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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; COPD; Breathlessness
• Intervention / Treatment: Other: MISSION ABC Integrated Care clinic

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)

• Study Type: Observational
• Enrollment (Actual): 342

Contacts and Locations

Study Locations

• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months
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	18 months
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.	18 months
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.	18 months
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.	18 months
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.	18 months
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	18 months
Any change in medication recorded	The number of new, changed or stopped prescriptions will be recorded.	18 months
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.	18 months
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.	18 months
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	6 months
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	6 months
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	6 months
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.	24 months
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.	18 months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: Pfizer; The Health Foundation; Wessex Academic Health Science Network; East Hampshire Better Local Care Fund

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2017
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Dyspnea
• Other Study ID Numbers: PHT/2016/84

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No