Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Health Services Research
Published in: BMC Health Services Research 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Arritxu Etxeberria, Itziar Pérez, Idoia Alcorta, Jose Ignacio Emparanza, Elena Ruiz de Velasco, Maria Teresa Iglesias, Domingo Orozco-Beltrán, Rafael Rotaeche

Published in: BMC Health Services Research | Issue 1/2013

Login to get access

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
Appendix
Available only for authorised users
Literature
1.
Departamento de Sanidad y Consumo del Gobierno Vasco: Estrategia para afrontar la cronicidad en Euskadi. 2010, Vitoria-Gasteiz: Departamento de Sanidad y Consumo del Gobierno vasco
2.
Departamento de Sanidad y Consumo del Gobierno Vasco: Políticas de salud para Euskadi: Plan de Salud 2002–2010. 2002, Vitoria-Gasteiz
3.
Swinnen SG, Dain MP, Mauricio D, DeVries JH, Hoekstra JB, Holleman F: Continuation versus discontinuation of insulin secretagogues when initiating insulin in type 2 diabetes. Diab Obes Metab. 2010, 12 (10): 923-925. 10.1111/j.1463-1326.2010.01258.x.CrossRef
4.
Rotaeche R, Aguirrezabala J, Balagué L, Gorroñogoitia A, Idarreta I, Mariñelarena E, et al: Guía de Práctica Clínica sobre Hipertensión Arterial (actualización 2007). 2009, Vitoria-Gasteiz: Osakidetza-Servicio Vasco de Salud
5.
Institute of Medicine: Clinical Practice Guidelines. We Can Trust. 2011, Washington, DC: The National Academic Press
6.
Grupo de trabajo sobre implementación de GPC: Implementación de Guías de Práctica Clínica en el Sistema Nacional de Salud. Manual Metodológico. 2009, Madrid: Plan Nacional para el SNS del MSC
7.
8.
Grupo de Trabajo sobre Guías de Práctica Clínica: Elaboración de Guías de Práctica Clínica en el Sistema Nacional de Salud. Manual Metodológico. 2007, Madrid: Plan Nacional para el SNS del MSC. Instituto Aragonés de Ciencias de la Salud-I + CS, Guías de Práctica Clínica en el SNS: I + CSNº 2006/0I
9.
San Vicente R, Ibarra J, Pérez I, Berraondo I, Uribe F, Urraca J: Guía de Práctica Clínica sobre el manejo de los lípidos como factor de riesgo cardiovascular. 2009, Vitoria-Gasteiz: Osakidetza-Servicio Vasco de Salud
10.
Grupo de trabajo para la elaboración de la Guía de Práctica Clínica sobre Diabetes tipo 2: Guía de Práctica Clínica sobre Diabetes tipo 2. 2008, Madrid: Plan Nacional para el SNS del MSC. Agencia de Evaluación de Tecnologías Sanitarias del País Vasco, Guías de Práctica Clínica en el SNS: OSTEBA, No 2006/08
11.
Grol R, Wensing M, Eccles M: Improving Patient Care. The implementation of Change in. 2005, London: Clinical Practice: Elsevier
12.
Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, et al: Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004, 8 (6): iii-72.CrossRef
13.
Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp S, et al: Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes. Coch Datab Syst Rev. 2010, 3: 1-64. CD005470
14.
Rogers E: Diffusion of Innovations. 1962, New York: Free Press of Glencoe
15.
Fishbein M, Ajzen I: Belief, attitude, intention and behaviour: an introduction of theory and research. 1975, Reading, Massachusettes: Addison-Wesley
16.
Bandura A: Social foundations of thought and action: a social cognitive theory. 1986, Englewood Cliffs, NJ: Prentice Hill
17.
Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al: Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999, 282 (15): 1458-1465. 10.1001/jama.282.15.1458.CrossRefPubMed
18.
Pérez Irazusta I, Torres E, Alcorta I, Etxeberria A, Rotaeche R, Reviriego E: Exploración de barreras y facilitadores para la implementación de guías de práctica clínica:un estudio Delphi. Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad y Política Social.Servicio de Evaluación de Tecnologías Sanitarias del País Vasco (Osteba). 2009, Madrid: Informes de Evaluación de Tecnologías Sanitarias, OSTEBA Nº 2007/5
