The safety in primary care study: a randomised, controlled feasibility study
| ISRCTN | ISRCTN11426121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11426121 |
| Protocol serial number | N/A |
| Sponsor | HRB Primary Care Clinical Trials Network Ireland |
| Funder | Health Research Board |
- Submission date
- 08/06/2018
- Registration date
- 12/06/2018
- Last edited
- 01/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Research on patient safety has focused largely on hospital settings, and there is limited knowledge about patient safety in primary care. This study aims to assess the effectiveness of an intervention to improve patient safety in primary care. The purpose of this study is to evaluate whether a future larger study of the patient safety intervention should be carried out.
Who can participate?
Staff working in general practices in the Republic of Ireland and in Northern Ireland
What does the study involve?
Participating practices are randomly allocated to one of two groups to either receive the intervention over a 9-month period or to continue care as usual. The interventions include repeated completion of a safety questionnaire and feedback on these findings, and the review of patient records to identify any patients who may have been harmed as part of their care.
What are the possible benefits and risks of participating?
The findings from the study may increase knowledge of how often patients are harmed in primary care, contribute to improved patient safety practices in primary care, and inform future research on patient safety improvement. The benefits of participating are that there will be an increased awareness of patient safety in the practice that may lead to improved patient care. The risks are that participants may become distressed if they realise they contributed to a patient safety incident.
Where is the study run from?
1. NUI Galway (Ireland)
2. Queen's University Belfast (UK)
When is the study starting and how long is it expected to run for?
September 2015 to June 2017
Who is funding the study?
Health Research Board (Ireland)
Who is the main contact?
Dr Paul O'Connor
paul.oconnor@nuigalway.ie
Contact information
Scientific
Discipline of General Practice
NUI Galway
1 Distillery Road
Galway
H91 TK33
Ireland
| Phone | +353 (0)91492897 |
|---|---|
| paul.oconnor@nuigalway.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | The safety in primary care study: a randomised, controlled feasibility study |
| Study acronym | SAP-C |
| Study objectives | The purpose of this feasibility study is to evaluate the: 1. Willingness of practices to participate in the study 2. Retention of control and intervention practices 3. Response rates to questionnaires 4. Feedback from the intervention group on the feasibility, usefulness, and sustainability of the intervention 5. Effects of the intervention on safety climate |
| Ethics approval(s) | 1. Irish College of General Practitioners’ Research Ethics Committee, 14/01/2016 2. Office for Research Ethics Committees of Northern Ireland, 23/02/2016, ref: 16/NI/0008 |
| Health condition(s) or problem(s) studied | General practice |
| Intervention | Simple randomisation was employed, whereby participating practices were assigned to either the intervention or control group. Five practices received the intervention over a 9-month period. The intervention consisted of: 1) repeated safety climate (SC) measurement (using GP-SafeQuest questionnaire) and feedback, and 2) patient record reviews using a specialised trigger tool to identify instances of undetected patient harm. The five practices in the control group continued care as usual. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The evaluation of the study’s implementation process was the primary outcome. Outcomes of interest were: |
| Key secondary outcome measure(s) |
None |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | Staff working in general practices in the Republic of Ireland or Northern Ireland that have expressed a willingness to be involved in the study |
| Key exclusion criteria | People who do not work in a general practice that agreed to participate in the study |
| Date of first enrolment | 01/02/2016 |
| Date of final enrolment | 21/03/2016 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
- Ireland
Study participating centres
Galway
H91 TK33
Ireland
Belfast
BT9 7HR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Requests for access to data should be made to Dr Paul O’Connor (paul.oconnor@nuigalway.ie). The data will be available from December 2018. Data that could be made available is anonymous safety climate data, and the feasibility questionnaire data. Sharing data was not explicitly mentioned in the consent form. Therefore, requests for data sharing will have to be considered on a case-by-case basis by the members of the trial steering committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/01/2019 | 01/02/2019 | Yes | No |
| Protocol article | protocol | 16/09/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/02/2019: Publication reference added.
