Original Investigation 107 Post-discharge heart failure monitoring program in Turkey: Hit-PoinT Yüksel Çavuşoğlu, Mehdi Zoghi1, Mehmet Eren2, Evin Bozçalı3, Güliz Kozdağ4, Tunay Şentürk5, Güray Alicik6, Korhan Soylu7, İbrahim Sarı8, Rida Berilgen9, Ahmet Temizhan10, Erkan Gencer, Ahmet Lütfü Orhan2, Veli Polat3, Aysel Aydın Kaderli5, Meryem Aktoz6, Halit Zengin7, Mehmet Aksoy8, Mehmet Timur Selçuk10, Oktay Ergene9, Özlem Soran11; for the Hit-PoinT Investigators Department of Cardiology, Faculty of Medicine, Eskişehir Osmangazi University; Eskişehir-Turkey, 1Department of Cardiology, Faculty of Medicine, Ege University; İzmir-Turkey, 2Department of Cardiology, Dr Siyami Ersek Thoracic and Cardiovascular Surgery Education and Traning Hospital; İstanbul-Turkey, 3Department of Cardiology, Şanlıurfa Balıklıgöl Hospital; Urfa-Turkey, 4Department of Cardiology, Faculty of Medicine, Kocaeli University; Kocaeli-Turkey, 5Department of Cardiology, Faculty of Medicine, Uludağ University; Bursa-Turkey, 6Department of Cardiology, Faculty of Medicine, Trakya University; Edirne-Turkey, 7Department of Cardiology, Faculty of Medicine, Ondokuz Mayıs University; Samsun-Turkey, 8Department of Cardiology, Faculty of Medicine, Gaziantep University; Gaziantep-Turkey, 9Department of Cardiology, İzmir Atatürk Hospital; İzmir-Turkey, 10Department of Cardiology, Ankara Yüksek İhtisas Hospital; Ankara-Turkey, 11Department of Cardiology, Faculty of Medicine, University of Pittsburgh; Pittsburgh, PA-USA ABSTRACT Objective: The aim of this study was to assess the efficacy and feasibility of an enhanced heart failure (HF) education with a 6-month telephone follow- up program in post-discharge ambulatory HF patients. Methods: The Hit-Point trial was a multicenter, randomized, controlled trial of enhanced HF education with a 6-month telephone follow-up pro- gram (EHFP) vs routine care (RC) in patients with HF and reduced ejection fraction. A total of 248 patients from 10 centers in various geographical areas were randomized: 125 to EHFP and 123 to RC. Education included information on adherence to treatment, symptom recognition, diet and fluid intake, weight monitoring, activity and exercise training. Patients were contacted by telephone after 1, 3, and 6 months. The primary study endpoint was cardiovascular death. Results: Although all-cause mortality didn’t differ between the EHFP and RC groups (p=NS), the percentage of cardiovascular deaths in the EHFP group was significantly lower than in the RC group at the 6-month follow up (5.6% vs. 8.9%, p=0.04). The median number of emergency room visits was one and the median number of all cause hospitalizations and heart failure hospitalizations were zero. Twenty-tree percent of the EHFP group and 35% of the RC group had more than a median number of emergency room visits (p=0.05). There was no significant difference regarding the median number of all–cause or heart failure hospitalizations. At baseline, 60% of patients in EHFP and 61% in RC were in NYHA Class III or IV, while at the 6-month follow up only 12% in EHFP and 32% in RC were in NYHA Class III or IV (p=0.001). Conclusion: These results demonstrate the potential clinical benefits of an enhanced HF education and follow up program led by a cardiologist in reducing cardiovascular deaths and number of emergency room visits with an improvement in functional capacity at 6 months in post-discharge ambulatory HF patients. (Anatol J Cardiol 2017; 17: 107-12) Keywords: heart failure, disease management, cardiovascular, health education, outcomes Introduction tion per year in >75 year-old people (1). Data demonstrate that almost 15 million people have HF in European countries while 6 Heart failure (HF) is a common clinical syndrome associ- million have this condition in the United States (1, 2). The HAPPY ated with impaired quality of life, high morbidity, mortality, and study showed that the prevalence of HF is 2.9% in Turkey and frequent hospitalization that affects millions of people from all that almost 1.5 million people suffer from this condition in this around the world. Indeed, the rate of HF is expected to increase country (3). overtime due to the growing age of the population. Although the HF is a progressive disease with a poor prognosis. Despite prevalence of HF is reported to be 1%–3% in the general popula- improvements in