LAUNCH: 12 November 2013
Section 1
Introduction
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Add names and roles of facilitators
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Introduction
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Background
Housekeeping
Fire alarm
Workbooks
Refreshments
Ground Rules
Attendees #Hello My Name is ... And
Expectations
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Workshop Objectives
1. To
brief attendees about the open disclosure project and its
significance nationally.
2.To build understanding as to how the principles of open
disclosure link into the existing HSE Quality, Safety and Risk
framework.
3. To provide best practice guidance on how to implement the
Principles of open disclosure.
4. To provide information and training via case scenarios and
role play on delivering on the principles of open disclosure.
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Objectives
(continued)
5. To demonstrate the positive benefits for
patients//service users, their families and also the
benefits to staff.
6. To practice key skills needed to implement the
guidance effectively.
7. To explore the key components involved in the
open disclosure process
8. To provide awareness on the resources currently
available.
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Workshop Programme
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An introduction to Open Disclosure
What is an Adverse Event
Current status in Ireland
What do patients expect following an adverse
event?
Practising disclosure
The Clinicians view and considerations
The Disclosure Process
Summary
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DVD:
“And you weren’t even going to tell me”
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Section 2
An Overview of Open
Disclosure
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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.”
(Australian Commission on Safety and Quality in Health Care)
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What is an Adverse
Event?
An undesired patient outcome that may or
may not be the result of an error.
Or
An incident which resulted in harm
(World Health Organisation: The conceptual Framework for the
International Classification for Patient Safety: Version 1,1 2009)
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Principles
1. Acknowledgement
2. Truthfulness, timeliness and clarity of communication
3. Apology
4. Recognising patient and carer expectations
5. Professional Support
6. Risk management and systems improvement
7. Multidisciplinary responsibility
8. Clinical governance
9. Confidentiality
10. Continuity of care
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Levels of Transparency
required to change culture –
Lucian Leape 2015
• Transparency between clinicians and
patients/service users demonstrated by open
disclosure following adverse events
• Transparency between clinicians demonstrated by
peer review and other mechanisms to share
learning
• Transparency between healthcare organisations
demonstrated by shared learning and collaborative
working.
• Transparency between both clinicians and
organisations and the public demonstrated by
public reporting of patient safety data
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Additional layers of
transparency identified in
Evaluation of OD in ROI 2015
Transparency between:
 Clinicians and hospital management, through staff support and
a protective environment to disclose
 Health and social care organisations, patients and their families,
and representative patients’ organisations, in development of
open disclosure policies, training and practice.
Transparency results in : Improved patient outcomes, fewer
errors,
happier patients, lower costs,
increased public confidence.
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Empathy v Sympathy
• Empathy is the experience of being heard and
understood.
• Patients experience empathy when the clinician:
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Adopts appropriate body language, vocabulary and tone of voice.
Listens and summarises their story back to them.
Acknowledges the emotions they express.
Picks up and responds to their cues.
• It is very different to sympathy.
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Why are these principles
being advocated?
• They form the basis of an ethical response
• A “Blame and Shame” culture can interfere with finding the
contributory factors and root cause of an adverse outcome
• To promote a Fair, Just and Responsible culture
• There is emerging evidence that effective management may
improve patient acceptance
(MPS Mastering Adverse Outcomes Workshop)
(MPS Mastering Adverse Outcomes Workshop)
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Quote from Atul Gawande
(Surgeon)
“We look for medicine to be an orderly field of
knowledge and procedure but it is not.
It is an imperfect science, an enterprise of
constantly changing knowledge, uncertain
information, fallible individuals and at the same
time lives on the line.”
(Complications: A surgeons notes on an imperfect science 2003)
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Section 3
Current Status in the Republic
of Ireland
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Recommendations by the
Patient Safety Commission
• National Standards to be developed and
implemented
• Legislation to provide legal protection
• Open communication training for all healthcare
professionals
• Support and counselling programmes
• Research in to the impact on patients and families.
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Agencies Endorsing
Open Disclosure
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Statutory:
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Government: DOH
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Indemnifying: SCA/CIS
Medical Protection Society (MPS)
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Professional: The Nursing and Midwifery Board of Ireland (Previous ABA)
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Regulatory:
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WHO
HSE including non statutory organisations funded by the HSE
The Medical Council of Ireland
HIQA
CORU
PHECC
Mental Health Commission
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HSE
“A Patient can expect open and appropriate communication
throughout your care especially when plans change or if something
goes wrong.”
