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

Natalie Armstrong, Darrin Baines, Richard Baker, Richard Crossman, Melanie Davies, Ainsley Hardy, Kamlesh Khunti, Sudhesh Kumar, Joseph Paul O'Hare, Neil Raymond, Ponnusamy Saravanan, Nigel Stallard, Ala Szczepura, Andrew Wilson, ICCD Study Group, Natalie Armstrong, Darrin Baines, Richard Baker, Richard Crossman, Melanie Davies, Ainsley Hardy, Kamlesh Khunti, Sudhesh Kumar, Joseph Paul O'Hare, Neil Raymond, Ponnusamy Saravanan, Nigel Stallard, Ala Szczepura, Andrew Wilson, ICCD Study Group

Abstract

Background: World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders.

Methods/design: This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or

Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients.

Discussion: Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.

Trial registration: [ClinicalTrials.gov: Identifier NCT00945204].

Figures

Figure 1
Figure 1
Study design and flow chart.

References

    1. Goyder EC, McNally PG, Drucquer M, Spiers N, Botha JL. Shifting of care for diabetes from secondary to primary care, 1990–5: review of general practices. BMJ. 1998;316:1505–1506. doi: 10.1136/bmj.316.7143.1505.
    1. Griffin SJ. The management of diabetes. BMJ. 2001;323:946–947. doi: 10.1136/bmj.323.7319.946.
    1. NHS Atlas reveals diabetes “postcode lottery”. .
    1. Hippisley-Cox J, O’Hanlon S, Coupland C. Association of deprivation, ethnicity, and sex with quality indicators for diabetes: population based survey of 53,000 patients in primary care. BMJ. 2004;329:1267–1269. doi: 10.1136/bmj.38279.588125.7C.
    1. Collins MM, O’Sullivan T, Harkins V, Perry IJ. Quality of life and quality of care in patients with diabetes experiencing different models of care. Diabetes Care. 2009;32:603–605. doi: 10.2337/dc08-1169.
    1. Vermunt PW, Milder IE, Wielaard F, de Vries JH, Van Oers HA, Westert GP. Lifestyle Counseling for Type 2 Diabetes Risk Reduction in Dutch Primary Care: Results of the APHRODITE study after 0.5 and 1.5 years. Diabetes Care. 2011;34:1919–1925. doi: 10.2337/dc10-2293.
    1. Millett C, Gray J, Saxena S, Netuveli G, Khunti K, Majeed A. Ethnic disparities in diabetes management and pay-for-performance in the UK: the Wandsworth Prospective Diabetes Study. PLoS Med. 2007;4:e191. doi: 10.1371/journal.pmed.0040191.
    1. Millett C, Saxena S, Ng A, Mainous A 3rd, Majeed A. Socio-economic status, ethnicity and diabetes management: an analysis of time trends using the health survey for England. J Public Health (Oxf) 2007;29:413–419. doi: 10.1093/pubmed/fdm058.
    1. Millett C, Khunti K, Gray J, Saxena S, Netuveli G, Majeed A. Obesity and intermediate clinical outcomes in diabetes: evidence of a differential relationship across ethnic groups. Diabet Med. 2008;25:685–691. doi: 10.1111/j.1464-5491.2008.02452.x.
    1. Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348:383–393. doi: 10.1056/NEJMoa021778.
    1. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359:1577–1589. doi: 10.1056/NEJMoa0806470.
    1. Holman RR, Paul SK, Bethel MA, Neil HA, Matthews DR. Long-term follow-up after tight control of blood pressure in type 2 diabetes. N Engl J Med. 2008;359:1565–1576. doi: 10.1056/NEJMoa0806359.
    1. Ray KK, Seshasai SR, Wijesuriya S, Sivakumaran R, Nethercott S, Preiss D, Erqou S, Sattar N. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009;373:1765–1772. doi: 10.1016/S0140-6736(09)60697-8.
    1. Ahroni JH, Boyko EJ, Davignon DR, Pecoraro RE. The health and functional status of veterans with diabetes. Diabetes Care. 1994;17:318–321. doi: 10.2337/diacare.17.4.318.
    1. Van der Does FE, De Neeling JN, Snoek FJ, Kostense PJ, Grootenhuis PA, Bouter LM, Heine RJ. Symptoms and well-being in relation to glycemic control in type II diabetes. Diabetes Care. 1996;19:204–210. doi: 10.2337/diacare.19.3.204.
    1. Papanas N, Tsapas A, Papatheodorou K, Papazoglou D, Bekiari E, Sariganni M, Paletas K, Maltezos E. Glycaemic control is correlated with well-being index (WHO-5) in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2010;118:364–367. doi: 10.1055/s-0029-1243623.
    1. Renders CM, Valk GD, Griffin SJ, Wagner EH, Van Eijk JT, Assendelft WJ. Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review. Diabetes Care. 2001;24:1821–1833. doi: 10.2337/diacare.24.10.1821.
    1. Olivarius NF, Beck-Nielsen H, Andreasen AH, Horder M, Pedersen PA. Randomised controlled trial of structured personal care of type 2 diabetes mellitus. BMJ. 2001;323:970–975. doi: 10.1136/bmj.323.7319.970.