therapy, mortality and morbidity remain very tion, it increases dramatically from 10% to 15% after 65 years of high. After HF hospitalization, mortality is reported to be 10% age, and incidence approaches 20 people per 1000 in the popula- after 30 days and 22% after 1 year (4). The recently published Address for correspondence: Dr. Yüksel Çavuşoğlu, Eskişehir Osmangazi Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı, 26480, Eskişehir-Türkiye Phone: +90 222 239 29 79 E-mail: yukselc@ogu.edu.tr Accepted Date: 19.02.2016 Available Online Date: 26.07.2016 ©Copyright 2017 by Turkish Society of Cardiology - Available online at www.anatoljcardiol.com DOI:10.14744/AnatolJCardiol.2016.6812 108 Çavuşoğlu et al.Hit-PoinT Anatol J Cardiol 2017; 17: 107-12 EURObservational Research Programme Heart Failure Pilot Sur- vey demonstrated that the rate of 1-year mortality or rehospital- History of HF hospitalization within previous 6-month ization was 36% in hospitalized HF patients and 18% in chronic 248 patients enrolled and randomized HF patients (5). These large numbers, and repeated prolonged hospitalizations for HF, also create a substantial economic bur- den on the health care system (6). Therefore, HF requires special EHP (n=125) RC (n=123) management strategies to overcome its worst clinical outcomes. Disease management programs for the treatment of patients with HF have been advocated in order to optimize therapy, im- Phone follow-up at 1- and 3 month prove patient compliance, and decrease hospitalizations. Over the last two decades, the efficacy of many different HF man- Phone follow-up or in-hospital visit at 6-month agement programs on clinical outcomes and quality of life have been evaluated (7–15). However, most are costly and unfeasible for use in various geographic areas. The post-discharge Heart Figure 1. Study design and follow-up plan Failure Monitoring Program in Turkey (Hit-PoinT) trial was de- EHFP - enhanced heart failure education program; HF - heart failure; RC - routine care signed to assess the efficacy and feasibility of cardiologist-led accordance with the guidelines of the Declaration of Helsinki. All enhanced HF education at the time of hospital discharge with a patients gave written informed consent before enrollment. 6-month telephone follow-up program in post-discharge ambula- Patients were recruited between March 2010 and April 2013. tory HF patients compared with routine care. In total, 248 eligible patients with chronic HF at 10 cardiology clinics in various geographical areas were randomly assigned Methods in a 1:1 ratio to receive either EHFP or RC at the time of hospital discharge (Fig. 1). In Turkey, there are currently no set standard Study population discharge instructions utilized across the country for patients Inclusion criteria included: 1) >18 years of age, 2) discharged with HF, therefore, in the RC group, patients were discharged from hospital with a diagnosis of HF within 6 months of random- from hospital without receiving any education or follow-up in- ization, 3) current symptoms of HF despite optimal medical ther- structions. Prescriptions were given along with the suggestion apy consistent with recent guidelines (angiotensin-converting of a follow-up office visit. enzyme inhibitor or angiotensin receptor blocker, beta blocker, In the EHFP group, patients were educated by a cardiolo- mineralocorticoid receptor antagonist, and diuretics), 4) New gist and a nurse on HF management during discharge and a HF York Heart Association (NYHA) functional class II–IV and left education booklet was provided. Patients were followed for 6 ventricular ejection fraction (LVEF) <40% as measured by trans- months after randomization and were contacted by telephone at thoracic echocardiography. 