A. The Practice
Anticoagulant medication
25. Dr B thinks the Practice should have prescribed anticoagulant medication for his mother from May 2016. He said he was told the rhythm of his mother’s heart was irregular during a previous pacemaker check. He believes anticoagulant medication would have prevented his mother’s stroke at the end of the following year.
26. Atrial fibrillation (AF) is a condition that causes an irregular and often fast heartbeat. Complications of AF include stroke and blood clots, heart failure, and reduced quality of life. Anticoagulants are medicines that help to prevent blood clots. They are given to people at a high risk of getting clots, to reduce their chances of developing serious conditions such as strokes and heart attacks.
27. One of the most common adverse effects of anticoagulants is bleeding. Therefore, in addition to the patient’s risk of stroke, the GP must consider the patient’s risk of bleeding. This is in line with the NICE CKS on AF.
28. Mrs A had clear health problems including anaemia, bleeding from her back passage (haemorrhoids), and reduced kidney function. The risks involved with anticoagulants had to be considered carefully. Our GP adviser said, from the information available at that time, this was a difficult decision for the GP.
29. Section 16d of the GMC’s Good Medical Practice states that in providing clinical care, a doctor must consult colleagues where appropriate. Our GP adviser said the decision to prescribe anticoagulant medication does not lie with one clinician when other specialists are involved in the patient’s care. Here, as Mrs A was already under the care of the cardiologists, it would be expected they would take the lead and tell the GP if anticoagulant medication needed to be prescribed.
30. In June 2016 the GP records show the GP was aware of Mrs A’s increased shortness of breath and discussed this further with cardiologists with Hospital A’s cardiology team. They suggested a 24-hour ECG and an echocardiogram. It also appears that Mrs A’s creatinine clearance (a test of kidney function) was a borderline result (18-23). The NICE CKS on AF states that for several anticoagulants if the creatinine clearance level is below 30, the clinician needs to take caution before prescribing an anticoagulant. We found it was appropriate for the GP to seek cardiology input to help with this, which was in line with section 16d of the GMC’s Good Medical Practice.
31. The Practice has recognised it could have double-checked to see if the cardiologists had received the relevant investigation results and taken appropriate action. It said the Practice is taking steps to learn from this complaint, but we found this was not necessary in this circumstance. What the cardiology team should have done is considered later in this report.
32. Overall, from what we have seen, including the GP records and the GP advice we obtained, the Practice would not be expected to prescribe anticoagulant medication without direction from the cardiologists who were treating Mrs A for her heart problem. There is evidence the Practice thought about the right things (her anaemia, bleeding and kidney function) when assessing Mrs A. They referred her to the appropriate specialists and sought relevant advice about how to treat her. There is no documentation or evidence which suggests the Practice was told to prescribe any anticoagulant medication.
33. We found the Practice acted in line with the relevant national guidelines.
Dr B’s concerns in October 2017
34. Dr B said he reported to the Practice his worry when he thought his mother had a mini-stroke. He said they dismissed his concerns and did not take appropriate action. This must have been a worrying time for him.
35. We have looked at the GP records to see what was documented at the time. In his original complaint to the Practice, Dr B said he asked for a home visit as he suspected his mother had a mini-stroke at night. He did not say why he thought this. He said the GP decided it was likely to be a urinary tract infection.
36. The GP records show that on 10 October 2017, Mrs A had a chest infection and a GP prescribed antibiotics for her. Although it is not recorded in Mrs A’s GP records, the Practice said the GP asked Dr B to contact them again if she did not improve. This was appropriate safety-netting advice given the circumstances.
37. On 16 October 2017, Dr B called the Practice again and requested a home visit. In line with its standard practice the GP spoke with Dr B to decide if a home visit was indicated. It is documented Dr B provided an update about his mother’s current situation. The GP records show Dr B said his mother’s chest infection had gotten better, but she had experienced a general decline over the previous two weeks. The GP recorded the likely decline was due to Mrs A’s recent acute infection, with a background of dementia, and she would take time to recover. This was a reasonable explanation based on Mrs A’s medical history and the information provided by Dr B. There is nothing written in the notes to suggest Dr B told the Practice he thought his mother had a mini-stroke.