(National Healthcare Charter: You and Your Health Service, 2010 - Revised 2012.)
“Safety Incident Management occurs within the framework of the
principles of open disclosure, integrated risk management, just
culture and fair procedures. This policy must be read within the
context of the HSE/SCA Open Disclosure National Guidelines 2013.”
(HSE Safety Incident Management Policy 2014)
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DOH: Minister Leo Varadkar
2015
“In the Health Information Bill, we will legislate to protect open disclosure.
Saying sorry is not an admission of liability. Open disclosure is health sector
policy and I encourage all health service staff to observe it always”.
(Speech by Minister Varadkar to the IMO AGM, in Kilkenny on Saturday 11th April 2015)
It is important that the patients and their families are kept informed and that
feedback is forthcoming on investigations. It is vital that we establish the
steps that need to be taken to prevent a recurrence of adverse events.
Written answers: February 2015
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State Claims Agency
“At the heart of open disclosure lies the
concept of open, honest and timely
communication. Patients and relatives must
receive a meaningful explanation following
an adverse event”.
(Ciarán Breen, Director of the SCA 2015)
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Medical Protection Society
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Medical Council
“Patients and their families are entitled to
honest, open and prompt communication
with them about adverse events that may
have caused them harm.”
(Medical Council’s Guide to The Professional Conduct and
Ethics for Registered Medical Practitioners 2009)
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The Nursing and Midwifery
Board of Ireland
“Safe quality practice is promoted by nurses
and midwives actively participating in
incident reporting, adverse event reviews
and open disclosure”
(Code of Professional Conduct and Ethics for Registered
Nurses and Registered Midwives December 2014)
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HIQA National Standards for
Safer Better Healthcare 2012
Standard: 3.5:
“Service providers 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.”
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CORU:
“If a service user suffers harm, speak openly and
honestly to them as soon as possible about what
happened, their condition and their ongoing care
plan”
(The Codes for Dietitians 2014, Speech and Language
Therapists 2014 and Occupational Therapists 2014)
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Pre Hospital Emergency Care Council
(PHECC)
PHECC wholly endorses the HSE principles of open disclosure.
PHECC is committed to the process of open disclosure as included in
the Education and Training Standards since 2007. We believe that
the open disclosure process encourages the reporting of adverse
events which leads to a manifestation of the patients’ autonomy and
ultimately leads to opportunities for systems improvement and
delivery of the highest standards of care delivery.
In addition PHECC is committed to information being available
following the incident review as being an essential component of an
open disclosure policy.
(statement from PHECC April 2015)
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Mental Health Commission
2015
“The
Mental Health Commission fully endorses Open Disclosure
and communicating with service users and their families
following adverse events in healthcare. As Open Disclosure
is now national policy, the Commission will be making it a
requirement in its revised Code of Practice on the
Notification of Deaths and Incident Reporting “.
Statement from the Mental Health Commission May 2015
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WHO
“The inclusion of open disclosure processes in many
hospitals today reflects the increasing importance
of professionalism and honesty with patients and
their carers. This in turn is increasing
opportunities for partnerships with patients”.
http://(www.who.int/patientsafety/education/curriculum/who_mc_topic-8.pd
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Section 4
The Patient/Service User’s
Perspective
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Exercise 1
• Watch the DVD – (approximately 5 minutes)
• Focus on the patient – Mrs Ling
• As you are watching it think about what the
patient’s needs are.
• What does the patient require/expect from her GP
during the consultation?
• What does the patient expect following the
consultation in relation to her ongoing care?
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The Open Disclosure Process using the MPS
A.S.S.I.S.T Model of Communication: (p27)
A – Acknowledge – problem and impact
S – Sorry – express regret
S – Story – hear patient’s story and summarise back to
them
I – Inquire – seek questions to be answered, provide answers, give
information,
S – Solution – seek patient’s ideas on the way forward
- agree a plan
T – Travel – avoid abandonment – continued care –
increased contact.
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Do patients
want to know?
At least 98%
want to be
told the truth
Hobgood et al 2005, Mazor et al
2004
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What are patients
saying?
• They want:
 A truthful discussion
 To have their story heard and acknowledged
 Information to their level of satisfaction
 An expression of regret or sorrow
 Information on how similar outcomes will be
prevented in the future
 An agreed plan for ongoing care and follow-up
(Gallagher 2003, Hobgood et al 2005, Mazor et al 2004)
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Exploratory Study
• CIS agreed to assist with research with patients or
their families who had been involved in an adverse
event, on whose behalf claims were settled by the
State Claims Agency.
