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RELEASE- HF: REsponsible roLl-out of E-heAlth through Systematic Evaluation – Heart Failure


Hartfalen  kent een grillig beloop met tijdelijke periodes van meer klachten en beperkingen die regelmatig leiden tot ziekenhuisopnames, gezondheidsverlies en hoge zorgkosten.
Telebegeleiding (TB) helpt patiënten en zorgverleners op afstand te ondersteunen in de behandeling door relevante parameters en symptomen van hartfalen te monitoren en patiënten op afstand nieuwe kennis en vaardigheden aan te leren. ennis uit voorgaand onderzoek laat zien dat dat TB veelbelovend is, maar helaas niet bij iedereen en bij elke type TB.
In 29 ziekenhuizen met en ziekenhuizen zonder TB wordt 2 jaar lang een intensieve dataverzameling uitgevoerd, waarin bij meer dan 5000 patiënten wordt achterhaald of, hoe lang en welk type TB hij/zij ontvangt, wat het zorggebruik is en de gezondheidsuitkomsten zijn. Zo willen we erachter komen bij welke patiënten en wel type TB (kosten)effectief is.


Samenvatting van de aanvraag

RESEARCH QUESTIONS (RQ’s) The overall objective is to identify in which subgroup of Heart Failure (HF) patients telemedicine (TM) is not cost-effective and to identify which TM strategies are most cost-effective. A specific set of key uncertainties will be investigated in this proposal, but at the same time the foundation of an ongoing prospective data collection of important clinical outcomes, patient characteristics, and features of the applied TM strategy will be built to further tailor the use of TM in the Netherlands. PATIENT-related uncertainties: Does TM as part of regular HF care, compared to regular HF care alone lead to better patient outcomes and is TM cost-effective in: 1. younger versus older HF patients? 2. female versus male HF patients? 3. patients with higher versus lower socio-economic status? 4. less severe versus severe HF patients? 5. unstable versus stable HF patients? 6. HF patients without depression versus depressed patients? 7. recently diagnosed versus not recently diagnosed HF patients? INTERVENTION-related uncertainties: Does TM as part of regular HF care lead to better patient outcomes and is TM cost-effective when: 8. vital signs are automatically monitored versus manual entering? 9. vital signs are monitored invasively versus non-invase monitoring? 10. digital self-management incl. education is provided versus no provision of self-management incl. education? 11. remote clinical review/videoconferencing is available versus no remote clinical review/videoconferencing available? 12. offered 24/7 days versus office hours only? Since intervention-related questions can only be addressed in patient exposed to TM the power to address the patient-related RQ’s will be higher. Therefore, we will address the above RQ’s in a stepwise fashion. HYPOTHESIS TM as an integrated part of routine care compared to routine care only in Dutch HF care is expected to lead to better patient outcomes and is cost-effective overall, but with high large heterogeneity in effect size among different types of interventions and among different subgroups of patients. Unravelling which patient and intervention characteristics are associated with (little) effectiveness is an essential step towards better targeted/tailored TM approaches that are substantially more cost-effective. STUDY DESIGN RELEASE will be a prospective multi-center registry-based cohort study (variation on Trials Within Cohorts(TWICS)-design) to assess in which subgroup of patients TM is most (cost-)effective and to determine which intervention components of TM are most (cost-)effective. RELEASE makes use of the current large variation in implementation of TM in NL (Real World evidence). The hallmark is a uniform, detailed and ongoing data collection (NHR – National Heart Registration) of clinical relevant outcomes, key patient/HF characteristics, comorbidities, and whether and which TM feautures have been used. Patients are recruited over a 24 months period and follow-up data will be collected from patients at three distinct time points: baseline (T0), 6m (T6) and 12m (T12) follow-up. STUDY POPULATION RELEASE concerns all consecutive HF patients eligible for TM (users/non-TM users) who, according to the Dutch consensus standard TM: • are recently (<3m) diagnosed with HF, and/or • had a recent (<12m) hospital (re-)admission for exacerbation HF, and/or • had a recent (<12m) HF exacerbation, necessitating changes in medication, and/or • not on optimal medical therapy according to recent HF guidelines and/or • have symptoms of anxiety and/or depression and/or • need support with recognizing early symptoms of worsening HF Exclusion criteria are haemodialysis or cardiac intervention (revascularization, LVAD, resynchronization, TAVI) planned <28 days Note: the study population used differs depending on the type of RQ’s under investigation (RQ1-7: total study population, RQ 8-12: only patients exposed to TM). INTERVENTION Telemedicine (remote monitoring/support) as part of routine Dutch HF care. The type of (intervention components of) TM and in whom it is (not) used may differ within and across centers. Critical features of TM intervention content and implementation process in each of the centers, is identified and mapped through Intervention Component Analysis (ICA) to facilitate comparison across interventions/settings. COMPARISON Routine guideline-based HF care only (no TM) is the comparator with regard to the patient sub-group analyses. Intervention characteristics are analyzed by comparing patients exposed to different types of TM-components. PRIMARY OUTCOME Days spent outside the hospital 1year (number of hospital-free days in 1 year) SECONDARY OUTCOMES Incremental Cost Effectiveness Ratios Symptoms Quality of life Mortality Admissions Outpatient visits Costs SAMPLE SIZE / DATA-ANALYSIS N=29 hospitals, n=5184 patients. Analysis: Linear mixed models to account for clustering within hospitals with interaction (subgroup) analysis. Cost-utility / Budget impact analysis.



Looptijd: 63%
Looptijd: 63 %
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Verantwoordelijke organisatie:
Universitair Medisch Centrum Utrecht