1- and 3-month and by telephone and/or an in-hospital visit after Patients were excluded from this study if they met the fol- 6 months by a study cardiologist or study nurse to collect clinical lowing criteria: severe renal failure requiring dialysis, serum data and to go over the HF education material. During the tele- creatinine >2.5 mg/dL, severe chronic obstructive pulmonary phone follow up, correction of doses or regimen of medication disease, chronic or intermittent inotropic support, acute coro- were made by a cardiologist or a nurse under the supervision nary syndromes defined by progressive angina or chest pain at of a cardiologist. Patients were invited to come to the hospital rest or new ECG changes and/or serial increase in cardiac tro- if needed. ponin levels, recent percutaneous coronary interventions (PCI), cardiogenic shock, hypertrophic cardiomyopathy, acute myo- Cardiologists/nurses training and patient’ education carditis, severe primary valvular heart disease, dysfunction of Before beginning the study, two cardiologists and two nurses a prosthetic heart valve, pericardial disease, pregnancy, uncon- from each center participated in a one-day training course re- trolled thyroid disease, currently enrolled in another HF study, or garding HF patient education and the study protocol. A printed life expectancy less than 6 months. HF education booklet was prepared in order to unify the edu- cation content between centers. In accordance with the study Trial design and protocol protocol, one session of HF education was implemented by a The Hit-PoinT trial was a randomized, multicenter, controlled cardiologist together with a nurse at randomization, in which the study designed to assess cardiologist lead enhanced HF educa- primary educator was the cardiologist. Patient education took tion followed by a 6-month telephone follow-up program (EHFP) almost one hour (30 min by the cardiologist and 30 min by the with routine care (RC) in post-discharge ambulatory HF patients nurse), or more if needed. at 10 centers including university and state hospitals in various The contents of the baseline education included the descrip- geographical areas in Turkey (16). The study protocol was ap- tion, causes, symptoms, prognosis and treatment of HF. In this proved by the ethics committee and the study was performed in context, patients in the EHFP group were informed about life Çavuşoğlu et al. Anatol J Cardiol 2017; 17: 107-12 Hit-PoinT 109 style changes, salt intake, fluid and alcohol intake, the impor- Table 1. Baseline clinical and laboratory characteristics and tance of weight monitoring, managing weight gain, daily mea- medications surement of blood pressure, adherence to medications, partici- RC (n=123) EHFP (n=125) P pation in daily routine activities, exercise training, recognition of Mean age, years 61.1±13.2 60.6±14.3 0.763 worsening HF symptoms, and when to contact the cardiologist. Also, digital home scales with a HF education booklet were pro- Male gender, % 70 76 0.281 vided to patients in the EHFP group. During telephone follow-up, Mean weight, kg 75.2±15.3 79.1±19.1 0.078 in addition to study endpoints, adoption of life style changes and Systolic BP, mm Hg 110.6±15.5 111.2±16.9 0.809 adherence to medications were assessed and patients were re- Diastolic BP, mm Hg 68.8±8.8 70.3±11.1 0.249 minded about salt and fluid intake, weight monitoring, daily rou- Heart rate, bpm 78.4±13.8 77.7±13.8 0.706 tine activities, and exercise training. Diabetes, % 37 35 0.718 Outcome measures Hyperlipidemia, % 25 40 0.008 The primary endpoint of this study was cardiovascular mor- Ischemic HF, % 65 67 0.817 tality. Secondary endpoints were all-cause hospitalization and NYHA III-IV, % 61 60 0.630 emergency room visits, all-cause mortality and the rate of hospi- LVEF, % 26.2±7.1 27.4±7.1 0.193 talization for HF after 6 months as well as NYHA functional clas- Atrial fibrillation, % 32 29 0.515 sification adjusted for baseline results. Sodium, mg/dL 135.7±12.4 135.7±12.2 0.991 Statistical analysis Potassium, mg/dL 4.4 +0.7 4.5+0.6 0.417 The statistical analysis was performed using the Statisti- BUN, mg/dL 38.1±24.5 35.9±24.4 0.486 cal Package for Social Sciences software 20.0 (IBM SPSS Creatinine, mg/dL 1.18+0.9 1.21+0.9 0.825 20, SPSS Inc, Chicago, US). The variables were expressed as Medication mean±standard deviation and median (25.