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The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care

The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular... Background: The appropriate care for people with cardiovascular risk factors can reduce morbidity and mortality. One strategy for improving the care for these patients involves the implementation of evidence-based guidelines. To date, little research concerning the impact of such implementation strategies in our setting has been published. Aims. To evaluate the effectiveness of a multifaceted tailored intervention in the implementation of three cardiovascular risk-related guidelines (hypertension, type 2 diabetes and dyslipidemia) in primary care in the Basque Health Service compared with usual implementation. Methods/Design: A two-year cluster randomized clinical trial in primary care in two districts in the Basque Health Service. All primary care units are randomized. Data from all patients with diabetes, hypertension and those susceptible to coronary risk screening will be analyzed. Interventions. The control group will receive standard implementation. The experimental group will receive a multifaceted tailored implementation strategy, including a specific web page and workshops for family physicians and nurses. Endpoints. Primary endpoints: annual request for glycosylated hemoglobin, basic laboratory tests for hypertension, cardiovascular risk screening (women between 45–74 and men between 40–74 years old). Secondary endpoints: other process and clinical guideline indicators. Analysis: Data will be extracted from centralized computerized medical records. Analysis will be performed at a primary care unit level weighted by cluster size. Discussion: The main contribution of our study is that it seeks to identify an effective strategy for cardiovascular guideline implementation in primary care in our setting. Trial registration: Current Controlled Trials, ISRCTN88876909 Keywords: Diabetes, Education, Medical continuing, Guidelines, Health plan implementation, Hyperlipidemias, Hypertension, Primary health care, Risk factors, Cardiovascular * Correspondence: [email protected] Hernani Health Center, Gipuzkoa Health District, Basque Health Service, c/Aristizabal 1, 20120 Hernani, Spain Full list of author information is available at the end of the article © 2013 Etxeberria et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 2 of 7 http://www.biomedcentral.com/1472-6963/13/438 Background was drafted within the framework of the National Health Diabetes and cardiovascular risk factors System's Clinical Practice Guideline Program in collab- High blood pressure, dyslipidemia and diabetes are the oration with the Health Technology Assessment Agency main clinical conditions presented by patients with mul- Osteba. These three guidelines are available from tiple morbidities [1]. Guiasalud [7] and have been included in the National Cardiovascular disease is the leading cause of death in Guideline Clearinghouse. both the Basque Country and Spain as a whole. Despite this, cardiovascular disease-related mortality has decreased Design of CPG implementation strategies over the past few years due, amongst other reasons, to the The publication and dissemination of a CPG does not, better diagnosis and treatment of cardiovascular risk fac- however, ensure its application in clinical practice, there- tors [2]. fore effective and viable implementation plans for the Current data suggest that there remains significant organizational context at which it is aimed must be de- room for improvement in cardiovascular risk factor and signed. Implementation must be considered to be a diabetes care in our setting. According to data from the planned process whose main characteristics are dyna- Provider Agreement in 2008 only 41.3% of diabetic pa- mism and uniqueness [6]. tients in the Autonomous Community of the Basque It is important that guideline implementation inter- Country had a glycosylated hemoglobin (HbA1c) level of ventions are designed in accordance with a coherent the- less than 7.5%, basic analysis was performed in 44.9% of oretical foundation, a body of evidence to support them patients and only 27% had a blood pressure of less than and taking into account the barriers and facilitators of 140/80 mm Hg. the local setting [6,11-13]. The almost anecdotal use of tools to calculate cardio- vascular risk at that time suggests that statin treatment Theoretical foundation in primary prevention is chosen on the basis of choles- Grol’s 10-step model [11] is a theoretical reference for terol level rather than overall cardiovascular risk [3]. guideline implementation [6]. This model brings to- As far as hypertensive patients in our setting are con- gether elements from different disciplines, such as the cerned, it is estimated that only 33% have their blood diffusion of innovation theory [14], the reasoned action pressure well controlled and that 46.4% do not receive theory [15] and social cognitive theory [16], and postulates the antihypertensive agent of choice [4]. that professionals pass through different phases or stages (orientation, insight, acceptance, change and maintenance) Clinical practice guidelines as a tool for improving when achieving a change, with specific barriers predomin- healthcare ating in each phase. This study concentrates on the orien- The implementation of evidence-based clinical practice tation, insight and acceptance phases. guidelines (CPGs) may help to ensure that the care of patients with cardiovascular risk factors or diabetes Barriers and facilitators complies with the best quality criteria and standards. Although there are numerous studies concerning the CPGs are statements that include recommendations barriers and facilitators for CPG implementation [17], intended to optimize patient care which are informed by this is not the case in our setting. As a result, before de- a systematic review of evidence and an assessment of signing the guideline implementation intervention, we the benefits and harms of alternative care options [5]. As undertook a study to explore the barriers faced by CPGs such, they have the potential to reduce variability and in primary care using the Delphi technique [18]. The improve healthcare [6]. main barriers detected are the following [18]. In the past few years we have witnessed the consolida- tion of a CPG program in both the Basque Country and Dimension: Presentation of the guidelines: the Spanish National Health System as a whole that has – The teaching method used by the speakers at each led to the Guiasalud program [7], the development of a session. common methodology for drafting such guidelines [8] – The choice of speaker. and the availability of an increasing number of guide- Dimension: Format of the guidelines: lines prepared in Spain. – The need for a summarized version. Thus, in the cardiovascular field, 2008 and 2009 saw – The need to stimulate and promote the on-line the publication of the “Clinical practice guideline on the version, which makes term search easier, and the management of lipids as a cardiovascular risk factor” [9], links within the guidelines and to other material of an update to the regional “Clinical practice guideline on interest. arterial hypertension” [4] and the “Clinical practice – The need to enhance user participation (discussion guideline on type 2 diabetes” [10], the latter of which fora, asking questions, debates, etc.). Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 3 of 7 http://www.biomedcentral.com/1472-6963/13/438 Dimension: Use and utility facilitators: As no single implementation strategy is effective in all – Application of CPGs gives good results in clinical contexts, the impact of such strategies needs to be evalu- practice. ated by way of studies with a robust design and low risk – The need to attach action protocols or other of bias. Randomized designs are the gold-standard for practical tools to the guidelines. assessing healthcare interventions [12,25]. Internal barriers: Although we are witnessing significant support for the – Willingness of the physicians themselves. drafting of CPGs by public health organisations in Spain, – Too much time and effort required to understand evaluation of their subsequent implementation remains the CPGs. uncommon [26]. – Lack of acceptance of guidelines as a work tool. In our setting, the availability of three recently published – Discouragement due to lack of use at other CPGs in the cardiovascular field provides a unique oppor- healthcare levels. tunity to assess CPG implementation strategies in primary External barriers: care. – Specialized practice does not follow the guidelines. – Lack of dissemination and implementation in Main endpoint specialized care. To evaluate the effectiveness of a multifaceted tailored – Pressure from the pharmaceutical industry. intervention in the implementation of three cardiovas- – Methodology followed to learn the guidelines. cular risk-related CPGs (hypertension, type 2 diabetes and lipids as cardiovascular risk factor) in primary Effectiveness of guideline implementation interventions care in the Basque Health Service compared with usual According to Grimshaw’s systematic review [12], the ef- implementation. fectiveness of different clinical practice guideline dissem- ination and implementation strategies varies but, in Secondary endpoints general, tends to be modest. The dissemination of edu- cational materials tends to be poorly effective but at  To evaluate the impact of the intervention on the low-cost, whereas continual medical training is more degree of compliance with process quality indicators effective if undertaken in small groups using realistic and subrogate clinical endpoints for the care of scenarios [19-21]. The efficacy of opinion leader-based patients with type 2 diabetes. training tends to vary [12]. Multifaceted interventions  To evaluate the impact of the intervention on the appear to make sense if they are intended to overcome degree of compliance with process quality indicators specific barriers [19]. Indeed, tailored interventions are and subrogate clinical endpoints for the care of more effective than passive guideline dissemination [13]. patients with hypertension. In the field of diabetes, the review by Shojania [22]  To evaluate the impact of the intervention on the showed that multifaceted interventions provided a larger degree of compliance with coronary risk screening effect than interventions involving a single compo- process quality indicators. nent. Educational interventions showed an acceptable  To evaluate the impact of the intervention on the efficacy. In the field of hypertension, educational in- prescription of statins in primary and secondary terventions aimed at healthcare professionals resulted prevention. in a modest improvement in blood pressure control [23]. The most effective strategy for implementing the Methods/Design use of risk tables in cardiovascular disease prevention Study design and setting is still unknown [24]. This study is a cluster randomized trial conducted in two urban primary care districts in the Basque Health Context Service (Ekialde and Bilbao). These districts cover 36.9% The intervention and study were designed in the context of the population in the Basque Country. Primary care of a primary care research group with a clinical and/ units (PCU) will be randomly assigned. or methodological profile involved in the drafting and A cluster-type design is selected as the intervention implementation of evidence-based guidelines. The inter- was aimed at professionals working in a PCU and due to vention was aimed at primary care professionals (physi- the risk of contamination between professionals working cians and nurses) and no organisational changes or in the same PCU [27,28]. interventions in patients were considered. A further A repeated cross-sectional design is used for all pa- assumption was that the proposed interventions had tients who attend during the baseline period (pre- to be feasible and result in a reasonable cost to the intervention, or “PRE”) and in the post-intervention period health system. (“POST”), with different samples. Such an approach is Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 4 of 7 http://www.biomedcentral.com/1472-6963/13/438 appropriate when the aim of the study is to determine the – Patients who commenced statin treatment during impact of CPG implementation on the population and the study period. provides greater long-term power [27,28]. It also allows – Patients diagnosed with ischemic heart disease minor baseline differences that may arise due to cluster during the study period. randomization to be compensated. The study design is shown in Figure 1. The exclusion criteria are: patients assigned physicians or nurses who declined to participate in the study, youn- Study population ger than 14 years of age, patients assigned to physicians Consent to participate was received from the heads of occupying two or more medical posts belonging to the all PCUs from both districts, therefore they were all ran- intervention and control groups at the same time, and domized (43 PCUs). All professionals (physicians and patients who don’t attend their PCU during the study nurses) appointed to medical jobs in family medicine period. who agreed to participate in the study were included. Data from all patients who attend their PCU during the Interventions study period (PRE and POST intervention) and assigned The control group will receive usual implementation, to the PCUs and physicians/nurses who participate in namely mailing of the guideline, publication in the intra- the study will be analyzed, if they complied with one of net and presentation sessions in the PCU. These sessions the following inclusion criteria: will be led by physicians trained by the trainers respon- sible for teaching the intervention group. – A diagnosis of type 2 diabetes in the medical record. In addition to the control group interventions, the – A diagnosis of hypertension in the medical record. multifaceted implementation for the experimental group – Population susceptible to cardiovascular risk also includes: screening: women aged 45–74 years and men aged 40–74 years with no ischemic heart disease. – Identical presentation sessions to those for the control group but given by physicians who took part in the guideline development process. – The design of a specific web page with the Eligible PCUs: 43 (patients assigned to 448 medical positions) guideline recommendations aimed at the action, with quick access, application tools (algorithms and tables with links to the main Randomization recommendations, patient materials), the possibility to ask questions, links to drug-related information. Intervention: 21 PCUs Control: 22 PCUs Physicians: 213 Physicians: 235 – Three-hour workshops for family physicians and Baseline measurements Baseline nurses, eight cardiovascular risk workshops for (PRE) measurements (PRE) family physicians and a further eight for nursing staff, and four diabetic foot workshops for nursing staff. These workshops will be mostly Multifaceted intervention Usual implementation led by the physicians responsible for the guidelines with the colaboration of two non-involved nurses. Endpoints Primary endpoints Post-intervention Post-intervention measurements measurements – Diabetes: percentage of patients with annual request (POST) (POST) for glycosylated haemoglobin (HbA1c). – Hypertension: percentage of patients with annual request for basic analysis, including albumin- creatinine ratio. Data extraction and analysis – Dyslipidemia: males between 40–74 and females between 45–74 years with at least one cardiovascular risk assessment (except males and Figure 1 Study design. females with cardiovascular disease). Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 5 of 7 http://www.biomedcentral.com/1472-6963/13/438 Secondary endpoints generated randomization sequence. Randomization is per- formed centrally by a researcher not involved in the study – Diabetes: percentage of patients with HbA1c lower who was blind to the identity of the PCU. than 7%, percentage of patients with blood pressure lower than 140/80 mm Hg, percentage of patients Masking with confirmed basic analysis, percentage of patients Professionals implementing the intervention are not with confirmed cardiovascular risk assessment, blinded to the assignment group. However, data extrac- percentage of patients with confirmed foot tion will be performed centrally by computer technicians examination and new pharmacological treatment not involved in the study and data will be treated by re- started with metformin. search personnel after anonymisation. – Hypertension: percentage of non-diabetic patients with blood pressure lower than 140/90 mm Hg, Analysis percentage of patients with annual cardiovascular Data will be extracted from centralized computerized risk assessment, percentage of patients starting medical records. Analysis will be performed at the PCU pharmacological treatment with diuretics, beta- level taking the cluster design into account [32]. Indica- blockers or angiotensin-II receptor blockers. tors will be obtained for each PCU before and after – Dyslipidemia: percentage of patients aged between the intervention and the differences will be weighted 35 and 74 years with no cardiovascular disease by cluster size. All analyses will be performed using starting a statin treatment with previous Student’s t-test as implemented in SPSS 19. A sec- cardiovascular risk assessment, new statin ondary multi-level analysis will be performed using treatments in women aged over 35 years with no MLwiN (version 2.21) to determine the intracluster cardiovascular disease or diabetes, percentage of correlation coefficients (ICCs). patients with a new diagnosis of coronary heart Analysis will be performed on an intention-to-treat disease receiving statin treatment. basis. Sample size Ethical considerations The following aspects were taken into account when cal- This trial was approved by the Clinical Research Ethics culating the sample size: Committee of the Basque Country. The protocol was regis- tered in the Current Controlled Trials database (ISRCTN On average, 45-50% of diabetic patients assigned to 88876909). Funding was provided by the Spanish Ministry a healthcare professional undergo at least two of Health as part of the 2007–2008 collaboration agree- annual HbA1c analyses (standard deviation 15-20%). ment anticipated in the National Health System’squality An annual analysis is requested in around 35% of plan between the Carlos III Research Institute, an autono- hypertensive patients. (Data taken from the Provider mous body that forms part of the Spanish Ministry of Agreement, 2007). Science and Innovation, and the Basque Government’s From a clinical and operational viewpoint, an Department for Health and Consumer Affairs (OSTEBA). intervention strategy would be worthwhile if these averages could be increased to 55-60% for diabetes Discussion and 43% for hypertension. There is a growing need to identify effective implemen- The size of the PCUs is similar, with around 10 tation strategies for CPGs for the management of cardio- physicians per PCU, and the number of patients vascular risk factors in primary care. This study is one of assigned to each clinician is also similar. the few cluster randomized trials concerning the imple- The intracluster correlation coefficient (ICC) is 0.10 mentation of clinical practice guidelines in Spanish pri- [29-31]. mary care. This study focuses on multiple cardiovascular risk fac- In light of these considerations, approximately 100 tors as primary endpoints. Its pragmatic design is aimed physicians per group (10 PCUs in each group) would be at determined the actual impact of implementing CPGs needed for an α of 0.05 and a β of 0.20. Applying the for type 2 diabetes, hypertension and dyslipidemia via a cluster-related design effect gives a final number of 20 multifaceted intervention based on identifying local bar- PCUs per group (intervention and control). riers to CPG implementation, and it is aimed at primary care professionals. Randomization The limitations of this study include the use of medical Allocation is performed by clusters. PCUs are assigned to records as data source. Giving the nature of the study, the intervention or control group following a computer- the intervention cannot be masked. Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 6 of 7 http://www.biomedcentral.com/1472-6963/13/438 The findings of this study will allow a more effective Madrid: Plan Nacional para el SNS del MSC. Instituto Aragonés de Ciencias de la Salud-I + CS; 2007. Guías de Práctica Clínica en el SNS: I + CSNº 2006/0I. CPG planning in the primary cardiovascular care field to 9. San Vicente R, Ibarra J, Pérez I, Berraondo I, Uribe F, Urraca J: Guía de be designed. Similarly, it will allow the key aspects of Práctica Clínica sobre el manejo de los lípidos como factor de riesgo recommendation implementation in our setting to be cardiovascular. Vitoria-Gasteiz: Osakidetza-Servicio Vasco de Salud; 2009. 10. Grupo de trabajo para la elaboración de la Guía de Práctica Clínica sobre identified. All this information may prove useful in the Diabetes tipo 2: Guía de Práctica Clínica sobre Diabetes tipo 2. Madrid: Plan organisational transformation currently underway in the Nacional para el SNS del MSC. Agencia de Evaluación de Tecnologías Basque Country to adapt the health system to the care Sanitarias del País Vasco; 2008. Guías de Práctica Clínica en el SNS: OSTEBA, No 2006/08. needs of patients with chronic diseases. 11. Grol R, Wensing M, Eccles M: Improving Patient Care. The implementation of Change in. London: Clinical Practice: Elsevier; 2005. Abbreviations 12. Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, et al: CPG: Clinical Practice Guideline; HbA1c: glycosylated hemoglobin; Effectiveness and efficiency of guideline dissemination and ICC: Intracluster Correlation Coefficient; PCU: Primary Care Unit. implementation strategies. Health Technol Assess 2004, 8(6):iii-72. 13. Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, et al: Competing interests Tailored interventions to overcome identified barriers to change: effects The authors declare that they have no competing interests. on professional practice and health care outcomes. Coch Datab Syst Rev 2010, 3:1–64. CD005470. Authors’ contributions 14. Rogers E: Diffusion of Innovations. New York: Free Press of Glencoe; 1962. RR, AE, IP, IA designed and planned the study. DO gave advice concerning 15. Fishbein M, Ajzen I: Belief, attitude, intention and behaviour: an introduction the study design. JIE calculated the sample size and helped to design the of theory and research. Reading, Massachusettes: Addison-Wesley; 1975. study. JIE and MI planned the statistical analysis. ERV helped to plan the 16. Bandura A: Social foundations of thought and action: a social cognitive study and the intervention. AE drafted the study protocol. All authors theory. Englewood Cliffs, NJ: Prentice Hill; 1986. reviewed the draft version, made suggestions and approved the final 17. Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al: Why version. don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999, 282(15):1458–1465. 18. Pérez Irazusta I, Torres E, Alcorta I, Etxeberria A, Rotaeche R, Reviriego E: Acknowledgements Exploración de barreras y facilitadores para la implementación de guías de Juan Chinchilla, for designing the web page. práctica clínica:un estudio Delphi. Plan de Calidad para el Sistema Nacional de Eva Reviriego, for helping to design the web page. Salud del Ministerio de Sanidad y Política Social.Servicio de Evaluación de Ana Bustinduy, for advice concerning how to define and obtain the Tecnologías Sanitarias del País Vasco (Osteba). Madrid: Informes de indicators. Evaluación de Tecnologías Sanitarias, OSTEBA Nº 2007/5; 2009. The management teams in the Bilbao and Gipuzkoa regions and the Healthcare Directorate of Osakidetza, for supporting the project. 19. Robertson R, Jochelson K: Interventions that change clinician behaviour: Rosa Rico and OSTEBA, for supporting the project. mapping the literature. London: NICE; 2006. BIOEF, for translating the protocol. 20. Forsetlund L, Bjorndal A, Rashidian A, Jamtvedt G, O’Brien MA, Wolf F, et al: Continuing education meetings and workshops: effects on professional Author details practice and health care outcomes. Coch Datab Syst Rev 2009, 2:1–99. Hernani Health Center, Gipuzkoa Health District, Basque Health Service, CD003030. c/Aristizabal 1, 20120 Hernani, Spain. Bidasoa Integrated Healthcare 21. Mansouri M, Lockyer J: A meta-analysis of continuing medical education Organization, Basque Health Service, Irun, Spain. University Hospital, IIS effectiveness. J Contin Educ Health Prof 2007, 27(1):6–15. Biodonostia, San Sebastian, Spain. Bilbao Health District, Basque Health 22. Shojania K, Ranji S, Shaw L, Charo L, Lai J, Rushakoff R, et al: Diabetes Service, Bilbao, Spain. Miguel Hernandez University, Alicante, Spain. Mellitus Care. Vol. 2. In Closing The Quality Gap: A Critical Analysis of Quality Alza Health Centre, Basque Health Service, San Sebastian, Spain. Improvement Strategies. Edited by Shojania KG, McDonald KM, Wachter RM, Owens DK. Rockville, MD: Agency for Healthcare Research and Quality; 2004. Received: 10 June 2013 Accepted: 10 October 2013 23. Glynn LG, Murphy AW, Smith SM, Schroeder K, Fahey T: Interventions used Published: 24 October 2013 to improve control of blood pressure in patients with hypertension. Coch Datab Syst Rev 2010, 3:1–111. CD005182. 24. van Steenkiste B, Grol R, van der Weijden T: Systematic review of References implementation strategies for risk tables in the prevention of cardiovascular 1. Departamento de Sanidad y Consumo del Gobierno Vasco: Estrategia para diseases. Vasc Health Risk Manage 2008, 4(3):535–545. Epub 2008/10/02. afrontar la cronicidad en Euskadi. Vitoria-Gasteiz: Departamento de Sanidad 25. Eccles M, Grimshaw J, Campbell M, Ramsay C: Research designs for studies y Consumo del Gobierno vasco; 2010. evaluating the effectiveness of change and improvement strategies. 2. Departamento de Sanidad y Consumo del Gobierno Vasco: Políticas de Qual Safety Health Care 2003, 12(1):47–52. salud para Euskadi: Plan de Salud 2002–2010. Vitoria-Gasteiz; 2002. 26. Romero A, Alonso C, Marin I, Grimshaw J, Villar E, Rincon M, et al: 3. SwinnenSG, Dain MP,MauricioD,DeVries JH,HoekstraJB, Holleman F: Efectividad de la implantación de una guía clínica sobre la angina Continuation versus discontinuation of insulin secretagogues when inestable mediante una estrategia multifactorial. Ensayo clínico initiating insulin in type 2 diabetes. Diab Obes Metab 2010, aleatorizado en grupos. RevEspCardiol 2005, 58(6):640–648. 12(10):923–925. 27. Ukoumunne OC, Gulliford MC, Chinn S, Sterne JA, Burney PG, Donner A: 4. Rotaeche R, Aguirrezabala J, Balagué L, Gorroñogoitia A, Idarreta I, Methods in health service research. Evaluation of health interventions at Mariñelarena E, et al: Guía de Práctica Clínica sobre Hipertensión Arterial areawide and organisation-based interventions in health and health (actualización 2007). Vitoria-Gasteiz: Osakidetza-Servicio Vasco de Salud; care: a systematic review. Health Technol Assess 1999, 3(3):92. 28. Donner A, Klar N: Design an Analysis of Cluster Randomization Trials in Health 5. Institute of Medicine: Clinical Practice Guidelines. We Can Trust. Washington, Research. New York: John Wiley& Sons, Ltd; 2000. DC: The National Academic Press; 2011. 29. Kerry SM, Bland JM: Sample size in cluster randomisation. BMJ 1998, 6. Grupo de trabajo sobre implementación de GPC: Implementación de Guías 316(7130):549. de Práctica Clínica en el Sistema Nacional de Salud. Manual Metodológico. Madrid: Plan Nacional para el SNS del MSC; 2009. 30. Perria C: Strategies for the introduction and implementation of a 7. Biblioteca de guías de práctica clínica en el Sistema Nacional de Salud. guideline for the treatment of type 2 diabetics by general practitioners Available from: http://portal.guiasalud.es/web/guest/home. (GPs) of the Lazio region of Italy (IMPLEMEG study): protocol for a 8. Grupo de Trabajo sobre Guías de Práctica Clínica: Elaboración de Guías de cluster randomised controlled trial [ISRCTN80116232]. BMC Health Serv Práctica Clínica en el Sistema Nacional de Salud. Manual Metodológico. Res 2004, 4(1):13. Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 7 of 7 http://www.biomedcentral.com/1472-6963/13/438 31. Eccles M, Hawthorne G, Whitty P, Steen N, Vanoli A, Grimshaw J, et al: A randomised controlled trial of a patient based Diabetes Recall and Management System: the DREAM trial: a study protocol [ISRCTN32042030]. BMC Health Serv Res 2002, 2(1):5. 32. Kerry SM, Bland JM: Analysis of a trial randomised in clusters. BMJ 1999, 316(7124):54. doi:10.1186/1472-6963-13-438 Cite this article as: Etxeberria et al.: The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care. BMC Health Services Research 2013 13:438. 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The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care

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Medicine & Public Health; Public Health; Health Administration; Health Informatics; Nursing Management/Nursing Research
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Abstract

Background: The appropriate care for people with cardiovascular risk factors can reduce morbidity and mortality. One strategy for improving the care for these patients involves the implementation of evidence-based guidelines. To date, little research concerning the impact of such implementation strategies in our setting has been published. Aims. To evaluate the effectiveness of a multifaceted tailored intervention in the implementation of three cardiovascular risk-related guidelines (hypertension, type 2 diabetes and dyslipidemia) in primary care in the Basque Health Service compared with usual implementation. Methods/Design: A two-year cluster randomized clinical trial in primary care in two districts in the Basque Health Service. All primary care units are randomized. Data from all patients with diabetes, hypertension and those susceptible to coronary risk screening will be analyzed. Interventions. The control group will receive standard implementation. The experimental group will receive a multifaceted tailored implementation strategy, including a specific web page and workshops for family physicians and nurses. Endpoints. Primary endpoints: annual request for glycosylated hemoglobin, basic laboratory tests for hypertension, cardiovascular risk screening (women between 45–74 and men between 40–74 years old). Secondary endpoints: other process and clinical guideline indicators. Analysis: Data will be extracted from centralized computerized medical records. Analysis will be performed at a primary care unit level weighted by cluster size. Discussion: The main contribution of our study is that it seeks to identify an effective strategy for cardiovascular guideline implementation in primary care in our setting. Trial registration: Current Controlled Trials, ISRCTN88876909 Keywords: Diabetes, Education, Medical continuing, Guidelines, Health plan implementation, Hyperlipidemias, Hypertension, Primary health care, Risk factors, Cardiovascular * Correspondence: [email protected] Hernani Health Center, Gipuzkoa Health District, Basque Health Service, c/Aristizabal 1, 20120 Hernani, Spain Full list of author information is available at the end of the article © 2013 Etxeberria et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 2 of 7 http://www.biomedcentral.com/1472-6963/13/438 Background was drafted within the framework of the National Health Diabetes and cardiovascular risk factors System's Clinical Practice Guideline Program in collab- High blood pressure, dyslipidemia and diabetes are the oration with the Health Technology Assessment Agency main clinical conditions presented by patients with mul- Osteba. These three guidelines are available from tiple morbidities [1]. Guiasalud [7] and have been included in the National Cardiovascular disease is the leading cause of death in Guideline Clearinghouse. both the Basque Country and Spain as a whole. Despite this, cardiovascular disease-related mortality has decreased Design of CPG implementation strategies over the past few years due, amongst other reasons, to the The publication and dissemination of a CPG does not, better diagnosis and treatment of cardiovascular risk fac- however, ensure its application in clinical practice, there- tors [2]. fore effective and viable implementation plans for the Current data suggest that there remains significant organizational context at which it is aimed must be de- room for improvement in cardiovascular risk factor and signed. Implementation must be considered to be a diabetes care in our setting. According to data from the planned process whose main characteristics are dyna- Provider Agreement in 2008 only 41.3% of diabetic pa- mism and uniqueness [6]. tients in the Autonomous Community of the Basque It is important that guideline implementation inter- Country had a glycosylated hemoglobin (HbA1c) level of ventions are designed in accordance with a coherent the- less than 7.5%, basic analysis was performed in 44.9% of oretical foundation, a body of evidence to support them patients and only 27% had a blood pressure of less than and taking into account the barriers and facilitators of 140/80 mm Hg. the local setting [6,11-13]. The almost anecdotal use of tools to calculate cardio- vascular risk at that time suggests that statin treatment Theoretical foundation in primary prevention is chosen on the basis of choles- Grol’s 10-step model [11] is a theoretical reference for terol level rather than overall cardiovascular risk [3]. guideline implementation [6]. This model brings to- As far as hypertensive patients in our setting are con- gether elements from different disciplines, such as the cerned, it is estimated that only 33% have their blood diffusion of innovation theory [14], the reasoned action pressure well controlled and that 46.4% do not receive theory [15] and social cognitive theory [16], and postulates the antihypertensive agent of choice [4]. that professionals pass through different phases or stages (orientation, insight, acceptance, change and maintenance) Clinical practice guidelines as a tool for improving when achieving a change, with specific barriers predomin- healthcare ating in each phase. This study concentrates on the orien- The implementation of evidence-based clinical practice tation, insight and acceptance phases. guidelines (CPGs) may help to ensure that the care of patients with cardiovascular risk factors or diabetes Barriers and facilitators complies with the best quality criteria and standards. Although there are numerous studies concerning the CPGs are statements that include recommendations barriers and facilitators for CPG implementation [17], intended to optimize patient care which are informed by this is not the case in our setting. As a result, before de- a systematic review of evidence and an assessment of signing the guideline implementation intervention, we the benefits and harms of alternative care options [5]. As undertook a study to explore the barriers faced by CPGs such, they have the potential to reduce variability and in primary care using the Delphi technique [18]. The improve healthcare [6]. main barriers detected are the following [18]. In the past few years we have witnessed the consolida- tion of a CPG program in both the Basque Country and Dimension: Presentation of the guidelines: the Spanish National Health System as a whole that has – The teaching method used by the speakers at each led to the Guiasalud program [7], the development of a session. common methodology for drafting such guidelines [8] – The choice of speaker. and the availability of an increasing number of guide- Dimension: Format of the guidelines: lines prepared in Spain. – The need for a summarized version. Thus, in the cardiovascular field, 2008 and 2009 saw – The need to stimulate and promote the on-line the publication of the “Clinical practice guideline on the version, which makes term search easier, and the management of lipids as a cardiovascular risk factor” [9], links within the guidelines and to other material of an update to the regional “Clinical practice guideline on interest. arterial hypertension” [4] and the “Clinical practice – The need to enhance user participation (discussion guideline on type 2 diabetes” [10], the latter of which fora, asking questions, debates, etc.). Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 3 of 7 http://www.biomedcentral.com/1472-6963/13/438 Dimension: Use and utility facilitators: As no single implementation strategy is effective in all – Application of CPGs gives good results in clinical contexts, the impact of such strategies needs to be evalu- practice. ated by way of studies with a robust design and low risk – The need to attach action protocols or other of bias. Randomized designs are the gold-standard for practical tools to the guidelines. assessing healthcare interventions [12,25]. Internal barriers: Although we are witnessing significant support for the – Willingness of the physicians themselves. drafting of CPGs by public health organisations in Spain, – Too much time and effort required to understand evaluation of their subsequent implementation remains the CPGs. uncommon [26]. – Lack of acceptance of guidelines as a work tool. In our setting, the availability of three recently published – Discouragement due to lack of use at other CPGs in the cardiovascular field provides a unique oppor- healthcare levels. tunity to assess CPG implementation strategies in primary External barriers: care. – Specialized practice does not follow the guidelines. – Lack of dissemination and implementation in Main endpoint specialized care. To evaluate the effectiveness of a multifaceted tailored – Pressure from the pharmaceutical industry. intervention in the implementation of three cardiovas- – Methodology followed to learn the guidelines. cular risk-related CPGs (hypertension, type 2 diabetes and lipids as cardiovascular risk factor) in primary Effectiveness of guideline implementation interventions care in the Basque Health Service compared with usual According to Grimshaw’s systematic review [12], the ef- implementation. fectiveness of different clinical practice guideline dissem- ination and implementation strategies varies but, in Secondary endpoints general, tends to be modest. The dissemination of edu- cational materials tends to be poorly effective but at  To evaluate the impact of the intervention on the low-cost, whereas continual medical training is more degree of compliance with process quality indicators effective if undertaken in small groups using realistic and subrogate clinical endpoints for the care of scenarios [19-21]. The efficacy of opinion leader-based patients with type 2 diabetes. training tends to vary [12]. Multifaceted interventions  To evaluate the impact of the intervention on the appear to make sense if they are intended to overcome degree of compliance with process quality indicators specific barriers [19]. Indeed, tailored interventions are and subrogate clinical endpoints for the care of more effective than passive guideline dissemination [13]. patients with hypertension. In the field of diabetes, the review by Shojania [22]  To evaluate the impact of the intervention on the showed that multifaceted interventions provided a larger degree of compliance with coronary risk screening effect than interventions involving a single compo- process quality indicators. nent. Educational interventions showed an acceptable  To evaluate the impact of the intervention on the efficacy. In the field of hypertension, educational in- prescription of statins in primary and secondary terventions aimed at healthcare professionals resulted prevention. in a modest improvement in blood pressure control [23]. The most effective strategy for implementing the Methods/Design use of risk tables in cardiovascular disease prevention Study design and setting is still unknown [24]. This study is a cluster randomized trial conducted in two urban primary care districts in the Basque Health Context Service (Ekialde and Bilbao). These districts cover 36.9% The intervention and study were designed in the context of the population in the Basque Country. Primary care of a primary care research group with a clinical and/ units (PCU) will be randomly assigned. or methodological profile involved in the drafting and A cluster-type design is selected as the intervention implementation of evidence-based guidelines. The inter- was aimed at professionals working in a PCU and due to vention was aimed at primary care professionals (physi- the risk of contamination between professionals working cians and nurses) and no organisational changes or in the same PCU [27,28]. interventions in patients were considered. A further A repeated cross-sectional design is used for all pa- assumption was that the proposed interventions had tients who attend during the baseline period (pre- to be feasible and result in a reasonable cost to the intervention, or “PRE”) and in the post-intervention period health system. (“POST”), with different samples. Such an approach is Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 4 of 7 http://www.biomedcentral.com/1472-6963/13/438 appropriate when the aim of the study is to determine the – Patients who commenced statin treatment during impact of CPG implementation on the population and the study period. provides greater long-term power [27,28]. It also allows – Patients diagnosed with ischemic heart disease minor baseline differences that may arise due to cluster during the study period. randomization to be compensated. The study design is shown in Figure 1. The exclusion criteria are: patients assigned physicians or nurses who declined to participate in the study, youn- Study population ger than 14 years of age, patients assigned to physicians Consent to participate was received from the heads of occupying two or more medical posts belonging to the all PCUs from both districts, therefore they were all ran- intervention and control groups at the same time, and domized (43 PCUs). All professionals (physicians and patients who don’t attend their PCU during the study nurses) appointed to medical jobs in family medicine period. who agreed to participate in the study were included. Data from all patients who attend their PCU during the Interventions study period (PRE and POST intervention) and assigned The control group will receive usual implementation, to the PCUs and physicians/nurses who participate in namely mailing of the guideline, publication in the intra- the study will be analyzed, if they complied with one of net and presentation sessions in the PCU. These sessions the following inclusion criteria: will be led by physicians trained by the trainers respon- sible for teaching the intervention group. – A diagnosis of type 2 diabetes in the medical record. In addition to the control group interventions, the – A diagnosis of hypertension in the medical record. multifaceted implementation for the experimental group – Population susceptible to cardiovascular risk also includes: screening: women aged 45–74 years and men aged 40–74 years with no ischemic heart disease. – Identical presentation sessions to those for the control group but given by physicians who took part in the guideline development process. – The design of a specific web page with the Eligible PCUs: 43 (patients assigned to 448 medical positions) guideline recommendations aimed at the action, with quick access, application tools (algorithms and tables with links to the main Randomization recommendations, patient materials), the possibility to ask questions, links to drug-related information. Intervention: 21 PCUs Control: 22 PCUs Physicians: 213 Physicians: 235 – Three-hour workshops for family physicians and Baseline measurements Baseline nurses, eight cardiovascular risk workshops for (PRE) measurements (PRE) family physicians and a further eight for nursing staff, and four diabetic foot workshops for nursing staff. These workshops will be mostly Multifaceted intervention Usual implementation led by the physicians responsible for the guidelines with the colaboration of two non-involved nurses. Endpoints Primary endpoints Post-intervention Post-intervention measurements measurements – Diabetes: percentage of patients with annual request (POST) (POST) for glycosylated haemoglobin (HbA1c). – Hypertension: percentage of patients with annual request for basic analysis, including albumin- creatinine ratio. Data extraction and analysis – Dyslipidemia: males between 40–74 and females between 45–74 years with at least one cardiovascular risk assessment (except males and Figure 1 Study design. females with cardiovascular disease). Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 5 of 7 http://www.biomedcentral.com/1472-6963/13/438 Secondary endpoints generated randomization sequence. Randomization is per- formed centrally by a researcher not involved in the study – Diabetes: percentage of patients with HbA1c lower who was blind to the identity of the PCU. than 7%, percentage of patients with blood pressure lower than 140/80 mm Hg, percentage of patients Masking with confirmed basic analysis, percentage of patients Professionals implementing the intervention are not with confirmed cardiovascular risk assessment, blinded to the assignment group. However, data extrac- percentage of patients with confirmed foot tion will be performed centrally by computer technicians examination and new pharmacological treatment not involved in the study and data will be treated by re- started with metformin. search personnel after anonymisation. – Hypertension: percentage of non-diabetic patients with blood pressure lower than 140/90 mm Hg, Analysis percentage of patients with annual cardiovascular Data will be extracted from centralized computerized risk assessment, percentage of patients starting medical records. Analysis will be performed at the PCU pharmacological treatment with diuretics, beta- level taking the cluster design into account [32]. Indica- blockers or angiotensin-II receptor blockers. tors will be obtained for each PCU before and after – Dyslipidemia: percentage of patients aged between the intervention and the differences will be weighted 35 and 74 years with no cardiovascular disease by cluster size. All analyses will be performed using starting a statin treatment with previous Student’s t-test as implemented in SPSS 19. A sec- cardiovascular risk assessment, new statin ondary multi-level analysis will be performed using treatments in women aged over 35 years with no MLwiN (version 2.21) to determine the intracluster cardiovascular disease or diabetes, percentage of correlation coefficients (ICCs). patients with a new diagnosis of coronary heart Analysis will be performed on an intention-to-treat disease receiving statin treatment. basis. Sample size Ethical considerations The following aspects were taken into account when cal- This trial was approved by the Clinical Research Ethics culating the sample size: Committee of the Basque Country. The protocol was regis- tered in the Current Controlled Trials database (ISRCTN On average, 45-50% of diabetic patients assigned to 88876909). Funding was provided by the Spanish Ministry a healthcare professional undergo at least two of Health as part of the 2007–2008 collaboration agree- annual HbA1c analyses (standard deviation 15-20%). ment anticipated in the National Health System’squality An annual analysis is requested in around 35% of plan between the Carlos III Research Institute, an autono- hypertensive patients. (Data taken from the Provider mous body that forms part of the Spanish Ministry of Agreement, 2007). Science and Innovation, and the Basque Government’s From a clinical and operational viewpoint, an Department for Health and Consumer Affairs (OSTEBA). intervention strategy would be worthwhile if these averages could be increased to 55-60% for diabetes Discussion and 43% for hypertension. There is a growing need to identify effective implemen- The size of the PCUs is similar, with around 10 tation strategies for CPGs for the management of cardio- physicians per PCU, and the number of patients vascular risk factors in primary care. This study is one of assigned to each clinician is also similar. the few cluster randomized trials concerning the imple- The intracluster correlation coefficient (ICC) is 0.10 mentation of clinical practice guidelines in Spanish pri- [29-31]. mary care. This study focuses on multiple cardiovascular risk fac- In light of these considerations, approximately 100 tors as primary endpoints. Its pragmatic design is aimed physicians per group (10 PCUs in each group) would be at determined the actual impact of implementing CPGs needed for an α of 0.05 and a β of 0.20. Applying the for type 2 diabetes, hypertension and dyslipidemia via a cluster-related design effect gives a final number of 20 multifaceted intervention based on identifying local bar- PCUs per group (intervention and control). riers to CPG implementation, and it is aimed at primary care professionals. Randomization The limitations of this study include the use of medical Allocation is performed by clusters. PCUs are assigned to records as data source. Giving the nature of the study, the intervention or control group following a computer- the intervention cannot be masked. Etxeberria et al. BMC Health Services Research 2013, 13:438 Page 6 of 7 http://www.biomedcentral.com/1472-6963/13/438 The findings of this study will allow a more effective Madrid: Plan Nacional para el SNS del MSC. Instituto Aragonés de Ciencias de la Salud-I + CS; 2007. Guías de Práctica Clínica en el SNS: I + CSNº 2006/0I. CPG planning in the primary cardiovascular care field to 9. San Vicente R, Ibarra J, Pérez I, Berraondo I, Uribe F, Urraca J: Guía de be designed. Similarly, it will allow the key aspects of Práctica Clínica sobre el manejo de los lípidos como factor de riesgo recommendation implementation in our setting to be cardiovascular. Vitoria-Gasteiz: Osakidetza-Servicio Vasco de Salud; 2009. 10. Grupo de trabajo para la elaboración de la Guía de Práctica Clínica sobre identified. All this information may prove useful in the Diabetes tipo 2: Guía de Práctica Clínica sobre Diabetes tipo 2. Madrid: Plan organisational transformation currently underway in the Nacional para el SNS del MSC. Agencia de Evaluación de Tecnologías Basque Country to adapt the health system to the care Sanitarias del País Vasco; 2008. Guías de Práctica Clínica en el SNS: OSTEBA, No 2006/08. needs of patients with chronic diseases. 11. Grol R, Wensing M, Eccles M: Improving Patient Care. The implementation of Change in. London: Clinical Practice: Elsevier; 2005. Abbreviations 12. 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JIE calculated the sample size and helped to design the of theory and research. Reading, Massachusettes: Addison-Wesley; 1975. study. JIE and MI planned the statistical analysis. ERV helped to plan the 16. Bandura A: Social foundations of thought and action: a social cognitive study and the intervention. AE drafted the study protocol. All authors theory. Englewood Cliffs, NJ: Prentice Hill; 1986. reviewed the draft version, made suggestions and approved the final 17. Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al: Why version. don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999, 282(15):1458–1465. 18. Pérez Irazusta I, Torres E, Alcorta I, Etxeberria A, Rotaeche R, Reviriego E: Acknowledgements Exploración de barreras y facilitadores para la implementación de guías de Juan Chinchilla, for designing the web page. práctica clínica:un estudio Delphi. Plan de Calidad para el Sistema Nacional de Eva Reviriego, for helping to design the web page. Salud del Ministerio de Sanidad y Política Social.Servicio de Evaluación de Ana Bustinduy, for advice concerning how to define and obtain the Tecnologías Sanitarias del País Vasco (Osteba). Madrid: Informes de indicators. Evaluación de Tecnologías Sanitarias, OSTEBA Nº 2007/5; 2009. The management teams in the Bilbao and Gipuzkoa regions and the Healthcare Directorate of Osakidetza, for supporting the project. 19. Robertson R, Jochelson K: Interventions that change clinician behaviour: Rosa Rico and OSTEBA, for supporting the project. mapping the literature. London: NICE; 2006. BIOEF, for translating the protocol. 20. Forsetlund L, Bjorndal A, Rashidian A, Jamtvedt G, O’Brien MA, Wolf F, et al: Continuing education meetings and workshops: effects on professional Author details practice and health care outcomes. Coch Datab Syst Rev 2009, 2:1–99. 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