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

NCT03096509

Last updated date
Study Location
Portsmouth Hospitals NHS Trust
Portsmouth, , PO6 3LY, United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
COPD, Asthma, Breathlessness
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Unable to give informed consent


- Level of literacy precludes inclusion in questionnaire-based study

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COPD, Asthma, BreathlessnessParticipatory Action Research to Evaluate the Delivery of the MISSION ABC Service Model and Assess Health Service and Clinical Outcomes
NCT03096509
  1. Portsmouth,
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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
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)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients invited to a MISSION ABC clinic, all Healthcare Professionals attending.
Condition
  • COPD
  • Asthma
  • Breathlessness
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 23, 2017)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2018
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03096509
Other Study ID Numbers PHT/2016/84
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:Undecided
Responsible Party Portsmouth Hospitals NHS Trust
Study Sponsor Portsmouth Hospitals NHS Trust
Collaborators
  • Wessex Academic Health Science Network
  • East Hampshire Better Local Care Fund
  • Pfizer
  • The Health Foundation
Investigators Not Provided
PRS Account Portsmouth Hospitals NHS Trust
Verification Date March 2017