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

<< SafetyCosts and economic evaluation >>

Clinical Effectiveness

Authors: Mirjana Huic, Pernilla Östlund, Romana Tandara Hacek, Jelena Barbaric, Marius Ciutan, Cristina Mototolea, Silvia Gabriela Scintee

Summary

Aim: To determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, and change in management or utilization of health service compared with current practice.

Methods: A systematic literature search, according to the predefined search strategy (not limited by publication date but limited to English language), was performed according to the Cochrane methodology, in standard medical and HTA databases. Relevant references (after duplicates were removed) were screened and assessed for eligibility independently by two reviewers. References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme (as described in Project Scope), and the predefined inclusion/exclusion criteria. The quality of the included systematic reviews (SRs) was assessed using AMSTAR tool {Shea 2007}. The results from the included SRs were included according to the methodology suggested by Whitlock 2008 { } and Robinson 2014 { } on how to integrate existing SRs into new SRs. Risk of bias of included RCTs was evaluated independently by two reviewers using the Cochrane risk of bias checklist and EUnetHTA methods guidelines on internal validity of RCTs. Data extraction was performed by one reviewer on pre-defined extraction tables and double-checked regarding completeness and accuracy by a second reviewer. Any differences in extraction results were discussed to achieve consensus; any disagreements were resolved by a third reviewer. Quantitative synthesis from existing SRs were used and presented in Result section when available for specific assessment element questions. No new meta-analysis was performed. Primary outcomes were mortality (overall and disease-specific), morbidity (disease-specific symptoms, disease progression) and Health-related quality of life (HRQoL). Secondary outcomes were impact on re-hospitalization rate (disease-specific, all-cause); emergency room visit rate; cardiology visit rate; primary care visit rate; body functions; work ability; return to previous living conditions; activities of daily living and patient satisfaction (worthwhile use, willing to use again).

Results: 591 records were identified through database searching and 28 additional records were identified through other sources; 428 remained after duplicates were removed. One hundred full-text articles were assessed for eligibility and after the exclusion of 76 full-text articles, five high quality SRs and 19 full text published RCTs were included in our SR. Of the included RCTs, only three were judged to be of low risk of bias. STS produced a mortality benefit and reduced HF-specific readmission rates. For the outcomes QoL and utilization the evidence was insufficient. Yet, the majority of studies presented statistically significant QoL improvements. A majority of the RCTs found no significant difference in the number of emergency room visits in either group. Since little evidence was identified on the potential harms of STS (described in the Safety Domain), it was not possible to assess overall benefits and harms of STS in adults with chronic heart failure. No evidence found to answer some assessment element questions, related on outcomes such as work ability, return to previous living conditions, activities of daily living, worthwhile of STS and willing to use STS again.

Conclusion: STS reduces HF-specific readmission and mortality. A majority of the studies presented statistically significant improvements in QoL. Some research gaps and transferability issues were recognized. Further research is needed on effects of STS on QoL and utilization outcomes as well as patient satisfaction during long term follow-up.

Introduction

The Clinical Effectiveness Domains describes the range and size of beneficial health effects expected through the use of the technology {HTA Core Model Handbook Online, Version 1.5}. The two key elements are that effective interventions should be directly compared and studied in patients who are typical of day-to-day health care settings {HTA Core Model Application for Pharmaceuticals, 2.0}.

The aim of this relative effectiveness assessment was to determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure, improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, and change in management or utilization of health service compared with current practice.

Primary outcomes were mortality (overall and disease-specific), morbidity (disease-specific symptoms, progression) and Health-related quality of life (HRQL).

Secondary outcomes were impact on re-hospitalization rate (disease-specific, all-cause); emergency room visit rate; cardiology visit rate; primary care visit rate; body function; work ability; return to previous living conditions; activities of daily living and patient satisfaction (worthwhile use, willing to use again).

