Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

Structured telephone support (STS) for adult patients with chronic heart failure

Structured telephone support (STS) for adult patients with chronic heart failure compared to Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home) in the prevention of Chronic cardiac failure in adults and elderly with chronic heart failure (CHF) AND hospitalization due to heart failure at least once AND without implanted devices

(See detailed scope below)

HTA Core Model Application for Medical and Surgical Interventions (2.0)
Core HTA
Published
Tom Jefferson (Agenas - Italy), Marina Cerbo (Agenas - Italy), Nicola Vicari (Agenas - Italy)
Neill Booth (THL - Finland), Plamen Dimitrov (NCPHA - Bulgaria), Mirjana Huic (AAZ - Croatia), Valentina Rupel (IER - Slovenia), Alessandra Lo Scalzo (Agenas - Italy), Ingrid Wilbacher (HVB - Austria)
Agenas - Agenzia nazionale per i servizi sanitari regionali
AAZ (Croatia), Agenas (Italy), ASSR RER (Italy), Avalia-t (Spain), CEM (Luxembourg), GÖG (Austria), HVB (Austria), IER (Slovenia), ISC III (Spain), NCPHA (Bulgaria), NIPH (Slovenia), NSPH (Greece), NSPH MD (Romania), SBU (Sweden), SNHTA (Switzerland), THL (Finland), UTA (Estonia).
9.9.2014 11.18.00
4.12.2015 17.51.00
Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 8 August 2022]. Available from: http://corehta.info/ViewCover.aspx?id=305

Structured telephone support (STS) for adult patients with chronic heart failure

<< Collection summaryDescription and technical characteristics of technology >>

Health Problem and Current Use of the Technology

Authors: Ingrid Wilbacher, Nadine Berndt, Francesca Gillespie

Summary

CUR1: For which health conditions and for what purposes is structured telephone support (STS) for adult patients with chronic heart failure used?

Structured telephone support, as subject of the current Core HTA, is one specific type of remote heart failure monitoring. It is monitoring and/or self-care management using simple telephone technology, usually initiated by a healthcare professional (e.g. nurse, physician, social worker or pharmacist), and in which data is stored by a computer.

Telemedicine is an approach using remote monitoring e.g. by structured telephone support of prognostic factors in order to promote an early identification of clinical deterioration in HF patients, prevent hospital readmission for acute decompensated HF, and avoid further complications {3}. Signs and symptoms reported by patients are collected by a healthcare professional who subsequently enters and stores the data into a monitoring system. The data are then reviewed by healthcare professionals, usually physicians or nurses. Appropriate action can be initiated, and deterioration can be rapidly detected, which leads to decrease in unnecessary hospital visits, a decrease in hospital (re-)admissions, an improved quality of life. {75}. The highest risk period for hospital readmission is the first few weeks after discharge {90}. Overall, telemonitoring has the potential to improve patient safety and quality of care {21}.

CUR2: What kind of variations in use are there across countries/regions/settings?

There were 62 studies from Europe cited in the reviews. Out of the 62 European studies 16 mentioned educational strategies within the telemedicinal programme. The involved persons were cardiologists (3 studies), multidisciplinary teams at least for the care plan (25 studies), physician-/primary care led (1 study each), nurse-led (4 studies), not mentioned in the reviews (32 studies).

The transfer mode was in 17 studies via telephone/ cell phone transmission, in 4 studies through implantable devices, 1 study describes interactive videoconferencing, transtelephonic monitoring, 1 study described hospital-at-home service, 2 studies just described non-invasive telemonitoring, in 36 the transfer mode was not clear.

Most studies report care provided by a multidisciplinary team, but a great deal of heterogeneity regarding the professionals involved was described. Collaboration between primary care and secondary care was scarcely reported. In almost all the studies, nurses played a coordinating or leading role, but description of the specialization of clinical background were lacking. Almost all programmes also had physicians involved, which could be cardiologists, and/or primary care physicians or other specialists such as geriatricians or internists. Additionally, other professionals (i.e. psychologist, dietician, physical therapist, social worker, pharmacist) were involved in the programmes, mostly as a member of the multidisciplinary team or occasionally as the main provider of an intervention (e.g. a pharmacist). A different variation of systems for telemonitoring was found, ranging from assessment of symptoms and/or vital signs to data transmission and automatic alarms. {51}

Substantial heterogeneity among studies was noted {119}, the content of the telemedicine interventions vary between patient groups and with regard to duration and content.

CUR3 / ORG1: Who decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?

Three of the reviews reported eligibility and exclusion criteria for patients included in the studies, but there was no answer on who decides or who should decide to use telemedicine for what patient.

CUR4: Is structured telephone support (STS) for adult patients with chronic heart failure a new, innovative mode of care, an add-on to or modification of a standard mode of care or replacement of a standard mode of care?

Eight of the included reviews try to look at the indicators for novelty and how they lead to a novel attitude – like including the patient - and new settings – like different patient- and physician roles - of health care. They still describe telemedicine as „changing modality“, „promising“, „complementary“, „potentially“, „modality“, and a common insecurity about what exactly is defined as telemedicine and what kind of programmes were modified into telemedicine (like disease management programmes which are technically supported) seems to occur.

Generally, telemedicine and telemonitoring can be seen as relatively new, currently as an adjunct to current care with the chance of more patient-self-care-involvement and improved quality of therapeutic monitoring, but without a clear unique idea where it should lead to and how it should be implemented.

