Open Access Open Badges Study protocol

Adverse events analysis as an educational tool to improve patient safety culture in primary care: A randomized trial

Clara González-Formoso1*, María Victoria Martín-Miguel2, Ma José Fernández-Domínguez3, Antonio Rial4, Fernando Isidro Lago-Deibe5, Luis Ramil-Hermida6, Margarita Pérez-García7 and Ana Clavería1

Author Affiliations

1 Quality Unit, Vigo Primary Care Region, Galician Health Service, (Rosalía de Castro 21-23), Vigo (36201), Spain

2 Health Center of Matamá, Vigo Primary Care Region, Galician Health Service, (Babio s/n), Vigo (36312), Spain

3 Teaching Unit of Family and Community Medicine, Galician Health Service, (Avenida de Zamora 13), Ourense (32005), Spain

4 Department of Methodology, Faculty of Psychology, University of Santiago de Compostela, (Campus Sur s/n), Santiago de Compostela, (15872), Spain

5 Health Center of Sárdoma, Galician Health Service, (Baixada a Laxe 76), Vigo, (36204), Spain

6 Health Center of Fontenla Maristany, Ferrol Primary Care Region, Galician National Health Service. (Plaza de España 19), Ferrol (15403), Spain

7 Health Center of Mariñamansa, Galician Health Service, (Peña Rey s/n), Ourense, (32005), Spain

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BMC Family Practice 2011, 12:50  doi:10.1186/1471-2296-12-50

Published: 14 June 2011



Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience.

Our study aims to achieve the following:

- Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia.

- Find and analyze educational tools to improve patient safety culture in primary care.

- Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care.

Design and methods


Experimental unifactorial study of two groups, control and intervention.

Study population

Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain.


From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned.


Residents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group-either intervention or control-through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After the intervention has ended, the survey will once again be provided to all participants.

Outcome measures

Change in safety culture as measured by Hospital Survey on Patient Safety Culture

CONSORT Extension for Non-Pharmacologic Treatments 2008 was applied.


The most significant limitations on the project are related to selecting a tool to measure the safety environment, the training calendar of residents in Family and Community Medicine in last year of studies and the no-answer bias inherent to research conducted through self-administered surveys.

The development and application of a safety culture in the health sector, specifically in primary care, is as yet limited. Thus, identifying the strengths and weaknesses in the safety environment may assist in designing strategies for improvement in the primary care health centers of our region.

Trial registration