| Heart failure(HF),a clinical syndrome characterized by myocardial remodeling and impaired cardiac systolic/diastolic function,has a high morbidity and mortality rate,posing a serious threat to a patient’s life and health and creating a significant burden on public health.According to the ANNUAL REPORT ON CARDIOVASCULAR HEALTH AND DISEASES IN CHINA(2021),the prevalence of HF in China is 1.3%among residents aged 35 and above,which has increased by 44.0%since 2000,with approximately 8.9 million HF patients in China.The 2020 Clinical Performance and Quality Measures for Heart Failure in China showed that the mortality rate of hospitalized heart failure patients was 2.8%.In 1997,the Decision of the CPC Central Committee and the State Council on Health Reform and Development proposed the establishment of a "two-way referral system".A hierarchical diagnosis system refers to the process of diagnosing and treating patients at different levels of hospitals based on the severity and urgency of their condition and the difficulty of treatment.A two-way referral is the core measure to achieve a hierarchical diagnosis system.This can give full play to the advantages of large and medium-sized hospitals in talents,technology and equipment while rationally allocating medical resources,narrowing the gap between regions in disease diagnosis and treatment,thereby changing patients’ medical habits and forming a reasonable and orderly medical pattern.Developed countries already have a relatively complete medical and health service,primary care responsibility,referral and follow-up systems.China attaches great importance to the hierarchical diagnosis system and two-way referral,and has introduced a series of policies to ensure its development and implementation,However,there are still some problems such as lack of unified standards,procedures,and long-term and effective management systems,resulting in the role of primary care institutions in diagnosis and treatment is not fully played,and some patients do not receive the whole standardized inhospital and out-of-hospital management,which affects the long-term prognosis.In 2017,Qilu Hospital of Shandong University(Qilu Hospital)undertook a key research and development project of the Ministry of Science and Technology of China,"Research on long-term management of chronic heart failure and establishment of evaluation and quality control system" by which to carry out the exploration of two-way referral of heart failure patients.By establishing unified referral standards,procedures,follow-up management system,and implementation referral work of heart failure patients to obtain data and characteristics,to provide reliable and realistic data for the improvement of heart failure twoway referral policy in China,and further clarify the feasibility and problems of two-way referral implementation in China,explore the experience and model suitable for heart failure diagnosis and treatment in China,and optimize the management of heart failure patients.Therefore,Qilu Hospital is the first hospital in China to carry out two-way referral for HF patients.A feasible "1+X" hierarchical diagnosis system with Qilu Hospital as the core has been gradually established in practice,where "1"refers to the core unit,Qilu Hospital or higher-level hospital,and "X" represents other medical institutions at different levels and types in cities,counties,urban and rural areas within the medical field,collectively referred to as collaborating hospitals or lower-level hospitals The impact of the two-way referral model on the standardized treatment and prognosis of heart failure patients was evaluated by comparing the drug regimen,recovery of heart function during the standardized treatment of HF patients under the two-way referral model and those who were seen and followed up at Qilu Hospital.The results showed that the patients with heart failure in this model had a high percentage of down-turn and follow-up rate,heart failure drug utilization rate and on-target rate.The improvement of cardiac remodeling and cardiac function,the reduction of cardiovascular death and heart failure hospitalization rate could not only reach the level of Qilu Hospital,but also its data was better than the current domestic date,it provides first-hand information for the two-way referral of heart failure,and provides experience and basis for the improvement of national two-way referral policy.However,this model also has some problems which need to be popularized and verified.Objective1.To establish a systematic and standardized "1+X" two-way referral model for heart failure(HF)suitable for the local area.2.To investigate the feasibility of the HF two-way referral model with Qilu Hospital as the core.3.To evaluate the impact of the "1+X" two-way referral model on follow-up rate,heart failure drug utilization rate and on-target rate and improvement in heart failure prognosis in heart failure patients.4.To provide reliable and real data for two-way referral of heart failure in China and summarize the problems existing in practice,so as to provide a basis for the improvement of national two-way referral policy.Methods1.Establish a "1+X" two-way referral model for heart failureWe planned to set up a three-level hierarchy of tertiary hospitals(nationally renowned and provincial/municipal level)-secondary hospitals-community hospitals,but in the actual operation process,there were many factors that made the three-level referral model impossible to implement.Therefore,the heart failure team of Qilu Hospital has collaborated with several medical units to establish a medical circle and a standardized,systematic and enforceable " 1+X" two-way referral model,formulated referral criteria and referral processes,assessed referral risks,designed case report forms(CRF)for the first time,managed,educated and followed up on referred patients,and enhanced learning for doctors within basic hospital,etc.We will promote the development of two-way referral model in our province.1.1 Referral Criteria(1)Criteria for CHF patients transferred from Qilu Hospital to collaborating hospitals:①Patients with CHF whose etiology has been identified and whose symptoms have improved to NYHA II-III after treatment;②Patients with CHF whose respiratory failure has been corrected and whose condition is relatively stable;③Patients with CHF whose cardiogenic shock has been corrected and whose hemodynamics is stable;④Patients with CHF whose malignant arrhythmia has been controlled;⑤Patients with CHF whose vital signs are stable and entering convalescent rehabilitation(2)Criteria for CHF patients transferred from collaborating hospitals to Qilu Hospital:①Patients with CHF who are still not getting better after active treatment;②Patients with unclear etiology of CHF;③Patients with CHF complicated with complex arrhythmia or multiple organ dysfunction;④Patients with CHF who need interventional or surgical treatment and cannot be completed in lower-level hospitals;⑤Patients with initial or decompensated or advanced CHF;⑥Patients with CHF with unstable hemodynamics;⑦Patients with CHF who were discharged to higher-level hospitals to adjust the initial treatment plan were improved.1.2 Referral Process(1)The process of referral from Qilu Hospital to collaborating hospitalsPatients whose conditions are relatively stable and meet the referral criteria can be transferred to the collaborating hospitals for continued treatment and follow-up by the heart failure doctors at Qilu Hospital.Formulate standard treatment plans and suggestions before referral and contact the person in charge of the receiving hospital.The referral can only be made after obtaining the consent of the person in charge,patient and family members.The person in charge of the receiving clinic directly hands over the condition and treatment plan of the referred patients,strictly follows the guidelines for heart failure treatment and the plan formulated by the Qilu Hospital for treatment,follow-up and management,and actively feeds back the treatment results.Regular medical quality evaluation and control of collaborating hospitals.(2)The process of referral from collaborating hospitals to Qilu HospitalThe person in charge of heart failure at Qilu hospital assesses the risk of referral by remote consultation,and patients who meet the criteria for referral can be referred after obtaining the consent of the person in charge,the patient and the family members.Patients with CHF who are not suitable for referral should make treatment plans after consultation by doctors in higher-level hospitals,and continue to be treated and followed up in collaborating hospitals.2.Research SubjectsPatients with heart failure admitted to the medical community between March 2018 and June 2022.The patients with heart failure participating in two-way referral were determined according to the inclusion criteria,the patients with two-way referral in visit were selected according to the exclusion criteria and the loss of follow-up criteria,and the patients in the two-way referral group and the core hospital treatment group were determined for inclusion in the analysis according to the grouping criteria and exclusion criteria.2.1 Inclusion criteria(1)Patients who meet the diagnosis of CHF according to the Chinese Guidelines for Diagnosis of CHF;(2)Patients with CHF who visit Qilu Hospital or cooperative hospital and meet the referral criteria;(3)CHF patients who volunteered to join this study.2.2 Exclusion criteria(1)Patients with severe liver and kidney diseases(Child Pugh C 级,eGFR<30ml/min/1.73m2),hematopoietic system,tumors