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

A. Health Problem and Current Use of the Technology

Utilisation

  • CUR1 [from A0001]: For which health conditions and for what purposes is structured telephone support (STS) for adult patients with chronic heart failure used?
  • CUR2 [from A0012]: What kind of variations in use are there across countries/regions/settings?
  • CUR3 / ORG10 [from G0009]: Who decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?
  • CUR4 [from F0001]: 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?

Target Population

  • CUR5 [from A0007]: What is the target population in this current assessment of Structured telephone support (STS) for adult patients with chronic heart failure?
  • CUR6 [from A0023]: How many people belong to the target population?

Target Condition

  • CUR7 [from A0002]: What is the disease or health condition in the scope of this assessment?
  • CUR8 [from A0003]: What are the known risk factors for the disease or health condition?
  • CUR9 [from A0004]: What is the natural course of the disease or health condition?
  • CUR10 [from A0005]: What are the symptoms and burden of disease for the patient at different stages of the disease?
  • CUR11 [from A0009]: What aspects of the consequences / burden of disease are targeted by Structured telephone support (STS) for adult patients with chronic heart failure?

Current Management of the Condition

  • CUR12 [from A0017]: What are the differences in the management for different stages of the disease or health condition?
  • CUR13 [from A0024]: How is the disease or health condition currently diagnosed according to published guidelines and in practice?
  • CUR14 [from A0025]: How is the disease or health condition currently managed according to published guidelines and in practice?

Regulatory Status

  • CUR15 [from A0020]: What is the marketing authorisation status of Structured telephone support (STS) for adult patients with chronic heart failure?
  • CUR16 [from A0021]: What is the reimbursement status of Structured telephone support (STS) for adult patients with chronic heart failure across countries?

B. Description and technical characteristics of technology

Other

  • TEC1 [from A0022]: Who manufactures structured telephone support (STS) for adult patients with chronic heart failure?

Training and information needed to use the technology

  • TEC2 [from B0012]: What kind of qualification and quality assurance processes are needed for the use or maintenance of Structured telephone support (STS) for adult patients with chronic heart failure?
  • TEC3 [from B0014]: What kind of training and information should be provided for the patient who uses Structured telephone support (STS) for adult patients with chronic heart failure, or for his family?
  • TEC4 [from B0015]: What information of Structured telephone support (STS) for adult patients with chronic heart failure should be provided for patients outside the target group and the general public?

Features of the technology

  • TEC5 [from B0001]: What is Structured telephone support (STS) for adult patients with chronic heart failure and the comparator(s)?
  • TEC6 [from B0005]: In what context and level of care are Structured telephone support (STS) for adult patients with chronic heart failure and the comparator used?
  • TEC7 [from B0018]: Are the reference values or cut-off points clearly established?

Investments and tools required to use the technology

  • TEC8 [from B0007]: What material investments are needed to use Structured telephone support (STS) for adult patients with chronic heart failure?
  • TEC9 [from B0008]: What kind of special premises are needed to useStructured telephone support (STS) for adult patients with chronic heart failure and the comparator(s)?
  • TEC10 [from B0009]: What equipment and supplies are needed to use Structured telephone support (STS) for adult patients with chronic heart failure and the comparator?
  • TEC11 [from B0010]: What kind of data and records are needed to monitor the use of Structured telephone support (STS) for adult patients with chronic heart failure and the comparator?
  • TEC12 [from B0011]: What kind of registers are needed to monitor the use Structured telephone support (STS) for adult patients with chronic heart failure and comparator?

C. Safety

Patient safety

  • SAF1a [from C0001]: What is the frequency of all AEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • SAF1b [from C0001]: What is the frequency of discontinuation of Structured telephone support (STS) due to adverse events in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • SAF1c [from C0001]: What is the frequency of and what are the serious-SAEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • SAF1d [from C0001]: What is the frequency of SAE leading to deaths with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • SAF1e [from C0001]: What are the most frequent AEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • SAF2 [from C0005]: Are there susceptible patient groups that are more likely to be harmed through use of the home telemonitoring Structured telephone support (STS)
  • SAF3 [from C0007]: Are there special issues in the use of the Structured telephone support (STS) that may increase the risk of harmful events?

Safety risk management

  • SAF4 [from C0060]: How does the safety profile of the Structured telephone support (STS) vary between two different approach (human to human or human to machine interface)?
  • SAF5 [from C0062]: How can one reduce safety risks for adults with chronic heart failure (including technology-, user-, and patient-dependent aspects)?

D. Clinical Effectiveness

Mortality

  • EFF1 [from D0001]: What is the effects of Structured telephone support (STS) on overall mortality in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF2 [from D0002]: What is the effects of Structured telephone support (STS) on disease-specific mortality in adults with chronic heart failure, compared to standard care without Structured telephone support (STS) ?