CUR5: What is the target population in this current assessment of structured telephone support for adult patients with chronic heart failure?

In this current assessment of structured telephone support for adult patients with chronic heart failure, the target population is patients who have signs or symptoms of HF, or an underlying non-diagnosed abnormality of the cardiac structure that is likely to lead to HF.

According to the large number of studies that have been conducted on the clinical effectiveness of telemonitoring in HF patients, the appropriate target population of telemonitoring generally concerns elderly, with a definitive clinical diagnosis of HF, with a mean age generally around the 70s (patients may also be significantly younger or older), or with chronic HF, often who have had a cardiovascular hospitalization or a hospitalization for HF within the previous 12 months, who have been discharged to home, often with moderate or severe symptoms of HF (New York Heart Association, NYHA class II-IV), a LVEF ≤ 30 %, and who are administered diuretics, ACE inhibitors and beta blockers.

Structured telephone support may not be not suitable for every patient diagnosed with HF. According to Koehler et al. 2011 {64}, telemonitoring is particularly suitable for patients who are recently hospitalized due to HF, medically unstable, or classified being in the NYHA Class II and III. Koehler also recommends performing telemonitoring during the 12 event-free months after hospitalization for HF {64}.

Guidelines of the ESC recommend remote monitoring of patients reporting symptoms (including drug adverse effects) and signs of HF (Class I recommendation, Level of Evidence: C) {19}.

Patients with cognitive impairment, a mental illness, a life expectancy less than one year, hearing impairment, language barrier or another chronic disease are often not eligible for a telemonitoring intervention such as structured telephone support {93}. This has been confirmed by Paré et al. 2010 {92} who outlined on the basis of their systematic review on the clinical effects of home telemonitoring in the context of diabetes, asthma, HF and hypertension that telemonitoring likely to not be suitable for everyone, because most studies excluded patients with a moderate to severe cognitive, physical, visual or hearing disability. Patients who did not own a phone or who a very short life expectancy (less than 1 year) were often excluded as well. The beneficial effects on state of health are observed mostly among those patients whose health state is rather serious {92}.

CUR6: How many people belong to the target population?

HF is a large and global public health problem that will become more important with the aging of the world population. The number of patients with HF is predicted to increase considerably in countries with fast ageing populations, like Japan. Up to one person in five is expected to develop HF at some point in their life in economically developed countries {70}. In 2007, it was already estimated that approximately 1–2 % of the adult population in developed countries had HF and that the incidence approached on average 5–10 per 1000 persons per year with a significantly higher incidence in higher age groups {82}.

 

In 2011, it was estimated that 26 million adults worldwide were living with HF {6}, leading some to describe it as a global pandemic {2}. Of these patients at least 15 million are European {19}, whereas almost 7 million Americans ≥ 20 years of age have HF {120}. According to the AHA, at least 850.000 patients are yearly newly diagnosed with HF in the US with the incidence approaching 1 per 100 people 65 years of age and older.  %Data on the incidence and prevalence of HF in the developing world are largely absent, but it is estimated that there is also an increasing number of patients with HF in the developing countries due to the emerging pandemic of cardiovascular diseases {78}.  % % %

HF is a condition that becomes more common with increasing age. In North America and Europe, persons 50 years of age or under are hardly ever found to have HF {32},{7},{107}, and more than 80 % are 65 years of age or older {6}. Hence, particularly in those older than 50 years of age the prevalence and incidence increase progressively with age. Generally speaking, in 2007 the prevalence was estimated to be 10-20 % in persons with the age between 70 and 80 while it was rising significantly to ≥10 % among persons 70 years of age or older {82}. In the Dutch Rotterdam study, the prevalence of HF was 1 % in the age group of 55-64 years, 3 % in the age group of 65-74 years and 13 % in the age group of 75-85 years {81}. Moreover, according US estimates, the remaining lifetime risk for development of new HF remains at 20 % at 80 years of age, even in the face of a much shorter life expectancy {83}.  

 

Overall, the prevalence of systolic HF and diastolic HF is estimated to be equal between men and women. According to the ESC (2012), at least half of patients with HF have a low or reduced ejection fraction. HF with a preserved ejection fraction or diastolic HF is present in approximately 50 % the patients with HF {77},{29}. In younger age groups, systolic HF occurs more frequently in men than in women because myocardial infarction occurs at an earlier age in men. Diastolic HF is more common in the elderly, in women, in individuals with longstanding hypertension, diabetes, renal failure, anemia, and atrial fibrillation {19}. Studies show that the accuracy of the diagnosis of HF by clinical means alone is often inadequate. This applies particularly to female, elderly, and obese patients, leading to a potential underrepresentation of the patients who have HF {106},{60},{77}.

 

The globally increasing prevalence of HF is not merely due to the ageing of the population. It is also due to improvements in the treatment of acute coronary syndromes, effective prevention in those at high risk or those who have already survived a first coronary event, a longer survival of cardiac patients and HF patients, and the increasing epidemiology of cardiovascular diseases in the developing countries  {84},{100},{116}. An increase in risk factors for HF such as diabetes, sedentary behavior and obesity also contribute to the increasing pool of HF patients. Factors that on the other hand decrease the incidence of HF are a decline in the number of new cases with myocardial infarction, a decline in the severity of acute myocardial infarction and the improvement of care {40},{85}. The improvement of care for hypertension and coronary artery disease, particularly in Western Countries, also account for a decreasing incidence {86}.

