Heart Failure and Palliative Care making a difference?

Transcription

1 Heart Failure and Palliative Care making a difference? Miriam Johnson Wolfson Palliative Care Research Centre University of Hull Saint Catherine's, Scarborough

2 Overview Just to recap What s so difficult? Are we making a difference? How? What next?

3 Knowledge and communication difficulties Little lay understanding of disease Didn t understand importance of symptoms and when to call GP >50% talked about death and dying Socially isolated Confusion or short term memory loss Difficulties getting to appointments Perception that doctors didn t want to give information they don t take you into their confidence either they think you re stupid..or else not interested.. A Rogers et al BMJ :

4 Dying of lung cancer or cardiac failure:. Heart failure patients have: a different illness trajectory different concerns, a poorer understanding of illness and prognosis, less opportunity to address end of life issues health, social and palliative care services are less readily available Care should be pro-active and designed to meet specific needs S Murray et al BMJ 2002; 325:

5 Overview What s so difficult?

6 Terminology End of life care Terminal care Care of the dying Palliative care Supportive care Patient-centred care

7 Policy Identifying those in the last year of life 138 consecutive NYHA III/IV community dwelling patients Seattle Heart Failure Model: 12% sensitivity; 99% specific GSF prognostic indicator: 83% sensitivity; 22% specific 86% met criteria for end of life care 82% difficult refractory symptoms 24% 2 admissions in last year for heart failure symptoms Haga et al Heart 2012

8 Prognosis the holy grail If we wait until incontrovertible, completely obvious, irreversible, no chance of stabilisation or improvement deterioration The patient will be dead

9 GP research database records for deaths in , 689 evaluable decedents Heart failure only Cancer only Heart failure and cancer Number on the palliative care register at time of death Total N (%) Total N (%) Total N (%) Total (100) Time between palliative care register and death Palliative care register N (% ) 234 (7) (100) Heart failure only N (% ) Cancer only N (% ) Palliative care register N (%) (48) 803 (100) 1 week 69 (29) 294 (8) 30 (12) > 1 week to 6 weeks 40 (17) 755 (21) 61 (24) Palliative care register N (%) 257 (32) Heart failure and cancer N (%) Gadoud A, et al Palliative Care among Heart Failure Patients in Primary Care: A Comparison to Cancer Patients Using English Family Practice Data. PLoS ONE 2014, 9(11): e113188

10 Overview Are we making a difference?

11 Does it make a difference? clinical trials Phase 3 RCT, single site Out patients, N=72 Intervention: MDT specialists in heart failure, pall care, OT, physio Outcomes Improved KCCQ QoL p=0.047; Reduction in total symptom burden p=0.035 Increased self-efficacy p=0.041; NYHA improved p=0.015; Fewer rehospitalisations p= 0.009; No difference in mortality Brannstrom M et al Eur J Heart Failure 2014

12 Does it make a difference? clinical trials Phase 3 RCT, single site IPs with acute HF, N = 232 Intervention: PC consult and follow-up vs standard care Primary outcomes at 1 month Improved symptom burden (ESAS) (p < 0.001). QOL score (MLwHF) better (p < 0.001). Secondary outcomes ACP = only secondary outcome associated with PC (HR 2.87, p = No increased risk of inpatient 30-day readmission, hospice use, and death Sidebottom A et al JPM 2015; 8:

13 Does it make a difference? clinical trials Phase 3 RCT, 3 sites, N=84 End-stage heart failure (ESHF) after hospital discharge and referred for palliative service Intervention multi-professional palliative care service Primary outcome readmission and count of readmissions within 4 and 12 weeks Results; lower readmission rate at 12 weeks; RR = 0.55 (0.35 to 0.88). improvement in depression, dyspnoea and total ESAS score at 4 weeks. Better quality of life (McGill QOL and chronic HF questionnaires). Wong FK et al Heart 2016

14 Does it make a difference? clinical trials Phase 3 RCT, 1 site, N = 150; Intervention: usual care + palliative intervention Primary end points: KCCQ and FACIT-Pal, assessed at 6 months Secondary endpoints: HADS, FACIT-Sp, hospitalizations, mortality. Results: PAL group better KCCQ (9.49 points, 95% CI 0.94 to 18.05, p = 0.030); FACIT-Pal (11.77 points, 95% CI: 0.84 to 22.71, p = 0.035). HADS-depression (-1.94 points; p = 0.020) HADS-anxiety (-1.83 points; p = 0.048) FACIT-Sp (3.98 points; p = 0.027). No difference: rehospitalisation or mortality Rogers JG et al J Am.Coll.Cardiol 2017