and other primary diseases;(2)Those with mental disorders and other behavioral and learning disabilities;(3)Those who have serious adverse reactions or contraindications to drugs for treating CHF.2.3 Criteria for lost follow-up(1)Those who have not been hospitalized or adjusted in outpatient service for more than 4 weeks during standardized diagnosis and cannot be connected by telephone follow-up or are unwilling to continue diagnosis;(2)Those who have not returned to the clinic for more than one year during the followup and cannot be connected by telephone follow-up.2.4 Grouping Standards(1)Two-way referral group①Attendance at our medical circle;②Consistent diagnosis of heart failure with reduced ejection fraction(LVEF≤40%);③Age≥18 years old;④Meet the referral criteria and complete at least one referral.(2)Core hospital treatment group①Consultations and standardized follow-up at Qilu Hospital without participation in two-way referral;②Consistent diagnosis of heart failure with reduced ejection fraction(LVEF≤40%);③Age≥18 years old.3.Information CollectionA case report form(CRF)was designed for recording and was collected and filled out by the responsible persons of the participating hospitals.Clinical data of patients were collected,including demographic information,heart failure etiology and concomitant diseases,lifestyle(smoking,alcohol consumption),home self-measurement blood pressure,heart rate,symptoms,signs,cardiac ultrasound indicators laboratory indicators,medication regimen and adjustment at the time of enrollment and at each follow-up visit(1 month,3 months,6 months,12 months).4 Follow-Up ManagementWe produced "Follow-up Manual for Standardized Treatment and Management of Chronic Heart Failure ",which was distributed to patients and instructed them to fill in to enhance their understanding of the disease and strengthen their out-of-hospital management.We record daily home self-measurement blood pressure,heart rate,and volume of intake and output,etc.;adjust the drug dose at the heart failure clinic every 2-4 weeks,and gradually titrate to the target dose or the maximum tolerated dose before the attending physician decides the patient’s follow-up time.Echocardiography and laboratory tests will be performed every 3-6 months.A specialist from the Heart Failure Team is responsible for follow-up of outpatients with heart failure and regularly reminds patients who are due for following up.5 Training of primary medical practitionersThe Qilu heart Failure team conducted tours in 17 prefecture-level cities in Shandong province to educate primary medical practitioners on the new progress in the diagnosis and treatment of heart failure,how to standardize the diagnosis and treatment of heart failure according to the guidelines,and impart management experience of heart failure by academic exchange conferences,classic case sharing,short-term clinical observation,and face-to-face and hands-on experience teaching were carried out regularly.6 Evaluation and control of HF medical qualityQuality control indicators are set up,and medical quality evaluation and control are conducted regularly in referring units to ensure the efficient implementation of two-way referral.These included:assigned personnel for the treatment and management of patients referred for heart failure;Fill in and feedback the two-way referral case report form;Patients with heart failure were regulated and managed according to the diagnosis and treatment standards of heart failure.Detailed health education was carried out for patients with heart failure.Attend heart failure conferences and academic activities regularly.7.Statistical AnalysisThe data were statistically analyzed using SPSS 26.0,and the measures obeying normal distribution were expressed as mean± standard deviation(x±s),and measures with nonnormal distribution were expressed using median(first quartile,third quartile)[Q2(Q1,Q3)].Comparisons of repeated-measures data obeying normal distributions were performed using repeated-measures ANOVA,and comparisons of repeated-measures data with non-normal distributions were performed using the nonparametric Friedman test.Count data were expressed as frequencies or rates(%),and comparisons between two groups were analyzed using the chi-square test or Fisher’s exact test.Comparison of trends in change between groups was performed using generalized linear mixed models.The effect of different factors on the change of dichotomous outcome variables over time was analyzed by Kaplan-Meier analysis and COX regression.logistic regression was used to analyze the relationship between categorical variables and influencing factors.P<0.05 was defined as statistically different.Results1.Information of Referral Hospitals(1)In the medical field formed with Qilu Hospital as the core,62 medical institutions cooperate and implement two-way referral management.The level 2 tertiary hospitals being the majority.