ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments USA Intervention: Structured telephone support Comparator: Usual care non-Hispanic and Hispanic people with documented systolic dysfunction Mean age: 59 years USA All-cause mortality All-cause hospitalisation Quality of life Strata: community Tsuyuki Intervention: Structured telephone support Comparator: Usual care People discharged from hospital with HF Mean age: 72 years Canada All-cause mortality Strata: recent admission Wakefield Intervention: Structured telephone support Comparator: Usual care People hospitalised for HF exacerbation Mean age: 69 years USA All-cause mortality All-cause hospitalisation Strata: recent admission Table 91: Summary of studies included in the Cochrane review153 - Telemonitoring Study Intervention and comparison Population Outcomes Comments Antonicelli Intervention: Telemonitoring Comparator: Usual Care People hospitalised for worsening symptoms and All-cause mortality All-cause hospitalisation Quality of life Strata: recent admission Quality of life downgraded for risk of bias as all scores were not matched at Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments signs of HF Mean age: 78 years M/F (%): 78/22 Italy baseline and final values were reported. Intervention: Telemonitoring Comparator: Usual care People with HF and NYHA class I-IV Mean age: 66 years M/F (%): 70/30 The Netherlands All-cause mortality Strata: mixed Biannic Intervention: Telemonitoring Comparator: Usual care Elderly people with severe HF recently hospitalised for HF Mean age: M/F (%): France All-cause mortality All-cause hospitalisation Quality of life Strata: recent admission Intervention: Telemonitoring Comparator: Usual care People with HF who have been admitted to hospital within the past year Mean age: 72 years M/F (%): 71/29 USA All-cause mortality All-cause hospitalisation Quality of life Strata: mixed Quality of life downgraded for risk of bias as all scores were not matched at baseline and final values were reported. (TENS- Structured telephone support People with a All-cause mortality All-cause Strata: recent admission Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments Telemonitoring Comparator: Usual care recent admission for HF and Mean age: 67 years M/F (%): 77/23 Germany, Netherlands, UK hospitalisation De Lusignan Intervention: Telemonitoring Comparator: Usual care People with HF confirmed by a cardiologist, identified from the database of an academic general practice Mean age: 75 years Gender not reported UK All-cause mortality Strata: mixed Dendale Intervention: Telemonitoring Comparator: Usual care People hospitalised with HF Mean age: 76 years M/F (%): 65/35 Belgium All-cause mortality All-cause hospitalisation Strata: recent admission Giordano Intervention: Telemonitoring Comparator: Usual care People with confirmed HF with LVEF<40% and at hospitalisation for acute HF in the prior year Mean age: 57 years All-cause mortality All-cause hospitalisation Unable to obtain full text paper. Included in mixed strata Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments Italy Goldberg Intervention: Telemonitoring Comparator: Usual care People hospitalised with NYHA class III- IV, with a LVEF < Mean age: 59 years USA All-cause mortality All-cause hospitalisation Quality of life Strata: recent admission Koehler Intervention: Telemonitoring Comparator: Usual care People with HF in NYHA class II or III with an LVEF of Mean age: 66.9 years Germany All-cause mortality All-cause hospitalisation Quality of life Strata: mixed Quality of life downgraded for risk of bias as final scores were reported by the study with no report of baseline scores. Intervention: Telemonitoring Comparator: Usual care People who were hospitalised for HF with NYHA class III- IV Mean age: 73.9 years Sweden All-cause mortality All-cause hospitalisation Strata: recent admission Mortara Structured telephone support Telemonitoring Comparator: Usual care People with HF NYHA class II-IV and Mean age: 60 years All-cause mortality All-cause hospitalisation Strata: mixed Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments UK, Poland, Italy Intervention: Telemonitoring Comparator: Usual care People with HF hospitalised for >24 hours within 4 weeks prior to the study Median age (IQR): M/F(%): Austria All-cause mortality All-cause hospitalisation Strata: recent admission Intervention: Telemonitoring Comparator: Usual care Ambulatory people diagnosed with HF Mean age: 55.1 years Canada All-cause mortality All-cause hospitalisation Quality of life Strata: mixed Soran Intervention: Telemonitoring Comparator: Usual care People with a diagnosis of HF secondary to systolic dysfunction Mean age: 76 years USA All-cause mortality All-cause hospitalisation Strata: Mixed Intervention: Telemonitoring Comparator: Usual care People with HF hospitalisations in the last 6 months and at high risk of All-cause mortality Strata: recent admission Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments early re- hospitalisation Mean age: 72 years Italy Vuorinen Intervention: Telemonitoring Comparator: Usual care People with systolic HF Mean age: 58 years Finland All-cause mortality Strata: mixed Woodend Intervention: Telemonitoring Comparator: Usual care People with symptomatic HF (NYHA Class II or greater) Mean age: 68 years Canada All-cause mortality All-cause hospitalisation Strata: recent admission Table 92: Summary of studies included in the update of the Cochrane review Study Intervention and comparison Population Outcomes Comments Al-Sutari Intervention: Structured telephone support Comparator: Usual care People with heart and NYHA class II or III) who attended the cardiac clinic of an educational hospital Mean age: 64.78 All-cause mortality All-cause hospitalisation Strata: community Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments Jordan Intervention: Structured telephone support Comparator: Usual care People living in the community with a diagnosis of HF Mean age: 55.3 USA Quality of life Strata: community Intervention: Structured telephone support + telemonitoring Comparator: Usual care People admitted to hospital as inpatients or on observation being treated for decompensated HF Median age (IQR): M/F(%): USA All-cause mortality All-cause hospitalisation Quality of life Strata: recent admission Quality of life downgraded for risk of bias as final scores were reported by the study with no report of baseline scores. Intervention: Structured telephone support Comparator: Usual care People with clinical signs and symptoms of HF Mean age: 72.6 USA All-cause mortality All-cause hospitalisation Strata: recent admission Stavrianopo Intervention: Structured telephone support Comparator: Usual care People with HF Quality of life Strata: mixed Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Intervention and comparison Population Outcomes Comments Greece Monitoring Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 93: Clinical evidence summary: Structured telephone support versus usual care Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with structured telephone support (95% CI) Recent admission All-cause mortality 5359 months due to risk of bias, imprecision, publication bias (from 2 fewer to 32 fewer) All-cause hospitalisation 4549 months due to risk of bias, publication bias (from 26 fewer to 30 more) Quality of life (SF-36 Physical health component) Better indicated by higher due to risk of bias The mean QoL in the control groups was The mean QoL in the intervention groups was Quality of life (SF-36 Physical functioning component) Better indicated by higher due to risk of bias The mean QoL in the control groups was The mean QoL in the intervention groups was Quality of life (MLWHFQ) Better indicated by lower imprecision The mean QoL in the control groups was The mean QoL in the intervention groups was (6.48 lower to 4.88 higher) Monitoring Chronic Heart Failure NICE 2018. 