15 Limitations Sidebottom and Rogers didn t achieve the sample size Achieved statistically significant findings Poor precision (Rogers) More NYHA IV in control group (Wong) Missing data is an issue approx 17-40% (e.g in Rogers; death [30%] or withdrawal [12%] Only Rogers explicitly describes an approach to managing this (linear mixed models analysis) None were cluster trials, and contamination of control arm is possible, and some in the PC arm did not receive the intervention Populations, interventions, controls and outcomes were heterogeneous so meta-analysis not possible 15

16 A carer s verdict..when initially introduced to palliative care..and it is explained to you, the first emotion is one of utter relief that someone is offering a safety net in a time of crisis....for the first time in a very long time, that feeling of frustration, helplessness and aloneness is dispelled.

17 Subcutaneous furosemide-making a difference Rationale Community based parenteral diuretic is an attractive option for some with advanced decompensated HF. Normal volunteers Patients Case series Audit Pharmacodynamics/Pharmacokinetics/safety 5 hour infusion Phase II trial IV vs SC 5 hour infusion Ongoing pilot trial 17

18 Pharmacokinetics/safety 10 participants NYHA II Single infusion 80mg IV or SC furosemide over 5 hours Findings: 100% bioavailability Erythema/oedema at site monitored 1 transient very slight erythema during SC furosemide administration. 8 very slight erythema after completion Sica et al. Subcutaneous Furosemide in Patients With HF JACC:BASIC TO TRANSLATIONAL SCIENCE 2018;3:

19 Phase 2 pilot Methods 41 outpatients with decompensated HF single 80mg SC 5 hour infusion or IV bolus* of furosemide. Primary outcome: 6-h urine output, Secondary outcomes: weight change, natriuresis, adverse events. *dose calculated on 1:1 current oral dose Results IV (mean dose: 123 +/- 47 mg) vs SC (80 mg over 5 h) 6-h urine output (median IV: 1,425 ml; IQR: 1,075 to 1,950 ml; vs. median SC: 1,350 ml; IQR: 900 to 1,900 ml; p = 0.84). Mean weight loss (1.5 +/- 1.1 kg IV vs /- 1.2 kg in the SC group; p = 0.95). Hourly urine output hour 2 (425 ml IV vs. 250 ml SC; p = 0.02) hour 6 (125 ml, IV vs. 325 ml, SC; p = 0.005). Natriuresis (IV: 7.3 +/ meq/l vs. SC: / meq/l; p =0.05). There was no worsening renal function, ototoxicity, or skin irritation with either formulation. Thirty-day hospitalization rates were similar. Gilotra NA et al. Efficacy of Intravenous Furosemide Versus a Novel, ph-neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. JACC:HEART FAILURE.doi.org/ /j.jchf

20 Scarborough experience Started using subcutaneous furosemide (0.9% sodium chloride) 2006 According to protocol* in the context of audit and HF-pall care MDT Reported first 43 episodes 2011 median loss of 5.6 kg [IQR ]). The daily dose mg. The median number of days 10.5 (range 2 48; IQR ). Site reactions occurred in 10/43 (23%); all mild except two, prevention of hospital admission or transfer/facilitation of home discharge: 26/28 (93%); Only 14 episodes community based Symptoms and signs not routinely collected other than site reactions *approval currently York NHS Trust Zacharias H et al Pall Med Journal

21 Increasing community based experience 57 episodes in 52 participants (men 32 [62%]; mean age 73.6 [Range 48 to 93]) 751 SCF days All but one had New York Heart Association Class III/IV; 75% home = preferred place of care. A) HOME (n=33). 97% prevent hospital admission mean weight change = 4.62kg (SD 4.87; range 17 to +8.5). One admitted to hospital with pulmonary oedema as a terminal event; aim of admission comfort measures only in the dying phase. B) HOSPICE (n=12). 83% stabilized and discharged home. mean weight change = 4.73Kg (SD 5; range 11.7 to +2.5). 21

22 Increasing community based experience Symptoms: Breathlessness: baseline mean 8/10; vs end of the SCF episode mean 5.2/10. Peripheral oedema: baseline median grade 3 vs end median grade 1 Crepitations: Baseline grade 2 (45%) vs end grade 2 (3%). Median days 10 (range 1 to 98; IQR 7 to 16). Mean daily starting dose = 134mg/24 hours Mean daily finishing dose = 116mg/24 hours Adverse events: 36% episodes: erythema (15); bruising (1); lump (1); pain and irritation (1); infection requiring antibiotics [one of which required drainage for an abscess] (4). 22

