Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial

A W Murphy, M E Cupples, S M Smith, M Byrne, M C Byrne, J Newell, SPHERE study team, C Leathem, A Houlihan, M O'Malley, V Spillane, H Grealish, P Ryan, M Corrigan, M D'Eath, J Wilson, A Kelly, E O'Shea, P Gillespie, M Donnelly, J Hinde, A Alvarez, A Simpkin, A W Murphy, M E Cupples, S M Smith, M Byrne, M C Byrne, J Newell, SPHERE study team, C Leathem, A Houlihan, M O'Malley, V Spillane, H Grealish, P Ryan, M Corrigan, M D'Eath, J Wilson, A Kelly, E O'Shea, P Gillespie, M Donnelly, J Hinde, A Alvarez, A Simpkin

Abstract

Objective: To test the effectiveness of a complex intervention designed, within a theoretical framework, to improve outcomes for patients with coronary heart disease.

Design: Cluster randomised controlled multicentre trial.

Setting: General practices in Northern Ireland and the Republic of Ireland, regions with different healthcare systems.

Participants: 903 patients with established coronary heart disease registered with one of 48 practices.

Intervention: Tailored care plans for practices (practice based training in prescribing and behaviour change, administrative support, quarterly newsletter), and tailored care plans for patients (motivational interviewing, goal identification, and target setting for lifestyle change) with reviews every four months at the practices. Control practices provided usual care.

Main outcome measures: The proportion of patients at 18 month follow-up above target levels for blood pressure and total cholesterol concentration, and those admitted to hospital, and changes in physical and mental health status (SF-12).

Results: At baseline the numbers (proportions) of patients above the recommended limits were: systolic blood pressure greater than 140 mm Hg (305/899; 33.9%, 95% confidence interval 30.8% to 33.9%), diastolic blood pressure greater than 90 mm Hg (111/901; 12.3%, 10.2% to 14.5%), and total cholesterol concentration greater than 5 mmol/l (188/860; 20.8%, 19.1% to 24.6%). At the 18 month follow-up there were no significant differences between intervention and control groups in the numbers (proportions) of patients above the recommended limits: systolic blood pressure, intervention 98/360 (27.2%) v control, 133/405 (32.8%), odds ratio 1.51 (95% confidence interval 0.99 to 2.30; P=0.06); diastolic blood pressure, intervention 32/360 (8.9%) v control, 40/405 (9.9%), 1.40 (0.75 to 2.64; P=0.29); and total cholesterol concentration, intervention 52/342 (15.2%) v control, 64/391 (16.4%), 1.13 (0.63 to 2.03; P=0.65). The number of patients admitted to hospital over the 18 month study period significantly decreased in the intervention group compared with the control group: 107/415 (25.8%) v 148/435 (34.0%), 1.56 (1.53 to 2.60; P=0.03).

Conclusions: Admissions to hospital were significantly reduced after an intensive 18 month intervention to improve outcomes for patients with coronary heart disease, but no other clinical benefits were shown, possibly because of a ceiling effect related to improved management of the disease.

Trial registration: Current Controlled Trials ISRCTN24081411.

Conflict of interest statement

Competing interests: None declared.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787492/bin/mura614933.f1_default.jpg
Fig 1 Flow of practices and patients through study
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787492/bin/mura614933.f2_default.jpg
Fig 2 Change in blood pressure, cholesterol concentration, and SF-12 physical and mental health components