Although various studies have been conducted in the past to capture the epidemiology of HF, there is still a scarcity of epidemiological data. The absence of gold-standard criteria for the diagnosis of HF, together with a lack of agreement on a definition of HF itself, explains why studies fail to use a uniform assessment of HF.

CUR7: What is the disease or health condition in the scope of this assessment?

According to the European Society of Cardiology, heart failure is a clinical syndrome in which patients have typical symptoms and signs resulting from an abnormality of cardiac structure or function. Although often life threatening, typical symptoms and signs resulting from an abnormality of cardiac structure or function, i.e. heart failure, leading to failure of the heart to deliver oxygen at a rate corresponding to the needs of the body are usually less dramatic than those associated with a myocardial infarction {77}.

The current 10th edition of the International Classification (ICD) system classifies heart failure as an intermediate, not underlying cause of death. It is described as congestive heart failure including congestive heart disease and right ventricular failure. It is also defined as left ventricular failure including cardiac asthma, left heart failure, and oedema of lung and pulmonary oedema with mention of heart disease (unspecified) or heart failure. Heart failure (unspecified) can be due to cardiac, heart or myocardial failure not otherwise specified. Heart failure is further defined as the incidence of heart failure due to rheumatic heart disease, hypertensive heart disease, ischemic heart disease and inflammatory heart disease. Complicating abortion or ectopic or molar pregnancy, obstetric surgery and procedures are excluded. Moreover, heart failure due to hypertension (with renal disease), heart failure following cardiac surgery or due to presence of cardiac prosthesis, and neonatal cardiac failure are excluded from the classical definition of heart failure by the ICD-10 {113}.

CUR8: What are the known risk factors for the disease or health condition?

Risk factors for HF (AHA):

-increasing age (AHA);

-male gender (AHA);

-African American race (AHA);

-hypertension (AHA);

-obesity (AHA);

-low socio-economic status (AHA);

-cigarette smoking (AHA);

-history of atrial fibrillation (AHA);

-diagnosis of CHD (AHA);

-atherosclerosis {115},{77};

-low level of adiponectin and a high level of pro-B-type natriuretic peptide (BNP) in the bloodstream {83};

-increased urinary albumin excretion, an elevated serum γ-glutamyl transferase, higher levels of hematocrit, increased circulating concentrations of resistin, cystatin C, inflammatory markers (interleukin-6 and tumor necrosis factor-α) and low serum albumin levels {83};

-previous recognized or unrecognized viral infection {77};

-increased alcohol intake {77};

-chemotherapy {77};

-‘idiopathic’ dilated cardiomyopathy.

Risk factors for hospitalization in heart failure {30}:

-higher age;

-nonwhite race;

-low socio-economic status;

-lack of employment ;

-living alone, smoking;

-ischemic etiology;

-low systolic blood pressure;

-higher NYHA class (III or IV);

-prior HF hospitalization;

-presence of hypertension;

-diabetes mellitus;

-anemia;

-hyponatremia;

-history of renal insuffiency;

-worsening renal function;

-chronic obstructive pulmonary disease;

-obstructive sleep apnea;

-depression;

-low quality of life;

-absence of emotional support or social network;

-low adherence to therapies (Giamouzis et al., 2011).

Risk factors for hospital readmission among older persons with a new onset of HF {8}:

  • diabetes mellitus;

  • NYHA class III or IV;

  • chronic kidney disease;

  • reduced ejection fraction (< 45 %);

  • muscle weakness;

  • slow gait;

  • having a depression.

 

Greater survival for patients with established CHF (“reverse epidemiology”) {54}:

  • obesity;

  • < >< >

    Substantial heterogeneity in the results {33};

  • Telehealth programmes demonstrated clinical effectiveness in patients with CHF compared with usual care {114};

  • It was not clear as to the extent to which these effects were due to tele-monitoring per se or to the improvement in access to care{44};

  • Despite the beneficial effects reported by meta-analyses of small non-controlled studies, major randomized controlled trials have failed to demonstrate a positive impact of this strategy {102};

  • Prior to being accepted as a standard of care, more evidence from large, randomized clinical trials is required {34};

  • Structured telephone support and telemonitoring are effective in reducing the risk of all-cause mortality and CHF-related hospitalisations; in patients with CHF; they improve quality of life, reduce costs, and evidence-based prescribing {48};

  • The present review demonstrated that home telemonitoring is generally clinically effective, and no patient adverse events were reported in the included studies {93};

  • Telemonitoring appears to be an acceptable method for monitoring of HF patients {75}.

 CUR12: What are the differences in the management for different stages of the disease or health condition?

There is interest in new approaches of telemonitoring {1}, but at the moment there is no guideline recommendation available (possible) {45,24,1,110,3,33,44} for telemonitoring in general but for multidisciplinary CHF management programmes {87}.

CUR13: How is the disease or health condition currently diagnosed according to published guidelines and in practice?

Most guidelines agree on three essential stages of care for patients with heart failure:

-Diagnosis (should be timely and accurate);

-Treatment (should be appropriate to each patient and available urgently if necessary);

-Longterm management (should include follow-up, monitoring and support).

Disagree is observed on which diagnostic tools should be used for all patients with suspected heart failure and in which order.

Especially for invasive diagnostics there are some differences and challenges according to the interpretation of the diagnostic and prognostic value.