(2)Hospitals with a follow-up rate of ≥50%account for 62.9%.2.Information of Referral Patients(1)Among the 329 HF patients who met the referral criteria and voluntarily participated in the two-way referral,66.5%(219/329)of patients are followed up.(2)Among the HF patients who participated in the two-way referral,78.7%are referred from higher-level hospitals to lower-level hospitals.(3)Among the HF patients who participated in the two-way referral and were followed up,70.3%are male,with a mean age of(53± 15)years.Patients from rural areas account for 71.2%.Dilated cardiomyopathy and ischemic heart disease are the first and second leading causes of HF,respectively.3.Effectiveness of Patient Management under a Two-Way Referral System(1)Among the 329 patients participating in the two-way referral program,the follow-up rates at 1,3,6 and 12 months were 82.3%,83.6%,87.0%,80.0%,respectively.(2)The usage rates of β-blockers,renin-angiotensin-aldosterone system inhibitors at the time of referral are 98.2%,and 97.7%,respectively.Under two-way referral management,drug utilization rates are gradually increasing,reaching a maximum of 98.8%,98.8%,respectively.There was no statistical difference between drug use rates in any of the months of follow-up(P>0.05).The drug dose is gradually titrated according to the patient’s symptoms,blood pressure,and heart rate,and the target rate continues to increase.There are 48.8%of patients have reached the target dose or maximum tolerated dose for β-blockers by the 12th month of follow-up,and 60.8%have reached the target dose or maximum tolerated dose for ACEI/ARB/ARNI by the 12th month of follow-up.(3)LVEF was 35(30,40)%and LVEDd was 63(58,68)mm at the time of referral.LVEF recovered to 50(48,55)%and LVEDd decreased to 57.5(54,59)mm at 12 months after referral Friedman’s test showed statistical differences between LVEF and LVEDd at each month of follow-up,and subsequent two-by-two comparisons showed statistical differences at each month of follow-up compared to the time of referral(all P<0.05).The percentage of complete recovery of LVEF gradually increased,reaching 32.5%at the 12th month of referral.(4)The proportion of patients classified as NYHA Ⅰ and Ⅱ gradually increase,while the proportion of patients classified as NYHA Ⅲ and Ⅳ gradually decrease.The proportion of patients with improved NYHA classification shows a gradually increasing trend,with the most significant improvement observed in the 12th month of follow-up,where the proportion reached 57.5%.(5)Among the heart failure(HF)patients enrolled in the study,the NT-proBNP concentration is 1368.0(569.9,3401.3)pg/ml at the time of referral.The NT-proBNP concentration significantly decrease compared to that at the time of referral,with a statistically significant difference(P<0.05).(6)During the follow-up period,among the 329 HF patients participating in the two-way referral system,15 patients died from worsened HF,resulting in a mortality rate of 4.8%.Among the 219 patients who are followed up,18 patients are readmitted due to worsened HF,resulting in a readmission rate of 8.2%.A total of 35 non-heart failure reasons readmission events occur,resulting in a non-heart failure causes readmission rate of 16.0%.There were 8 patients who died due to exacerbation of heart failure,and the mortality rate from heart failure causes was 3.7%.4.Results of a comparative analysis of the impact of Two-Way Referral System on the treatment and prognosis of patients with HFrEF(1)According to the above inclusion criteria,exclusion criteria and grouping criteria,157 HFrEF patients in the two-way referral group and 200 HFrEF patients in the core hospital group were included in the comparative analysis.(2)There were statistical differences between the two groups in terms of source,smoking,IVS,LVEF,and systolic blood pressure.The two-way referral group had more patients from rural areas,more patients with a history of smoking,and lower IVS,LVEF,and systolic blood pressure than the core hospital group.There were no statistical differences between the two groups in terms of gender,age,history of alcohol consumption,heart failure etiology,comorbidities,NYHA classification,LAEDd,LVEDd,LVPW,NT-proBNP,eGFR,diastolic blood pressure,and heart rate.(3)The follow-up rates of patients in the two-way referral group were 88.7%,84.9%,77.2%,and 73.8%at the 1st,3rd,6th,and 12th months after referral,respectively.The follow-up rates at the 6th and 12th months were higher in the two-way referral group than in the core hospital group and were statistically different(P<0.05).