrollment: 342
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients invited to a MISSION ABC clinic, all Healthcare Professionals attending.

Brief 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. 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.

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Acceptability of clinic process measured through the collection of qualitative feedback.
timeFrame: up to 18 months
Secondary outcomes:
measure: Number of changes in primary diagnosis or classification of disease severity resulting from a MISSION clinic appointment.
timeFrame: 18 months
measure: Number of additional co-morbid medical conditions identified from a MISSION clinical encounter.
timeFrame: 18 months
measure: Frequency of uptake and attendance at the enhanced asthma education programme ESMENA
timeFrame: 18 months
measure: Changes in patients' perceived confidence in self-management before and after MISSION clinics and education sessions measured through questionnaire feedback
timeFrame: 18 months
measure: Uptake and acceptability of HCP education through the MISSION process
timeFrame: 18 months
measure: Number of patients where inhaler technique is improved at the first MISSION clinical encounter
timeFrame: 18 months
measure: Number of referrals to the smoking cessation service embedded in the MISSION clinics that results in a quit attempt
timeFrame: 18 months
measure: Any change in medication recorded
timeFrame: 18 months
measure: Number of triggers on remote monitoring that can be managed remotely
timeFrame: 18 months
measure: Number of additional secondary care referrals made as a result of the MISSION ABC process.
timeFrame: 18 months
measure: Change in disease-specific symptom control questionnaires from baseline to 3 and 6 months
timeFrame: 6 months
measure: Change in the productivity measure WPA from baseline to 3 and 6 months
timeFrame: 6 months
measure: Change in the patient activation measure from baseline to 3 and 6 months.
timeFrame: 6 months
measure: Changes in unscheduled health care usage per patient in the 12 months before and after MISSION ABC
timeFrame: 24 months
measure: Acceptability of each innovation measured
timeFrame: 18 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
Study officials:
References:
citation: 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.