38. The GP advised Dr B to bring in a sample of her urine. This was an appropriate action so they could check if she had a urinary tract infection. Infections can be serious if left untreated and so prompt action is important. Urinary tract infections can present without classical urinary symptoms in the elderly, and can cause general decline and confusion, especially in patients with dementia.
39. We found the GP’s actions were in line with section 15a of the GMC’s General Medical Practice. This states a doctor must ‘adequately assess the patient’s conditions, taking account of their history…where necessary, examine the patient’. Our GP adviser said there was no information to suggest Mrs A was clinically unwell at that time or that she needed an assessment. In its complaint response, the Practice said the GP told Dr B to call back if his mother did not improve. This was appropriate in the circumstances. Dr B did not contact the Practice again until 11 December 2017, almost two months later.
40. We do not doubt Dr B’s account of what happened. When investigating this point, we paid particular attention to what he told us and looked to see if there was any evidence in the medical records which we could use to support his account. We have been unable to identify any records or any other supporting information which would allow us to challenge or criticise the information provided by the Practice. We appreciate how disappointing this will be for Dr B. It is important any findings we make, and any failings we identify, are supported in the evidence available to us and we have to acknowledge where there is a lack of evidence to support a complaint.
41. For this reason, although we do not dispute what Dr B has said, we have not seen any evidence that would allow us to uphold this point of his complaint.
B. London North West University Healthcare NHS Trust
42. Dr B said his mother saw three different cardiologists in 2016 and 2017. He complained they did not make necessary changes to her medication, specifically anticoagulant medication. He believes lack of action may have contributed to his mother’s stroke in December 2017.
Anticoagulant medication
43. In September 2016, the cardiologist noted Mrs A had excessive leg swelling and shortness of breath. Dr B said he mentioned that a few months previously the pacemaker clinic expressed concerns she was showing signs of AF. He said he asked about anticoagulant medication.
44. The September 2016 cardiology clinic letter shows, at that time, the cardiologist was also aware of some investigations (transthoracic echo and 24-hour heart monitoring) carried out at different hospitals, but they did not have the results. They recorded they had requested an urgent transthoracic echo and would see Mrs A again with the results.
45. Section 15 of the GMC’s Good Medical Practice says if doctors ‘assess, diagnose or treat patients, you must:
a. adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient b. promptly provide or arrange suitable advice, investigations or treatment where necessary’.
46. Our cardiology adviser said the doctor who saw Mrs A in clinic should have tried to obtain the relevant information, including the 24-hour heart monitoring and the results of the pacemaker check, particularly as Dr B appears to have informed them about the possibility of his mother’s AF.
47. Alternatively, the cardiologist could have arranged for an investigation at the same hospital where she was seen so that they could review the results.
48. Although the cardiologist in September 2016 requested an urgent transthoracic echo, and this was carried out in the same month, they did not review Mrs A again until February 2017. This was five months after the investigation. The cardiologist noted a creatinine level of 133, potassium level of 5.5, and GFR 33. These results suggest a loss of kidney function. The Trust said as Mrs A was elderly and frail, with known chronic kidney disease, the cardiologist suggested a referral to the nephrologists (kidney specialists) for an expert opinion.
49. Our cardiology adviser questioned why input from a nephrologist was required at that stage. They said this would not have changed the outcome, since the doses of anticoagulant medication can be adjusted later, if required. This would be in line with the NICE CKS on AF. They said the cardiologist should have decided about appropriate medication and could have consulted the British National Formulary or phoned the hospital pharmacist if there was uncertainty about dosage initially.
50. The 2014 NICE Guideline on the management of AF states the risk of stroke should be assessed when someone shows signs of AF.