CUR14: How is the disease or health condition currently managed according to published guidelines and in practice?

Global assessment

-Despite clear recommendations regarding evidence-based medications, many patients with heart failure do not receive a prescription for potentially beneficial medication because they do not always comply with guidelines {45}

Europe

-In Europe prescription doses are often below those recommended {26},{28},{65};

-In Europe guidelines incorporate follow-up, monitoring  and support, however, about a quarter (7/26) of the countries reported having heart failure management programmes in more than 30 % ot their hospitals {49}  and even when in place, they are not always used.

USA

-In the US most hospital had fewer than half of 10 key recommended practices in place and fewer than 3 % had 10 in place {4};

-In the US more than a quarter of patients with heart failure did not receive an appropriate prescription {26},{28},{65}.

Australia

  • A recent Australian consensus statement {88}report that the management of chronic heart failure remains a pressing problem, with many apparent indicators of poor case detection, including discordant management with evidence-based treatment, recurrent hospital admission, and disconnected care issues these that are amplified among marginalised populations.

 

CUR15: What is the marketing authorisation status of Telemonitoring in home care for patients with chronic cardiovascular diseases?

For equipment used as „telemedicine“ or „telemonitoring“ in a (community-)setting and/or within a disease management programme the devices seem to be individually created for the local need and based on a software for data-collection via mobile App, internet or as a database where data are written in while telephone interviews.

There is a database for medical devices within the EU (http://ec.europa.eu/health/medical-devices/market-surveillance-vigilance/eudamed/index_en.htm) which is access-restricted.

CUR16: What is the reimbursement status of structured telephone support (STS) for adult patients with chronic heart failure across countries?

This question is left un-answered. Due to the situation of high complexity among the use and settings within the terminus of „telemonitoring/ telemedicine“ and the new or developmental status of the intervention(s) no explicit answer can be provided in the frame of an HTA.

Introduction

The present domain describes the current state of the health condition, i.e. chronic heart failure and the current state of the health technology, i.e. structured telephone support under consideration for this Core HTA. HF is generally characterized by an underlying cardiac dysfunction that impairs the ability of the left ventricle to either fill with blood or contract to eject blood. It is not a disease but a collection of signs, symptoms, and pathophysiology. Typical symptoms are dyspnea or fatigue. Different stages of chronic HF are distinguished, particularly earlier and later stages, and acute and chronic stages {47}{86}. Patients diagnosed with HF have a high risk of readmission especially in the first weeks after hospital discharge. HF is associated with significant reduced quality of life, morbidity, and mortality {90}.

In 2011, it was estimated that 26 million adults worldwide were living with HF {6}, leading some to describe it as a global pandemic {2}. Due to the aging population, an improved survival after a cardiac event and better treatment of HF, the prevalence rates of HF are expected to rise {75}. Particularly in those older than 50 years of age the prevalence and incidence of HF increase progressively. Up to one person in five is expected to develop HF at some point in their life in economically developed countries {70}.

HF puts a considerable burden on the healthcare systems around the globe, largely due to high hospital (re)admission rates, and long hospital stays. The rising healthcare costs, rapid advances in communication and diagnostic technology, and the availability of low-cost telemedicine equipment are important factors that have significantly contributed to the increasing use of telemedicine for the provision of care {71}. A range of different technological modalities for monitoring and/or self-care management exists in telemedicine, including structured telephone support {13}.

Structured telephone support is one specific type of remote heart failure monitoring. It is monitoring and/or self-care management using simple telephone technology, usually initiated by a healthcare professional (e.g. nurse, physician, social worker or pharmacist) who collects relevant patient data and stores them in a computer. Data can hence be reviewed by the healthcare professional and if necessary, action can immediately be untaken {47},{ 99}(Chaudry et al., 2007).

For the PICO question as defined in October 2014, we focused on adult persons (aged 16 or more) suffering from congestive heart failure getting home-telemonitoring (defined as domiciliary detection, recognition, identification, location and transmission of vital functions and other biological information) compared to no home telemonitoring. After the PICO was adjusted in the beginning of 2015, we focused on adult patients with chronic heart failure receiving structured telephone support (STS) compared to no structured telephone support. 

This domain provides basic information about heart failure and telemonitoring aspects.

Methodology

Frame

The collection scope is used in this domain.

TechnologyStructured telephone support (STS) for adult patients with chronic heart failure
Description

Telemonitoring via structured telephone support with focus on patient reported signs (symptoms of congestion, peripheral edema, pulmonary congestion, dyspnea on exertion, abdominal fullness), medication adherence, physiological data (like heart rate, blood pressure, body weight – measured by the patient with home-device), activity level; done in regular schedules using risk stratification (with fixed algorithm by call center staff or experience-based by specialized staff); done by dedicated call centers, center-based staff, nurses, AND reduced visits to a GP or heart center

Intended use of the technologyPrevention

Remote transmission of information to alleviate symptoms, relieve suffering and allow timely treatment for chronic heart failure

Target condition
Chronic cardiac failure
Target condition description

Heart failure is a condition in which the heart has lost the ability to pump enough blood to the body's tissues. With too little blood being delivered, the organs and other tissues do not receive enough oxygen and nutrients to function properly.

Target population

Target population sex: Any. Target population age: adults and elderly. Target population group: Patients who have the target condition.