For this relative effectiveness assessment we planned to find and update recent, high quality systematic review (SR), with PICO (Patient-Intervention-Comparison-Outcome) scheme relevant for this assessment. Whitlock et al. 2008 { } and Robinson et al. 2014 { } in their published articles, regarding how to integrate existing systematic reviews into new systematic reviews, found that consensus among systematic review organizations and the Evidence-based Practice Centers (EPCs) about some aspects of incorporating existing systematic reviews already exist, but areas of uncertainty remain: how to synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews. According their published data, use of existing systematic reviews may include: (1) using the existing systematic review(s)’ listing of included studies as a quality check for the literature search and screening strategy conducted for the new review (Scan References); (2) using the existing systematic review(s) to completely or partially provide the body of included studies for one or more Key Questions in the new review (Use Existing Search); (3) using the data abstraction, risk of bias assessments, and/or analyses from existing systematic reviews for one or more Key Questions in the new review (Use Data Abstraction/Syntheses), or (4) using the existing systematic review(s), including conclusions, to fully or partially answer one or more Key Questions in the new review (Use Complete Review).

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
D0001MortalityWhat is the expected beneficial effect of the intervention on overall mortality?yesWhat 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)?
D0002MortalityWhat is the expected beneficial effect on the disease-specific mortality?yesWhat 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) ?
D0003MortalityWhat is the effect of the technology on the mortality due to causes other than the target disease?noRelevant only for the target disease.
D0005MorbidityHow does the technology affect symptoms and findings (severity, frequency) of the target condition?yesHow 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)?
D0006MorbidityHow does the technology affect the progression (or recurrence) of the target condition?yesHow does Structured telephone support (STS) affect the progression of chronic heart failure of adults patients, compared to standard care without Structured telephone support (STS)?
D0010Change-in managementHow does the technology modify the need for hospitalization?yesDoes 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)?
D0023Change-in managementHow does the technology modify the need for other technologies and use of resources?yesDoes 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)?
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)?
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)?
D0012Health-related Quality of lifeWhat is the effect of the technology on generic health-related quality of life?yesWhat 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)?
D0013Health-related Quality of lifeWhat is the effect of the technology on disease specific quality of life?yesWhat 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)?
D0011FunctionWhat is the effect of the technology on patients’ body functionsyesWhat 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)?
D0014FunctionWhat is the effect of the technology on work ability?yesWhat 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)?
D0015FunctionWhat is the effect of the technology on return to previous living conditions?yesWhat 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)?
D0016FunctionHow does use of the technology affect activities of daily living?yesHow 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)?
D0017Patient satisfactionWas the use of the technology worthwhile?yesWas the use of Structured telephone support (STS) worthwhile?
D0018Patient satisfactionIs the patient willing to use the technology again?yesAre adults with chronic heart failure willing to use the Structured telephone support (STS) again?
D0029Benefit-harm balanceWhat are the overall benefits and harms of the technology in health outcomes?yesWhat are the overall benefits and harms of the Structured telephone support (STS) in adults with chronic heart failure?
C0006Patient safetyWhat are the consequences of false positive, false negative and incidental findings generated by using the technology from the viewpoint of patient safety?noNot important for Structured telephone support (STS).

Methodology description

A systematic literature search, according the predefined search strategy (Appendix 1) (not limited by publication date but limited to English language), was performed according to the Cochrane methodology {Higgins 2011}, in standard medical and HTA databases.

Information sources

Specifically, the following databases were searched: MEDLINE accessed through OVID or Pubmed; CINAHL with Full Text (EBSCOhost), SCI-EXPANDED (Web of ScienceTM Core Collection) and Cochrane Library searching the following databases: The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Database of Systematic Reviews (Cochrane Reviews), The Database of Abstracts of Reviews of Effects (DARE) and The Health Technology Assessment Database (HTA).

This was complemented by hand search of the following websites: http://www.cadth.ca/en/products/health-technology-assessment; http://www.york.ac.uk/inst/crd/publications.htm; http://guidance.nice.org.uk/Date; http://hta.lbg.ac.at; http://kce.fgov.be; http://www.hiqa.ie/; http://www.agenas.it. The reference lists of relevant systematic reviews and health technology assessment reports were checked for relevant studies.

In addition, the following clinical trials registries were assessed, for registered ongoing clinical trials or results posted: ClinicalTrials.gov, ISRCTN, EU Clinical Trials Register, and International Clinical Trials Registry Platform (ICTRP).

Relevant references (after duplicates were removed) were screened and assessed for eligibility independently by two reviewers. References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme (as described in Project Scope),  and the inclusion/exclusion criteria listed below:

Q What are the effects of Structured telephone support (STS) on adults with chronic heart failure?