–75. percentiles). We ACEI, % 79 71 0.152 assumed an underlying 30% event rate for the primary end point ARB, % 22 27 0.280 in the control group and 10% in the intervention group within 6 months of enrollment with a power of 90% and a two-sided alpha Beta blocker, % 95 96 0.737 level of 0.05, so a total sample size of 248 patients was required to Diuretic, % 98 97 0.420 detect such a difference. Data analysis was performed accord- Digoxin, % 49 40 0.161 ing to the intention-to-treat principle by assigned study groups. Nitrate, % 31 28 0.614 Continuous data were analyzed using an independent sample t- Ca blocker, % 3 8 0.109 test or a paired sample t-test for the analysis of normally distrib- Antiarrhythmic, % 13 15 0.731 uted variables, or Mood's Median test was used for the analysis ACE - angiotensin-converting enzyme inhibitor; ARB - angiotensin receptor blocker; of non-normally distributed variables. Categorical data were pre- BP - blood pressure; BUN - blood urea nitrogen; Ca - calcium; EHFP - enhanced heart sented as frequencies and percentages, and analyzed using a failure education program; HF - heart failure; LVEF - left ventricular ejection fraction; chi-square test and Fisher's exact test; p values <0.05 were con- NYHA - New York Heart Association; RC - routine care sidered statistically significant. To test for significant differences between two percentages, the T-Test of proportions was used. In total, there were 28 deaths (18 due to cardiovascular causes) after the 6-month follow up. Of those who died due to Results cardiovascular cause, the number of cardiovascular deaths in the EHFP group was significantly lower than the number of car- A total of 248 patients with HF were enrolled into the Hit-PoinT diovascular deaths reported in the RC group (46.7% vs 84.6%, study, of which 125 were randomly assigned to the EHFP group and p=0.04). Although all-cause mortality did not differ between the 123 to the RC group. The mean age of all patients was 60.8±13.8 two groups (p=NS), the percentage of cardiovascular deaths in years. Patients were predominantly men (73%) with NYHA class II– the EHFP group was significantly lower than in the RC group at IV HF symptoms who had a mean ejection fraction of 26.8%±7.3%. the 6-month follow up (5.6% vs. 8.9%, p=0.04) (Table 2). There were no significant differences in baseline characteristics The median number of emergency room visits was one while between the EHFP and the RC groups, except for rate of hyper- the median number of all cause hospitalizations and heart fail- lipidemia that was more prevalent in the former (p<0.008). Use of ure hospitalizations was zero. Twenty-tree percent of the EHFP pharmacologic therapy at baseline in patients demonstrated com- group and 35% of the RC group had more than median number pliance with guideline-recommended therapy, and baseline clini- of emergency room visits (p=0.05). Forty percent of the EHFP cal characteristics, laboratory measures, and the use of cardio- group and 38% of the RC group had more than median number vascular medication are shown in Table 1. of all cause hospitalization (p=0.80) and 30% of the EHFP and 110 Çavuşoğlu et al.Hit-PoinT Anatol J Cardiol 2017; 17: 107-12 Table 2. 6-month adverse outcomes by treatment assignment tremendous promise for patients not receiving comprehensive care, but that does not mean they are universally effective. These RC (n=123) EHFP (n=125) P programs should be feasible and tailored according to the geo- Primary endpoint graphic and economic needs of different countries. The formal, Cardiovascular mortality, 11 (8.9%) 7 (5.6 %) 0.04 controlled testing of validated methods for patient education n (%) should be encouraged. The variables should not only be knowl- Secondary endpoints edge but should also include a clinical outcome and functional Median number of emergency 40 (35%) 26 (23%) 0.05 capacity assessment (14). In this context, the Hit-PoinT study has room visits >1, n (%) demonstrated that simple and easily-organized enhanced HF pa- Median number of all-cause 43 (38%) 47 (40%) 0.80 tient education and follow-up program, in addition to routine HF hospitalizations >0, n (%) care, is feasible and effective for improving clinical outcomes. Median number of HF 35 (29%) 37 (30%) 0.95 In recent years, various HF management programs have been hospitalizations >0, n (%) developed to determine the effect of multidisciplinary manage- All-cause mortality, n (%) 13 (10.5%) 15 (12%) 0.75 ment programs on the risk of hospital admission and mortality in EHFP - enhanced heart failure education program; HF - heart failure; RC - routine care patients with chronic HF (7–15). Although HF disease manage- ment programs have been shown to provide favorable clinical 70 outcomes in terms of reducing morbidity and even mortality, find- 60% P=0.001 61% ings from most studies have not been completely consistent and 60 Baseline not all have revealed positive results (17, 18). However, recent 50 6-month meta-analyses evaluating HF disease management programs 40 32% have reported potential improvements in quality of life and cost, 30 in addition to reductions in mortality or re-hospitalization (19, 20). 20 Previously, home-based automated high-tech monitoring 12% 10 systems compared to enhanced patients education and follow- up have been reported to have no significant effect on cardiovas- 0 EHFP RC cular death and readmission rate within 6 months and, therefore, enhanced patient education and follow-up was found to be as Figure 2. The percentage of patients with NYHA Class III or IV in RC and successful as the use of sophisticated home monitoring devices EHFP groups EHFP - enhanced heart failure education program; NYHA - New York Heart Association; (21). Several studies have also examined the effects of telephone RC - routine care intervention. Galbreath et al. (22) showed that initial weekly and, later, monthly telephone intervention provided a borderline sta- 29% of the RC group had more than median number of heart tistically significant reduction in all-cause mortality during an failure hospitalization (p=0.95). At baseline, 60% of patients in 18-month follow-up. In another study, centralized telephone in- the EHFP group and 61% of patients in the RC group were in terventions compared to usual care were found to be effective in NYHA Class III or IV, while at 6-month follow up only 12% in the reducing HF hospital admissions, but mortality was not different EHFP group and 32% in the RC group were in NYHA Class III or between the two groups (23). In another randomized controlled IV (p=0.001) (Fig. 2). trial of telephone case management, no significant differences were found in HF hospitalization, HF days in the hospital, HF cost, Discussion all-cause hospitalizations, mortality, or quality of life (24). These different findings suggest that a one-size-fits-all model for dis- The results of Hit-PoinT study showed that an enhanced HF ease management is not appropriate for all patients, for all health education led by a cardiologist and followed by telephone by a care systems, or for all countries (21). cardiologist and/or a nursed trained on HF reduced the cardio- Studies that assessed the impact of nurse-led disease man- vascular deaths and number of emergency room visit, and also agement programs have also shown conflicting results. The RE- significantly improved NYHA functional capacity at 6 months in MADHE study, a long-term prospective randomized controlled post-discharge ambulatory HF patients but provided no signifi- study using repetitive education at 6-month intervals and moni- cant changes in the number of all-cause hospitalization, hospi- toring for HF outpatients,found benefits of such a group program talization for HF or all-cause mortality. among a population of relatively young patients (25). In contrast, Although pharmacological and device therapies for the treat- Coordinating Study Evaluating Outcomes of Advising and Coun- ment of HF patients have been shown to significantly improve seling in Heart Failure (COACH) study examining the effect of survival and decrease hospitalizations, uneven use of evidence- nurse-led disease management program of 2 levels of intensity based therapies has led to the development of disease manage- (basic support and intensive support) on death and readmission ment programs. HF disease management programs have shown reported no benefit (13). Two other studies on nurse-directed HF Çavuşoğlu et al. Anatol J Cardiol 2017; 17: 107-12 Hit-PoinT 111 clinics reported favorable effects, but were conducted in expe- of this study was that there was no assessment on changes in rienced hospitals (26, 27). In the TEN-HMS study, Cleland et al. quality of life, adherence to treatment, and the number of am- (28) studied the outcomes of home telemonitoring, nurse tele- bulatory visits, which makes it difficult to evaluate the impact of phone support, and usual care and found an increase in HF hos- intervention. Thus, addition of home visits, more frequent tele- pitalization and no significant decrease in the number of days phone contact, repetitive education, or more frequent hospital spent in the hospital for HF with home telemonitoring when com- visits to study design would be important to determine more sig- pared to nurse telephone support and usual care during 240-day nificant clinical outcomes. follow-up. However, in long-term follow-up of their three study groups, they reported a significant reduction in mortality in pa- Conclusions tients receiving home telemonitoring or nurse telephone support when compared to usual care (34%, 31%, and 51% respectively, The Hit-PoinT study was a randomized, multicenter, con- p=0.032) (28). In a meta-analysis of telemonitoring and struc- trolled clinical trial which aimed to evaluate a simple, easily- tured telephone disease management programs for HF, Clark et organized, and widely-applicable HF disease management model al. (29) reported a significant overall effect of telemonitoring on feasible for use in developing countries. The results of Hit-PoinT all-cause mortality compared to usual care but a non-significant demonstrated the potential clinical benefits of enhanced HF effect for structured telephone monitoring programs. education and follow up program led by a cardiologist in reduc- The results of the Hit-Point study are generally consistent ing cardiovascular deaths and number of emergency room visits, with the findings of many other studies on HF disease manage- as well as an improvement in functional capacity at 6 months in ment programs. Our results showed a reduction in cardiovas- post-discharge ambulatory HF patients. cular death and emergency room visits, and an improvement in functional capacity, although no effect on HF hospitalization, Conflict of interest: None declared. all-cause hospitalizations, or all-cause mortality were found. Currently, there are no set HF discharge instructions in place in Peer-review: Externally peer-reviewed. Turkey; thus, HF patients are discharged without any specific in- Acknowledgements: This study had been designed, supported and structions. The observed benefits to the intervention group can conducted by the Working Group on Heart Failure of the Turkish Society be explained by the education part of the program, better am- of Cardiology. bulatory care, and improved adherence to medical therapy. Re- admissions to hospital for HF or other associated conditions are Previous Presentation: Presented in part at the Scientific Sessions frequent and hospitalizations should be considered as a conse- and Resuscitation Science Symposium of the American Heart Associa- quence of the clinical course of this disease. Disease manage- tion, 16-17 November, 2013; Dallas, Texas. ment programs require close contact and follow-up with patients and this level of collaboration may lead to an increase in hospital- Appendix: Investigators and Nurses ization or offset the positive effects of disease management pro- Eskişehir, Turkey: Yüksel Çavuşoğlu, Erkan Gencer, Nilgün Akyol grams on readmission. On the other hand, it could be speculated and Julide Coşkun. İzmir, Turkey: Mehdi Zoghi. İstanbul, Turkey: Mehm- that close contact allows for identification of life-threatening et Eren, Ahmet Lütfü Orhan, Songül Gençoğlu and Semra Akkaya. Urfa, factors and helps to overcome these problems in a timely man- Turkey: Evin Bozçalı, Veli Polat, Leyla Bilgiç and Belma Bayraklı. Kocae- li, Turkey: Güliz Kozdağ and Nursen Alkaya. Bursa, Turkey: Aysel Aydın ner, which might have a positive effect on death rates. In long- Kaderli, Tunay Şentürk, Sevil Dede and Munise Dırık. Edirne, Turkey: term follow-up, it can be expected to find a significant effect on Meryem Aktoz, Güray Alicik, Arzu Dereli and Serpil Menekşe. Samsun, all-cause mortality, as has been shown in TEN-HMS study (28). Turkey: Halit Zengin, Korhan Soylu, Canan Gülboy and Şoray Ünyeli. Gaziantep, Turkey: Mehmet Aksoy, İbrahim Sarı, Meral Çakır and Sima Study limitations Annaç. Ankara, Turkey: Ahmet Temizhan and Mehmet Timur Selçuk. İzmir, Turkey: Oktay Ergene, Rida Berilgen, Dilek Yurtsever and Gülhan Because of the design of this study, both patients and inves- Şimşek. Pittsburgh, U.S: Özlem Soran. tigators could not be blinded to treatment groups, and this might have introduced some bias into the trials. The other principal References limitation was the 6-month duration of the follow-up period. In- deed, because of the comprehensive list of exclusion criteria, 1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, findings are only applicable to such a cohort. 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