51. The CHA2DS2-VASc Score (a validated tool to predict the risk of stroke) takes into account several risk factors including heart failure, hypertension, age, diabetes mellitus, previous transient ischaemic attack (TIA) or stroke, vascular disease, and gender (the risk for a female is a little higher). The higher the score, the higher the risk of stroke.
52. Mrs A had multiple risk factors and, from the information available at that time, her CHA2DS2-VASc score was 4. This translates to a 4% to 5% per year risk of stroke (compared to someone in the normal population with no risk factors who would have a risk of 1% to 2%). Therefore, she had a high-risk score for stroke.
53. The aim of treatment is to prevent complications, particularly stroke, and alleviate symptoms. Drug treatments include anticoagulants to reduce the risk of stroke and antiarrhythmics to restore or maintain the normal heart rhythm, or to slow the heart rate in people who remain in atrial fibrillation.
54. Section 1.5.3 of the NICE Guidance on the Management of AF states, clinicians should ‘Offer anticoagulation to people with a CHA2DS2-VASc score of 2 or above, taking bleeding risk into account.’ This guidance also says they should discuss the options for anticoagulation with the person and base the choice on their clinical features and preferences.
55. The August 2016 24-hour ambulatory ECG report alone states ‘worsening HF symptoms; Runs of AF on ECG’. Dr B said the pacemaker check earlier in the year also suggested AF.
56. Our cardiology adviser said if the cardiologist had seen the relevant and up-to-date investigation results in September 2016, the likelihood is they would have concluded that Mrs A was at high risk for thromboembolic events (blocked blood vessels as a result of blood clots). Considering her risk of bleeding and medical history, they would have recommended anticoagulation to be started by the GP. They would have also stopped the aspirin (which as stated previously is not recommended for patients with AF).
57. Even if Mrs A was a high risk for bleeding, steps could have been taken to address this. Section 1.4.2 of the NICE Guidance on the management of AF states clinicians should offer ‘modification and monitoring of risk factors’. For most people the benefits of anticoagulation would still outweigh the risks.
58. From what we have seen the clinicians should have started Mrs A on anticoagulant medication. Our cardiology adviser said warfarin, or possibly the newer oral anticoagulation medications (NOACs) which were in use in 2016/17, should have been considered seriously. This decision should have been made after a full assessment and discussion with Mrs A and her son.
59. Even if the cardiologists thought they needed input from a nephrologist to help with their clinical decision-making, they should have started her on anticoagulants first as they could have adjusted the dosage later, if necessary. They should have also stopped the aspirin.
60. This did not happen. We found there was a missed opportunity to decide about, and to start Mrs A on, appropriate anticoagulant medication. The Trust has not acknowledged this.
61. We have considered carefully the impact of the failings we have identified.
Impact of failings
62. AF has the potential to cause an obstruction of a blood vessel in the brain or the body by a blood clot. 20–30% of all strokes are attributed to this.
63. Section 9.2 of the ESC Guidelines states anticoagulants reduce the risk of stroke by nearly two thirds. In other words, these treatments can prevent about 60% of strokes that would have occurred in people with AF. Mrs A did not take any anticoagulant medication until after her stroke in December 2017. She was taking aspirin (an antiplatelet that stops platelets sticking together) but this does not offer as much protection (said to be around 21%) as an anticoagulant, especially not in a high-risk patient such as Mrs A. In any case, the 2014 NICE Guideline on the management of AF states aspirin is not recommended for a person with AF.
64. The most commonly prescribed anticoagulant is warfarin. There are also newer types of anticoagulants, NOACs, that are becoming increasingly common.
65. The anticoagulant medication reduces the chances of blood clots. The protection this offers takes effect almost immediately with NOACs, and within two to four hours. If the clinicians’ decided warfarin was more appropriate to use, then this can take two or three days to establish a steady level. Either way, it would not have taken long for Mrs A to gain some protection from the anticoagulant medication.
66. Dr B, understandably, wonders whether anticoagulant medication might have prevented his mother’s stroke and subsequent death. We have considered this carefully.
67. The ESC Guidelines state, in general, patients without clinical stroke risk factors do not need anticoagulant therapy (OAC), while patients with stroke risk factors (i.e., CHA2DS2-VASc score of 1 or more for men, and 2 or more for women) are likely to benefit from OAC.
68. Mrs A had a number of significant medical conditions. Our cardiology adviser said the most significant factor was her AF as it can lead to a clot in the left atrium (that collects the returning blood to the heart). Mrs A had an impaired left ventricle, high blood pressure, and chronic kidney disease (stage 3). Although there may have been a risk of stroke with these conditions, our cardiology adviser said without AF the clinicians would not have been so concerned about it to start anticoagulation.
69. The use of anticoagulant medication is never a 100% guarantee to prevent all strokes. However, it will reduce the chances of this happening by about 60%. This is why it is important to start this treatment promptly.
70. Taking into account the CHA2DS2-VASc score, Mrs A’s risk of stroke was 4% to 5% per year. While this was significantly more than for someone without AF, there was a 95% chance that she would not have a stroke. From what we have seen, although her risk was increased by not starting anticoagulant medication, it was still low.
71. Although there was a missed opportunity to reduce her risk of stroke, on a balance of probabilities, we cannot conclude with any certainty that her stroke was avoidable. We do not doubt the stroke will have contributed to her physical deterioration and this must have been difficult for her and her family.
72. Dr B believes his mother's death was preventable. Mrs A died in March 2018, three months after her stroke. She was in hospital receiving treatment for heart failure and possible pneumonia, and then sadly had a cardiac arrest. The certified cause of death was ‘cardiopulmonary degeneration’ and ‘Frailty of old age’.
73. Mrs A was over 80 years old with significant health problems. When a person has a stroke, especially when they are already older and frail like Mrs A, they have increased weakness and reduced mobility, and they will deteriorate more quickly. Our cardiology adviser said from the information available her life expectancy would not have been long.
74. Mrs A died of a cardiac arrest, several months after her stroke. On a balance of probability, it seems more likely than not her death was not avoidable or preventable. However, unfortunately due to the failings we identified, her family will be always left wondering if this missed chance might have made a difference to the outcome for Mrs A. We cannot underestimate how upsetting this information will be for Dr B and his family. The Trust has not acknowledged this.
75. Therefore, we have partly upheld Dr B’s complaint about the Trust and have made recommendations for further work. Our recommendations are set out at the end of this report.
C. London Ambulance Service NHS Trust
Assessment on 10 December 2017
76. Dr B said on 10 December 2017, his mother was poorly, vomiting, and could not stand or sit. He complained that a paramedic assessed her and did not identify that she had a stroke. Dr B said based on the paramedic’s advice, he agreed to keep his mother at home. He thinks this was a missed opportunity to provide ‘clot-busting’ treatment to avoid the permanent effects of a stroke.
77. That afternoon, Dr B flagged down a paramedic who was attending a call nearby. The Trust referred to this as a ‘running call’. The paramedic told the control room and attended to Mrs A. The paramedic recorded that Mrs A’s symptoms started at 9am. She felt unwell, had vomited twice, was feeling lethargic and had not eaten that day.
78. The guidance mainly used by paramedics and other grades of ambulance staff is the JRCALC Guidelines. Paramedics are also expected to perform to a standard of proficiency as set by their regulator, the Health and Care Professions Council (HCPC).
79. When assessing a medical patient, the guidance advises a primary survey is completed to identify any obvious life-threatening conditions that require immediate treatment or transportation. The primary survey includes assessment of the airway, breathing, consciousness level and cardiac/circulation, and a record of initial observations recorded. It also includes the FACE test (face, arms, speech, time), the recommended test for stroke.
80. This is followed by a full history and an appropriate physical examination, with further observations/investigations, for example, blood glucose monitoring and ECG (electro-cardiograph).
81. The Patient Report Form (PRF), a record of the attendance, completed by the paramedic, is legible and has been completed in full. This is in line with the JRCALC Guidelines. Our paramedic adviser said this provides reassurance the assessment was thorough and of an appropriate standard.
82. The paramedic checked Mrs A for signs of sepsis, abdominal aortic aneurysm, and urinary tract infection. There were no signs of these conditions. The paramedic documented Mrs A did not want to go to hospital and had capacity to make that decision. They concluded it was appropriate to refer Mrs A to her GP. They advised her to maintain her fluid intake. It is also recorded they arranged for a neighbour (who said they were a GP) to check on her during the day. The paramedic also advised them to call NHS111 if Mrs A or her family had any concerns. Dr B signed the PRF, on behalf of his mother, to say he understood the advice.
83. We found the assessment carried out on 10 December 2017 was in line with the JRCALC Guidelines. It is understandable Dr B would be concerned about his mother being poorly. Mrs A’s symptoms were non-specific and as there were no other symptoms (for example, dizziness or headache), it was appropriate to have referred Mrs A to her GP. The symptoms described do not suggest Mrs A had had a stroke. We found nothing wrong here.
11 December 2017
84. Dr B complained about the delay in an ambulance being sent on 11 December 2017, and the care provided. He complained the paramedics did not identify his mother was having a stroke. He complained that by the time she was taken to hospital the following day it was too late to give her treatment to reverse the permanent effects of her stroke.
85. Following the paramedic’s attendance the previous day (10 December 2017), Mrs A’s GP arranged for an Advanced Nurse Practitioner (ANP) to visit her the next day and make a further assessment. The ANP called the Service on 11 December 2017 to request an ambulance to take Mrs A to hospital. This was agreed by the ambulance control room. An ambulance attended four hours later.
86. On 11 December 2017, three calls were made to the Service at 7.04pm (ANP), 8.35pm (Dr B) and 10.32pm (Dr B). We have taken a closer look at these.
7.04pm
87. The ANP assessed Mrs A. They reported she had not been eating or drinking for three days, was very tired and lethargic, and suspected she might have a urinary tract infection. There was also a discussion with the clinician from the Service’s Clinical Hub (in the control centre) about Mrs A’s presenting condition. The ANP requested an ambulance response within an hour. It is assumed the referring clinician is able to assess the clinical urgency for the patient to be treated at hospital and therefore how quickly an ambulance is needed.
88. The Service said it had introduced an initiative, with staff assigned to lower priority patients and healthcare professional requests, when no clinical intervention is indicated. They agreed a Non-Emergency Transport Service (NETS) vehicle would be sent within a target of one hour.
89. In its complaint response, the Service said a referral to NETS was made but they did not have a resource available. It said at that time there was a significant demand for patients triaged as higher priority emergencies. It added it also did not have a frontline ambulance available. The Service said the request was ‘held’ awaiting an ambulance becoming available. This is normal practice in emergency care.
8.35pm & 10.32pm
90. Dr B called the Service at 8.35pm about the estimated time of arrival of the ambulance and then again at 10.32pm.
91. We have listened to the call recordings and the information provided by Dr B during these calls. Mrs A’s condition had not been reported as having changed until Dr B’s second call at 10.32pm. He said his mother had been vomiting and showing signs of slurred speech. At this time the call handler noted Mrs A was no longer alert and applied the Service’s stroke protocol. The call was upgraded to a Category 2, with a local target response of 60 minutes.
92. We found the Service triaged all calls on 11 December 2017 correctly and in line with the JRCALC Guidelines. We found nothing wrong here.
Attendance at 11.04pm
93. The attending ambulance crew recorded that Mrs A did not want to go to hospital because it was late. However, they later recorded they had no contact with Mrs A and that they had in fact spoken with her son, Dr B, who had then relayed information to her. They wrote Dr B said he would call back for an ambulance the next morning. The crew documented the paramedic who reviewed her the day before had not had any concerns about her capacity (the ability to use and understand information to make a decision). They provided safety-netting advice regarding actions to take should she deteriorate and left at 11.40pm.