Target population description

Patients with chronic heart failure (CHF; defined as I50 http://www.icd10data.com/ICD10CM/Codes/I00-I99/I30-I52/I50-/I50 ) AND hospitalization due to heart failure at least once  AND without implanted devices

ComparisonUsual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist or patient has to move (≠ at home)
Description

Usual care defined as regular schedules of visits of the patient at the heart center/ GP/cardiologist; patient has to move (≠ at home)

Outcomes

Mortality (disease specific and all cause) progressions, admissions, re-admissions, QoL or HRQoL, harms

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
A0001UtilisationFor which health conditions and for what purposes is the technology used?yesFor which health conditions and for what purposes is structured telephone support (STS) for adult patients with chronic heart failure used?
A0012UtilisationWhat kind of variations in use are there across countries/regions/settings?yesWhat kind of variations in use are there across countries/regions/settings?
G0009UtilisationWho decides which people are eligible for the technology and on what basis?yesWho decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?
F0001UtilisationIs the technology a new, innovative mode of care, an add-on to or modification of a standard mode of care or replacement of a standard mode of care?yesIs Structured telephone support (STS) for adult patients with chronic heart failure a new, innovative mode of care, an add-on to or modification of a standard mode of care or replacement of a standard mode of care?
A0011UtilisationHow much is the technology utilised currently and in the future?noOverlapping with Question B0003
B0003UtilisationWhat is the phase of development and implementation of the technology and the comparator(s)?noThis overlaps with the "management" in the CUR domain and will be answered there
A0007Target PopulationWhat is the target population in this current assessment of the technology?yesWhat is the target population in this current assessment of Structured telephone support (STS) for adult patients with chronic heart failure?
A0023Target PopulationHow many people belong to the target population?yesHow many people belong to the target population?
A0002Target ConditionWhat is the disease or health condition in the scope of this assessment?yesWhat is the disease or health condition in the scope of this assessment?
A0003Target ConditionWhat are the known risk factors for the disease or health condition?yesWhat are the known risk factors for the disease or health condition?
A0004Target ConditionWhat is the natural course of the disease or health condition?yesWhat is the natural course of the disease or health condition?
A0005Target ConditionWhat are the symptoms and burden of disease for the patient at different stages of the disease?yesWhat are the symptoms and burden of disease for the patient at different stages of the disease?
A0009Target ConditionWhat aspects of the consequences / burden of disease are targeted by the technology?yesWhat aspects of the consequences / burden of disease are targeted by Structured telephone support (STS) for adult patients with chronic heart failure?
A0006Target ConditionWhat are the consequences of the disease or the health condition for the society (i.e. the burden of the disease)?noWe will answer the epidemiological aspects in A0023
A0017Current Management of the ConditionWhat are the differences in the management for different stages of the disease or health condition?yesWhat are the differences in the management for different stages of the disease or health condition?
A0024Current Management of the ConditionHow is the disease or health condition currently diagnosed according to published guidelines and in practice?yesHow is the disease or health condition currently diagnosed according to published guidelines and in practice?
A0025Current Management of the ConditionHow is the disease or health condition currently managed according to published guidelines and in practice?yesHow is the disease or health condition currently managed according to published guidelines and in practice?
A0018Current Management of the ConditionWhat are the other typical or common  alternatives to the current technology?noThe comparator is defined in the PICO. The different telemedical tools are not seen as "alternatives".
A0020Regulatory StatusWhat is the marketing authorisation status of the technology?yesWhat is the marketing authorisation status of Structured telephone support (STS) for adult patients with chronic heart failure?
A0021Regulatory StatusWhat is the reimbursement status of the technology across countries?yesWhat is the reimbursement status of Structured telephone support (STS) for adult patients with chronic heart failure across countries?

Methodology description

Information sources

The basic common project search was used for this domain, added by guidelines and references found within the search results (handsearch). Methodological differences are mentioned in each assessment element.

Quality assessment tools or criteria

For the basic description of the health problem and the current management options within this domain a descriptive review without data use was provided, therefore no quality assessment about the studies’ methodology was done.

Analysis and synthesis

The common literature search that was done by the project leaders’ librarian for this Core HTA was scanned, in case articles were selected as being relevant based upon their title and abstract they were read in fulltext from all three authors,  and relevant answers for the assessment element questions were extracted. The three authors divided the questions into three parts. Each part had a main researcher and was checked by the other two. The draft document was sent to the domain reviewers, and their feedback was considered and implemented.

Result cards

Utilisation

Result card for CUR1: "For which health conditions and for what purposes is structured telephone support (STS) for adult patients with chronic heart failure used?"

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CUR1: For which health conditions and for what purposes is structured telephone support (STS) for adult patients with chronic heart failure used?
Method
Short Result
Result

Importance: Important

Transferability: Completely

Result card for CUR2: "What kind of variations in use are there across countries/regions/settings?"

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CUR2: What kind of variations in use are there across countries/regions/settings?
Method
Short Result
Result

Importance: Important

Transferability: Completely

Result card for CUR3 / ORG10: "Who decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?"

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CUR3 / ORG10: Who decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?
Method
Short Result
Result

Importance: Important

Transferability: Partially

Result card for CUR4: "Is Structured telephone support (STS) for adult patients with chronic heart failure a new, innovative mode of care, an add-on to or modification of a standard mode of care or replacement of a standard mode of care?"

