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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
PACE (Professional Asthma Care Education)
Lay Led Expert Patient Programme
Asthma self management education by a specialist nurse
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring ethnicity, primary care, education

Eligibility Criteria

3 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barts and TheLondon, Queen Marys's School of Medicine and Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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.

Usual Care

Outcomes

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.

Secondary Outcome Measures

Secondary outcomes are generic (EQ5D) and disease specific quality of life (AQ20 and North of England scales), prescribing and costs.

Full Information

First Posted
September 14, 2005
Last Updated
June 3, 2009
Sponsor
Barts & The London NHS Trust
Collaborators
Asthma UK, Social Action for Health, Department of Health (Service Support), Noreen Clarke, Professor of Public Health, Michigan University
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1. Study Identification

Unique Protocol Identification Number
NCT00214669
Brief Title
Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Randomised Trial
Acronym
OEDIPUS
Official Title
Can Education for South Asians With Asthma and Their Clinicians Reduce Unscheduled Care? A Cluster Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Barts & The London NHS Trust
Collaborators
Asthma UK, Social Action for Health, Department of Health (Service Support), Noreen Clarke, Professor of Public Health, Michigan University

4. Oversight

5. Study Description

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: provides self-management advice and a treatment plan, makes a follow-up appointment in primary care 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: provides self-management advice and a treatment plan, makes a follow-up appointment for the patient in primary care 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
ethnicity, primary care, education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
PACE (Professional Asthma Care Education)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lay Led Expert Patient Programme
Other Intervention Name(s)
Expert Patient Programme
Intervention Description
Lay-led 'expert-patient' education in small groups for patients, using an adaptation of Stanford University's chronic disease self-management programme.
Intervention Type
Behavioral
Intervention Name(s)
Asthma self management education by a specialist nurse
Intervention Description
asthma education and self management, asthma action plans
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Griffiths, MB BS, DPhil
Organizational Affiliation
Queen Mary's School of medicine and Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts and TheLondon, Queen Marys's School of Medicine and Dentistry
City
London
ZIP/Postal Code
E1 4NS
Country
United Kingdom

12. IPD Sharing Statement

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

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