94. The JRCALC Guidelines state ambulance clinicians should ‘rely on their persuasive powers to achieve a conversation and then to conduct an assessment’. Furthermore section 6 of the HCPC Standards of Conduct state paramedics must ‘Manage Risk’ and take all reasonable steps to reduce the risk of harm to service users as far as possible. Section 8.7 of the HCPC Standards of Proficiency require paramedics to understand the need to provide service users or people acting on their behalf with the information necessary to enable them to make informed decisions.
95. Dr B told the ambulance crew his mother was asleep and had not wanted to go to hospital at that time of night. Our paramedic adviser said, having listened to the recordings of the 999 calls, it is clear Dr B would be interpreting for her. It appears he was taking the role of her advocate/carer and would be the person initially the crew might have had to use their powers of persuasion upon.
96. It is not possible to assess whether the crew did in fact try to sufficiently persuade Dr B to let them assess his mother, before agreeing on a plan of action. In its complaint response, the Service recognised the crew might have been more proactive in trying to use the capacity and consent tool to see and assess Mrs A. Yet, it is also the case that a person must be assumed to have capacity, unless it is established that they lack capacity. Based on the information available at the time, provided by her son, it appears the crew had no reason to suspect Mrs A lacked capacity to decide to allow them to assess her. On balance, we cannot criticise the Service here.
97. Dr B believes the crew failed to recognise that his mother had a stroke. From the information recorded, the crew was not able to see or assess Mrs A and all conversations were through her son. They offered to take Mrs A to hospital, and this was declined. We found nothing wrong here.
98. The following day Dr B called the Service requesting an ambulance for his mother, as instructed by the ambulance crew the previous evening.
99. Mrs A was taken to Hospital B and later that day was transferred to Hospital C where she had a CT MRI scan. It appears it was only at this point the clinicians were able to diagnose that Mrs A had experienced a posterior circulation stroke. This is more difficult to recognise and treat effectively than other stroke types. The detailed neurological examination skills required to diagnose this type of stroke are outside the scope of practice of the ambulance paramedic staff.
100. In summary we found the Service handled the calls and attendances in line with the relevant guidelines.
Delay
101. Overall, we found the Service categorised and prioritised the calls on 11 December 2017 appropriately. They do this to work out which patients need to be seen and in what order. Following the ANP’s request at 7.04pm it took four hours for an ambulance to arrive. It is understandable that Dr B would question this delay. The target times are the aims for the Service as a whole, and not for individual cases. Unfortunately, there may be delays in dispatching paramedics. This can be for a large number of reasons, including the demand for the Service at any one time and its capacity.
102. The Service acknowledged the response time was ‘very disappointing’. It said on 11 December 2017, the Service received 5844 ‘999’ calls. It said this ‘seriously exceeded the already worrying daily average, 5005 x 999 calls’. When the events in this case happened between 7pm and 11pm, the Service received 1192 ‘999’ calls, including 132 ‘Category 1’ calls (a local target response of 45 minutes) and a further 309 ‘Category 2’ calls.
103. The Service said this represents ‘a challenging spike in demand within such a relatively short period’. It added that operational staffing was below plan due to staff sickness absence, vehicle defects, and job vacancies.
104. Surge Plans are local protocols that come into effect when a Service is experiencing unusually high demand and it cannot respond to calls as it would like to. Here the Service said its Surge Plan had been implemented but ‘the combination of these factors meant that some patients had to wait longer than we would have hoped’.
105. Although we have seen nothing to suggest that the delay was avoidable, the Service has apologised for the delay and for not reaching the standards it aims to achieve. This is an appropriate action to take in the circumstances and is in line with the Ombudsman’s Principles of Good Complaint Handling.
106. We have not upheld Dr B’s complaint about the Service.