• To provide an insight into Irish patients’
experiences of adverse events
• To assist in determining the outcomes desired by
patients and their families following an adverse
event
• To provide an insight into the factors (if any) that
prompted patients or their families to take legal
action following an adverse event
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Reasons for taking legal action:
Respondents’ comments
• “ I consulted legal representatives to represent
me and my family at the inquest into my husband’s
death. As the hospital never acknowledged the two
serious incidents that led to my husband’s death I
felt I needed a solicitor to help me communicate
with them”.
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“I felt that they thought that offering me
compensation without acknowledging the wrong in
not giving me any explanation would make it ok”
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Reasons for taking legal action:
Respondents’ comments
“I felt forced to take legal action because it was the
only action open to me. I took the matter to a
solicitor because I felt I had an obligation to others
as well as to myself to do so”
“Staff were secretly telling me that a mistake had
been made! It was very obvious to the maternity
hospital that a mistake had been made but they
focused on closing ranks and protecting the
organisation and healthcare professionals
involved. I was told my daughter would be dead
within 12 months…”
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Media Cases
HSE finally says sorry to woman whose cancer was missed
three times (2012)
Their solicitor said the couple’s ordeal was compounded in that for five
years the various defendants contested this case and brought the
family to the point where they had to give up their privacy.
He added that only in the past week “most of the defendants
acknowledged what was very clearly their mistake”.
He said this “was appalling behaviour which caused additional harm”.
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Media Cases:
Missed Diagnosis: Meningitis (2011)
The family sued the HSE for the mental distress arising out of their baby's
wrongful death.
The HSE apologised “unreservedly for the wrongful death of their son while in
our care" and extended its "deepest sympathy".
The mother stated that “the letter of apology was worth its weight in gold” .
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Media Cases:
“As a grieving family we were met with a wall of
silence and denial for almost three years before
liability was admitted, and four years before we got
an apology. I find this appalling." Had the hospital
admitted wrongdoing and apologised on day one,
as it certainly should have, the unnecessary pain
and worry of legal proceedings would have been
avoided."
(Feb, 2012).
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The Importance of Open
Disclosure for Patients
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The process can assist with providing closure for the patient/family and
quicker emotional recovery.
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It can help to rebuild trust and confidence within healthcare.
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OD facilitates patient involvement in decisions relating to their ongoing
care.
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OD prevents patient misconceptions in relation to the cause of the
adverse event.
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Patients are more willing to continue an effective relationship with the
Health Care Provider.
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Feelings of desertion after an adverse event are a major contributor to
litigious intent.
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Why Patients Sued
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Patients felt rushed
No explanations given
Felt less time spent
Felt ignored
(Hickson et al 1994)
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91% wanted to prevent a recurrence.
90% wanted an explanation.
68% wanted the doctor to know how they felt.
45% due to attitude of hospital staff following the error.
(Vincent et al 1994)
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To correct deficient standards of care
To find out what happened and why
To enforce accountability
Compensation for accrued and
future costs
(Vincent 1994, Bismark 2006)
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Quote from a
Patient Advocate
Open disclosure is not about blame.
It is not about accepting the blame.
It is not about apportioning blame.
It is about integrity and being truly professional
And the reason:
You hold our lives in your hands and we, as
patients, want to hold you in high regard.”
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Exercise 2: (p29)
• Read the case scenario provided.
• In your allocated groups of three you will take turns in
playing the role of (a) Doctor, (b) Patient and (c) Observer
• You will be allocated 5 minutes for each role play.
• Do not be concerned if you have not completed the
consultation.
• At the end of 5 minutes provide feedback on the consultation
using the A.S.S.I.S.T Model.
• You will then swap roles.
• There will be a general feedback session at the end of the
session when all three persons have experienced the role of
the Doctor, Patient and Observer.
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Section 5
The Clinicians Perspectives and
Considerations
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Exercise 3:
(p 16)
• Watch the DVD
• Consider the feelings and emotions of the doctor
whose patient is being referred to by their medical
colleague.
• Consider that you are this doctor.
• Write down all the feelings you may be
experiencing and your possible reactions to this
conversation.
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The Importance of Open
Disclosure for Staff
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Improved staff recovery.
It encourages a culture of honesty and openness.
Staff are more willing to learn from adverse events.
It enhances management and clinician
relationship.
It leads to better relations with patients and their
families.