P Individuals aged 16 or more with chronic heart failure (New York Heart Association (NYHA) I-IV), without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure

I Structured telephone support (STS)

C Usual care (UC) without Structured telephone support (STS)

O Domain Specific Outcomes: mortality (overall and disease-specific); morbidity (disease-specific symptoms, progression); re-hospitalization rate (disease-specific, all-cause); emergency room visit rate; cardiology visit rate; primary care visit rate; Health-related quality of life (HRQL): both generic and disease-specific; body function; work ability; return to previous living conditions; activities of daily living; patient satisfaction (worthwhile use, willing to use again)

Study Design 

D Evidence synthesis studies (SRs, HTA reports) [updating RCTs i.e. RCT fitting the PICO which have been published after the last search date of the latest SR/HTA document]

 

Inclusion criteria:

1) SRs and HTAs and RCTs comparing chronic heart failure patients management /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure/ delivered via structured telephone support with usual care;

2) Patients are randomized to structured telephone support or usual care without structured telephone support (STS);

3) One or more of the EFF outcomes were reported;

4) Sufficient methodological details are reported to allow critical appraisal of study quality;

5) Publication in English;

6) Report on humans only.

 

Exclusion criteria:

Primary or secondary studies which:

1) Do not involve adult patients with CHF /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), CRTs or pacemakers, who have been admitted to hospital at least once for chronic heart failure/;  

2)  Do not compare CHF management delivered via structured telephone support with usual care in patients with CHF living within the community;

3) Home visits were performed as part of the intervention or by the clinical staff involved in the intervention

4) Do not provide data for our outcomes of interest in an extractable format;

5) Papers with RCTs without sufficient methodological details to allow critical appraisal of study quality;

6) The papers (publications) published in a language other than English; 

7) Duplicate of original publication.

 

Differences in selection results were discussed in order to achieve consensus; a third reviewer were involved in case of disagreement. The study selection process was presented according to the PRISMA flowchart {Liberati 2009} (Appendix 2).

Finding and updating a recent, high quality SR (with PICO scheme relevant for this relative effectiveness assessment) was planned. The publications by Whitlock et al. 2008 { } and Robinson et al. 2014 { }, regarding how to integrate existing SRs into new SRs, were used. To answer our research questions all four approaches in using existing systematic reviews, described in Robinson et al. 2014 { }, were used: (1) using the existing SR(s)’ listing of included studies as a quality check for the literature search and screening strategy conducted for the new review (Scan References); (2) using the existing SR(s) to completely or partially provide the body of included studies for one or more Key Questions in the new review (Use Existing Search); (3) using the data abstraction, risk of bias assessments, and/or analyses from existing SRs for one or more Key Questions in the new review (Use Data Abstraction/Syntheses), and (4) using the existing SR(s), including conclusions, to fully or partially answer one or more Key Questions in this SR (Use Complete Review).

Quality assessment tools or criteria

(Write your text here)

The quality of the included SR was assessed using AMSTAR {Shea 2007}.

Risk of bias of included RCTs was evaluated independently by two reviewers using the Cochrane risk of bias checklist and EUnetHTA methods guidelines on internal validity of RCTs {Higgins 2011; EUnetHTA 2013}.

Direct evidence on primary outcomes was planned to be assessed by using the GRADE-methodology {Guyatt 2008}. This approach specifies four levels of quality:

High: further research is very unlikely to change our confidence in the estimate of effect;

Moderate: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimates;

Low: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate;

Very low: we are very uncertain about the estimate.

Analysis and synthesis

(Write your text here)

Data extraction was performed by one reviewer on pre-defined extraction tables and double-checked regarding completeness and accuracy by a second reviewer. Any differences in extraction results were discussed to achieve consensus; a third reviewer was involved in case of disagreement.

The following information was extracted from included secondary studies (SRs or HTAs):Study general information: Author; Year of publication; Reference number; Study objectives; Study characteristics: Study types included in the review; Number of studies included in the review; Review timeframe; Comparison(s); Patients groups (number of patients and health technology used) in the included studies; Outcomes and follow-up: Main outcomes reported; Main study findings; Conclusions: Authors' conclusions. (Appendix 3)

The following information was extracted from included primary studies:

Data on Study characteristics (study design, registration number, country and centre, study period, ethics committee approval, sponsor, study methodology); Patient characteristics (age, gender, NYHA I-IV); Outcomes; Intervention; Comparator; Flow of patients; Statistical analysis; Results on primary and secondary outcomes; and Conflict of interest data were extracted. (Appendix 4)

Quantitative synthesis from existing SRs were used and presented in Result section wherever appropiate. No new meta-analysis was performed.