References

    1. Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U, et al. Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. Lancet 2001;357:995-1001.
    1. Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med 2005;143:659-72.
    1. McAlister FA, Lawson FME, Teo KK, Armstrong PW. Randomised trials of secondary prevention programmes in coronary heart disease: systematic review. BMJ 2001;323:957-62.
    1. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al. Designing and evaluating complex interventions to improve health care. BMJ 2007;334:455-9.
    1. Moher M, Yudkin P, Wright L, Turner R, Fuller A, Schofield T, et al. Cluster randomised controlled trial to compare three methods of promoting secondary prevention of coronary heart disease in primary care. BMJ 2001;322:1338-42.
    1. Campbell S, Reeves D, Kontopantelis E, Middleton E, Sibbald B, Roland M, et al. Quality of primary care in England with the introduction of pay for performance. N Engl J Med 2007;357:181-90.
    1. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ 2000;321:694-6.
    1. Murphy AW, Cupples ME, Smith S, Byrne M, Leathem C, Byrne MC. The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411]. Curr Control Trials Cardiovasc Med 2005;6:11.
    1. Heartwatch National Programme Centre, Independent National Data Centre. Heartwatch clinical report: March 2003 to December 2005—second report. Dublin: Department of Health and Children, 2006.
    1. Byrne M, Cupples ME, Smith SM, Leathem C, Corrigan M, Byrne MC, et al. Development of a complex intervention for secondary prevention of coronary heart disease in primary care using the UK Medical Research Council Framework. Am J Manage Care 2006;12:261-6.
    1. Leathem CS, Byrne MC, Cupples ME, Byrne M, Corrigan M, Murphy AW, et al. Using the opinions of coronary heart disease patients in designing a health education booklet for use in general practice consultations. Primary Health Care Res Develop J 2009;10:189–99.
    1. Byrne M, Corrigan M, Cupples ME, Smith SM, Leathem C, Murphy AW. The SPHERE Study: using psychological theory to inform the development of behaviour change training for primary care staff to increase secondary prevention of coronary heart disease. Ir J Psychol 2005;26:53-64.
    1. Bandura A. Social foundation of thought and action. Engelwood Cliffs, NJ: Prentice-Hall, 1986.
    1. Cupples ME, Byrne MC, Smith SM, Leathem C, Murphy AW. Secondary prevention of cardiovascular disease in different primary healthcare systems, with and without pay-for-performance. Heart 2008;94:1594-600.
    1. Roe L, Strong C, Whiteside C, Neil A, Mant D. Dietary intervention in primary care: validity of the DINE method for diet assessment. Fam Pract 1994;11:375-81.
    1. Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci 1985;10:141-6.
    1. Campbell NC, Ritchie LD, Thain J, Deans HG, Rawles JM, Squair JL. Secondary prevention in coronary heart disease: a randomised trial of nurse led clinics in primary care. Heart 1998;80:447-52.
    1. Byrne M, Murphy AW. Secondary prevention of heart disease: a baseline survey of patients’ lifestyles and service provision in the north western and western health boards. Research and Development Report No 2. Galway: Department of General Practice, National University of Ireland Galway, 2002.
    1. Cupples ME, McKnight A. Randomised controlled trial of health promotion in general practice for patients at high cardiovascular risk. BMJ 1994;309:993-6.
    1. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702-8.
    1. Holm S. A simple sequentially rejective multiple test procedure. Scand J Stat 1979;6:65–70.
    1. Jolly K, Bradley F, Sharp S, Smith H, Thompson S, Kinmonth AL, et al. Randomised controlled trial of follow up care in general practice of patients with myocardial infarction and angina: final results of the Southampton heart integrated care project (SHIP). The SHIP Collaborative Group. BMJ 1999;318:706-11.
    1. Khunti K, Stone M, Paul S, Baines J, Gisbourne L, Farooqi A, et al. Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster randomised controlled trial. Heart 2007;93:1398-405.
    1. Bender R, Lange S. Adjusting for multiple testing—when and how? J Clin Epidemiol 2001;54:343-9.
    1. Feise RJ. Do multiple outcome measures require p-value adjustment? BMC Med Res Methodol 2002;2:8.
    1. Rothman KJ. No adjustments are needed for multiple testing. Epidemiology 1990;1:43-6.
    1. Buckley B, Byrne MC, Dineen B, Smith SM. Service organisation for the secondary prevention of ischaemic heart disease. (Protocol) Cochrane Database Syst Rev 2007;4: CD006772. DOI: .
    1. Wheeler JR, Janz NK, Dodge JA. Can a disease self management program reduce health care costs? The case of older women with heart disease. Med Care 2003;41:706-15.
    1. Lorig KR, Sobel DS, Stewart AL, Brown BW, Bandura A, Ritter P, et al. Evidence suggesting that a chronic disease self management program can improve health status while reducing hospitalisation. A randomised controlled trial. Med Care 1999;37:5-14.
    1. Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW, Bandura A, et al. Chronic disease self management program: 2-year health status and health care utilisation outcomes. Med Care 2001;39:1217-23.
    1. Hardoon SL, Whincup PH, Lennon LT, Wannamethee SG, Capewell S, Morris RW, et al. How much of the recent decline in the incidence of myocardial infarction in British men can be explained by changes in cardiovascular risk factors? Evidence from a prospective population-based study. Circulation 2008;117:598-604.
    1. Bennett K, Kabir Z, Unal B, Shelley E, Critchley JA, Perry I, et al. Explaining the recent decrease in coronary heart disease mortality rates in Ireland, 1985-2000. J. Epidemiol Community Health 2006;60:322-7.
    1. DeWilde S, Carey IM, Richards N, Whincup PH, Cook DG. Trends in secondary prevention of ischaemic heart disease in the UK 1994 2005: use of individual and combination treatment. Heart 2008;94:83-8.
    1. Davies MJ, Heller S, Skinner TC, Campbell MJ, Carey ME, Cradock S, et al. Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial. BMJ 2008;336:491-5.
    1. Glynn LG, Reddan D, Newell J, Hinde J, Buckley B, Murphy AW. Chronic kidney disease and mortality and morbidity among patients with established cardiovascular disease: a West of Ireland community-based cohort study. Nephrol Dial Transplant 2007;22:2586-94.
    1. Smith SM, O’Dowd T. Chronic diseases: what happens when they come in multiples? Br J Gen Pract 2007;57:268-70.
    1. Capewell S, O’Flaherty M. Maximising secondary prevention therapies in patients with coronary heart disease. Heart 2008;94:8-9.
    1. Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ 2008;336:876-80.
    1. Schulz KF, Altman DG, Moher D. Allocation concealment in clinical trials. JAMA 2002;288:2406-7.
    1. O’Dowd T, O’Kelly M, O’Kelly F. Structure of general practice in Ireland 1982-2005. Dublin: Irish College of General Practitioners, 2006.

Source: PubMed

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