Maintains personal and professional integrity
Lightens the burden of guilt
Allows for reflective learning
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Why disclosure
is difficult
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Culture: Historic Medical Culture of Non disclosure
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Institutional Barriers: “Blame and Shame” approach – no institutional support or
mechanisms to facilitate disclosure
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Fear of litigation
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Fear concerning professional advancement
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Fear with regard to reputation
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Fear of being reported to professional body
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Fear of the Media
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Fear of the patient’s/family’s response
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Financial concerns
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Uncertainty with regard to extent of information to be disclosed
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Lack of training and guidance for healthcare professionals
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University of Michigan
Health System
2002, Adopted full disclosure policyMoved from, “Deny and defend” to
“Apologise and learn when we’re wrong, explain and vigorously
defend when we’re right and view court as a last resort”
August 2001-August 2007
• Ratio of litigated cases : total reduced from 65-27%.
• Average claims processing time reduced from 20.3 months to 8
months.
• Insurance reserves reduced by > two thirds.
• Average litigation costs more than halved.
• Savings invested into patient safety initiatives.
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The six recognised stages of staff
reaction following an adverse event
1. Chaos: Error realised and recognised. How and why did it
happen. Care for the patient.
2. Intrusive reflections: Re-evaluate the event. Haunted reenactments of the event. Self isolation.
3. Restoring personal integrity: Managing gossip Questioning
trust. Fear.
4. Enduring the inquisition: Realisation of seriousness. Wonder
about repercussions. Who can I talk to?
5. Obtaining emotional first aid: Seeking personal and
professional support. Where can I turn to for help?
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The six recognised stages of staff
reaction following an adverse event:
6. Moving On—Dropping Out, Surviving or Thriving:
• Despite a desire to move on, many professionals find it
difficult to do so. This stage has three potential paths:
– Dropping Out—changing professional role, leaving the
profession or moving to a different practice location.
– Surviving—performing at the expected performance
levels (“doing OK”) but continue to be affected by the
event.
– Thriving—making something good out of the adverse
event.
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Debriefing:
• “On the basis of research results organisations should be
focusing on training their managers to be able to provide
timely, empathetic and practical support and information in
the aftermath of a traumatic event.”
(Research commissioned by the British Occupational Health Research Foundation)
• Providing employees with a little help in a timely manner post
event is more beneficial than extensive help provided later,
when individuals are less emotionally available.
(Lindeman 1994; Caplan, 1964)
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Resources:
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Employing organisation
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Work Colleagues/Peers
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Managers
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Your own GP
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EAP/Occupational Health
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The HSE Policy for Preventing and Managing Critical Incident Stress 2012 developed by
the National Health and Safety Advisers Group.
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The HSE and State Claims Agency staff support booklet 2013: Supporting staff
following an adverse event: The “ASSIST ME” model
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Section 6
The Disclosure Process
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Levels of Disclosure
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Criteria for determining the appropriate level of response
Lower-level response
Near misses and no-harm incidents
No permanent injury
No increased level of care (e.g. transfer to operating theatre or intensive care unit) required
No, or minor, psychological or emotional distress
Higher-level response
Death or major permanent loss of function
Permanent or considerable lessening of body function
Significant escalation of care or major change in clinical management (e.g. admission to
hospital, surgical intervention, a higher level of care, or transfer to intensive care unit)
Major psychological or emotional distress
At the request of the patient
Reference: Open disclosure: ‘Just-in-time’ information for healthcare providers
Australian Open Disclosure Framework 2013
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Preparation:
• A preliminary team discussion to establish the known facts
must take place prior to meeting with the patient.
• To establish the facts takes time, not all facts need to be
established prior to meeting the patient/family.
• Think ahead and plan responses to questions which may
arise
• A key contact person is assigned, so the patient has a named
contact person.
• Are additional supports required? e.g. interpreter
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The Disclosure Team
• Lead Discloser – Ideally the patient’s consultant.
• Deputy Discloser – To assist, ensure patient/ family
understands.
• Key Contact –
– Links with patient/ family
– Keeps them informed
– Meet and Greet
• Scribe – Confidentiality, Shorthand, Legibility.
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Deciding who should
lead the discussion:
• A decision as to who leads the disclosure meeting
must be made early.
• Take account of- Experience/
training/communication skills/impact of the event
on staff involved.
• Is the lead consultant the most appropriate, is
he/she able to lead, especially if the outcome was
catastrophic?
• Multiple specialities involved..?
• Can disclosure be more harmful than beneficial ?