Result cards

Mortality

Result card for EFF1: "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)?"

View full card
EFF1: 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)?
Method
Result

Importance: Critical

Transferability: Partially

Result card for EFF2: "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) ?"

View full card
EFF2: 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) ?
Method
Result

Importance: Important

Transferability: Partially

Morbidity

Result card for EFF3: "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)?"

View full card
EFF3: 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)?
Method
Result

Importance: Important

Transferability: Partially

Result card for EFF4: "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)?"

View full card
EFF4: 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)?
Method
Result

Importance: Important

Transferability: Partially

Change-in management

Result card for EFF5: "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)?"

View full card
EFF5: 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)?
Method
Result

Importance: Important

Transferability: Partially

Result card for EFF6a: "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: "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)?" and EFF6c: "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)?"

View full card
EFF6a: 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)?
Method
Result

Importance: Important

Transferability: Partially

EFF6b: 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)?
Method
Result

Importance: Important

Transferability: Partially

EFF6c: 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)?
Method
Result

Importance: Important

Transferability: Partially

Health-related Quality of life

Result card for EFF7: "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)?"

View full card
EFF7: 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)?
Method
Result

Importance: Important

Transferability: Partially

Result card for EFF8: "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)?"

View full card
EFF8: 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)?
Method
Result

Importance: Important

Transferability: Partially

Function

Result card for EFF9: "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)?"

View full card
EFF9: 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)?
Method
Result

Importance: Optional

Transferability: Partially

Result card for EFF10: "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)?"

View full card
EFF10: 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)?
Method
Result

Importance: Optional

Transferability: Partially

Result card for EFF11: "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)?"

View full card
EFF11: 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)?
Method
Result

Importance: Optional

Transferability: Partially

Result card for EFF12: "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)?"

View full card
EFF12: 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)?
Method
Result

Importance: Optional

Transferability: Partially

Patient satisfaction

Result card for EFF13: "Was the use of Structured telephone support (STS) worthwhile?"

View full card
EFF13: Was the use of Structured telephone support (STS) worthwhile?
Method
Result

Importance: Optional

Transferability: Partially

Result card for EFF14: "Are adults with chronic heart failure willing to use the Structured telephone support (STS) again?"

View full card
EFF14: Are adults with chronic heart failure willing to use the Structured telephone support (STS) again?
Method
Result

Importance: Optional

Transferability: Partially

Benefit-harm balance

Result card for EFF15: "What are the overall benefits and harms of the Structured telephone support (STS) in adults with chronic heart failure?"

View full card
EFF15: What are the overall benefits and harms of the Structured telephone support (STS) in adults with chronic heart failure?
Method
Result

Importance: Important

Transferability: Partially

Discussion

The aim of this relative effectiveness assessment was to determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure (New York Heart Association (NYHA) I-IV) and without implantable cardiac defibrillators (ICDs), CRTs or pacemakers who have been admitted to hospital at least once for chronic heart failure, improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, and change in management or utilization of health service compared with current practice.

Five existing SRs have been integrated {Feltner et al, 2014; Kotb et al, 2015; Pandor et al, 2013; Inglis et al, 2011; Clark et al, 2007} according to the methodology described in Whitlock et al. 2008 { } and Robinson et al. 2014 { }, into this SR. Additionally, 19 RCTs have been included to answer domain assessment element questions that were not answered by the five SRs. We were faced with already recognized areas of uncertainty: how to appropriately synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews.

STS produced a mortality benefit and reduced HF-specific readmission rates. In the most recent SR and HTA published by Feltner et al, 2014 { }, STS interventions produced a mortality benefit, with  RR (95% CI) 0.74 (0.56–0.97), in time period of 3-6 months, with Number needed to treat (NNT) of 27. Kotb et al, 2015 { } in Network meta-analysis (NMA), reported that structured telephone support significantly reduced the odds of mortality (Odds Ratio 0.80; 95% Credible Intervals [0.66 to 0.96]) compared to usual care. Pandor et al, 2013 { } with data from 11 studies evaluated STS, with duration of follow-up ranged from 6 months to 18 months, found that compared with usual care, STS HH was beneficial (but not statistically significant) in reducing all-cause mortality [hazard ratio (HR) 0.77, 95% credible interval (CrI) 0.55 to 1.08]. No favourable effect on mortality was observed with STS HM.