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CUR4: Is Structured telephone support (STS) for adult patients with chronic heart failure a new, innovative mode of care, an add-on to or modification of a standard mode of care or replacement of a standard mode of care?
Method
Short Result
Result

Importance: Important

Transferability: Partially

Target Population

Result card for CUR5: "What is the target population in this current assessment of Structured telephone support (STS) for adult patients with chronic heart failure?"

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CUR5: What is the target population in this current assessment of Structured telephone support (STS) for adult patients with chronic heart failure?
Method
Short Result
Result

Importance: Critical

Transferability: Completely

Result card for CUR6: "How many people belong to the target population?"

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CUR6: How many people belong to the target population?
Method
Short Result
Result

Importance: Critical

Transferability: Completely

Target Condition

Result card for CUR7: "What is the disease or health condition in the scope of this assessment?"

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CUR7: What is the disease or health condition in the scope of this assessment?
Method
Result

Importance: Critical

Transferability: Completely

Result card for CUR8: "What are the known risk factors for the disease or health condition?"

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CUR8: What are the known risk factors for the disease or health condition?
Method
Short Result
Result

Importance: Critical

Transferability: Completely

Result card for CUR9: "What is the natural course of the disease or health condition?"

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CUR9: What is the natural course of the disease or health condition?
Method
Result

Importance: Critical

Transferability: Completely

Result card for CUR10: "What are the symptoms and burden of disease for the patient at different stages of the disease?"

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CUR10: What are the symptoms and burden of disease for the patient at different stages of the disease?
Method
Result

Importance: Critical

Transferability: Completely

Result card for CUR11: "What aspects of the consequences / burden of disease are targeted by Structured telephone support (STS) for adult patients with chronic heart failure?"

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CUR11: What aspects of the consequences / burden of disease are targeted by Structured telephone support (STS) for adult patients with chronic heart failure?
Method
Short Result
Result

Importance: Critical

Transferability: Partially

Current Management of the Condition

Result card for CUR12: "What are the differences in the management for different stages of the disease or health condition?"

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CUR12: What are the differences in the management for different stages of the disease or health condition?
Method
Result

Importance: Important

Transferability: Partially

Result card for CUR13: "How is the disease or health condition currently diagnosed according to published guidelines and in practice?"

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CUR13: How is the disease or health condition currently diagnosed according to published guidelines and in practice?
Method
Result

Importance: Important

Transferability: Partially

Result card for CUR14: "How is the disease or health condition currently managed according to published guidelines and in practice?"

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CUR14: How is the disease or health condition currently managed according to published guidelines and in practice?
Method
Result

Importance: Important

Transferability: Partially

Regulatory Status

Result card for CUR15: "What is the marketing authorisation status of Structured telephone support (STS) for adult patients with chronic heart failure?"

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CUR15: What is the marketing authorisation status of Structured telephone support (STS) for adult patients with chronic heart failure?
Method
Result

Importance: Important

Transferability: Partially

Result card for CUR16: "What is the reimbursement status of Structured telephone support (STS) for adult patients with chronic heart failure across countries?"

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CUR16: What is the reimbursement status of Structured telephone support (STS) for adult patients with chronic heart failure across countries?
Method
Short Result
Result

Importance: Optional

Transferability: Not

Discussion

We found clear descriptions and stages for heart failure, despite the fact that HF is more or less a range of (increasingly frequent) symptoms than a disease with a certain cause and treatment. There is a long list of underlying risk factors for developing and worsening the condition which also can be used as monitoring indicators for deterioration. In 2007, it was already estimated that approximately 1–2 % of the adult population in developed countries had HF and that the incidence approached on average 5–10 per 1000 persons per year with a significantly higher incidence in higher age groups {82}.

 

However, available epidemiological data in HF are not comprehensive since they only describe a fraction of patients with this syndrome. Due to the absence of gold-standard criteria for the diagnosis of HF and the lack of agreement on a definition of HF, there are considerable variations in the estimates of HF. Moreover, the highly selected hospitalized patients, retrospective analysis, and other non-cardiac related may bias the real estimates {116},{82}.

 

The condition starts symptom-free and is worsening by impairment in daily living (physical activity) due to increasingly frequent symptoms. The stages/ classes are described in detail (ESC, NYHA, ACC/AHA, Killip).

For telemonitoring there is a long list on expectations for potential advantages within the care of chronically ill patients (with HF). The idea is to shift a part of care (the observation of deterioration) towards the patient self- or homecare. Studies from Europe mainly highlight educational strategies within the telemedicinal programme. The involved health professionals are cardiologists, multidisciplinary teams and physician-/nurse- primary care. At the moment there is no guideline recommendation available for telemonitoring in general but for multidisciplinary CHF management programmes. The transfer mode described for telemonitoring is mainly via telephone/ cell phone transmission, or through implantable devices, interactive videoconferencing, transtelephonic monitoring are other options. Substantial heterogeneity among studies was noted. Telemonitoring is mainly described as new and additive technology, especially for Europe, although the history of telemedicine started in 1987 in the US.

Telemonitoring may not be suitable for every patient. It is particularly suitable for patients who are recently hospitalized due to HF, medically unstable, or classified being in the NYHA Class II and III. Guidelines of the ESC recommend remote monitoring of patients reporting symptoms (including drug adverse effects) and signs of HF (Class I recommendation, Level of Evidence: C). Patients with cognitive impairment, a mental illness, a life expectancy less than one year, language barrier or another chronic disease are often not eligible for a telemonitoring intervention {93},{92}. Patients who do not own a phone were often excluded from the studies as well. The beneficial effects on state of health are observed mostly among those patients whose health state is rather serious {92}.

Most guidelines agree on three essential stages of care for patients with heart failure, which are a timely accurate diagnosis, appropriate treatment and long-term management, but there is disagree observed on which diagnostic tools should be used for all patients with suspected heart failure and in which order. Especially for invasive diagnostics there are some differences and challenges according to the interpretation of the diagnostic and prognostic value.

For the invasive device-monitoring there are companies mentioned in the included studies which provide their registration status online. For other equipment used as „telemedicine“ or „telemonitoring“ in a (community-)setting and/or within a disease management programme the devices seem to be individually created for the local need and based on a software for data-collection via a telephone app, internet or as a database where data are written in while telephone interviews. Due to restricted access for the European registries and some no-name descriptions of the content of telemonitoring, the registration could not be followed for all systems found in the studies. Also the reimbursement status was not evaluated due to the huge heterogeneity of different products and different product-combinations.

We did not restrict the included studies in this domain by study-methodology, because we wanted to provide a basic overview. For some of the assessment elements we had to exceed the common basic literature search.

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Appendices

The used strategies described as telemonitoring for the European studies in the used reviews

Study

country

found where?

who?

what?

transfer mode

education?

Aguado 2010

Spain

Jaarsma 2013

multidisciplinary team

multidisciplinary team care plan educational strategies optimized treatments increased access to care

 

yes

Aimonino 2007

Italy

Jaarsma 2013

physician-led

multidisciplinary team educational strategies optimized treatments increased access to care

hospital-at-home-service

yes

Aldamiz-Echevarria 2007

Spain

Feltner 2014

 

home-visiting programmes

 

 

Angermann 2011

Germany

Pandor 2013

 

symptoms and medication monitoring

telephone

yes

Antonicelli 2008

Italy

Conway 2014; Gorthi 2014; Jaarsma 2013; Pandor 2013; Xiang 2013

multidisciplinary team

BP, HR, weight, 24h urine output, and ECG; care plan educational strategies optimized treatments increased access to care; telemonitoring; Disease Management Programmes

non-invasive Telemonitoring

 

Antonicelli 2010

Italy

Giamouzis 2012

 

weight, blood pressure, heart rate, 24h urine, weekly ECG

telephone

 

Balk 2008

NL

Conway 2014; Gorthi 2014; Jaarsma 2013;  Xiang 2013

multidisciplinary team

care plan educational strategies increased access to care; scale, medication, dispenser; Disease Management Programmes; Teleguidance

non-invasive Telemonitoring

 

Barlow 2007

UK

Schmidt 2010

 

home-telemonitoring

 

 

Blue 2001

Scotland

Whellan 2005, Jerant 2005, Gorthi 2014, Jaarsma 2013, Xiang 2013

multidisciplinary team, nurse-led

care plan educational strategies optimized treatments, case management, DMP

 

yes

Bondmass 2001

Europe

Jerant 2005

multidisciplinary team

 

telephone

 

Boyne 2011

NL

Xiang 2013

 

scale, pulse monitoring

 

 

Brotons 2009

Spain

Jaarsma 2013

multidisciplinary team

multidisciplinary team care plan educational strategies optimized treatments increased access to care

 

yes

Cabezas 2006

Spain

Feltner 2014

 

structured  support

telephone

 

Capomolla 2002

Italy

Jerant 2005, Gorthi 2014, Whellan 2005

cardiologist

Disease Management Programmes Using Outpatient Visits

telephone

 

Capomolla 2004

Italy

Conway 2014, Clark 2007, Pandor 2013, Gorthi 2014, Xiang 2013

 

weight, systolic BP, HR, vital signs (including weight, systolic blood pressure, heart rate), DMP

interactive voice response

 

Cleland 2005

Europe, Germany, NL, UK

Conway 2014, Jaarsma 2013, Chaudry 2007, Xiang 2013, Giamouzis 2012, Gorthi 2014, Pandor 2013, Clark 2007

nurse, multidisciplinary team

education and monitoring; weight, BP, and ECG; increased access to care;weight

telephone

yes

Cline 1998

Sweden

Gorthi 2014, Whellan 2005

cardiologist

Disease Management Programmes Using Outpatient Visits

 

 

Dar 2009

UK

Feltner 2014, Giamouzis 2012, Gorthi 2014, Jaarsma 2013, Pandor 2013, Xiang 2013

multidisciplinar team

weight, blood pressure, heart rate, pulse oximetry;  care plan optimized treatments educational strategies increased access to care; DMP

telephone

 

de la Porte 2007

NL

Gorthi 2014

 

Disease Management Programmes Using Outpatient Visits

 

 

de Lusignan 2001

UK

Jerant 2005, Conway 2014, Clark 2007, Xiang 2013

 

multidisciplinary clinic; pulse, BP, weight; vital signs (pulse, blood pressure, weight) and clinical status;

interactive videoconferencing, transtelephonic monitoring

 

Del Sindaco 2007

Italy

Jaarsma 2013

multidisciplinary team

care plan optimized treatments educational strategies increased access to care, hybrid DM programme

 

yes

Dendale 2011

Belgium

Pandor 2013

 

weight, blood pressure, heart rate; scale, pulse

cell phone transmission

 

Ekman 1998

Sweden

Jerant 2005, Feltner 2014, Gorthi 2014, Whellan 2005

Primary care physician

outpatient clinic-based interventions

telephone

 

