Evaluation of Intermediate Care Clinics for Diabetes (ICCD)

August 7, 2012 updated by: University Hospitals, Leicester
The aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intermediate care clinics (ICC) are suggested as one method of improving care for people with type 2 diabetes, but their effectiveness and cost effectiveness is not known. Their aim is to provide a multidisciplinary community based service to support general practices in achieving good control of their patients. Two local PCTs (Leicester City and Warwickshire) have agreed to establish intermediate care clinics as part of a cluster randomised trial of their effectiveness.

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.

Study Type

Interventional

Enrollment (Actual)

1997

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • :Leicester, Leicestershire, United Kingdom, LE1 6TP
        • University of Leicester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type 2 diabetes from participating practices across NHS Leicester, Warwickshire and Coventry.

Exclusion Criteria:

  • Patients unable to give informed consent,
  • Terminal cancer, OR
  • Pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: access to intermediate care clinics
Other: 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.
No Intervention: usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l),
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants reaching target for individual risk factors (blood pressure, HbA1c or cholesterol)
Time Frame: 18 months
18 months
10 year risk for CHD and stroke assessed by the UKPDS risk engine
Time Frame: 18 months
18 months
Control of risk factors in all patients with type 2 diabetes in participating practices using anonymised routine data
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Collaborators

Warwick Medical School

Investigators

  • Principal Investigator: Andrew D Wilson, MD, University of Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (Estimate)

July 24, 2009

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICCD/NIHR SDO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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