Morbidity

  • EFF3 [from D0005]: How does Structured telephone support (STS) affect disease-specific symptoms and findings (severity, frequency) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF4 [from D0006]: How does Structured telephone support (STS) affect the progression of chronic heart failure of adults patients, compared to standard care without Structured telephone support (STS)?

Change-in management

  • EFF5 [from D0010]: Does Structured telephone support (STS) impact on the re-hospitalization rate (disease-specific and all-cause) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF6a [from D0023]: Does Structured telephone support (STS) impact on the emergency room visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF6b [from D0023]: Does Structured telephone support (STS) impact on the cardiology visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF6c [from D0023]: Does Structured telephone support (STS) impact on the primary care visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?

Health-related Quality of life

  • EFF7 [from D0012]: What is the effect of Structured telephone support (STS) on generic health-related quality of life of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF8 [from D0013]: What is the effect of Structured telephone support (STS) on disease specific quality of life of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?

Function

  • EFF9 [from D0011]: What is the effect of Structured telephone support (STS) on body functions of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF10 [from D0014]: What is the effect of Structured telephone support (STS) on work ability of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF11 [from D0015]: What is the effect of Structured telephone support (STS) on return to previous living conditions of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • EFF12 [from D0016]: How does Structured telephone support (STS) affects activities of daily living of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?

Patient satisfaction

  • EFF13 [from D0017]: Was the use of Structured telephone support (STS) worthwhile?
  • EFF14 [from D0018]: Are adults with chronic heart failure willing to use the Structured telephone support (STS) again?

Benefit-harm balance

  • EFF15 [from D0029]: What are the overall benefits and harms of the Structured telephone support (STS) in adults with chronic heart failure?

E. Costs and economic evaluation

Resource utilization

  • ECO1 [from E0001]: What types of resources are used when delivering Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, usual care' without STS (resource-use identification)?
  • ECO2 [from E0002]: What amounts of resources are used when delivering Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS (resource-use measurement)?
  • ECO3 [from E0009]: What were the measured and/or estimated costs of Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS (resource-use valuation)?

Measurement and estimation of outcomes

  • ECO4 [from E0005]: What is (are) the measured and/or estimated health-related outcome(s) of Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?

Examination of costs and outcomes

  • ECO5 [from E0006]: What are the estimated differences in costs and outcomes between Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?

Characterising uncertainty

  • ECO6 [from E0010]: What are the uncertainties surrounding the costs and economic evaluation(s) of Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?

Characterising heterogeneity

  • ECO7 [from E0011]: To what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?

Validity of the model(s)

  • ECO8 [from E0012]: To what extent can the estimates of costs, outcomes, or economic evaluation(s) be considered as providing valid descriptions of Structured telephone support (STS) for adult patients with chronic heart failure and its comparator, 'usual care' without STS?

F. Ethical analysis

Beneficence/nonmaleficence

  • ETH1 [from F0010]: What are the known and estimated benefits and harms for patients when implementing or not implementing STS?
  • ETH2 [from F0011]: What are the benefits and harms of STS for other stakeholders (relatives, other patients, organisations, commercial entities, society, etc.)?

Autonomy

  • ETH3 [from F0005]: Is STS used for patients/people that are especially vulnerable?
  • ETH4 [from F0004]: Does the implementation or use of STS affect the patient´s capability and possibility to exercise autonomy?
  • ETH5 [from F0006]: Is there a need for any specific STSs or supportive actions concerning information in order to respect patient autonomy when STS is used?
  • ETH6 [from F0007]: Does the implementation or withdrawal of STS challenge or change professional values, ethics or traditional roles?

Respect for persons

  • ETH7 [from F0009]: Does the implementation or use of STS affect the user´s moral, religious or cultural integrity?
  • ETH8 [from F0101]: Does STS invade the sphere of privacy of the patient/user?

Justice and Equity

  • ETH9 [from F0012]: How does implementation or withdrawal of STS affect the distribution of health care resources?
  • ETH10 [from F0013]: How are technologies with similar ethical issues treated in the health care system?
  • ETH11 / SOC3 [from H0012]: Are there socio cultural factors that could prevent a group CHF patients (defined by e.g. age, ethnicity, income, geographic area, working staus, geneder etc.) to use Structured telephone support (STS)?

Legislation

  • ETH12 [from F0014]: Does the implementation or use of STS affect the realisation of basic human rights?

Ethical consequences of the HTA

  • ETH13 [from F0017]: What are the ethical consequences of the choice of end-points, cut-off values and comparators/controls in the assessment?
  • ETH14 [from F0102]: Does the economic evaluation of STS contain any ethical problems?
  • ETH15 [from F0103]: What are the ethical consequences of the assessment of STS?