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ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with structured telephone support (95% CI) Quality of life (EQ-5D) Better indicated by higher due to imprecision The mean QoL in the control group was The mean QoL in the intervention group was (0.03 lower to 0.11 higher) Quality of life (HFSS) Better indicated by higher due to risk of bias The mean QoL in the control groups was The mean QoL in the intervention groups was (2.4 lower to 4.8 higher) Adherence to intervention (weight self daily) Better indicated by higher due to risk of bias, imprecision The mean adherence to intervention in the control groups was The mean adherence to intervention in the intervention groups was Adherence to intervention (check ankles and feet for swelling) Better indicated by higher due to risk of bias, imprecision The mean adherence to intervention in the control groups was The mean adherence to intervention in the intervention groups was Adherence to intervention (follow fluid recommendations) Better indicated by higher due to risk of bias, imprecision The mean adherence to intervention in the control groups was The mean adherence to intervention in the intervention groups was Adherence to intervention (follow low-salt diet) due to risk of bias, The mean adherence to intervention in the control groups was The mean adherence to intervention in the intervention groups was Monitoring Chronic Heart Failure NICE 2018. 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ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with structured telephone support (95% CI) Better indicated by higher Adherence to intervention (take medication) Better indicated by higher due to risk of bias The mean adherence to intervention in the control groups was The mean adherence to intervention in the intervention groups was (0.04 lower to 0.24 higher) Community All-cause mortality 4495 months due to imprecision, publication bias (from 28 fewer to 5 more) All-cause hospitalisation 2694 months due to imprecision, publication bias (from 44 fewer to 107 fewer) Quality of life (MLWHFQ) Better indicated by lower months HIGH The mean QoL in the intervention groups was Quality of life (HDS) Better indicated by lower due to risk of bias, imprecision The mean QoL in the control groups was The mean QoL in the intervention groups was Mixed Monitoring Chronic Heart Failure NICE 2018. 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ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with structured telephone support (95% CI) months due to risk of bias, imprecision (from 28 fewer to 137 more) All-cause hospitalisation 254 months due to risk of bias, imprecision (from 48 fewer to 216 more) Quality of life (MLWHFQ) Better indicated by lower due to risk of bias, imprecision The mean QoL in the control groups was The mean QoL in the intervention groups was Quality of life (KCCQ HRQoL) Better indicated by higher due to risk of bias, imprecision The mean QoL in the control groups was The mean QoL in the intervention groups was 1 Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias 2 Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs 3 Funnel plots constructed by the Cochrane authors showed asymmetry and the potential of a strong publication bias in the studies included within the review 4 Unable to calculate as studies reported MD and were analysed using the generic inverse variance method Table 94: Clinical evidence summary: Telemonitoring versus usual care Outcomes No of Quality of the evidence Relative Anticipated absolute effects Monitoring Chronic Heart Failure NICE 2018. 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ISBN: Participants (studies) Follow up (GRADE) effect Risk with Usual care Risk difference with telemonitoring (95% CI) Recent admission All-cause mortality 1480 months due to risk of bias, publication bias (from 38 fewer to 85 fewer) All-cause hospitalisation 1400 months due to risk of bias, imprecision, publication bias, inconsistency (from 12 fewer to 208 fewer) Quality of life (SF-12 Physical) Better indicated by higher HIGH The mean QoL in the control groups was The mean QoL in the intervention groups was (0.15 lower to 4.95 higher) Quality of life (SF-12 Mental) Better indicated by higher HIGH The mean QoL in the control groups was The mean QoL in the intervention groups was (2.1 lower to 3.5 higher) Quality of life (HDS) Better indicated by lower HIGH The mean QoL in the control groups was The mean QoL in the intervention groups was (2.7 lower to 1.3 higher) Quality of life (MLWHFQ) Better indicated by lower due to risk of bias The mean QoL in the intervention groups was Monitoring Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with telemonitoring (95% CI) months (6.88 lower to 0.87 higher) Quality of life (SF-36 Mental component summary) Better indicated by higher due to risk of bias, imprecision The mean QoL in the control groups was The mean QoL in the intervention groups was (0.52 lower to 10.52 higher) Quality of life (SF-36 Physical component summary) Better indicated by higher due to risk of bias, imprecision The mean QoL in the control groups was The mean QoL in the intervention groups was (5.71 lower to 5.71 higher) Community All-cause mortality 20 due to risk of bias, imprecision (from 258 fewer to 651 more) Mixed All-cause mortality 2360 months due to risk of bias, publication bias (from 29 fewer to 22 more) All-cause hospitalisation 2052 publication bias, (from 54 fewer to 81 more) Monitoring Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with telemonitoring (95% CI) months inconsistency Quality of life (SF-36 Physical functioning component) Better indicated by higher due to risk of bias The mean QoL in the control groups was The mean QoL in the intervention groups was Quality of life (MLWHFQ) Better indicated by lower months due to risk of bias, imprecision The mean QoL in the control groups was The QoL in the intervention groups was Quality of life (SF-36 Mental component summary) Better indicated by higher due to risk of bias, imprecision The mean QoL in the control groups was The mean QoL in the intervention groups was Quality of life (SF-36 Physical component summary) Better indicated by higher due to risk of bias The mean QoL in the control groups was The mean QoL in the intervention groups was (2.89 lower to 2.89 higher) 1 Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias 2 Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs 3 Funnel plots constructed by the Cochrane authors showed asymmetry and the potential of a strong publication bias in the studies included within the review Monitoring Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with telemonitoring (95% CI) =83%, unexplained by subgroup analysis for age, year of publication and intensity of intervention =55%, unexplained by subgroup analysis for age 6 Unable to calculate as studies reported MD and were analysed using the generic inverse variance method. Table 95: Clinical evidence summary: Telemonitoring + structured telephone support versus usual care Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with structured telephone support and telemonitoring (95% CI) Recent admission All-cause mortality 1437 due to risk of bias, imprecision (from 22 fewer to 88 fewer) All-cause hospitalisation 1437 due to risk of bias (from 34 fewer to 74 more) Quality of life (MLHWFQ) Better indicated by lower due to risk of bias, imprecision The mean QoL in the intervention groups was 1 Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias Monitoring Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Outcomes No of Participants (studies) Follow up Quality of the evidence (GRADE) Relative effect Anticipated absolute effects Risk with Usual care Risk difference with structured telephone support and telemonitoring (95% CI) 2 Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs 3 Unable to calculate as studies reported MD and were analysed using the generic inverse variance method Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 8.4.4 Economic evidence No relevant economic evidence was identified in the 2003 guideline (CG5). Two studies were included in the 2010 guideline update (CG108): one UK cost-consequence analysis comparing remote monitoring to usual care using data collected during the Home-HF study,83 and one Italian cost- consequence analysis comparing home-based telecardiology and usual care based on a prospective . However, these studies were excluded from this review. The UK study was excluded from this review as the intervention was not considered to be applicable, whereas the Italian study was excluded due to methodological limitations. This is listed in appendix I, with reasons for exclusion given. Four additional health economic studies were identified in this update. One additional health economic study was identified with the relevant comparison and has been included in this review.252, This is summarised in the health economic evidence profile below (Table 96) and the health economic evidence table in appendix G. Two economic studies relating to this review question were identified but were excluded due to methodological limitations.92, 315 One study was identified but selectively excluded as, the committee judged that other available evidence was of greater applicability and methodological quality, and therefore this study was selectively excluded. 360 These are listed in appendix I, with reasons for exclusion given. See also the health economic study selection flow chart in appendix D. Monitoring Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 96: Health economic evidence profile: Structured telephone support vs telemonitoring vs usual care Study Applicability Limitation s Other comments Costs (a) Effects (a) Incremental cost (b) Incremental effects (b) Cost effectiveness (b) Uncertainty Pandor [Thokala ] Directly applicable (c) Potentially serious limitations (d) Cost-utility analysis Comparators: 1. Usual care 2. Structured telephone support human to machine interface 3. Structured telephone support human to human interface 4. Home telemonitoring Clinical data determined from a NMA of RCT data Lifetime horizon 6 month intervention, after which receive usual care. effects) Prob. CE: 5% at Prob. CE: 12% threshold QALY gained Prob. CE: 83% threshold Abbreviations: CE: cost effective; ICER: Incremental Cost Effectiveness Ratio; NMA: network meta-analysis; QALY: quality-adjusted life years; RCT: randomised controlled trial (a) Cost/effect in order of least to most costly intervention. (b) Full incremental analysis of available strategies: first strategies are ruled out that are dominated (another strategy is more effective and has lower costs) or subject to extended dominance (the strategy is more effective and more costly but the incremental cost effectiveness ratio is higher than the next most effective option and so it would never be the most cost effective option); incremental costs, incremental effects and incremental cost effectiveness ratios are calculated for the remaining strategies by comparing each to the next most effective option. (c) Assesses structured telephone support with human to machine contact and human to human contact separately. (d) May not reflect full body of available evidence: two additional studies were included in the NMA used to determine treatment effect that were not included in the clinical review of this guideline, and five more recent studies included in the guideline review that were not included in the NMA. Utility decrement of heart failure hospitalisation considered to be overestimated. Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 8.4.5 Evidence statements Clinical Overall 41 studies were included in the review. The committee discussed the potential influence of publication bias on the direction and magnitude of the study results. Funnel plots , showed publication bias which was taken into consideration when assessing the quality of the evidence. Outcomes were also downgraded if risk of bias was present or if there was imprecision due to wide confidence intervals. Structured telephone support The studies contained within the following strata compared structured telephone support to usual care. There was a high degree of heterogeneity between the interventions with both the intensity and focus varying from study to study. Recent admission This strata included studies with populations comprising of people who have recently been admitted to hospital (n=5359). For the outcome all-cause mortality, 14 studies (n=5359) were included. The quality of the evidence was low and showed a clinically important reduction in deaths. The outcome all-cause hospitalisations contained 11 studies (n=4549), was rated low quality and showed no clinical effect. For the outcome QoL the majority of the evidence was rated as moderate quality. A number of different scales were used (MLWHF, EQ-5D and SF-36). The effect estimates were based on single studies and ranged from showing a clinically important improvement in QoL to no clinical difference. A single study (n=287) reported the outcome adherence to intervention. This evidence was very low quality and showed no clinical effect. Community This strata included studies with populations comprising of people who were recruited within the community. For the outcome all-cause mortality, 9 studies (n=4495) were included. The quality of the evidence was low and did not demonstrate a clear effect with the confidence interval ranging from a decrease and increase in all-cause mortality.The outcome all-cause hospitalisations contained 6 studies (n=2694), was rated low quality and showed a clinically important reduction in hospitalisations. For the outcome QoL the quality of the evidence ranged from high to very low quality depending on the scale being used. High quality evidence was obtained for 4 studies (n=2103) using the MLWHF score which showed no clinically important effect. For the scores (HDS and HFSS) there was a clinically important improvement in QoL and no clinical effect observed respectively. Mixed This strata included studies which did not specify which population were included. They therefore potentially represent a mixture of both people who have had a recent admission to hospital and those who were recruited within the community. For the outcome all-cause mortality, 1 study was included (n=254). The quality of the evidence was very low and did not demonstrate a clear effect with the confidence interval ranging from a decrease and increase in all-cause mortality.The outcome all-cause hospitalisations contained the same study and was rated low quality, and also showed a clinically important increase in hospitalisations (again associated with wide confidence). For the outcome QoL a single study (n=50) rated as very low quality showed a clinically important improvement in QoL using both the MLWHF and KCCQ HRQoL scales. Telemonitoring Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 The studies contained within the following strata compared telemonitoring to usual care. There was also a high degree of heterogeneity between the interventions with technology used, interface and level of data acquisition varying from study to study. Recent admission For the outcome all-cause mortality, 9 studies (n=1480) were included. The evidence was low quality and showed a clinically important reduction in deaths. The outcome all-cause hospitalisation contained 8 studies (n=1400) was very low quality and showed a clinically important reduction in hospitalisations. This outcome displayed a significant level of heterogeneity (I2 =83%), unexplained by subgroup analysis for age, year of publication and intensity of intervention which was taken into consideration when judging the quality of the evidence. For the outcome QoL the evidence ranged from high to very low quality. High quality evidence (1 study, n=280) was found for the scales SF-12 and HDS, which both showed no clinical effect. Very low quality evidence was found for the SF-36 scale (1 study, n=57), the mental component summary showed a clinically important improvement in QoL, while the physical component showed no clinical effect. Community For this strata a single study (n=20) reported all-cause mortality alone. The evidence was very low quality and did not demonstrate a clear effect with the confidence interval ranging from a decrease and increase in all-cause mortality. Mixed For the outcome all-cause mortality, 8 studies (n=2360) were included. The evidence was low quality and did not demonstrate a clear effect with the confidence interval ranging from a decrease and increase in all-cause mortality The outcome all-cause hospitalisation contained 6 studies (n=2052) was also low quality and showed no clinical effect. This outcome was also subject to heterogeneity =55%), unexplained by subgroup analysis for age which was taken into consideration when judging the quality of the evidence. For the outcome QoL the evidence ranged from low to very low quality. Depending on the scale used the clinical outcome varied. For the physical functioning component of the SF-36 there was evidence of a clinically important improvement in QoL. However, for the mental component summary there was evidence of a clinically important reduction in QoL. For the scale MLWHF there was no evidence of a clinical effect. Telemonitoring + structured telephone support Recent admission A single study (n=1437) looked at the effect of telemonitoring in addition to structured telephone support. For the outcome all-cause mortality (low quality) there was evidence of a clinically important reduction in deaths. For the outcome all-cause hospitalisations (moderate quality) there was evidence of a clinically important increase in hospitalisations. For the outcome QoL (low quality) the MLWHF showed no clinical effect. Economic One cost utility analysis found that home telemonitoring was cost effective compared to usual care, structured telephone support (human-to-machine interface), and structured telephone support (human-to-human interface) for managing heart failure (ICER: 6,616 per QALY gained compared to usual care). It also found that usual care was dominant (less costly and more effective) compared to structured telephone (human-to-machine interface), and structured telephone support (human-to-human interface) was extendedly dominated Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 compared usual care and home telemonitoring. This analysis was assessed as directly applicable with potentially serious limitations. 8.4.6 Recommendations and link to evidence Recommendations No recommendation Research recommendation No research recommendation Relative values of different outcomes The committee agreed that the critical outcomes for decision-making were all-cause mortality and all-cause hospitalisation and important outcomes were adherence to the intervention and quality of life. Quality of the clinical evidence Forty-six studies were included in the structured telephone support (STS) and telemonitoring (TM) review. The quality of the evidence ranged from very low to high. Studies were predominantly downgraded because of a risk of bias or imprecision due to wide confidence intervals. The committee noted that adherence to the intervention was not commonly reported by the studies. The authors of the Cochrane review constructed funnel plots to assess for reporting bias within the studies included in the review. This was taken into consideration when assessing the quality of the evidence for outcomes in strata which contained more than 5 studies. The funnel plots demonstrated a strong publication bias. Several outcomes also displayed statistical heterogeneity within the results reported by the studies. This was not explained by subgrouping the results by age, year of publication or the intensity of the intervention. Trade-off between clinical benefits and harms Overview of evidence The committee noted the likely publication bias in the evidence identified. The committee had requested inclusion of all studies in the review as it had thought it was likely that publication bias would be an issue in the evidence and that a more comprehensive search strategy not limited to larger studies would enable this to be more clearly identified. The committee was reassured that evidence was available from multiple larger studies for some interventions and endpoints but concerned that for other endpoints only data from one study was available with the most obvious deficiency being for quality of life data. The committee had reservations about the trial designs. The evidence as presented compared active interventions with usual care. One potential confounder was the effect of contact alone but without direct advice on changing management. This could result in a placebo effect that would be subsumed within the likely effects of intervention. Secondly, it was possible that trial results would also be dependent on the extent and adequacy of baseline management. An ideally managed population recruited to a trial might not show any benefit from additional intervention; conversely a population with lower quality management might show a large degree of benefit reflecting reversion to local guideline standards. The committee agreed that the lack of information regarding the usual care arm of the included studies reduced their ability to be confident that the effects observed in the intervention arm were not being overestimated by less than Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations No recommendation Research recommendation No research recommendation standard care within the usual care group. Furthermore, the committee did not feel that they could be confident that the usual care prescribed in the studies was representative of current UK practice. Structured telephone support The clinical evidence for STS in people with chronic heart failure suggested that there was a clinically important reduction in mortality for those who have had a recent hospital admission and those who were recruited within the community. There was no clinical effect of STS on hospitalisations in people who had recently been admitted. While in people recruited within the community, STS showed a clinically important reduction in hospitalisations. The differences between the interventions used in each study also made it difficult to interpret the effectiveness of STS overall. For example there was a significant degree of variability in the intensity (i.e. daily calls compared to monthly calls), and the focus of the STS (i.e. clinical monitoring of heart failure signs and symptoms with clinical support provided compared to self- management education). The effect of STS on QoL was variable depending on the measurement scale used e.g. the SF-36 or MLWHF. A number of the QoL outcomes were also associated with a large degree of uncertainty due to wide confidence intervals surrounding the effect estimate again making it difficult for the committee to interpret the true clinical effect. The committee agreed that the impact of STS on QoL would be variable depending on the persons willingness to engage with the intervention and the specific focus of the STS. For example STS that mainly focused on highlighting worrying symptoms might not have the same effect as an intervention aimed at providing education and support. Only one study reported patient adherence to STS which showed no clinically important effect. The committee agreed that in practice adherence to STS would be variable depending on the intensity and focus of the intervention and the motivation of the individual. The committee discussed the potential harms associated with STS. The committee agreed that a proportion of elderly patients found it alarming when their phone rang, had difficulty using or did not like using their phone and this caused them a significant degree of anxiety. Monitoring the signs and symptoms of heart failure on a regular basis may also provoke anxiety in some people due to the distress associated with having attention drawn to their diagnosis. The committee acknowledged that using ad hoc telephone appointments and calls to the appropriate clinicians was a relevant form of providing Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations No recommendation Research recommendation No research recommendation support and managing a number of symptoms for people with heart failure. However, the committee did not feel as though the evidence supported a recommendation to offer or not offer structured telephone support and decided not to make a recommendation. Telemonitoring The clinical evidence for TM in people with chronic heart failure suggested that there was a clinically important reduction in mortality and hospitalisations for those who have had a recent hospital admission. Only a single study was included within the community strata for TM. The majority of the evidence that was not from a recently admitted population did not specify the exact nature of the population included within the study. These papers were therefore included within a mixed strata and represented a potential combination of both recently admitted and community dwelling people. This evidence showed a clinically important reduction in mortality. However, TM did not have a clinically important effect on hospitalisation. The committee would have expected either group (e.g. recently admitted or recruited within the community) to have a different baseline risk of mortality or hospitalisations in the usual care arm. Therefore, due to the nature of the evidence included within this mixed strata, the committee found it challenging to accurately interpret the clinical outcomes. The general issues raised by the committee regarding the body of evidence for TM were similar to those discussed for STS. The committee did not feel they could be confident that the evidence reflected a true clinical benefit of TM based on the lack of information regarding the standard of care in the usual care arm and the heterogeneity between the TM interventions included in the review. For example there was a significant degree of variability in the intensity (e.g .monitoring during office hours compared with 24 hours per day/seven days per week), and the nature of the technology (e.g. interactive voice response involving the manual input of data using a telephone keypad in response to questions from an interactive voice response system compared to the automatic transmission of physiological data from a measuring device to a central server). The committee also noted that telemonitoring (in a proportion of the included studies) was associated with increased opportunity for people to be contacted by the specialist heart failure team or for people to contact them for advice and support. This made it difficult to ascertain whether the decrease in mortality and hospitalisations were due to the application of telemonitoring or due to the additional access to specialist opinion and care. Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations No recommendation Research recommendation No research recommendation The committee discussed the potential harms associated with TM. These included the fact that some of the devices used to remotely monitor parameters such as heart rate were unreliable and therefore clinicians were unwilling to base treatment and management decisions on this data. The committee agreed that a lack of user knowledge relating to the technology being employed could result in improper use or overconfidence in the capabilities of the technology. This could lead to people under reporting potentially important symptoms based on the assumption that the system will relay this measurement data directly to the clinician. The potential also exists for people to become dependent on the technology which may impair their ability to self-manage their condition. Similar to STS, the committee noted that monitoring the signs and symptoms of heart failure on a regular basis provoked anxiety in some people and made them hyperaware of their symptoms. The committee also agreed that a lack of user support regarding the specific TM technologies could compromise motivation and willingness to engage with the technology resulting in compliance and adherence issues which could negatively impact patient safety. The committee also agreed that telemonitoring could result in a reduction in face-to-face care. This has the potential to hinder thorough clinical assessment and good treatment decisions. The use of telemonitoring may also have a negative impact on the ability of both the care giver and receiver to establish a good clinical relationship which the committee noted was fundamental to the quality and safety of the care provided. The committee acknowledged that for a subset of specific and vulnerable people this form of monitoring would be appropriate and may be of benefit when provided for a specific length of time and for a specific purpose. In addition, the committee recognised that there was a potential inequality issue for people living in rural areas with a substantial travel time to specialist care centres. For these people telemonitoring may be appropriate and this decision should be made at an individual level. The committee did not feel as though the evidence supported a recommendation to offer or not offer TM and decided not to make a recommendation. Trade-off between net clinical effects and costs Six published economic evaluations were identified for this review. Four of the studies were excluded as they were considered to have very serious limitations, and one study was selectively excluded due to the availability of more applicable evidence. Reasons for exclusion are provided in Appendix J. Therefore, only one study was included in this review. This is a UK cost-utility analysis comparing STS with human to human contact, STS with human-to- machine contact, TM and usual care. The study found TM to be the most cost effective intervention (ICER: 6,616 per QALY gained compared to usual care). This study was assessed as directly applicable with potentially serious limitations. The economic evaluation was based on a network meta-analysis (NMA) comparing the interventions stated above. The committee acknowledged the difference in treatment effects determined in the