Condition category
Not Applicable
Date applied
08/06/2018
Date assigned
12/06/2018
Last edited
11/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul O'Connor

ORCID ID

Contact details

Discipline of General Practice
NUI Galway
1 Distillery Road
Galway
H91 TK33
Ireland
+353 (0)91492897
paul.oconnor@nuigalway.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The safety in primary care study: a randomised, controlled feasibility study

Acronym

SAP-C

Study hypothesis

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

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

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measure

The evaluation of the study’s implementation process was the primary outcome. Outcomes of interest were:
1. Willingness of practices to participate in the study, measured during the recruitment phase prior to the intervention
2. Response rates to safety climate questionnaire, measure at baseline and month 9
3. Feasibility questionnaire at month 9
4. Retention of control and intervention practices, measured at month 9
5. interviews on the feasibility, usefulness, and sustainability of the intervention at month 9

Secondary outcome measures

None

Overall trial start date

01/09/2015

Overall trial end date

30/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

This is a randomised controlled feasibility study, so the target was 10 general practices (8 from the Republic of Ireland and two from Northern Ireland)

Participant exclusion criteria

People who do not work in a general practice that agreed to participate in the study

Recruitment start date

01/02/2016

Recruitment end date

21/03/2016

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Discipline of General Practice
NUI Galway
Galway
H91 TK33
Ireland

Trial participating centre

Department of General Practice and Primary Care
Queen's University Belfast
Belfast
BT9 7HR
United Kingdom

Sponsor information

Organisation

HRB Primary Care Clinical Trials Network Ireland

Sponsor details

Discipline of General Practice
School of Medicine
NUI Galway
Galway
H91 TK33
Ireland
+353 (0)91 495308
info@primarycaretrials.ie

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Health Research Board

Alternative name(s)

HRB

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Ireland

Results and Publications

Publication and dissemination plan

The manuscript describing the trial is under review in a primary care journal, expected publication in winter 2018.

IPD sharing statement
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.

Intention to publish date

31/12/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27965872

Publication citations

Additional files

Editorial Notes