    1. Gray A, Clarke P, Farmer A, Holman R. Implementing intensive control of blood glucose concentration and blood pressure in type 2 diabetes in England: cost analysis (UKPDS 63) BMJ. 2002;325:860. doi: 10.1136/bmj.325.7369.860.
    1. Nocon A, Leese B. The role of UK general practitioners with special clinical interests: implications for policy and service delivery. Br J Gen Pract. 2004;54:50–56.
    1. Nocon A, Rhodes PJ, Wright JP, Eastham J, Williams DR, Harrison SR, Young RJ. Specialist general practitioners and diabetes clinics in primary care: a qualitative and descriptive evaluation. Diabet Med. 2004;21:32–38. doi: 10.1046/j.1464-5491.2003.01063.x.
    1. Mainous AG 3rd, Koopman RJ, Gill JM, Baker R, Pearson WS. Relationship between continuity of care and diabetes control: evidence from the Third National Health and Nutrition Examination Survey. Am J Public Health. 2004;94:66–70. doi: 10.2105/AJPH.94.1.66.
    1. Report on the Evaluation of Diabetes Intermediate Care Clinics in Cardiff (phase 1) .
    1. Diabetes: what is intermediate care? .
    1. Diabetes Intermediate Care (Consultant Led) .
    1. Lambeth Diabetes Intermediate Care Team. .
    1. Lambeth Diabetes Intermediate Care Team. Annual Review. 2008/09. .
    1. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321:694–696. doi: 10.1136/bmj.321.7262.694.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: The new Medical Research Council guidance. BMJ. 2007;337:979–983.
    1. Bellary S, O’Hare JP, Raymond NT, Gumber A, Mughal S, Szczepura A, Kumar S, Barnett AH. Enhanced diabetes care to patients of south Asian ethnic origin (the United Kingdom Asian Diabetes Study): a cluster randomised controlled trial. Lancet. 2008;371:1769–1776. doi: 10.1016/S0140-6736(08)60764-3.
    1. Khunti K, Stone M, Luan X, Gisbourne L, Baines J, Paul S. Clinics for intermediate review and intervention by nurse specialists in cardiology (the CLINIC trial) SAPC 33rd Annual Scientific Meeting. 2004. p. 2004.
    1. Leicestershire Diabetes Guidelines. .
    1. CG66. Type 2 diabetes. National clinical guideline for management in primary and secondary care (update) .
    1. UKPDS Risk Engine. .
    1. The Euroqol Group. EQ-5D User Guide: A measure of health-related quality of life developed by the EuroQol Group. The Netherlands: EuroQol Business Management; 1995.
    1. Bradley C. In: Handbook of Psyc Diabetes. Chur BC, editor. Switzerland: Harwood Academic Publishers; 1994. Diabetes treatment satisfaction questionnaire.
    1. Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997;20:760–766. doi: 10.2337/diacare.20.5.760.
    1. Gulliford MC, Naithani S, Morgan M. Continuity of care and intermediate outcomes of type 2 diabetes mellitus. Fam Pract. 2007;24:245–251. doi: 10.1093/fampra/cmm014.
    1. Baker R, Whitfield M. Measuring patient satisfaction: a test of construct validity. Qual Health Care. 1992;1:104–109. doi: 10.1136/qshc.1.2.104.
    1. Drummond MF, Sculpher MJ, Torrance GW, Methods for the economic evaluation of health care programmes. 3. Oxford: Oxford University Press; 2005.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33:337–343. doi: 10.3109/07853890109002087.
    1. The NHS Confederation. New GMS Contract 2003 Investing in General Practice. General Practitioners Committee. London: British Medical Association; 2003.
    1. Donner A, Klar N. Design and analysis of cluster randomization trials in health research. London: Arnold Publishers; 2000.
    1. Gulliford MC, Naithani S, Morgan M. Measuring continuity of care in diabetes mellitus: an experience-based measure. Ann Fam Med. 2006;4:548–555. doi: 10.1370/afm.578.
    1. MIQUEST. Services & Applications. .
    1. Guide to the methods of technology appraisal. .
    1. Graves N, Walker D, Raine R, Hutchings A, Roberts JA. Cost data for individual patients included in clinical studies: no amount of statistical analysis can compensate for inadequate costing methods. Health Econ. 2002;11:735–739. doi: 10.1002/hec.683.
    1. Richardson G, Manca A. Calculation of quality adjusted life years in the published literature: a review of methodology and transparency. Health Econ. 2004;13:1203–1210. doi: 10.1002/hec.901.
    1. Strauss A, Corbin J. Basics of Qualitative Research: Grounded Theory Procedures and Techniques. Newbury Park, CA: Sage; 1990.
    1. Bazeley P. Qualitative Data Analysis with NVivo. London UK: SAGE Publications Ltd; 2007.

Source: PubMed

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