Condition category
Not Applicable
Date applied
31/12/2010
Date assigned
07/02/2011
Last edited
07/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.sergas.es

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes