Staff stopped Mr Y’s antiplatelet medication
22. Mrs A and Mrs Y say a cardiologist advised staff to stop Mr Y’s antiplatelet medication, against advice from their stroke unit colleagues to continue with it.
23. We have considered whether the consultant cardiologist followed relevant standards and guidelines when providing advice about Mr Y’s antiplatelet medications. NICE guideline ‘Drug-eluting stents for the treatment of coronary artery disease’ [TA152] says that dual antiplatelet therapy (aspirin and another agent, often clopidogrel) should be used for 12 months after stenting.
24. The medical record from the cardiologist’s assessment strongly suggests the advice was based on their belief that Mr Y had not undergone recent stent implantation. The records state ‘No PCI’ [percutaneous coronary intervention - formerly known as angioplasty with stent] and ‘as no recent PCI – then can stop Aspirin + Clopidogrel & start anti-coagulation for PE’. Crossed through with a line on that same record states ‘recent PCI’. Mr Y had angioplasty with stent insertion to right coronary artery (RCA) graft on 23 July. This was just a month before.
25. The cardiologist’s advice to stop Mr Y’s antiplatelet medication, based on their belief that Mr Y had not undergone recent stent implantation, would be appropriate according to the guidelines. However, as the cardiologist incorrectly noted, Mr Y had not had stents. The advice they provided was therefore wrong and against clinical guidelines. Mr Y should have remained on antiplatelet medication because of his recent stent implantation.
26. Our adviser says other guidance in place at the time, NICE ‘Unstable Angina and NSTEMI: The Early Management of Unstable Angina and Non-ST-Segment-Elevation Myocardial Infarction’, [NG94], recognises there is an increased risk of bleeding with dual antiplatelet therapy, particularly when given with anticoagulants. Our adviser says in 2019, it was usual clinical practice to stop one of the antiplatelet agents (for example clopidogrel) if there was a high risk of bleeding.
27. In comments to us, the cardiologist says their advice was based on Mr Y’s risk of bleeding and the decision was tailored according to the individual patient, after weighing up the risks and benefits. As our adviser says, this could have been a reason to stop both antiplatelet agents. We accept that Mr Y was at a high risk of bleeding as he had melena (bleeding from his bowel) and had already bled while taking antiplatelet drugs. However, the records do not support this. The records do not show any explanation that this is why the cardiologist stopped Mr Y’s antiplatelet agents. The records show the cardiologist wrongly thought Mr Y had not had recent stenting.
28. We cannot say the cardiologist made the decision in line with standards and guidelines, and based it on the correct medical history, because there is not enough evidence to show this. If the advice was given based on clinical judgement, weighing up the benefits and risks, and departing from guidance, we would expect to see that rationale documented in the records, as a person centred decision. There is no reference in Mr Y’s records to weighing up the risk of bleeding.
29. There is therefore not enough evidence for us to say the cardiologist’s advice and decision was in line with the relevant standards and guidance. While we accept it may have been the right decision to stop Mr Y’s antiplatelet medication, we will never know because the stroke team re-started him on his medication within a few hours. We have therefore identified a failing.
30. We have considered the impact of this failing later in our report.
Staff observations and acting on family’s concerns
31. Mrs A and Mrs Y complain staff failed to appropriately observe Mr Y and delayed his diagnosis of stroke while he was an inpatient. They also complain staff did not act on the concerns they raised on a number of occasions about Mr Y’s stroke symptoms.
32. The Royal College of Physicians, National Early Warning Score (NEWS) 2 ‘standardising the assessment of acute-illness severity in the NHS’ 2017 are based on a scoring system. They measure respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion (including disorientation/agitation) and temperature.
33. The Nursing and Midwifery Council (NMC) ‘The Code. Professional standards of practice and behaviour for nurses, midwives and nursing associates’ 2015 also outlines the standards expected of nursing staff. These state nursing staff are expected to document any worsening signs or concerns and should make a timely referral to another practitioner when any action, care or treatment is required.
34. The guidelines used for interventions in the acute stage of a stroke or transient ischaemic attack are NICE ‘stroke and transient ischaemic attack in over 16s: diagnosis and initial management’ [NG128]. These guidelines set out prompt recognition of symptoms of stroke and initial management. They say doctors should use a validated tool to screen people with sudden onset of neurological symptoms and to establish diagnosis. Where a stroke is suspected, the patient should be admitted to the stroke unit and imaging should be performed immediately, and within 24 hours of symptom onset.
35. We have also considered which guidelines apply for staff communication with family members and actioning concerns. The General Medical Council (GMC), Good Medical Practice, ‘Domain 3: communication partnership and teamwork’ guidelines apply. They say you must be considerate to those close to the patient and be sensitive and responsive in giving them information and support.
36. The GMC guidelines, ‘Domain 1: knowledge skills and performance’, say you must promptly provide or arrange suitable advice, investigations or treatment where necessary.
37. We reviewed Mrs A’s detailed account of what happened and the medical records. The records from the late morning and early afternoon of 25 August do not indicate that the family raised concerns during this period, but we think, on the balance of probabilities, they did. There are two notes within the records from when Mr Y’s stroke was later investigated and diagnosed, referencing the family’s comments that Mr Y had symptoms from around 12/1pm. One of the notes also says: ‘they have raised this with staff. Was seen by medical team but not acted on.’ Mrs A’s detailed account in her complaint also describes what they told staff about Mr Y’s unusual symptoms. We are persuaded it is more likely than not this represents an accurate account of the events.
38. The morning of the 25 August, the family came back to visit Mr Y and immediately observed his changed condition. They say he was agitated and finding it hard to talk. He had slurred speech and seemed confused, his right-hand side was weak, and he was unable to hold a pen. He had difficulty swallowing and was unable to drink from a cup. The family raised this with nursing staff who said he came in that way an hour before. The family requested to see a doctor as soon as possible.
39. Nursing staff asked for a doctor to review Mr Y as they were concerned about ‘sweating’. The nursing staff escalated Mr Y’s care to a doctor due to this concern, in line with the NMC code above.
40. When the doctor came to see Mr Y later that afternoon, there is no reference to any form of neurological deficit or stroke-like symptoms, and Mr Y was noted to be ‘saying a few words’. There are no concerns documented about Mr Y’s communication. However, he was wearing an oxygen mask as he was short of breath. Our nurse adviser says this would have affected his verbal communication.
41. Our general physician adviser says the records indicate the focus of the assessment was solely around the nurses’ concern that Mr Y was ‘sweating’, and not any of the other symptoms the family observed and expressed to staff. Two doctors assessed Mr Y. They did this in line with the NEWS assessment of acute-illness guidance set out above. However, the basis for the assessment and detail of it does not indicate the doctors considered the full information available. The assessment does not record any concerns around speech difficulties, swallowing difficulty, confusion, and weakness the family raised with the nursing staff, and to the doctors when they came to assess Mr Y.
42. We have a clear account from the family of what happened during the doctors’ assessment. From the records and evidence we have seen, we think on the balance of probabilities, their account is correct. The family say they explained the symptoms they observed and told the more senior doctor they thought Mr Y either had, or was having, a stroke. They say the doctor reassured them Mr Y’s unusual symptoms were due to the PE.
43. As there is no record of any acknowledgement, consideration, or assessment of Mr Y’s other reported symptoms, the evidence does not persuade us the doctors acted in line with the GMC guidance or NICE guidance set out above. There is no indication the doctors assessed Mr Y while considering the information and history the family provided about his unusual symptoms and behaviour. The evidence indicates the doctors put Mr Y’s symptoms down to the PE without considering the possibility of stroke. There are no records suggesting the doctors screened Mr Y for stroke despite his onset of unusual neurological symptoms, as described by his family, to rule this out.
44. There are no nursing entries following the assessment until later that evening. There is no indication the clinical or nursing staff took action in response to the family’s concerns during this period.
45. At 9.53pm, the nurses acted in line with the NMC Code and escalated concerns that Mr Y had had a stroke to clinical staff. The medical registrar assessed him and promptly arranged investigations which diagnosed the stroke. They had discussions with the acute stroke service and sought management advice from a stroke specialist without delay. The observations and actions taken at this point are in line with the NICE guidelines on stroke.
46. We know Mr Y had a catastrophic stroke, but we cannot say exactly when it happened. So, we cannot know on the balance of probabilities if a better assessment that afternoon would have led to any further action. Similarly, we cannot know when between then and 9.53pm whether different action would have made a difference. We do think the Trust missed opportunities to investigate and potentially diagnose Mr Y’s stroke sooner because there is no evidence it adequately acted on the family’s concerns. We have therefore found a failing.
47. We consider the impact of this failing later in the report.
Delay in looking into distended stomach - missed opportunity to investigate and diagnose cancer
48. Mrs A and Mrs Y complain there was a delay of 13 days in looking into Mr Y’s distended stomach, while he was an inpatient. This was later diagnosed as peritoneal cancer. They complain staff missed opportunities to investigate and diagnose Mr Y’s cancer during his admission, despite noting his distended stomach from the day he was admitted, and again in subsequent assessments/examinations.
49. As we mention earlier the NMC Code says nurses should escalate any worsening condition or concerns to another practitioner.
50. The guidelines for the assessment of the abdomen are outlined in the British Medical Journal (BMJ), Best Practice, ‘Assessment of acute abdomen’.
51. Further general guidelines for doctors are set out in the General Medical Council (GMC) ‘Good Medical Practice’ (Domain 1: Knowledge, skills and performance).
52. We asked both our nurse and general physician advisers to look at whether staff appropriately assessed, observed, and investigated Mr Y’s abdomen and within a suitable timeframe, in line with the guidelines and standards.
53. The records indicate medical staff knew about Mr Y’s distended abdomen from when he was admitted on 25 August. Fluid in the abdomen is noted a number of times in the records and the plan in the admission proforma states ‘tap ascites’ meaning there was a plan to drain the fluid.
54. Our nurse adviser says there is nothing further nursing staff could have done as it was a medical issue. Our nurse adviser says staff appropriately identified Mr Y’s distended stomach following a number of medical examinations and any further investigations would be planned by the medical team.
55. According to the records, Mr Y’s abdomen was soft and there was dullness in the sides of the abdomen. Our physician adviser says this would suggest the cause of the distension may have been fluid retention (also known as ascites). The original CT scan, to diagnose PE, suggested evidence of this on admission. Our physician adviser says it was appropriate to assume Mr Y’s continued distension was a reflection of the ascites that had already been noted on this scan. Our adviser says Mr Y was unwell with difficulty breathing and had potentially developed a hospital acquired infection or pneumonia. Therefore, no specific or immediate investigations were needed in relation to his abdomen at this stage. It was appropriate for the treating clinician’s priority to be on his breathing, and other more concerning clinical issues, which needed investigation.
56. The first documentation of Mr Y’s distended stomach becoming painful, and tender is on 6 September. In line with the BMJ guidelines, a doctor arranged for Mr Y to have further investigations. Initially an X-ray and ultrasound scan were suggested. This was changed to an urgent CT scan of the abdomen and pelvis, following blood tests and a discussion with the surgical team. Our adviser says the approach was appropriate and timely. A CT scan was arranged urgently, and no bowel obstruction was noted. We have not found the Trust got anything wrong when observing and investigating Mr Y’s distended stomach.
57. Our adviser says the presence of a PE should lead to the investigation of why this occurred. Cancer is one the risks for development of a PE. However, following the diagnosis of PE, Mr Y was very unwell with a new stroke, poor nutrition requiring feeding using a tube through the nose and into the stomach, and the subsequent development of a chest infection or pneumonia. GMC ‘Good Medical Practice’ (Domain 1) guidelines say you should apply knowledge and experience to practice and must promptly provide or arrange suitable advice, investigations or treatment where necessary. Our adviser says there was limited opportunity to progress any investigations for causes of PE any sooner as Mr Y was not well enough for this to have been the priority.
58. When we weigh up the evidence, we think the Trust acted as quickly as it could in the circumstances to investigate Mr Y’s distended stomach. We have therefore not found the Trust delayed diagnosing or treating Mr Y’s cancer.
59. Our general physician adviser has provided further comments that we would like share to reassure Mrs A. They say the delay of a few days in diagnosing Mr Y’s cancer is very unlikely to have made any difference to the outcome. The abdominal CT reported advanced cancer deposits in the abdomen. Our adviser says this would have been present for a long time and as mentioned by the Trust at the time, it is more than likely to have contributed to the stroke and PE. The diagnosis was relayed to the appropriate team for treatment to be considered, but Mr Y became very unwell and deteriorated rapidly. A decision was therefore made to relieve his symptoms and keep him comfortable.
Poor complaint handling
60. Mrs A and Mrs Y say the complaint handling was unacceptable because the Trust: missed a number of issues in its response, did not accept any mistakes and used passive language to negate any blame. They say it did not carry out an independent analysis, took longer than it should have to provide the final response and offered a meeting by Zoom which the family feel was unacceptable in the circumstances.
There was no independent analysis, and the Trust did not acknowledge any mistakes and used passive language to negate blame
61. Our ‘Principles of Good Complaint Handling’ say public bodies should investigate complaints thoroughly and fairly. They say a member of staff who was not involved in the events should review the case, but members of staff involved should have an opportunity to respond. They also say public bodies should be open and honest and should give clear, evidence-based explanations and reasons for their decisions. When things have gone wrong, they should explain fully and say what they will do to put matters right as quickly as possible. They should take responsibility for the actions of their staff. In response to a complaint that has been upheld, public bodies should provide an apology, explanation, and acknowledgement of responsibility.
62. The Trust’s response, dated May 2020, confirms the investigation was overseen by a divisional manager and carried out by a matron for medicine, with comments from the individuals involved in Mr Y’s care. This is line with our ‘Principles of Good Complaint Handling’ as these members of staff were not involved in the events.
63. However, we think that while the investigation was led by individuals who were not involved in the events, it is not clear how they provided an independent input. This is because some parts of the response only refer to comments from the people involved and the independent investigator/s do not expand on this or provide their view. We think the Trust’s response should have been clearer.
64. The Trust’s response letter only includes comments from the cardiologist involved in Mr Y’s care. There is no further comment from the person leading the investigation. The Trust did not identify that the cardiologist was wrong to stop Mr Y’s antiplatelet medication.
65. At another point in the response letter the Trust says: ‘if his symptoms did start at midday as stated by your family, then regardless of what the outcome would have been, he missed the chance of being considered for the thrombectomy treatment and I would like to apologise for this.’ While the Trust apologises here for a missed opportunity, it has not taken a view on whether the family did report concerns and whether it made a mistake in failing to act on them sooner. The family feel the Trust has not acknowledged this mistake and used passive language to negate blame. We think the Trust’s response is ambiguous.
66. We do not think the Trust has investigated all the complaint thoroughly and fairly, in line with our principles. We do not think it has given clear, evidence-based explanations, or explained and acknowledged fully where things have gone wrong. The way its response is worded, and the apologies it provided, are unclear as to what the Trust’s view is. We therefore do not think the Trust has taken responsibility, in line with our principles above. We have identified failings in how the Trust responded to Mrs A’s complaint.
Delay in providing a response
67. The Trust’s complaints policy says it will acknowledge a complaint within three working days of receiving it. It says it aims to investigate and provide a response within 30 working days or, with complex cases, up to 40 working days. This can take longer and would be in agreement with the complainant, keeping them informed as far as reasonably practicable.
68. Our ‘Principles of Good Complaint Handling’ say public bodies should deal with complaints promptly, avoiding unnecessary delay. They should resolve problems and complaints as soon as possible. They should keep the complainant regularly informed about progress and the reasons for any delays.
69. Mrs A emailed the Trust her complaint on 19 February 2020. The Trust asked for consent documentation from Mrs A, which it received on 9 March 2020. The Trust provided a detailed response to Mrs A’s complaint on 13 May 2020. We appreciate COVID-19 had an impact on the Trust’s capacity and at that time it was under significant pressure. We accept that it provided its initial response letter as promptly as it could, within 57 working days, despite not meeting its complaint policy timescales.
70. Mrs A felt the Trust missed some issues and its response also prompted further questions for her and the family. She therefore sent an email to the Trust on 21 June 2020 with a list of specific questions for the Trust to address. The Trust sent Mrs A a letter on 9 September 2020, 81 days later, offering a meeting.
71. We cannot see any correspondence showing the Trust agreed this timescale with Mrs A or that it kept her informed throughout the process, in line with its complaint handling policy. Mrs A was therefore under the impression the Trust was preparing a second response in writing, as she had asked. The Trust has apologised for its delay in responding, but we have found the Trust did not appropriately communicate with her to keep her informed about its progress throughout this time, or avoid delay, in line with our ‘Principles of Good Complaint Handling’.
The Trust offered a virtual meeting and did not provide a response to all questions and concerns
72. The Trust’s complaints policy says where a complainant is not happy, in most instances, a meeting will be offered between the complainant and relevant service leads to discuss any ongoing concerns, and an additional response may be offered to reach a resolution.
73. In September 2020 to protect patients, the hospital had still strict restrictions on visitors. This was in line with government and NHS England guidance at the time to prevent the further spread of COVID-19.
74. Our ‘Principles of Good Complaint Handling’ say public bodies should treat complainants sensitively and in a way that takes account of their needs. They should communicate with the complainant in a way that is appropriate to them and their circumstances. They should also respond flexibly, which means considering how they may need to adjust their normal approach to handling a specific complaint. Our principles also say public bodies should investigate complaints thoroughly and fairly.
75. The Trust sent Mrs A a letter on 9 September 2020, offering a meeting by video call to answer her further questions. Mrs A declined as she wanted a response to her questions in writing and she did not feel a virtual meeting was appropriate. We can see the Trust’s offer of a meeting is in line with its complaint policy. We also accept that this was offered virtually due to government guidelines and Trust restrictions at the time, to prevent the further spread of COVID-19.
76. Mrs A declined the Trust’s offer of a meeting and asked for it to provide a response in writing. We cannot see it agreed to producing a written response, gave reasons why it could not respond further to her questions, or that it offered any alternative. Some of Mrs A’s questions the Trust did not acknowledge relate to why it did not follow part of the initial management to investigate Mr Y’s distended abdomen, and why it did not act on the family’s observations.
77. In line with its complaint handling policy, we think the Trust should have offered to provide a further response in writing to address Mrs A’s further concerns and questions, and to resolve the complaint. Our principles say public bodies should investigate complaints thoroughly and fairly and we do not think the Trust did this. We also do not think, in line with our principles above, the Trust agreed to communicate with the complainant in a way that was appropriate to them and their circumstances or responded flexibly to the circumstances to the case. We have therefore identified a failing because the Trust did not offer a further response to reach resolution and has therefore not responded to all of Mrs A’s concerns.
Impact of the failings identified
78. We have considered the effect of the failings we have identified. These were stopping Mr Y’s antiplatelet medication, not acting on the family’s observations and concerns that he had had a stroke, and poor complaint handling.
79. The family say stopping Mr Y’s antiplatelet medication could have caused the stroke which left him severely disabled. They feel this significantly contributed to his rapid demise and death two weeks later. We asked our consultant cardiologist adviser about whether stopping Mr Y’s antiplatelet medication could have caused, or contributed to, his stroke.
80. The Trust cardiologist gave advice to stop the antiplatelets the morning of 25 August. Mr Y therefore did not receive his usual morning dose of dual antiplatelet drugs the morning after his admission. Mr Y was then given antiplatelet drugs, aspirin and Claxene, in the early hours of 26 August. Our adviser says stopping antiplatelet agents for 24 hours does not stop the effect of the antiplatelet drugs. This would take around one week. This means that despite Mr Y not having received his usual antiplatelet drugs, antiplatelet activity would have continued, and the formation of clots could not be attributed to a brief period of one day without antiplatelet drugs.
81. When we weigh up the evidence, there is no indication that stopping Mr Y’s antiplatelet medication contributed to or caused his stroke, or his deterioration, and death. We therefore cannot link this impact to the failing we have identified, but we can appreciate why this is very concerning to the family. We understand how difficult it must have been to feel Mr Y received poor care at the end of his life. We think the cardiologist’s mistake contributed to an emotional impact on Mrs Y and Mrs A.
82. The family also feel Mr Y’s stroke left him severely disabled and significantly contributed to his rapid demise and death two weeks later. They also say due to the stroke, his treatment for cancer could not be considered. Mrs Y is struggling to manage on her own as she has lost her support from Mr Y, who took care of the house and finances. She has also been affected financially due to the loss of Mr Y’s pension.