(4)The utilization rates of β-blockers in the two-way referral group were 98.1%,98.5%,99.2%,98.9%,and 98.7%at the time of referral and at the 1st,3rd,6th,and 12th months after referral,respectively,with no statistical difference in the rates between the groups at the follow-up time points.There was also no statistical difference in the rate of β-blockers use among patients in the core hospital group at each follow-up time point,which was 97.5%,98.4%,97.4%,97.5%,and 96.4%at baseline and follow-up months 1,3,6,and 12,respectively.There was no statistical difference in the rate of β-blockers use between the two groups of patients at the corresponding follow-up time points.(5).The utilization rates of ACEI/ARB/ARNI in the two-way referral group were 98.7%,98.5%,100.0%,98.9%,and 100.0%at the time of referral and at the 1st,3rd,6th,and 12th months after referral,respectively,with no statistical difference in utilization rates between the groups at each follow-up time point.The ACEI/ARB/ARNI utilization rates of patients in the core hospital group were not statistically different at each follow-up time point and were 98.0%,99.5%,99.3%,100.0%,and 100.0%at baseline and at follow-up months 1,3,6,and 12,respectively.There was no statistical difference in ACEI/ARB/ARNI utilization rates between the two groups at the corresponding follow-up time points.(6).The target attainment rates of β-blockers and ACEI/ARB/ARNI in the two-way referral group were both highest at the 12th month after referral,49.3%and 65.8%,respectively;the target attainment rates of β-blockers and ACEI/ARB/ARNI in the core hospital group were also both highest at the 12th month of follow-up,65.4%and 79.8%,respectively.The results of univariate logistic regression and multifactorial logistic regression showed that bidirectional referral was not a factor influencing β-blocker and ACEI/ARB/ARNI on-target.(7)LVEF,LVEDd and NT-proBNP improved significantly and statistically(P<0.001)in both groups compared with those at referral.LVEF recovered to 42(34.51)%and 50(38,58)%at month 12 in the two-way referral group and the core hospital group,respectively,and LVEDd recovered to 57(52,65)mm and 56(52,61)mm at month 12,respectively.(8)After unadjusted and adjusted for gender,age,history of smoking,history of alcohol consumption and further adjustment for hypertension,diabetes,coronary artery disease,premature ventricular beats and atrial fibrillation,there was no statistical difference in the trends of LVEF,LVEDd and NT-proBNP between the two groups,indicating that the two-way referral group could obtain similar recovery of LVEF,LVEDd and NT-proBNP as the group attending the core hospital.(9)The recovery rate of LVEF was higher in the core hospital group(53.6%)than in the two-way referral group(30.9%)and was statistically different(P<0.01),but there was no statistical difference in LVEF recovery between the two groups after adjusting for group,sex,age,smoking history,alcohol history,patient origin,heart failure etiology,and baseline LVEDd,IVS,and LVEF(HR:0.600,95%CI:0.329-1.094,P=0.095).Subgroups included in sex(male,female),age(≤55 years,>55 years),patient origin(rural,urban),heart failure etiology(ischemic cardiomyopathy,non-ischemic cardiomyopathy),LVEF(≤25%,>25%),NT-proBNP(≤2000 pg/ml,>2000 pg/ml)The results of subgroup analysis showed that there was no statistical difference in LVEF recovery between the two-way referral group and the core hospital visit group.(10)The results of the composite event rate of cardiovascular death and heart failure hospitalization showed that the composite event rate was 7.6%in the two-way referral group and 6.5%in the core hospital group,and there was no statistical difference between the two groups.The Kaplan-Meier curve and Log Rank test showed that there was no statistical difference in the composite event rate of cumulative cardiovascular death and heart failure hospitalization between the two groups.Conclusion(1)The two-way referral standard and referral process of heart failure with Qilu Hospital as the core has been formulated,and the "1+X" two-way referral model of heart failure suitable for the region has been established.(2)The "1+X" two-way referral model centered on Qilu Hospital significantly improves the patient referral rate and follow-up rate,demonstrating feasibility.(3)The "1+X" two-way referral model centered on Qilu Hospital has a high rate of drug utilization and target achievement,and the improvement of cardiac remodeling and cardiac function,the reduction of cardiovascular mortality and heart failure rehospitalization rate among HF patients can reach the level of the core hospital.(4)The large-scale promotion and implementation of the two-way referral management mode of heart failure requires the coordination of the government,health authorities,community health service centers,hospitals and patients. |
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