Open Disclosure

At Medisec, we welcome and support the principles of Open Disclosure, and encourage our members to engage with patients in an open, honest and transparent manner when things go wrong. We are delighted to have Angela Tysall, Lead for Open Disclosure: HSE Quality Improvement Division, sharing her experience with us.

Open Disclosure in General Practice

Communicating openly and transparently with patients following adverse events

Angela Tysall
Angela Tysall

What is Open Disclosure?

“An open, consistent approach to communicating with patients when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse event.”

Open disclosure is also referred to as “open communication”.
(Australian Commission on Safety and Quality in Health Care)

The Background

On the 12th November 2013, Dr James Reilly, Minister for Health at that time, launched a national policy, national guidelines and associated documents on Open Disclosure. The policy and guidelines were developed by the HSE and the State Claims Agency, based on best practice globally and also on learnings from a two-year pilot programme in two acute hospitals here in Ireland: the Mater Misericordiae University Hospital, Dublin and Cork University Hospital.

Medical Council standards in the 2016 Guide to Professional Conduct and Ethics state that:

67 Open disclosure and duty of candour

67.1 Open disclosure is supported within a culture of candour. You have a duty to promote and support this culture and to support colleagues whose actions are investigated following an adverse event. If you are responsible for conducting such investigations, you should make sure they are carried out quickly, recognising that this is a stressful time for all concerned.

67.2 Patients and their families, where appropriate, are entitled to honest, open and prompt communication about adverse events that may have caused them harm. When discussing events with patients and their families, you should:

  • acknowledge that the event happened;
  • explain how it happened;
  • apologise, if appropriate; and
  • assure patients and their families that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.

Disclosure of harmful medical errors to patients has emerged as a professional and regulatory standard across medical specialties. The HIQA Standards for Safer Better Healthcare 2012 require that:

“Service providers should fully and openly inform and support service users as soon as possible after an adverse event affecting them has occurred or becomes known and continue to provide information and support as needed”.

The Principles of Open Disclosure

The principles of open disclosure include:

  • A timely acknowledgement to the patient/support person about what happened and what impact it had on the patient, physically, emotionally and socially.
  • An apology or expression of regret, which includes the phrase ‘I am sorry’ or ‘we are sorry’.
  • A factual explanation of what happened – without speculation or conjecture.
  • Providing an opportunity for the patient and their support persons to relate their experience/story.
  • A discussion of the potential consequences of the adverse event.
  • An explanation of the steps being taken to manage the adverse event and to minimise the likelihood of a recurrence of such an event.
  • Keeping the patient and their nominated support person(s) informed and involved in the review, learning and quality improvement process.
  • Providing ongoing practical support for patients to manage the effects of harm and agreeing on matters regarding their ongoing care and treatment.

The Open Disclosure Programme in Ireland also emphasises the principle of staff support. Modern health care is complex, delivered in high-pressure environments and often involves multiple practitioners working in teams and across organisations. Excellent outcomes are most often the result but sometimes, despite our best efforts, things can go wrong and staff may experience varying levels of traumatic stress following an adverse event. It is important that, while the care of the patient involved is paramount, organisations provide ongoing support for the staff involved in the event and also for staff not involved but who are also affected by the event.

Think about your GP Practice

How do you support and monitor colleagues involved in and affected by an adverse event?

The importance of Open Disclosure for patients and their families has been regularly highlighted by both the media here in Ireland and internationally over the past 3-4 years. In particular the impact of non-disclosure, often referred to as “the second harm” inflicted on our patients by our failure to communicate with them in an open, honest and transparent manner following an adverse event.

Open Disclosure is reasonably expected by patients and their families. Positive benefits include the maintenance of the patient’s confidence in the health care provider, prevention of misconceptions about what caused their adverse event, facilitation and partnership in decision making about future care, and assisting in the emotional recovery of the patient.

Aside from the fact that you have a professional and regulatory obligation to engage in Open Disclosure, it is important to emphasise that Open Disclosure should be motivated by an ethical, humane and patient-centred response which addresses the fundamental human needs and rights of patients to be treated with dignity and respect.

Professor Lucian Leape of Harvard University talks about the “Golden Rule” explaining that we should not deliver any less to our patients than we would expect for ourselves or for a loved one. It is as simple as that.

Open Disclosure and Complaints

Open Disclosure is a key component in the management of complaints and in bringing the complaint to a satisfactory resolution.