83. As we explain earlier, we cannot say, on the balance of probabilities, that the Trust would have diagnosed the stroke sooner with the right action, but we recognise it missed opportunities that might have led to an earlier diagnosis. We asked our general physician adviser about whether earlier recognition of Mr Y’s signs and symptoms of stroke would have made a difference to the outcome. Our adviser says if the signs and symptoms were picked up sooner and a CT scan had confirmed the stroke, Mr Y may have been eligible for thrombolysis (clot busting medication). This would be if the stroke diagnosis was made within four and a half hours of onset of symptoms. If so, thrombolysis may have led to some reduction in Mr Y’s disability in the initial period.
84. However, our general physician adviser says, on the balance of probabilities, this would not have affected the overall outcome. This is because Mr Y had widespread, non-curable cancer, pulmonary embolism, extensive cardiovascular disease, and a new stroke. Our adviser says this combination of medical issues would have led to a rapid and progressive decline in health, no matter how well the stroke was managed. Our general physician adviser also says thrombolysis would have been associated with a very high risk of bleeding complications and the risks of this would have required balancing with any potential benefits. Our general physician adviser says it is unlikely that any specific treatment would have been offered, other than palliative or supportive care.
85. We cannot say that the missed opportunities to investigate Mr Y’s stroke-like symptoms contributed to his rapid demise and death two weeks later. We do, however, recognise there was a small chance earlier recognition of his stroke may have led to him having thrombolysis, which could have made some difference to Mr Y’s later disability. Mrs Y and the family are left with some level of doubt about whether things could have been a bit better for Mr Y in his final days.
86. Sadly it was inevitable that Mr Y was going to die. Earlier diagnosis of stroke would not have led to successful cancer treatment. We therefore also cannot say Mrs Y would have been in a better position in terms of her difficulties in managing alone, or financially, as we cannot say Mr Y’s death would have been avoided.
87. We understand why Mrs A and Mrs Y feel their complaint is unresolved and that the Trust has not responded to all their questions and concerns. We appreciate that because they feel they have not had any acknowledgement or meaningful apology from the Trust for what happened, they cannot come to terms with it. They feel there is a lack of compassion from the Trust and that their comments fell on deaf ears. They think the Trust will continue to make mistakes.
88. We can see how the failings we have identified have had an emotional impact on Mrs A and Mrs Y. We appreciate the family are left with doubt about the severity of the impact of Mr Y’s stroke and whether his death could have been a little more peaceful and dignified, possibly at home or in a hospice. We understand Mr Y’s unexpected death has devastated them. We understand they have also lost trust in the hospital and NHS because they feel it provided poor care and made mistakes when treating Mr Y. They have not been able to come to terms with his death because of the circumstances. The Trust has compounded this with how it handled the complaint and Mrs Y and Mrs A have not had complete answers or acknowledgements of mistakes. They have suffered with their mental health since Mr Y’s death. We can see how the failings in his care, and the poor complaint handling we have found have contributed to this emotional impact and made things worse for them in their bereavement.
What the Trust has done to put things right
89. We have looked at what the Trust has done to put right the impact of the following failings we have identified.
· It incorrectly stopped Mr Y’s antiplatelet medication.
· It failed to act on the family’s concerns that Mr Y’s symptoms suggested a stroke.
· It made mistakes in how it handled the complaint.
90. From our review of the correspondence between Mrs A and the Trust, we can see the Trust apologised for not being able to address the issues appropriately at the time until it was too late to intervene. It also apologised Mr Y missed the chance of being considered for thrombectomy treatment, if his symptoms did start at midday as stated by the family. It apologised the service provided did not meet the family’s expectations and for the distress this has caused them.
91. The Trust has not explicitly accepted it got anything wrong and has focused on its view that the outcome would not have been any different. It has apologised without taking a view on what happened, or explained where it cannot make findings. Regardless of the outcome, we have identified failings by the Trust, and we cannot see it has acknowledged these. It has therefore not taken any action to put right the emotional impact these failings have had on the family, or to ensure it does not make the same errors in future.
92. Our ‘Principles of Good Complaint Handling’ say public bodies should be open and honest when accounting for their decisions and actions. When things have gone wrong, public bodies should explain fully and say what they will do to put matters right as quickly as possible. Our ‘Principles for Remedy’ say an apology means acknowledging the failure, accepting responsibility for it, explaining clearly why the failure happened and expressing sincere regret for any resulting injustice or hardship. We do not think the Trust has done enough in line with our principles and we think there is more it should do to put things right.