A majority of the studies (included in five published SRs) reported significantly lower HF-specific re-hospitalisation rate in STS group {Feltner 2014, Kotb 2015, Pandor 2013, Inglis 2011, Clark 2007}. Feltner et al, 2014 { } reported that 14 patients needed to be treated with structured telephone support (STS) interventions to reduced HF-specific readmission (NNT of 14). When sensitivity analysis was done including only RCT with follow-up period longer than 6 months this difference was not statisticaly significant anymore {Inglis 2011}. Two recently published RCTs  {Angermann 2012, Krum 2013} with 6 and 12 months follow-up period, reported non-significant difference in HF-specific re-hospitalization between STS and Usual care groups.

Few RCTs measured QoL or function using the same measures at similar time points; the limited data showed conflicting results. Insufficient evidence was found to answer questions related with utilization outcomes as well, so the evidence base was inadequate to make final conclusion for these outcomes. However, a majority of the studies presented statistically significant QoL improvements. Data found on the emergency room (ER) visit rate in STS group comparing with usual care was conflicting, but a majority of the results found no significant difference in the number of emergency room visits in either group. The same is true for the the most recent SR and HTA published by Feltner et al, 2014 { }; STS interventions had no effect on the rate of ER visits over 3 to 6 months. According the number of general practitioners visits, Krum et al, 2013 { }, during 12 months period, showed reduction in the utilization of general practitioners, with the control group visiting their general practitioner more than twice as often as the intervention group.

Since little evidence identified on the potential harms of STS {Chaudhry et al, 2010}, as described in Safety Domain, it was not possible to answer on overall benefits and harms of the Structured telephone support (STS) in adults with chronic heart failure.

We could not find answers to some of the assessment element questions, such as work ability, return to previous living conditions, activities of daily living, worthwhile of STS and willing to use STS again. For example no SRs, HTAs or RCTs have addressed the question “Was the use of Structured telephone support (STS) worthwhile?”. Indirect answers could be found in further RCTs (included in Inglis et al SR, published 2011 { }); showing that satisfaction (acceptance) of patients receiving health care via technology was rated between 76% to 100% {Clark 2007b; Krum 2009; Cleland 2005}. In the work by Laramee et al, 2003 { } patients in the intervention group were significantly more satisfied with their care in 13 of 16 items than the usual care group (P=.01). In RCT published by Riegel et al, 2002 { } patients in the intervention group were significantly more satisfied at 6 months with their care in STS than the usual care group (22.88±2.85 vs 6.17±4.87).

Out of 19 RCTs included in our new SR only three RCTs were judged as low risk of bias {DeBusk 2004, GESICA 2005, Chaudhry 2010},

Direct evidence on primary outcomes was not assessed by using the GRADE-methodology {Guyatt 2008} as planned, because of heterogeneity of follow up periods and quantitative synthesis from existing SRs was used and presented in the result section for specific outcomes.

Further research is needed on effects of STS on QoL and utilization outcomes as well as long term follow-up of patient satisfaction. Several methodological issues should be solved in future research on STS on QoL and utilization outcomes, like masking outcome assessment as well as clear description of usual care and long term follow up (12 month or longer). For answering questions related to patient satisfaction, other study designs than RCT could be appropriate; this part of assessment could be completely covered by Social aspects (SOC) Domain of the future versions of the full Core HTA Model.

Some methodological limitations that may affect comparability and applicability of the data reported in RCTs and SRs could be listed, such as different approaches of usual care as well of structured telephone support (different telephone follow-up, information or education provided pre-discharge, etc.); different providers of STS interventions (provided by pharmacist, physicians or nurses) and their experience in providing the STS.

The STS interventions presented in this assessment are applicable only to patients who are discharged to their home; it remains unclear whether STS interventions would benefit patients who are discharged to another institution. Also, due another limitation - narrow scope of our assessment, our results are not applicable to patients with chronic heart failure with implantable cardioverter-defibrillators (ICDs), cardiac resynchronisation therapy defibrillators (CRT-Ds) or pacemakers. Hindricks et al. 2014 and Parthiban et al. 2015 recently published data on remote monitoring in this selected group of patients { }. Due the fact that RCTs included in our assessment were published in a time  period ranging from 1999 to 2013, “usual care” in trials published earlier probably is not the same as “usual care”used in the most recent RCTs. Moreover, in general, trials did not report details of usual care. It also remains unclear if STS interventions in adults with chronic heart failure (who have been admitted to hospital at least once for chronic heart failure) will lead to different outcomes in rural or urban settings.

