Contact information
Type
Scientific
Primary contact
Ms Clara González-Formoso
ORCID ID
Contact details
Rosalía de Castro
21-23
36201 Vigo - Pontevedra
Vigo
36201
Spain
+34 986 816499
clara.gonzalez.formoso@sergas.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The adverse events analysis as an educational tool to improve patient safety culture between family physicians in primary care: an experimental unifactorial controlled randomised multicentre trial
Acronym
Study hypothesis
1. The registry of adverse events is a teaching tool that has a positive impact on patient safety culture in the Family and Community Medicine teaching units of Galicia
2. The Hospital Survey on Patient Safety Culture (SOPS) is valid for use in primary health care services
Ethics approval
Ethical Committee of Clinical Research of Galicia approved on the 30th September 2008 (ref: 2008/268)
Study design
Experimental unifactorial controlled randomised multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patient safety culture
Intervention
Residents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine throughout Galicia will be invited to participate. Tutor-resident pairs that agree 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.
Intervention group:
1. One training workshops will be conducted in each of the 7 areas included (except in Lugo where 2 will be given). Each workshop will last 2 hours.
2. Professionals in the tutor-resident pairs in the intervention group will record adverse events for 15 days.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The dependent variable will be patient safety culture as measured by the Hospital Survey on Patient Safety Culture (SOPS). The independent or explanatory variable will be participation in the intervention - training workshops, recording of adverse events in daily work and reception of feedback.
First round SOPS (3-6 months) and second round SOPS (9-12 months).
Secondary outcome measures
Reliability (internal consistency, repeatability), validity (content, criteria, construct) and change sensitivity (size of effect, paired t) of the Hospital Survey on Patient Safety Culture
First round SOPS (3-6 months) and second round SOPS (9-12 months).
Overall trial start date
01/01/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
27 tutor-resident pairs in each group (108 in total)
Participant exclusion criteria
Unwilling to participate
Recruitment start date
01/01/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Spain
Trial participating centre
Rosalía de Castro, 21-23
Vigo
36201
Spain
Sponsor information
Organisation
Department of Health of Galicia (Spain)
Sponsor details
Edificio Administrativo de San Lázaro
Santiago de Compostela
15703
Spain
+34 981 54 27 99
innovacion.xestion.saudepublica@sergas.es
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health of Galicia (Spain) (ref: PS08/43)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list