Title

Understanding the nature and frequency of avoidable harm in primary care (Phase 1)

Principal / Lead investigator
Co-investigators / research team
Type of study

Development of an educational programme

Summary

Introduction Most patient safety research has focused on specialist-care settings where there is an appreciation of the frequency and causes of medical errors, and the resulting burden of adverse events. There have, however, been few large-scale robust studies that have investigated the extent and severity of avoidable harm in primary care. To address this, we will conduct a 12-month retrospective cross-sectional study involving case note review of primary care patients. 

Methods and analysis We will conduct electronic searches of general practice (GP) clinical computer systems to identify patients with avoidable significant harm. Up to 16 general practices from 3 areas of England (East Midlands, London and the North West) will be recruited based on practice size, to obtain a sample of around 100 000 patients. Our investigations will include an ‘enhanced sample’ of patients with the highest risk of avoidable significant harm. We will estimate the incidence of avoidable significant harm and express this as ‘per 100 000 patients per year’. Univariate and multivariate analysis will be conducted to identify the factors associated with avoidable significant harm. 

Ethics/Dissemination The decision regarding participation by general practices in the study is entirely voluntary; the consent to participate may be withdrawn at any time. We will not seek individual patient consent for the retrospective case note review, but if patients respond to publicity about the project and say they do not wish their records to be included, we will follow these instructions. We will produce a report for the Department of Health's Policy Research Programme and several high-quality peer-reviewed publications in scientific journals. The study has been granted a favourable opinion by the East Midlands Nottingham 2 Research Ethics Committee (reference 15/EM/0411) and Confidentiality Advisory Group approval for access to medical records without consent under section 251 of the NHS Act 2006 (reference 15/CAG/0182).

Lay involvement

The PPI representatives are members of the project management group, which convenes at least once monthly, and they actively contribute to ongoing discussions about the conduct of the study. They will also contribute to at least one of the early meetings with GPs who will be involved in data collection so that they can provide their views on the operationalisation of definitions of avoidable significant harm in the study.

The PPI representatives also will run patient stakeholder events to provide emerging findings to service users in order to gauge likely responses to the publication of our report.

Who is the study sponsor?

Cardiff University

Does the study involve commercial partnership activity?

N/A

UKCRN portfolio number (if relevant)

To follow

Funder

The Secretary of State for Health

Total grant value

£ 130,630

Grant income to Wales

£ 24.455

Start date

01/10/2016

End date

30/04/2017

How could this research potentially benefit patients?

Even though the UK has been an exemplar of high-quality primary healthcare, it is important to develop an understanding of the frequency and causes of avoidable harm in this setting to reduce the risks.

The current study has been designed to address this serious gap in the literature. Once we have a better understanding of the epidemiology of avoidable significant harm in primary care, we will have the necessary evidence to design and evaluate interventions that will reduce the burden of avoidable harm.

Further information

To follow

Outputs generated (Reports / Publications / Impact)

Bell BG, Campbell S, Carson-Stevens A, et al Understanding the epidemiology of avoidable significant harm in primary care: protocol for a retrospective cross-sectional study. BMJ Open 2017;7:e013786. doi: 10.1136/bmjopen-2016-013786