guideline review and the Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations No recommendation Research recommendation No research recommendation NMA. However, as mentioned in the Trade-off between clinical benefits and harms section, overall the committee were concerned that the effects of both STS and TM in both systematic reviews were being overestimated due to the likely sub-gold standard care within the usual care arms. In addition, the committee were concerned about the large disutility applied for a heart failure hospitalisation in the model. They considered the disutility was applied for too long and as a result would skew the results towards the interventions being cost effective compared to usual care. Taking both of these limitations into account it was considered that the results from this economic evaluation suggesting that usual care had a 0% probability of being cost effective were unlikely to be true for current UK practice. Overall, the committee considered that there was too much uncertainty to determine whether STS and TM would be cost effective in current clinical practice. Other considerations The previous guideline (CG108) included studies where the intervention arm involved visits to the participant s home by a healthcare professional. The committee felt as though this input was likely to confound results from these studies and wasn t truly representative of remote monitoring, therefore they were excluded in the update of this evidence review. The committee discussed the research recommendation made in CG85 and concluded that a significant body of evidence had accumulated since the publication of the guideline. The committee agreed that due to the rapidly advancing nature of technology within the field, and the lack of any plateau in terms of the technology available to clinicians, made it difficult to future proof any further research recommendations. The committee agreed that until a level of consensus was reached between manufacturers regarding what physiological parameters are to be measured and with what interface, it was very difficult to suggest any further research in the area The committee therefore decided not to make a further research recommendation. The committee discussed current practice regarding TM and STS and agreed that this was subject to variation across the country. It was acknowledged that although many general practices may have access to the equipment it was not widely implemented due to a lack of infrastructure to support its use. The quantity of data that needs to be analysed as a result of TM has a significant effect on staff workload and associated changes to staff roles and responsibilities. This may impact their ability to perform important daily tasks and responsibilities potentially negatively impacting patient safety. The presence of publication bias within this area was acknowledged by the committee. They were aware of instances where small studies showing no effect had not been published and agreed that this also made it difficult to ascertain the potential clinical benefit of such an intervention. In addition to this the committee agreed that the intensification of more conventional methods of delivering care, such as more home visits or clinic visits could Chronic Heart Failure Monitoring NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Recommendations No recommendation Research recommendation No research recommendation deliver results similar to those of home telemonitoring. The committee discussed groups of people who may not be able to access STS which included those from socioeconomically disadvantaged groups who do not have access to touch tone telephone. In addition, people whose first language is not English may also have difficulty accessing this form of support. 8.5 Recommendations for monitoring heart failure 8.5.1 Clinical review 66.All people with chronic heart failure need monitoring. This monitoring should include: a clinical assessment of functional capacity, fluid status, cardiac rhythm (minimum of examining the pulse), cognitive status and nutritional status a review of medication, including need for changes and possible side effects an assessment of renal functiond 67.More detailed monitoring will be needed if the person has significant comorbidity or if their condition has deteriorated since the previous review. [2003] 68.The frequency of monitoring should depend on the clinical status and stability of the person. The monitoring interval should be short (days to 2 weeks) if the clinical condition or medication has changed, but is needed at least 6-monthly for stable people with proven heart failure. [2003] 69.People with heart failure who wish to be involved in monitoring of their condition should be provided with sufficient education and support from their healthcare professional to do this, with clear guidelines as to what to do in the event of deterioration. [2003] 8.5.2 Measuring NT-proBNP 70.Consider measuring NT-proBNP (N-terminal pro-B-type natriuretic peptide) as part of a treatment optimisation protocol only in a specialist care setting for people aged under 75 who have heart failure with reduced ejection fraction and an eGFR above d This is a minimum. People with comorbidities or co-prescribed medications will need further monitoring. Monitoring serum potassium is particularly important if a person is taking digoxin or an aldosterone antagonist. Chronic Heart Failure Referral and approach to care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 9 Referral and approach to care The update to the heart failure guideline includes topics where new evidence has emerged since the publication in 2010. A review of new evidence published after 2010 was carried out in order to determine whether any changes to current recommendations where likely to be required. The decision on which topics to include in the update of the guideline was made following consultation of the scope. This section includes multidisciplinary team working,transition and continuity between different heart failure care settings and information and support needs. The following topics were not within the scope of the update. For more information refer to Appendix R, the 2003 guideline: Discharge planning Support groups Anxiety and depression See See NICE s guideline on depression in adults with a chronic physical health problem 9.2 Team working in the management of heart failure Heart failure is a complex disorder whose management involves a number of professional groups. Members of different professional groups contribute their experience and expertise to meet the complex needs of the patients. For the care to be optimised, the efforts of these professionals are best delivered through multi-disciplinary team (MDT) working. Multidisciplinary teams are well established to support people with heart failure in the UK. A variety of models of care exist in heart failure and studies have documented the outcomes achieved by these different approaches. The role of the MDT in the care of patients with heart failure care was recognised in the NICE guidelines published in 2003. Since then has accumulated that has investigated the composition, competencies, needs for support, and the timing of different contributions of members of MDTs over a patient s journey. This question sought to establish the competencies that ought to be present in a MDT to deliver optimal care for patients with heart failure as care of these patients increasingly moves into a community setting. 9.2.2 Review question: What competencies should be present in the multidisciplinary teams involved in the outpatient or community-based care of people with heart failure? For full details see review protocol in Appendix A. Table 97: PICO characteristics of review question Population People with heart failure in a community or outpatient setting that is applicable to UK practice Stratification: Risk status at time of randomisation (high versus lower risk patients) High risk includes: new diagnosis recent decompensation (defined as hospital admission due to HF) severe and/or unresponsive disease (defined as NYHA III/IV) and Chronic Heart Failure Referral and approach to care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 requiring medicine titration, device implantation or other surgical intervention Intervention / Comparators: Studies comparing MDTs with usual care (regardless of how defined). For a study to be included, there must be a clear description of collaborative working between more than one healthcare profession or discipline. A study involving an intervention delivered by one specified health profession may be included where there is a clear description of multidisciplinary collaboration. The intervention must have included the delivery (on average) of at least two face-to- face meetings. Stratification: Length of intervention delivered in the study three months (short) > three months, six months (mid) > six months (long) Where study length varied due to recruitment dates, average length was used. Where study length varied due to the needs of the patient, the shortest duration of protocol was used. Outcomes CRITICAL - All-cause mortality (Time to event) - Quality of life (Continuous) - Unplanned hospitalisation (Count rate) IMPORTANT - Medicine optimization and adherence - Dying in preferred place of death (for palliative care patients) - Adverse events hypotension, hyperkalaemia, and renal function - Patient and carer experience Study design Systematic Review of RCTs RCTs (including cluster randomised) Comments Studies that were concerned with the care and discharge management of patients hospitalised for decompensation of heart failure come under the remit of the acute heart failure guidelines. Therefore, when patients were recruited in hospital, at least one face-to-face meeting was required after the patient had been discharged for the study to be included. There is no minimum duration of intervention, but the last outcome measure must be at least three months after the intervention begins. Studies that were concerned with interventions covered elsewhere in the guideline were excluded, as these will have separate guidance. Usual care was considered likely to differ significantly from the UK / NHS standard if the study was carried out in a country outside the OECD or in the United States. 9.2.3 Clinical evidence A search was conducted for randomised trials comparing management involving multidisciplinary team care (MDT) with usual care without an MDT. Twenty two studies were included in the review . Interventions were heterogeneous, and were categorised into 4 main strands based on the definitions in a recent Cochrane report 326 Chronic Heart Failure Referral and approach to care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Home-based MDT: multidisciplinary teams from secondary care that included an aspect of caring for people in their home. MDT clinic: multidisciplinary teams forming an outpatient clinic Nurse-led or pharmacist-led clinic: enhanced outpatient service with MDT working Case-management: active management of high-risk people with case managers taking responsibility for caseloads working in an integrated care system.326 Given the heterogeneous nature of the interventions and populations in the included studies, a number of additional tables have been included in this evidence report to summarise the key features of the included studies. Table 98 shows the included studies listed alphabetically with their population risk and length of intervention stratification, as well as their intervention strand. Table 99 lists the included studies by strata and provides details of the methods for each study. Table 100 expands on the population risk stratification for each study. Table 101 gives more information on the composition of the MDT involved in the intervention arm of each study. Table 102 gives more information on the intervention delivered, and on the usual care arm. Evidence from the studies is summarised in the clinical evidence summaries below (Table 103-123). No meta-analysis was conducted due to the heterogeneity in study and intervention designs; a separate evidence summary is provided for each study. Studies are grouped by the strata identified in Table 99. Table 98: List of studies included in the review Study Population risk strand Length strand Intervention strand Low Long Nurse-led clinic Aukland-HF trial High Long MDT clinic High Long Case management High Long MDT clinic COACH trial , Postmus 2011272 , , Jaarsma 2002158 ) High Long Basic: Nurse-led clinic Intensive: Home-based MDT DEAL-HF trial De la Porte 2007 87 High Long MDT clinic Del sindaco 200791 Del sindaco 201290 ) High Long MDT clinic High Mid Nurse-led clinic High Mid MDT clinic High Mid Nurse-led clinic High Mid MDT clinic HICMan trial Low Long Case-management Chronic Heart Failure Referral and approach to care NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3093-7 Study Population risk strand Length strand Intervention strand J-HOMECARE trial ) High Mid Case management ) High Short MDT clinic Low Long Case-management NorthStar trial Low Long MDT clinic High Mid MDT clinic OPTIMAL trial High Long Nurse-led clinic PREFER trial High Mid Home-based MDT PRICE trial High Long MDT clinic High Short MDT clinic Low Long MDT clinic: pharmacist-led Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 99: Study details (arranged by strata) First Author / Trial name n. Country Recruitment HFRE F or both Start s inpat ient QoL Outcomes: Mort/ Hosp Meds Length (months ) Last measure (months ) Face-to- face meeting s High Risk - Short interventions 98 Ireland Inpatients admitted with primary diagnosis HF both Yes Deaths, Admissions outpt 112 UK Patients that had been referred by GP for open access echo due to suspected HF, who had confirmed LVSD both No Death, Admissions High Risk - Mid-length interventions PREFER trial 72 Sweden Outpatients at geriatrics dept or PC with NYHA III-IV plus one of five markers of need for palliation both No EQ-5D (appears to be VAS) Deaths, Admissions 28 Australia Patients with HFREF from clinic for complex heart failure patients on sub- maximal medication doses HFRE F No MLWHF Death, Admissions 230 Canada Seen in ED or admitted with primary diagnosis HF Most HFRE F On dc Deaths, admissions Sweden Inpatients aged >65y screened for HF, NYHA III-IV both On dc Change in NYHA Death, Admission Gonzalez-Guerrero 117 Spain Admitted under geriatric department with acute HF both Yes Death or admission J-HOMECARE trial Tsuchihashi-makaya 168 Japan From cardiology hospital both Yes SF-8 Deaths, Admissions Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name n. Country Recruitment HFRE F or both Start s inpat ient QoL Outcomes: Mort/ Hosp Meds Length (months ) Last measure (months ) Face-to- face meeting s 200 Italy Inpatients <86y screened for congestive HF both Yes MLWHF Deaths, Admissions outpt High Risk - Long interventions Auckland-HF Zealand Admitted with HF both On dc MLWHF Q Deaths. Admissions mandate d GP visits) 186 Austria Hospitalised and signs/symptoms of HFREF HFRE F On dc Death, Admissions 234 Italy Patients in inpatient Heart Failure Unit, CHF and HFRE F On dc Time trade-off / Utility Cardiac death, Admissions Px 12 (ave.) 12 mean attend COACH trial - basic s Patients admitted to hospital (experienced HF centres) with signs and symptoms of HF for which hospitalisation was considered necessary NYHA II-IV, stabilised before entry to study both Yes NR Deaths, Admissions COACH Jaarsma - enhanced s Patients admitted to hospital (experienced HF centres) with signs and symptoms of HF for which hospitalisation was considered necessary NYHA II-IV, stabilised before entry to study both Yes NR Deaths, Admissions phone) DEAL-HF trial De la s Inpatients and cardiology outpatients recruited, NYHA both No SF-36* MLWHF* Death, Days in hospital Px* Creat- Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name n. Country Recruitment HFRE F or both Start s inpat ient QoL Outcomes: Mort/ Hosp Meds Length (months ) Last measure (months ) Face-to- face meeting s III-IV inine Del sindaco 200791 173 Italy Hospitalised, aged 70 or more, and discharged home. NYHA III-IV and required IV diuretics both On dc Deaths, Admissions OPTIMAL trial 208 Sweden Patients hospitalised with heart failure with NYHA II-IV and LV systolic dysfunction both On dc Nottingh am Health Profile Death, Admissions Px flex 6- Ave 37 mean attend PRICE trial Atienza 153 Spain Cardiology ward with diagnosis of primary HF both Yes MLWHF Q Deaths, Admissions Low risk (stable HF) Long interventions 160 Sweden Patients recruited from PC with CHF and LVEF<50% HFRE F No SF-36* Death, Admissions HICMan trial 197 Germany Patients recruited from PC with hospital admission with HF in last two years, objective CHF and LVEF<45% HFRE F KCCQ Death, Admissions 153 Sweden Recruited from PC, NYHA II-IV both No SF-36* Death Px 12 12 mean Northstar trial 921 Denmark Stable CHF on optimal meds, HFRE F No MLWHF Death, Admissions Px, Adv. effects 83 UK Elderly patients recruited from inpatient or outpatient with diagnosis CHF both No SF-36* MLWHF Death, Admissions Adher- ence *reported incompletely, therefore not included in analysis NR: measured but not reported Px: prescription of ACEi+/beta-blocker+/MRA dc: on discahrge Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Table 100: Papers according to population risk: risk strata and background rate of admission (IQR 0.6-1.6, values outside IQR are highlighted) Risk strata (proportions are estimates) First Author / Trial name New dxa ADHFb Severec Req. titrationd Other Overall risk category Admissions/pt/year in control High Risk - Short interventions 46% All NS None ADHF 1.0 All None 45% Most New 1.0 High Risk - Mid-length interventions PREFER trial Brannstrom 2014 50 None NS All None suitable for palliative care Severe 2.9 (high) None None 20% All from clinic for "complex HF" Titration 0.5 (low) NS 90% mean NYHA patients ADHF 2.4 (high) 40% All NS 60% from geriatric ward (ave J-HOMECARE trial Tsuchihashi-makaya 2013341 NS All 5% 50% ADHF NS High Risk - Long interventions Auckland-HF Doughty 2002103 NS All All 10% ADHF 1.6 NS All All 25% ADHF NS NS All 35% None ADHF 0.6 COACH trial Jaarsma 2008157 - basic NS All 50% 35% ADHF 0.7 Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: Risk strata (proportions are estimates) COACH Jaarsma 2008157 - enhanced NS All 50% 35% ADHF 0.7 DEAL-HF trial De la Porte 2007 87 NS 30% All 30% Severe NS Del sindaco 200791 NS All 60% 50% Older patients ADHF NS OPTIMAL trial Mejhert 2004 220 PRICE trial Atienza 200422 NS All 90% NS ADHF 0.5 (low) Low Risk (stable HF) - Long interventions NS NS 35% 25% Nil low risk 0.6 HICMan trial Peters-klimm 2010 257 None 25% 30% 25% Nil low risk 0.4 (low) None NS 50% 40% Nil low risk NS Northstar trial Schou 2013 300 None None 11% None Nil low risk 0.8 NS 25% mean NYHA NS Older patients Nil low risk 0.7 (a) New dx = identified as new diagnosis of heart failure at recruitment. (b) ADHF = Acute decompensated heart failure risk strata signifying recent decompensation, defined by selection to study due to visit to emergency dept or inpatient admission due to heart failure, with or without congestion. (c) Severe = proportion NYHA III-IV at baseline (note that if recruited while decompensated, this may be higher than their chronic severity). (d) Req. titration = Requiring medication titration, device implantation or surgical intervention if not stated, this was estimated by looking at baseline medication NS = not stated in study paper Table 101: Professions / Competencies delivering interventions (studies arranged by strata) First Author / Trial name Doctor (secondary care) Nurse (secondary care) Pharma- cist Diet- ician Occupation- al therapist Social worker Physio- therapist Primary care Details High Risk - Short interventions Ledwidge HF nurse Y Education from nurse and dietician in hospital, followed by telephone contact weekly for 12 weeks by HF nurse specialist. Appts at clinic after 2 and 6 Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name Doctor (secondary care) Nurse (secondary care) Pharma- cist Diet- ician Occupation- al therapist Social worker Physio- therapist Primary care Details weeks (unclear composition of clinic) Cardiologist Cardiac nurse MDT High Risk - Mid-length interventions PREFER trial Brannstrom Cardiologist + Palliative care physician HF nurse + Palliative care nurse Y Y HF team plus palliative nurse + palliative physician Cardiologist Cardiac nurse Nurse-led clinic in consultation with cardiologist, could make onward referrals to other professionals Cardiologist HF nurse Y Y Y Specialist HF clinic for 6 months, contact within 72h discharge and monthly visits Cardiologist HF nurse Y Physician Nurse-run clinic in cooperation with doctors, communication with PC and social care Gonzalez- Geriatrician Cardiac nurse Assessment prior to d/c, at 10d, 1m and 6m post d/c by the 'team', plus t/c contact 48h post-d/c (nurse) and 3/12 (geriatrician) J-HOMECARE trial Tsuchihashi- Cardiologist Cardiac nurse Y Y Y Nurse CM in liaison with MDT for 6 months Cardiologist Cardiac nurse Pre-discharge education by experienced cardiovascular nurse, thereafter, contact with nurse to reinforce message. Face-to- face meetings with a doctor and nurse three times in next six months High Risk - Long interventions Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. ISBN: First Author / Trial name Doctor (secondary care) Nurse (secondary care) Pharma- cist Diet- ician Occupation- al therapist Social worker Physio- therapist Primary care Details Auckland-HF Cardiologist Cardiac nurse Physician Explicit partnership with primary and secondary care, involving individualised and group education, scheduled visits to clinic (unclear composition) and GP and drug titration Cardiologist HF nurse CHF specialist nurse carried out home visits according to a schedule, or more if deterioration. Also scheduled medical reviews, with extra at request of nurse Cardiologist HF nurse Y Y Y Y MDT COACH trial - basic Cardiologist HF nurse Basic: additional visits with HF nurse at outpatient clinic, education protocol given. COACH Jaarsma - enhanced Cardiologist HF nurse Y Y Y Intensive: weekly telephone calls after d/c, home visit by HF nurse, home visit from MDT and monthly contact. DEAL-HF trial De Cardiologist HF nurse Y MDT Del sindaco Cardiologist HF nurse Cardiologist case-managed, with support from nurse who made regular telephone calls OPTIMAL trial Cardiologist Cardiac nurse Nurse-led clinic (under supervision of cardiologist) PRICE trial Cardiologist HF nurse Formal education package delivered prior to d/c, detailing self-care, with 3/12 opt appts to optimise medical therapy and reinforce self-care messages. Unclear MDT composition Low Risk (stable HF) - Long interventions Referral and approach to care Chronic Heart Failure NICE 2018. All rights reserved. Subject to Notice of rights. 