An early expression of regret or apology can minimise the possibility of a verbal complaint becoming a formal written complaint or the further escalation of a formal written complaint to independent review, the Ombudsman or the litigation process. If, following the investigation of the complaint, the service is found to be at fault, it is important to openly acknowledge this to the complainant, provide a factual explanation, apologise for the identified failure(s) in care/error and for the harm, distress and disappointment caused to the complainant as a result of this. It is also important to provide reassurance in relation to ongoing care and treatment and also in relation to the steps being taken by the service to manage the issues raised and to try to prevent a recurrence of these issues.

Open Disclosure and Litigation

Several studies in the United States have demonstrated a reduction in litigation following the adoption of an Open Disclosure policy. In 2002, the University of Michigan Healthcare System adopted an Open Disclosure policy and found on an examination of their incidents between 2001 and 2007 that the ratio of litigated cases reduced from 65% to 27% during that time and that their average litigation costs more than halved. A more recent study in Chicago, Illinois revealed comparable data. The impact of Open Disclosure on litigation here in Ireland has not yet been assessed.

Open Disclosure Legislation

The principal obstacle to Open Disclosure in Ireland is the absence of legal protection for participants. The Government gave its approval on 3rd November, 2015 to the drafting of provisions to support Open Disclosure of patient safety incidents. Provisions to support voluntary Open Disclosure had originally been included in the planned Health Information and Patient Safety Bill, but will now be included in the Department of Justice and Equality’s draft Bill on Periodic Payment Orders to facilitate earlier enactment. The legislation is part of a broader package of reforms aimed at improving the experience of those who are affected by adverse events.

Making Open Disclosure Work

Evidence from other countries has demonstrated that there are many essential components required to implement an Open Disclosure policy effectively within healthcare settings. In his review of international success stories in 2013, key conclusions drawn by Professor John Wakefield, Chair of the Australian National Open Disclosure Pilot Committee, are as follows:

  • Frontline clinicians must have an understanding of those clinical adverse events that require reporting and Open Disclosure.
  • There must be a general awareness and understanding among clinicians of the approach required in relation to Open Disclosure discussions and the importance of providing information on any significant matters relating to the event, the consideration of risk management and the need to provide an apology.
  • Clinicians must feel safe to report and at the same time have a willingness to seek advice and to be advised.
  • Clinicians need appropriate resources to tap into, by way of support.
  • An apology is wasted if a clinician has no sense that there is a problem or that an adverse event has occurred.
  • Training and support for staff is required and should be ongoing.
  • The impact of adverse events on clinicians should be recognised, with adequate support provided and an awareness that not all clinicians may be able to engage in Open Disclosure discussions as a result of personal trauma following the event.
  • Open Disclosure must be considered as a responsibility of the organisation and not just the staff involved. A multidisciplinary response to adverse events is a more supported approach and should include engagement from management, clinicians and quality and risk management staff.
  • Adequate preparation for Open Disclosure discussions with service users and their families is critical.

In Conclusion

Open Disclosure is now recognised as a practice that benefits patients, their families, staff and organisations. The Open Disclosure process is an integral part of incident management, patient safety and quality improvement programmes.

The established therapeutic relationship between you and your patients provides an advantage for communicating openly and transparently when things go wrong or do not go to plan and an apology or expression of regret from you to your patient can assist with their acceptance of the event and bring great comfort and healing.

Have you been affected by an Adverse Event?

Medisec’s team of medico-legal advisers are available 24/7 to guide, direct and support you in relation to any adverse event that may occur in your practice. Support is also available from the ICGP. Visit www.icgp.ie/DoctorsHealth for more details.

Further resources are available on: www.hse.ie/opendisclosure

References:
Australian commission on Safety and Quality in Healthcare: 2014. Implementing the Australian Open Disclosure Framework in small practices.
Australian commission on Safety and Quality in Healthcare: 2013 Open Disclosure: Just in time information for clinicians 2013
Donaldson, Sir Liam, Chief Medical officer, UK, Twitter Mobile, 2011
HIQA, 2012: National Standards for Safer Better Healthcare.
Leape, Professor Lucian: Apologising effectively to patients.
https://www.youtube.com/watch?v=kDfoJXq8BRA
Medisec Ireland, 2013: Medisec welcomes and supports the HSE and SCA launch of National Guidelines on Open Disclosure
http://www.medisec.ie/news/medisec-welcomes-launch-of-national-guidelines-on-open-disclosure
Wakefield, Professor J, Australian National Open Disclosure Pilot Committee, “Open Disclosure Best Practice: A “How To” guide from international success stories, 2013.
Guide to Professional Conduct and Ethics for Registered Medical Practitioners 8th Edition 2016


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