Giordano 2009

Italy

Conway 2014; Giamouzis 2012; Gorthi 2014, Jaarsma 2013, Xiang 2013

multidisciplinary team

one-led ECG, weight, blood pressure, ECG, drug dosage, education and monitoring; adherence to diet and treatment, monitoring of symptoms, control of fluid retention, and daily physical activity; multidisciplinary team care plan optimized treatments educational strategies increased access to care;

telephone

yes

Holland 2007

UK

Feltner 2014, Gorthi 2014, Jaarsma 2013

multidisciplinary team

educational strategies increased access to care, home-visiting programmes, Disease Management Programmes

 

yes

Jaarsma 1999

NL

Feltner 2014, Gorthi 2014, Jaarsma 2013, Whellan 2005, Jerant 2005

multidisciplinary team, nurse-led

Disease Management Programmes Using Home Visits

 

yes

Jolly 2009

UK

Xiang 2013

 

scale monitoring

 

 

Kielblock 2007

Germany

Conway 2014, Pandor 2013, Xiang 2013

 

weight, scale telemonitoring

 

 

Klersy 2009

Italy

Schmidt 2010, Sousa 2014

 

technology assisted strategies

telephone, technology (?)

 

Koehler 2011

Germany

Giamouzis 2012, Gorthi 2014

 

weight, blood pressure, ECG, drug dosage; Disease Management Programmes

cell phone transmission

 

Koronowski 1995

Israel

Jaarsma 2013

multidisciplinary team

intensive home-care surveillance

 

 

Landolina 2012

Italy

Gorthi 2014

 

Disease Management Programmes Using Invasive Hemodynamic Monitoring

 

 

Ledwidge 2002

Ireland

Gorthi 2014

 

Disease Management Programmes Using Outpatient Visits

 

 

Linne 2006

Sweden

Feltner 2014

 

 

 

yes

Lynga 2012

Sweden

Xiang 2013

 

scale monitoring

 

 

MacDonald 2002

Ireland

Whellan 2005

cardiologist

clinic follow up, cardiologist supervision

 

 

Martinez-Fernandez 2006

Spain

Schmidt 2010

 

home monitoring

 

 

Massie 2001

Italy

Jerant 2005

multidisciplinary team

standard telephone calls, transtelephonic monitoring

telephone

 

McDonald 2001

Ireland

Feltner 2014

 

outpatient clinic-based interventions

 

 

McDonald 2002

Ireland

Feltner 2014,Jerant 2005

multidisciplinary team

outpatient clinic-based interventions

telephone

 

Mendoza 2009

Spain

Jaarsma 2013

multidisciplinary team

increased access to care, hospital at home model

 

 

Mortara 2004

Europe

Jaarsma 2013

multidisciplinary team 

optimized treatments educational strategies increased access to care

 

yes

Mortara 2009

Europe, Italy, UK, Poland

Conway 2014, Gorthi 2014, Giamouzis 2012, Xiang 2013

 

education and monitoring; weight, systolic BP, HR, and symptoms, respiration rate, and physical activity; weight, BP, and symptoms; asthenia score, oedema score, changes in therapy, blood results;

telephone call, interactive voice response

 

Nucifora 2006

Italy

Feltner 2014

 

 

 

yes

Peters-Klimm 2010

Germany

Jaarsma 2013

multidisciplinary team

 care plan  educational strategies increased access to care, HF case management

 

yes

Piotrowicz 2010

Poland

Jaarsma 2013

multidisciplinary team

care plan educational strategies increased access to care; new home TeleCardia Rehab programme

 

yes

Robinson 2004

Germany

Jaarsma 2013

multidisciplinary team

care plan increased access to care, telehomecare

 

 

Rondinini 2008

Italy

Jaarsma 2013

multidisciplinary team, domiciliary-based nurse-led strategy

care plan educational strategies increased access to care

 

yes

Scherr 2009

Austria

Giamouzis 2012, Pandor 2013, Xiang 2013

 

weight, blood pressure, heart rate, dosage of medication; scale, medication dispenser, pulse monitoring

cell phone transmission

 

Schmidt 2007

Germany

Schmidt 2010

 

telemedicine

 

 

Stromberg 2003

Sweden

Feltner 2014, Gorthi 2014, Jerant 2005

multidisciplinary clinic

Disease Management programmes Using Outpatient Visits

telephone

 

Thompson 2005

UK

Feltner 2014, Jaarsma 2013

multidisciplinary team

optimized treatments educational strategies increased access to care, home-visiting programmes ,

 

 

TIM-HF 2011, Koehler 2010

Germany

Sousa 2014

 

TM (daily ECG, blood pressure, weight) sent to telemedical centers

 

 

Van Veldhuisen 2011

NL

Gorthi 2014

 

Disease Management programmes Using Invasive Hemodynamic Monitoring

 

 

Vavouranakis 2003

Greece

Jaarsma 2013

multidisciplinary team

optimized treatments educational strategies increased access to care

 

 

Villani 2007

Italy

Xiang 2013

 

scale, symptoms, pulse, urine output

 

 

Wierzchowiecki 2006

Poland

Jaarsma 2013

multidisciplinary team

care plan optimized treatments educational strategies increased access to care

 

 

Zugck 2008

Germany

Xiang 2013

 

scale, ECG, SPO2 monitoring

 

 


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