Open Access Study protocol

Effectiveness of a clinical practice guideline implementation strategy for patients with anxiety disorders in primary care: cluster randomized trial

Eugenia Tello-Bernabé1*, Teresa Sanz-Cuesta2, Isabel del Cura-González2, María L de Santiago-Hernando3, Montserrat Jurado-Sueiro3, Mercedes Fernández-Girón4, Francisca García-de Blas5, Higinio Pensado-Freire6, Francisco Góngora-Maldonado7, María J de la Puente-Chamorro6, Carmen Rodríguez-Pasamontes8 and Susana Martín-Iglesias9

Author Affiliations

1 Centro de Salud El Naranjo. Gerencia Atención Primaria. Servicio Madrileño de Salud. Spain

2 Unidad Apoyo a la Investigación. Gerencia Atención Primaria, Servicio Madrileño de Salud, Spain

3 Centro de Salud Castilla La Nueva. Gerencia Atención Primaria, Servicio Madrileño de Salud, Spain

4 Centro de Salud Mª Ángeles López Gómez. Gerencia Atención Primaria, Servicio Madrileño de Salud, Spain

5 Centro de Salud Mendiguchía Carriche. Gerencia Atención Primaria, Servicio Madrileño de Salud, Spain

6 Centro de Salud Francia. Gerencia Atención Primaria, Servicio Madrileño de Salud, Spain

7 Centro de Salud Humanes. Gerencia Atención Primaria, Servicio Madrileño de Salud, Spain

8 Centro de Salud Santa Isabel. Gerencia Atención Primaria, Servicio Madrileño de Salud, Spain

9 Dirección Asistencial Sur. Gerencia Atención Primaria, Servicio Madrileño de Salud, Spain

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Implementation Science 2011, 6:123  doi:10.1186/1748-5908-6-123

Published: 1 December 2011

Abstract

Background

Anxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs) have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low.

Method/design

This study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain). The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back) of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion.

The number of patients required is 296 (148 in each arm), all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). They are chosen by consecutive sampling.

The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D), and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.

Discussion

There is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care patients receive.

Trial registration

ISRCTN: ISRCTN83365316