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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096509
• Other study ID #: PHT/2016/84
• Status: Completed
• Start date: January 19, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2023
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Breathlessness
• COPD
• Dyspnea

Intervention

Other:
• MISSION ABC Integrated Care clinic
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.

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth

Sponsors (5)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust	East Hampshire Better Local Care Fund, Pfizer, The Health Foundation, Wessex Academic Health Science Network

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Any change in medication recorded	The number of new, changed or stopped prescriptions will be recorded.	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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