Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1997 participants
INTERVENTIONAL
2007-05-31
2011-10-31
Brief Summary
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Detailed Description
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Patients with type 2 diabetes in participating practices will be invited to take part. Those that agree will attend a baseline assessment by a study nurse. This will include measurement of HbA1C, body mass index, waist circumference, blood pressure, urine and lipids, as well as questionnaires about quality of life, satisfaction with current services and continuity of care. Practices will then be randomised to either usual care or intervention arms, the latter having access to the new clinics. Participating patients will be asked to attend a follow up assessment 18-24 months after the baseline assessments, when the same measurements will be repeated. We expect about 30% of patients in the intervention arm will have been referred to the ICC.
The primary outcome will be the percentage of patients achieving adequate control of HbA1, blood pressure and cholesterol, comparing all participants in the intervention and control arms, whether or not those in the intervention arm attended ICC. The study is powered to detect a 10% difference in this outcome, and will include 51 practices and 5100 patients. We will also examine the effect of the intervention on process measures, such as the number of contacts in hospital and general practice. In the intervention arm we will document in detail the inputs provided by ICC, so that if successful the model can be adopted elsewhere.
The economic evaluation will be undertaken from a societal perspective. A costing study will measure intervention and treatment costs in both groups. A comparative assessment of the marginal costs and outcomes of the intervention will be undertaken, to include cost-effectiveness ratios and cost-utility analysis. All findings will be subject to sensitivity analysis.
Additionally we will explore the views of patients in the intervention arm who attended ICC using semi-structures interviews to identify positive and negative aspects of the patients' experiences. We will also hold focus groups to explore views of professional stakeholders.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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access to intermediate care clinics
intermediate care clinics (ICCs)
The ICCs will be community based. Their aim is to support primary care, particularly smaller practices that have the most difficulty achieving good control. They will comprise a multidisciplinary team, and be led by specialist nurses who will place an emphasis on education and self management. Medical care will be provided by a diabetologist. The ICC will work closely with hospital based specialist teams and community services including podiatry and dietetics. Team members will work to local guidelines, adapted from national evidence based guidelines. Guidelines for referral to the ICCs will be common across all sites, and will include people with poorly controlled type 2 diabetes and those with poorly controlled cardiovascular risk factors.
usual care
No interventions assigned to this group
Interventions
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intermediate care clinics (ICCs)
The ICCs will be community based. Their aim is to support primary care, particularly smaller practices that have the most difficulty achieving good control. They will comprise a multidisciplinary team, and be led by specialist nurses who will place an emphasis on education and self management. Medical care will be provided by a diabetologist. The ICC will work closely with hospital based specialist teams and community services including podiatry and dietetics. Team members will work to local guidelines, adapted from national evidence based guidelines. Guidelines for referral to the ICCs will be common across all sites, and will include people with poorly controlled type 2 diabetes and those with poorly controlled cardiovascular risk factors.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Terminal cancer, OR
* Pregnant.
ALL
No
Sponsors
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Warwick Medical School
OTHER
University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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Andrew D Wilson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Locations
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University of Leicester
Leicester, Leicestershire, United Kingdom
Countries
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References
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Wilson A, O'Hare JP, Hardy A, Raymond N, Szczepura A, Crossman R, Baines D, Khunti K, Kumar S, Saravanan P; ICCD trial group. Evaluation of the clinical and cost effectiveness of intermediate care clinics for diabetes (ICCD): a multicentre cluster randomised controlled trial. PLoS One. 2014 Apr 15;9(4):e93964. doi: 10.1371/journal.pone.0093964. eCollection 2014.
Armstrong N, Baines D, Baker R, Crossman R, Davies M, Hardy A, Khunti K, Kumar S, O'Hare JP, Raymond N, Saravanan P, Stallard N, Szczepura A, Wilson A; ICCD Study Group. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of intermediate care clinics for diabetes (ICCD): study protocol for a randomized controlled trial. Trials. 2012 Sep 12;13:164. doi: 10.1186/1745-6215-13-164.
Other Identifiers
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ICCD/NIHR SDO
Identifier Type: -
Identifier Source: org_study_id