Authors of this assessment found some difficulties in full Core HTA Model, previously recognized, which will be solved in future versions of the Core Model (for example possible overlaps or duplication with other Domains assessment elements questions, need for grouping some of assessment element questions to avoid unnecessary slicing, as well as some problems with format of reporting). 

References

Whitlock EP, Lin JS, Chou R, Shekelle P, Robinskon KA. Using existing systematic reviews in complex systematic reviews. Ann Int Med. 2008;148(10):776-82.

Robinson KA, Whitlock EP, O’Neil ME, Anderson JK, Hartling L, Dryden DM, Butler M, et al. Integration of Existing Systematic Reviews. Research White Paper (Prepared by the Scientific Resource Center under Contract No. 290-2012-00004-C). AHRQ Publication No. 14-EHC016-EF. Rockville, MD: Agency for Healthcare Research and Quality. June 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.

Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, et al. The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration. PLoS. 2009;6(7):e1000100.

 

Shea BJ, Grimshaw JM, Wells GA, Boers M, Andersson N, Hamel C, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol. 2007;7:10. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1810543/pdf/1471-2288-7-10.pdf

European Network for Health Technology Assessment (EUnetHTA). Level of evidence. Internal validity of randomized controlled trials. EunetHTA; 2013.

 

Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P et al. GRADE: an emerging consensus on rating quality of evidence and strength of reccomendations. BMJ. 2008;336:924-6

 

Feltner C, Jones CD, Cené CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJ, et al. Transitional Care Interventions to Prevent Readmissions for Persons With Heart Failure: A Systematic Review and Meta-analysis. Ann Intern Med. 2014;160(11):774-8.

 

Feltner C, Jones CD, Cené CW, Zheng Z-J, Sueta CA, Coker-Schwimmer EJL, Arvanitis M, Lohr KN, Middleton JC, Jonas DE. Transitional Care Interventions To Prevent Readmissions for People With Heart Failure. Comparative Effectiveness Review No. 133. (Prepared by the Research Triangle Institute–University of North Carolina Evidence-based Practice Center under Contract No. 290-2012-00008-I). AHRQ Publication No. 14-EHC021-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

 

Kotb A, Cameron C, Hsieh S, Wells G. Comparative Effectiveness of Different Forms of Telemedicine for Individuals with Heart Failure (HF): A Systematic Review and Network Meta-Analysis. PLoS ONE. 2015; 10(2):e0118681.

 

Pandor A, Thokala P, Gomersall T, Baalbaki H, Stevens JW, Wang J, et al. Home telemonitoring or structured telephone support programmes after recent discharge in patients with heart failure: systematic review and economic evaluation. Health Technol Assess. 2013;17(32).

 

Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JGF. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database of Systematic Reviews. 2010, Issue 8. Art. No.:CD007228.

 

Clark RA, Inglis SC, McAlister FA, Cleland JGF, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007:doi:10.1136/bmj.39156.536968.55

 

Angermann CE, Stoerk S, Gelbrich G, Faller H, Jahns R, Frantz S, et al. Competence Network Heart Failure. Mode of action and effects of standardized collaborative disease management on mortality and morbidity in patients with systolic heart failure: the Interdisciplinary Network for Heart Failure (INH) study. Circ Heart Fail. 2012;5:25-35.

Barth V. A nurse-managed discharge program for congestive heart failure patients: outcomes and costs. Home Health Care Management and Practice. 2001;13(6):436–43.

 

Cleland JG, Louis AA, Rigby AS, Janssens U, Balk AH, TEN-HMS Investigators. Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: The Trans-European Network-Home-Care Management System (TEN-HMS) study. Journal of the American College of Cardiology. 2005;45(10):1654–64.

Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, et al. Telemonitoring in patients with heart failure. N Engl J Med. 2010;363:2301–9.

DeBusk RF, Miller NH, Parker KM, Bandura A, Kraemer HC, Cher DJ, et al.Care management for lowrisk patients with heart failure: A randomized, controlled trial. Annals of Internal Medicine. 2004;141(8):606–13.

DeWalt DA, Malone RM, Bryant ME, Kosnar MC, Corr KE, Rothman RL, et al. A heart failure self-management program for patients of all literacy levels: A randomized, controlled trial [ISRCTN11535170]. BMC Health Services Research. 2006;6:30.

