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

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ClinicalTrials.gov Identifier: NCT00214669
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 4, 2009
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

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date June 4, 2009
Study Start Date  ICMJE November 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
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.
Change History Complete list of historical versions of study NCT00214669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Secondary outcomes are generic (EQ5D) and disease specific quality of life (AQ20 and North of England scales), prescribing and costs.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Randomised Trial
Official Title  ICMJE Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Cluster Randomised Trial
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: PACE (Professional Asthma Care Education)
    • Behavioral: Lay Led Expert Patient Programme
    • Behavioral: Asthma self management education by a specialist nurse
  • No Intervention: 2
    Usual Care
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
375
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
300
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00214669
Other Study ID Numbers  ICMJE CG-09-05-IHS
04/060
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Barts & The London NHS Trust
Collaborators  ICMJE
  • Asthma UK
  • Social Action for Health
  • Department of Health (Service Support)
  • Noreen Clarke, Professor of Public Health, Michigan University
Investigators  ICMJE
Principal Investigator: Chris Griffiths, MB BS, DPhil Queen Mary's School of medicine and Dentistry
PRS Account Barts & The London NHS Trust
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP