A randomised controlled trial of a patient based Diabetes recall and Management system: the DREAM trial: A study protocol [ISRCTN32042030]

BackgroundWhilst there is broad agreement on what constitutes high quality health care for people with diabetes, there is little consensus on the most efficient way of delivering it. Structured recall systems can improve the quality of care but the systems evaluated to date have been of limited sophistication and the evaluations have been carried out in small numbers of relatively unrepresentative settings. Hartlepool, Easington and Stockton currently operate a computerised diabetes register which has to date produced improvements in the quality of care but performance has now plateaued leaving substantial scope for further improvement. This study will evaluate the effectiveness and efficiency of an area wide 'extended' system incorporating a full structured recall and management system, actively involving patients and including clinical management prompts to primary care clinicians based on locally-adapted evidence based guidelines.MethodsThe study design is a two-armed cluster randomised controlled trial of 61 practices incorporating evaluations of the effectiveness of the system, its economic impact and its impact on patient wellbeing and functioning.

[1]  R. Holman,et al.  Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. , 1998 .

[2]  M J Lincoln,et al.  A computer-generated reminder system improves physician compliance with diabetes preventive care guidelines. , 1995, Proceedings. Symposium on Computer Applications in Medical Care.

[3]  A H Briggs,et al.  Handling uncertainty when performing economic evaluation of healthcare interventions. , 1999, Health technology assessment.

[4]  E McColl,et al.  Developing outcome measures for ambulatory care--an application to asthma and diabetes. , 1995, Social science & medicine.

[5]  R. Harper,et al.  Management of cardiovascular disease , 1999, The Medical journal of Australia.

[6]  A. Melville,et al.  Complications of diabetes: renal disease and promotion of self-management , 2000, Quality in health care : QHC.

[7]  B. Ginsberg,et al.  Staged Diabetes Management: Computerizing a Disease State Management Program , 1998, Journal of Medical Systems.

[8]  Allen Hutchinson,et al.  Complications of diabetes: screening for retinopathy and management of foot ulcers , 2000, Quality in health care : QHC.

[9]  P. Greenhalgh.  Shared care for diabetes. A systematic review. , 1994, Occasional paper.

[10]  John E. Ware,et al.  SF-36 physical and mental health summary scales : a user's manual , 1994 .

[11]  A. L. Cochrane,et al.  Effectiveness and efficiency: random reflections on health services , 1972 .

[12]  J. Ware.  SF-36 health survey: Manual and interpretation guide , 2003 .

[13]  M. Davidson,et al.  Application of a Diabetes Managed Care Program: The feasibility of using nurses and a computer system to provide effective care , 1998, Diabetes Care.

[14]  A. Belton,et al.  Continuous Monitoring of Health Status Outcomes: Experience With a Diabetes Education Program , 1995, The Diabetes educator.

[15]  G O Barnett,et al.  Computerized concurrent review of prenatal care. , 1978, QRB. Quality review bulletin.

[16]  G. Nichols,et al.  Type 2 diabetes: incremental medical care costs during the first 8 years after diagnosis. , 1999, Diabetes care.

[17]  Clare Bradley,et al.  Handbook of Psychology and Diabetes : A Guide to Psychological Measurement in Diabetes Research and Practice , 1994 .

[18]  Greenhalgh Pm.  Shared care for diabetes: a systematic review , 1994 .

[19]  T. Cook,et al.  Quasi-experimentation: Design & analysis issues for field settings , 1979 .

[20]  J. Grimshaw,et al.  The design and analysis of a randomized controlled trial to evaluate computerized decision support in primary care: the COGENT study. , 2000, Family practice.

[21]  G. Alberti,et al.  Shared care in diabetes , 1995, BMJ.

[22]  S. Griffin,et al.  Diabetes care: the effectiveness of systems for routine surveillance for people with diabetes. , 2000, The Cochrane database of systematic reviews.

[23]  J Raftery,et al.  Costing in economic evaluation , 2000, BMJ : British Medical Journal.

[24]  J. Bond,et al.  Developing guidelines for day hospitals for older people: adaptation of national guidelines for local use , 1998 .

[25]  W. Hammond,et al.  Computerized decision support based on a clinical practice guideline improves compliance with care standards. , 1997, The American journal of medicine.

[26]  The Acropolis Affirmation Diabetes Care—St Vincent in Progress , 1995, Diabetic medicine : a journal of the British Diabetic Association.

[27]  M Eccles,et al.  Experimental and quasi-experimental designs for evaluating guideline implementation strategies. , 2000, Family practice.

[28]  A. N. Brand,et al.  A comparison of the standard and the computerized versions of the Well-being Questionnaire (WBQ) and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) , 1998, Quality of Life Research.

[29]  A. Donner,et al.  Randomization by cluster. Sample size requirements and analysis. , 1981, American journal of epidemiology.

[30]  R. J. Hayes,et al.  Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. , 1995, JAMA.

[31]  Igor Sartori,et al.  Empirical Evidence of Bias. Dimensions of Methodological Quality Associated with Estimates of Treatment Effects in Controlled Trials , 1996 .

[32]  Daniel Courgeau,et al.  Goldstein (H.) — Multilevel Statistical Models , 1997 .

[33]  D. McDowell,et al.  Measuring clinical performance and outcomes from diabetes information systems: an observational study , 2000, Diabetologia.

[34]  M. Eccles,et al.  A new self-completion outcome measure for diabetes: is it responsive to change? , 1997, Quality of Life Research.

[35]  Jonathan B. Brown,et al.  The progressive cost of complications in type 2 diabetes mellitus. , 1999, Archives of internal medicine.

[36]  L. Delbeke.  Quasi-experimentation - design and analysis issues for field settings - cook,td, campbell,dt , 1980 .

[37]  N.J.A. Vaughan.  The UK Diabetes Dataset: a Standard for Information Exchange , 1995, Diabetic medicine : a journal of the British Diabetic Association.