Galbreath AD, Krasuski RA, Smith B, Stajduhar KC, Kwan MD, Ellis R, et al. Long-term healthcare and cost outcomes of disease management in a large, randomized, community-based population with heart  failure. Circulation. 2004;110(23):3518–26.

 

Gattis WA, Hasselblad V, Whellan DJ, O’Connor CM. Reduction in heart failure events by the addition of a clinical  pharmacist to the heart failure management team. Archives of Internal Medicine. 1999;159:1939–45.

GESICA Investigators. Randomised trial of telephone intervention in chronic heart failure: DIAL trial. British Medical Journal. 2005;331(7514):425.

Laramee AS, Levinsky SK, Sargent J, Ross R, Callas P. Case management in a heterogeneous congestive heart failure population: A randomized controlled trial. Archives of Internal Medicine. 2003;163:809–817.

Mortara A, Pinna GD, Johnson P, Maestri R, Capomolla S, La Rovere MT, et al. Home telemonitoring in heart failure patients: The HHH study (Home or Hospital in Heart Failure). European Journal of Heart Failure. 2009;11:312–318.

 

Rainville EC. Impact of pharmacist intervention on hospital readmissions for heart failure. American Journal of Health-System Pharmacy. 1999;56:1339–42.

Ramachandran K, Husain N, Maikhuri R, Seth S, Vij A, Kumar M, et al. Impact of a comprehensive telephonebased disease management programme on quality-of-life in patients with heart failure. Natl Med J India. 2007;20:67–73.

Riegel B, Carlson B, Kopp Z, LePetri B, Glaser D, Unger A. Effect of a standardized nurse case-management telephone intervention on resource use in patients with chronic heart failure. Archives of Internal Medicine. 2002;162:705–12.

Riegel B, Carlson B, Glaser D, Romero T. Randomized Controlled Trial of Telephone Case Management in Hispanics of Mexican Origin With Heart Failure. Journal of Cardiac Failure. 2006;12(3):211–19.

Sisk JE, Hebert PL, Horowitz CR, McLaughlin MA, Wang JJ, Chassin MR. Effects of nurse management on the quality of heart failure care in minority communities: A randomized trial. Annals of Internal Medicine. 2006;145:273–83.

 

Tsuyuki RT, Fradette M, Johnson JA, Bungard TJ, Eurich DT, Ashton T, et al. A multicenter disease management program for hospitalized patients with heart failure. J Cardiac Fail. 2004;10:473–80.

 

Wakefield BJ, Ward MM, Holman JE, Ray A, Scherubel M, Burns TL, et al. Evaluation of home telehealth following hospitalization for heart failure: a randomized trial. Telemed J E Health.2008;14:753–61.

 

Krum H, Forbes A, Yallop J, Driscoll A, Croucher J, Chan B, et al. Telephone Support to Rural and Remote Patients with Heart Failure: The Chronic Heart Failure Assessment by Telephone (CHAT) study. Cardiovascular Therapeutics. 2013;31:230–37.

Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A et al. Implant-based multiparameter telemonitoring  of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014;384:583–90.

Parthiban N, Esterman A, Mahajan R, Twomey DJ, Pathak RK, Lau DH et al.  Remote Monitoring of Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Clinical Outcomes. J Am Coll Cardiol. 2015;65(24):2591-600.

Appendices

Appendix 1.     Search strategy, June 2015

EFF Appendix 1

Appendix 2. Flow chart of study selection

Figure 1. Flow chart of study selection, according to the PRISMA flowchart {Liberati 2009}

EFF Appendix 2

 

Appendix 3. Characteristics of included secondary studies: Systematic reviews/HTA, main study findings and authors conclusions

 

EFF Appendix 3

Appendix 4. RCTs included in SR of effectiveness and safety: Evidence tables and Risk of bias tables

EFF Appendix 4

Appendix 5.  List of included studies (RCTs) in the secondary studies (SRs or HTAs)

EFF Appendix 5

Appendix 6. List of included studies (RCTs) in this Systematic review of Clinical Effectiveness/Safety with Follow-up duration and Risk of bias

EFF Appendix 6

Appendix 7.  List of Ongoing RCTs in clinical trials registries

EFF Appendix 7

 

 

<< SafetyCosts and economic evaluation >>