G. Organisational aspects

Health delivery process

  • ORG1 [from G0001]: How does structured telephone support (STS) for adult patients with chronic heart failure affect the current work processes?
  • ORG2 [from G0100]: What kind of patient/participant flow is associated with structured telephone support (STS) for adult patients with chronic heart failure?
  • ORG3 [from G0002]: What kind of involvement has to be mobilized for patients/participants and important others?
  • ORG4 [from G0003]: What is the process ensuring proper education and training of the staff?
  • ORG5 [from G0004]: What kind of co-operation and communication of activities have to be mobilised?
  • ORG6 [from G0012]: How is the quality assurance and monitoring system of structured telephone support (STS) for adult patients with chronic heart failure organised?

Structure of health care system

  • ORG7 [from G0101]: What are the processes ensuring access to care of structured telephone support (STS) for adult patients with chronic heart failure for patients/participants?

Process-related costs

  • ORG8 [from G0007]: What are the likely budget impacts of implementing the technologies being compared?

Management

  • ORG9 [from G0008]: What management problems and opportunities are attached to structured telephone support (STS) for adult patients with chronic heart failure?
  • CUR3 / ORG10 [from G0009]: Who decides which people are eligible for structured telephone support (STS) for adult patients with chronic heart failure and on what basis?

Culture

  • ORG11 [from G0010]: How is structured telephone support (STS) for adult patients with chronic heart failure accepted?
  • ORG12 [from G0011]: How are the other interest groups taken into account in the planning / implementation of structured telephone support (STS) for adult patients with chronic heart failure?

H. Social aspects

Individual

  • SOC1 [from H0006]: How adult patients with CHF (and their important others) who uses Structured telephone support (STS) react and act upon this technology and how this affects their satisfaction, quality of life, empowerment?
  • SOC2 [from H0004]: What kind of changes may the use of Structured telephone support (STS) generate in the patients' social life (changes in work, travel ability, family life, patient/physician relationship)
  • ETH11 / SOC3 [from H0012]: Are there socio cultural factors that could prevent a group CHF patients (defined by e.g. age, ethnicity, income, geographic area, working staus, geneder etc.) to use Structured telephone support (STS)?
  • SOC4 [from H0003]: What kind of support and resources (e.g. ergonomic changes) are needed for the patient as STS is introduced? This imlies a descriptive response.

Information exchange

  • SOC5 [from H0007]: What is the knowledge and understanding of Structured telephone support (STS) in CCD patients?

I. Legal aspects

Authorisation and safety

  • LEG1 [from I0015]: Has Structured telephone support (STS) for adult patients with chronic heart failure national/EU level authorisation (marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?

Ownership and liability

  • LEG2 [from I0019]: Does Structured telephone support (STS) for adult patients with chronic heart failure infringe some intellectual property right?

Autonomy of the patient

  • LEG3 [from I0002]: Is the voluntary participation of patients guaranteed properly?
  • LEG4 [from I0004]: Is it possible to give future patients enough time to consider their decisions?

Privacy of the patient

  • LEG5 [from I0009]: Do laws/ binding rules require appropriate measures for securing patient data?

Equality in health care

  • LEG6 [from I0011]: Do laws/ binding rules require appropriate processes or resources to guarantee equal access to Structured telephone support (STS) for adult patients with chronic heart failure?
  • LEG7 [from I0014]: Is health-care tourism expected from/to other European countries?

Authorisation & safety

  • LEG8 [from I0016]: Does Structured telephone support (STS) for adult patients with chronic heart failure need to be listed in a national/EU register?
  • LEG9 [from I0017]: Does Structured telephone support (STS) for adult patients with chronic heart failure fulfil product safety requirements?

Ownership & liability

  • LEG10 [from I0020]: Does the introduction of Structured telephone support (STS) for adult patients with chronic heart failure presume some additional licensing fees to be paid?
  • LEG11 [from I0021]: What are the width, depth and length of the manufacturers guarantee?

Regulation of the market

  • LEG12 [from I0023]: Is Structured telephone support (STS) for adult patients with chronic heart failure subject to price control?
  • LEG13 [from I0024]: Is Structured telephone support (STS) for adult patients with chronic heart failure subject to acquisition regulation?
  • LEG14 [from I0025]: Is the marketing of Structured telephone support (STS) for adult patients with chronic heart failure to the patients restricted?

Legal regulation of novel/experimental techniques

  • LEG15 [from I0026]: Is Structured telephone support (STS) for adult patients with chronic heart failure so novel existing legislation was not designed to cover its regulation?
  • LEG16 [from I0027]: How the liability issues are solved according to existing legislation?