23 Questions Site reactions: How would subcutaneous furosemide in 0.9% saline compare with 10 days infusion with SUBQ? What is the comparative effectiveness, cost-effectiveness and safety of IV versus SC administration for community based patients with decompensated HF 23

24 Overview How?

25 Needs based care Systematic and regular holistic assessment Identify and triage needs of patient and carer Tools to help (Needs Assessment Tool- progressive disease:hf) Waller et al JPSM 2013 Service configuration MDT cardiology and palliative care

26 Training e.g. difficult conversations Uncertainty Misconceptions 85% patients with ICDs believed that re-programming meant that the heart would stop (Stromberg et al 2014) The elephant in the room (Barclay et al 2011) What about cardiology/coe trainees/hfnss/senior staff? Ismail Y et al British Journal of Cardiology 2015: linked Editorial Johnson MJ Emerging evidence Allows support for preferred place of care (Johnson et al BJC 2012) the way that its done Allows access to services and joined up care Reframing hope

27 Patient centred care NICE, ESC and AHA have recommended a patientcentred approach for CHF. An agreed global definition is lacking but include respect for patients needs, values, preferences, patient-healthcare professional collaboration, shared decision making Kane et al Heart Fail Rev 2015 DOI /s

28 When to involve specialist palliative care? Persistent, complex symptoms Other support needed, including for family Difficult things to talk through Preference in place of care Local service configuration Problem based, not prognosis based Extended team based, not either/or Integrated care

29 Heart failure and hospice care This guide sets out the principles and practical advice so that all agencies provide an integrated approach to improve the way we care for people with end-stage heart failure. Dr Mike Knapton Associate Medical Director British Heart Foundation 29

30 Key points for change Incremental steps to allow new relationships between clinical services. Hospices involved in service design and delivery for patients with heart failure. Mutual training and education : heart failure, care of older people and primary care teams to provide a generalist palliative care assessment and management hospice staff to be competent in basic cardiac care supported by their cardiac teams. Hospices should be accountable to commissioners, audit data regarding provision for people with heart failure, agreeing realistic service improvement targets. Understand the strengths of hospice care and where it can make a significant difference throughout the heart failure trajectory. 30

31 Example 1- palliative heart failure service Est 2000 Scarborough, district general hospital; urban/rural Palliative consultant led Consultant cardiologist Heart failure nurse specialists Palliative care nurse specialists Communication with primary care (written, nurse liaison) Cross setting (hospice, hospital, community); multiple funders Multi-disciplinary team meeting twice per month Referrals (access to all palliative care services) Education& training Local protocols (ICD reprogramming; subcut furosemide); Core component 1: cardiology and palliative care Core component 2: nursing and medical with opportunities for joint consultation Core component 3: communication with primary care Core component 4: key role for heart failure nurse specialist Core component 5: education and training Core component 6: audit & evaluation

32 Example 2- Caring Together Project Est 2011 Glasgow. Major regional tertiary hospital. Cardiology consultant led Consultant palliative physician Heart failure nurse specialists Palliative care nurse specialists Communication with primary care (written, nurse liaison) Cross setting (hospice, hospital, community); multiple funders Multi-disciplinary team meeting monthly Reconfigured cardiology service with dedicated palliative cardiology clinic, and medical ACP Evaluation Qualitative study Cohort: Palliative care needs of people admitted due to HF Core component 1: cardiology and palliative care Core component 2: nursing and medical with opportunities for joint consultation Core component 3: communication with primary care Core component 4: key role for heart failure nurse specialist Core component 5: education and training Core component 6: audit & Two cohort study (palliative cardiology clinic; usual care clinic): symptoms, evaluation QoL, service use, documentation of care plan

33 Overview What next?

34 What next? Agree Key components of care Which components can be embedded into routine heart failure care, e.g. ACP Which patients need referral to specialist palliative care Health-economic effectiveness of integrated models of care Educate and train Build on the progress in incorporating palliative care as part of the undergraduate curriculum Include meaningful palliative care education/training in post graduate clinical training Advanced communication skills for all caring for people with advanced heart failure Enshrine in policy

35 SUMMARY We are making a difference But people with HF are still disadvantaged Approach should be needs based Extended team based Alongside active HF treatment Let your cardiology teams know what you have to offer Professor of Palliative Medicine miriam.johnson@hyms.ac.uk