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Where to disclose:
• Preparation again essential
• Key contact to liaise with patient/family
• Meet and greet patient and family at predetermined location
• Consideration to off site meeting
• Well ventilated room
• Refreshments
• Bleeps, mobiles off.
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What to disclose
• Expression of regret/apology
• Factually correct information
• Steps taken or planned to try to prevent a recurrence
of the event.
• Practical support mechanisms, contact names,
information pamphlets, support networks.
• What happens next. Care plan – review etc.
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Documentation:
• Essential to ensure continuity and consistency
• Imperative that details of the adverse event are documented
in the clinical record including the details of clinical care
provided.
• The salient points of the open disclosure meeting should be
documented in the patient record including the exact wording
and context of any apology given.
• Non-clinical communications to be kept in a separate file i.e.
risk reviews, minutes of meetings etc
• Refer to pre-during and post documentation checklist in
workbook
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Considerations:
• Does the CEO/GM know that a disclosure meeting
is happening..?
• Should they be there?
• Are there any other members of the healthcare
team that need to know... e.g.
– Clinical Director
– Director of Nursing
– Allied Healthcare
– Public Health.
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Disclosing another clinician’s
error:
Challenges:
• Complex delivery of healthcare today across multiple care
settings.
• Which professional carries what responsibility?
• Talking with the patient about the event – confidence?
• Lack of guidance on this topic leading to uncertainty
• Spectrum of the error
• Lack of relevant information/firsthand knowledge of the event
• Fear as to how a colleague will react
• Strong cultural norms around loyalty/collegiality/solidarity
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Disclosing another
clinician’s error
Challenges continued
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Risk of acquiring an unfavourable reputation with colleagues
Power differentials – seniority, race, sex, cultural
Dependency on colleagues for referrals
Time constraints – e.g. coordinating meetings etc
Fear of punitive action by organisation
Fear of impacting on clinical relationship between the
clinician and their patient.
• Fear of triggering litigation
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Approaches
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Consider ethical duty/responsibility
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Patients and families come first
- rights to honest, open and transparent communication
- compassion
- difficulties in disclosure should not stand in the way
- ensuring correct clinical management of the patient’s condition
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Explore – Do not ignore!
- turn towards involved colleague
- colleague to colleague discussion
- obtain the facts – do not rush to judgement
- frame the conversation to minimize defensiveness – curiosity opposed to
accusations – manner – body language - tone
- establish what happened
- discuss and agree the way forward – clinical management - reporting, disclosure etc
- seek assistance from the organisation if necessary.
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Approaches
•
Institutional leadership
- ensuring disclosure conversations happen
- managing communication breakdown between
clinicians/teams
- managing disagreements regarding disclosure
obligations
- providing training/other resources
- strengthening a “just” culture
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Disclosure – lead by right person with other relevant persons present to
support lead discloser and patient/family.
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Sample Language:
• Refer to workbook and guidelines
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Common Pitfalls
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Talking too much/negative body language
Too many people involved in the disclosure meeting
Failure to recognise the elements of a grief reaction
Arguing or trying to prove you are right and over use of the
word “but” e.g. “I hear what you are saying but……..”
Failure to express enough empathy for the patient/family
situation
Use of medical jargon
Focusing on points of disagreements rather than on points of
solutions
Failure to follow through on actions agreed.
Lack of situational awareness
Punctuality
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Exercise 3: (p28)
• Watch the DVD – same scenario as before
(Exercise 1)
• GP consultation now using the A.S.S.I.S.T model
• Record the terminology used by the Dr which
applied to the various components of the
A.S.S.I.S.T model.
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Fact: Things go wrong and will
continue to go wrong ……..
• Adverse events happen to the best
people in the best places – none of
us are immune.
• We must be honest with our
patients, our colleagues and
with ourselves.
• Learning is difficult
where transparency is absent.
• Transparency must involve
an empathetic approach to the
patients and staff involved in
adverse events.
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Summary:
Loretta Evans 2011
“We were heartened by the efforts made by administrators and
clinicians in the Mater to accept responsibility and embrace the need for
change. We are grateful for those people in the Mater who helped us
along the way, those people who admitted that failings had occurred
and agreed to right them in the future, those who showed us
compassion and treated us as human beings rather than potential
litigants.
Financial compensation was never on our agenda. Money would never
have compensated us for losing our wonderful and precious son. Instead
we simply wanted answers, information, explanations, solid
reassurances that what went wrong would never happen again. We
wanted a proper and meaningful apology”.
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Contact Details:
Add contact details
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Thank you for your time
and
attention….any questions
?
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