Adverse events analysis as an educational tool to improve patient safety culture in primary care: an experimental study
| ISRCTN | ISRCTN41911128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41911128 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/12/2010
- Registration date
- 07/02/2011
- Last edited
- 12/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Clara González-Formoso
Scientific
Scientific
Rosalía de Castro, 21-23
36201 Vigo - Pontevedra
Vigo
36201
Spain
| Phone | +34 986 816499 |
|---|---|
| clara.gonzalez.formoso@sergas.es |
Study information
| Study design | Experimental unifactorial controlled randomised multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethical Committee of Clinical Research of Galicia approved on the 30th September 2008 (ref: 2008/268) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 27 tutor-resident pairs in each group (108 in total) |
| Total final enrolment | 138 |
| Key inclusion criteria | Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain |
| Key exclusion criteria | Unwilling to participate |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Rosalía de Castro, 21-23
Vigo
36201
Spain
36201
Spain
Sponsor information
Department of Health of Galicia (Spain)
Government
Government
Edificio Administrativo de San Lázaro
Santiago de Compostela
15703
Spain
| Phone | +34 981 54 27 99 |
|---|---|
| innovacion.xestion.saudepublica@sergas.es | |
| Website | http://www.sergas.es |
"ROR" |
https://ror.org/0181xnw06 |
Funders
Funder type
Government
Department of Health of Galicia (Spain) (ref: PS08/43)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/01/2019 | 12/02/2020 | Yes | No |
Editorial Notes
12/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
