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

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, ISRCTN8887690

Desprescripción de tratamientos de larga duración con bisfosfonatos para la osteoporosis en atención primaria en el País Vasco

Objetivo: Evaluar el impacto de una intervención multifactorial para promover la desprescripción de tratamientos con bisfosfonatos de duración superior a 5 años (BF5a) en la Comarca Gipuzkoa y compararlo con la intervención estándar en el resto de las organizaciones de servicios (OS) de Osakidetza. Métodos: Estudio de evaluación del impacto de dos intervenciones con medida de resultados antes y después, con un seguimiento de 8 meses. Se incluyeron todos los pacientes de Osakidetza que en julio de 2013 tenían un tratamiento activo con BF5a (prescripción electrónica). La intervención estándar (9 OS) consistió en el envío de un documento de consenso sobre desprescripción de BF5a y en facilitar los identificadores de pacientes con BF5a para su revisión por el médico de atención primaria. La intervención multifactorial (Comarca Gipuzkoa) incluyó, además, un consenso local con los especialistas de referencia y sesiones de formación en los centros de salud. Resultados: Se incluyeron 18.725 pacientes, el 94,7% mujeres. Con la intervención estándar, los porcentajes de desprescripción oscilaron entre el 26,4% (C. Bilbao) y el 49,4% (C. Araba), siendo del 37,2% en su conjunto. Con la intervención multifactorial la desprescripción fue del 44,6%, un 7,4% superior a la estándar (p <0,0001; intervalo de confianza del 95% [IC95%]: 5,4-9,4). Los desplazamientos a otros tratamientos fueron menos frecuentes con la intervención multifactorial, con una diferencia del 3,7% (p <0.0001; IC95%: −2,2 a −5,2). Conclusiones: Las intervenciones estándar y multifactorial son muy efectivas para disminuir los tratamientos innecesarios con bisfosfonatos. La intervención multifactorial es más efectiva que la estándar, aunque más compleja de llevar a cabo

Results from the CLUES study: a cluster randomized trial for the evaluation of cardiovascular guideline implementation in primary care in Spain

Abstract Background The implementation of evidence-based clinical practice guidelines (CPG) can improve patients care. To date, the impact of implementation strategies has not been evaluated in our context. This study is aimed to evaluate the effectiveness of a multifaceted tailored intervention targeting clinician education for the implementation of three cardiovascular risk-related CPGs (type 2 diabetes, hypertension and dyslipidemia) in primary care at the Basque Health Service compared with usual implementation. Methods We conducted a cluster randomized controlled trial in two urban districts with 43 primary care units (PCU). Data from all patients diagnosed with diabetes, hypertension and all those eligible for coronary risk (CR) assessment were included. In the control group, guidelines were introduced in the usual way (by email, intranet and clinical meetings). In the intervention group, the implementation also included a specific website and workshops. Primary endpoints were annual HbA1c testing (diabetes), annual general laboratory testing (hypertension) and annual CR assessment (dyslipidemia). Secondary endpoints were process, prescription and clinical endpoints related with guideline recommendations. Analysis was performed at a PCU level weighted by cluster size. Results Significant differences between groups were observed in primary outcomes in the dyslipidemia CPG: increased CR assessment for both women and men (weighted mean difference, WMD, 13.58 and 12.91%). No significant differences were observed in diabetes and hypertension CPGs primary outcomes. Regarding secondary endpoints, annual CR assessment was significantly higher in both diabetic and hypertensive patients in the intervention group (WMD 28.16 and 27.55%). Rates of CR assessment before starting new statin treatments also increased (WMD 23.09%), resulting in a lower rate of statin prescribing in low risk women. Diuretic prescribing was higher in the intervention group (WMD 20.59%). Clinical outcomes (HbA1c and blood pressure control) did not differ between groups. Conclusions The multifaceted implementation proved to be effective to increase the CR assessment and to improve prescription, but ineffective to improve diabetes and hypertension related outcomes. In order to obtain real improvements when cardiovascular issues are tackled, perhaps other or additional interventions need to be implemented besides education of professionals. Trial registration Current Controlled Trials, ISRCTN 88876909 (retrospectively registered on January 13, 2009

Additional file 2: of Results from the CLUES study: a cluster randomized trial for the evaluation of cardiovascular guideline implementation in primary care in Spain

Clues: Staff attendance at interventions in primary care units. Data containing a detailed description of staff attendance at interventions in primary care units in both groups (intervention and control). (DOCX 23 kb