19.
Robertson R, Jochelson K: Interventions that change clinician behaviour: mapping the literature. 2006, London: NICE
20.
Forsetlund L, Bjorndal A, Rashidian A, Jamtvedt G, O’Brien MA, Wolf F, et al: Continuing education meetings and workshops: effects on professional practice and health care outcomes. Coch Datab Syst Rev. 2009, 2: 1-99. CD003030
21.
Mansouri M, Lockyer J: A meta-analysis of continuing medical education effectiveness. J Contin Educ Health Prof. 2007, 27 (1): 6-15. 10.1002/chp.88.CrossRefPubMed
22.
Shojania K, Ranji S, Shaw L, Charo L, Lai J, Rushakoff R, et al: Diabetes Mellitus Care. Vol. 2. Closing The Quality Gap: A Critical Analysis of Quality Improvement Strategies. Edited by: Shojania KG, McDonald KM, Wachter RM, Owens DK. 2004, Rockville, MD: Agency for Healthcare Research and Quality
23.
Glynn LG, Murphy AW, Smith SM, Schroeder K, Fahey T: Interventions used 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 implementation strategies for risk tables in the prevention of cardiovascular diseases. Vasc Health Risk Manage. 2008, 4 (3): 535-545. Epub 2008/10/02
25.
Eccles M, Grimshaw J, Campbell M, Ramsay C: Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Safety Health Care. 2003, 12 (1): 47-52. 10.1136/qhc.12.1.47.CrossRef
26.
Romero A, Alonso C, Marin I, Grimshaw J, Villar E, Rincon M, et al: Efectividad de la implantación de una guía clínica sobre la angina inestable mediante una estrategia multifactorial. Ensayo clínico aleatorizado en grupos. RevEspCardiol. 2005, 58 (6): 640-648.
27.
Ukoumunne OC, Gulliford MC, Chinn S, Sterne JA, Burney PG, Donner A: Methods in health service research. Evaluation of health interventions at areawide and organisation-based interventions in health and health 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 Research. 2000, New York: John Wiley& Sons, Ltd
29.
30.
Perria C: Strategies for the introduction and implementation of a guideline for the treatment of type 2 diabetics by general practitioners (GPs) of the Lazio region of Italy (IMPLEMEG study): protocol for a cluster randomised controlled trial [ISRCTN80116232]. BMC Health Serv Res. 2004, 4 (1): 13-10.1186/1472-6963-4-13.CrossRefPubMedPubMedCentral
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): 5-10.1186/1472-6963-2-5.CrossRefPubMedPubMedCentral
32.
Kerry SM, Bland JM: Analysis of a trial randomised in clusters. BMJ. 1999, 316 (7124): 54.CrossRef
Metadata
Title
The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care
Authors
Arritxu Etxeberria
Itziar Pérez
Idoia Alcorta
Jose Ignacio Emparanza
Elena Ruiz de Velasco
Maria Teresa Iglesias
Domingo Orozco-Beltrán
Rafael Rotaeche
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2013
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-13-438

Other articles of this Issue 1/2013

BMC Health Services Research 1/2013 Go to the issue

Research article

Application of propensity scores to estimate the association between government subsidy and injection use in primary health care institutions in China

Research article

How health professionals conceive and construct interprofessional practice in rural settings: a qualitative study

Research article

Micro-costing the provision of emotional support and information in UK eye clinics

Study protocol

Implementation and effectiveness of 'care navigation', coordinated management for people with complex chronic illness: rationale and methods of a randomised controlled trial

Research article

Factors associated with involuntary admissions among patients with substance use disorders and comorbidity: a cross-sectional study

Research article

Implementing disability evaluation and welfare services based on the framework of the international classification of functioning, disability and health: experiences in Taiwan