Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Randomised Trial (OEDIPUS)

This study has been completed.
Sponsor:
Collaborators:
Asthma UK
Social Action for Health
Department of Health (Service Support)
Noreen Clarke, Professor of Public Health, Michigan University
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00214669
First received: September 14, 2005
Last updated: June 3, 2009
Last verified: May 2009
  Purpose

People from ethnic minority groups suffer worse ill-health from asthma than those from majority groups. No studies have reduced emergency care for people from minority groups. We have developed an education programme to address barriers to improved care for south Asian people with asthma. The study is set in Tower Hamlets and Newham - the UK's most deprived and ethnically diverse boroughs. We will invite all the local GP practices to take part, and using a computer programme, randomised them (like tossing a coin) into two groups - a group receiving usual care and a group receiving our educational programme. This comprises:

  • Education for specialist nurse and GPs and practice nurses, using our adaptation of an American education course, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
  • Lay-led 'expert-patient' education in small groups for patients, using an adaptation of another American course.
  • Improved follow-up in primary care through appointment-booking by the specialist nurse.We will invite south Asians aged 3-65 years with asthma after A&E attendance or hospital admission to take part. Those registered with practices receiving the educational programme will see the trial specialist nurse in a nurse-run clinic, where the nurse:

    1. provides self-management advice and a treatment plan,
    2. makes a follow-up appointment in primary care
    3. makes an appointment for lay-led 'expert-patient' sessions.Patients registered with 'usual care' practices receive usual care.

We will decide if our education programme works by comparing the number of emergency visits to GPs and hospital between the two groups.


Condition Intervention Phase
Asthma
Behavioral: PACE (Professional Asthma Care Education)
Behavioral: Lay Led Expert Patient Programme
Behavioral: Asthma self management education by a specialist nurse
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Cluster Randomised Trial

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Primary outcomes are time to first unscheduled contact with acute asthma, and proportion of participants with unscheduled care, assessed from patient records 12 months after recruitment. [ Time Frame: 12 months following recruitment date ]

Secondary Outcome Measures:
  • Secondary outcomes are generic (EQ5D) and disease specific quality of life (AQ20 and North of England scales), prescribing and costs. [ Time Frame: 12 months following recruitment date ]

Enrollment: 375
Study Start Date: November 2005
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.

Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Lorig's chronic disease self-management programme.

Improved follow-up in primary care through appointment-booking by the specialist nurse.

Behavioral: PACE (Professional Asthma Care Education)
Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
Behavioral: Lay Led Expert Patient Programme
Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Stanford University's chronic disease self-management programme.
Other Name: Expert Patient Programme
Behavioral: Asthma self management education by a specialist nurse
asthma education and self management, asthma action plans
No Intervention: 2
Usual Care

Detailed Description:

Health inequalities between ethnic minority and majority groups exist for all chronic diseases and are a government priority for action. For asthma, poorer outcomes for people from minority groups are a universal finding. No randomised trials have reduced emergency asthma care for ethnic minority groups.

We have developed an intervention to address barriers to improved asthma care for south Asian people with asthma. This cluster randomised controlled trial tests whether education for south Asians with asthma and their clinicians can reduce unscheduled care. The trial is set in Tower Hamlets and Newham - boroughs with UK's 1st and 3rd highest ethnic minority populations.

We will invite all 94 general practices in these boroughs to take part. Practices will be randomised with stratification to intervention and control groups. The intervention comprises:

  • Education for intervention specialist nurse and GPs and practice nurses from intervention practices, using our adaptation of Clarke's self-regulation education programme, designed to improve shared-decision making, goal-setting and patient-clinician partnership.
  • Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Lorig's chronic disease self-management programme.
  • Improved follow-up in primary care through appointment-booking by the specialist nurse.

We will recruit south Asians aged 3-65 years with asthma after A&E attendance or hospital admission. Participants registered with intervention practices will see the trial specialist nurse in a nurse-run hospital clinic, where the nurse:

  1. provides self-management advice and a treatment plan,
  2. makes a follow-up appointment for the patient in primary care
  3. makes an appointment for lay-led 'expert-patient' sessions.

Participants registered with control practices receive usual care. Primary outcomes are time to first unscheduled contact with acute asthma, and proportion of participants with unscheduled care, assessed from patient records 12 months after recruitment. Secondary outcomes are generic (EQ5D) and disease specific quality of life (AQ20 and North of England scales), prescribing and costs. The trial is powered to detect a 20% reduction in patients attending with unscheduled care (80% power 5% significance). Outcomes will be gathered by blinded researchers. Analysis will be carried out blind to allocation. Cost-effectiveness will be assessed using standard incremental cost-effectiveness ratios.

  Eligibility

Ages Eligible for Study:   3 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent hospital attendance (A&E, admitted) with uncontrolled asthma
  • or recent out of hours (GP service) walk in centre attendance with uncontrolled asthma
  • South Asian ancestry (Bangladeshi, Indian, Pakistani, Sri Lankan)
  • registered with a GP in Newham or Tower Hamlets

Exclusion Criteria:

  • patients not of South Asian origin
  • aged under 3 years
  • not currently registered with a local GP
  • physician diagnosis of pure COPD
  • patients unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214669

Locations
United Kingdom
Barts and TheLondon, Queen Marys's School of Medicine and Dentistry
London, United Kingdom, E1 4NS
Sponsors and Collaborators
Barts & The London NHS Trust
Asthma UK
Social Action for Health
Department of Health (Service Support)
Noreen Clarke, Professor of Public Health, Michigan University
Investigators
Principal Investigator: Chris Griffiths, MB BS, DPhil Queen Mary's School of medicine and Dentistry
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00214669     History of Changes
Other Study ID Numbers: CG-09-05-IHS, 04/060
Study First Received: September 14, 2005
Last Updated: June 3, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Barts & The London NHS Trust:
ethnicity
primary care
education

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014