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Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

ABSTRACT: Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone.The present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight).There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial.Clinicaltrials.gov, http://NCT01984840, November 14, 2013.

SUBMITTER: Udsen FW

PROVIDER: S-EPMC4039321 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

Udsen Flemming Witt FW Lilholt Pernille Heyckendorff PH Hejlesen Ole O Ehlers Lars Holger LH

Trials 20140521

<h4>Background</h4>Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual ca ...[more]

PMID: 24886225

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Project description:OBJECTIVES:To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. DESIGN:A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. SETTING:Community-based setting in the geographical area of North Denmark Region in Denmark. PARTICIPANTS:26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. INTERVENTIONS:In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. MAIN OUTCOME MEASURE:Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. RESULTS:From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI -754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI -0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). CONCLUSIONS:Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. TRIAL REGISTRATION:Clinicaltrials.gov, NCT01984840, 14 November 2013.

Project description:BACKGROUND:Several heart failure studies have shown promising results for implementing telehealthcare. These studies have led to clinical and political interest in telehealthcare as a way to improve heart failure outcomes and lower costs. However, there is a need for large-scale clinical trials with cost-effectiveness assessments. METHODS/DESIGN:The present study is known as the TeleCare North Heart Failure Trial in Denmark. We are studying the health effectiveness and cost-effectiveness of a telehealth (Telekit) solution compared with usual care for patients with heart failure. The design is a multicenter, two-arm, parallel-group, nonblinded, superiority randomized controlled trial. Outpatient healthcare centers will be responsible for recruiting eligible participants (600 participants are expected) for the trial in the geographic area of the North Denmark Region. Participants are qualified for inclusion if they have been diagnosed according to national guidelines and are categorized in New York Heart Association class 2, 3, or 4. Patients must have a permanent residence and be motivated to use telehealth care. The primary outcomes are changes in health-related quality of life (assessed using the Kansas City Cardiomyopathy Questionnaire, the EuroQol EQ-5D-5L questionnaire, and the Short Form Health Survey [SF-36]) and in the incremental cost-effectiveness ratio measured from baseline to follow-up. The secondary outcomes are changes in mortality and in physiological indicators such as blood pressure, pulse, and weight. DISCUSSION:The TeleCare North Heart Failure Trial is intended to improve the international evidence base for the health effectiveness and cost-effectiveness of telehealthcare for patients with heart failure. The expectation is that the results of the trial can be generalized to all municipalities in Denmark and serve as an inspiration for further international research. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02860013 ). Registered on 28 July 2016.

Project description:PURPOSE:Results from the Danish cluster-randomized trial of telehealthcare to 1,225 patients with chronic obstructive pulmonary disease (COPD), the Danish Telecare North Trial, concluded that the telehealthcare solution was unlikely to be cost-effective, by applying international willingness-to-pay threshold values. The purpose of this article was to assess potential sources of variation across subgroups, which could explain overall cost-effectiveness results or be utilized in future economic studies in telehealthcare research. METHODS:First, the cost-structures and cost-effectiveness across COPD severities were analyzed. Second, five additional subgroup analyses were conducted, focusing on differences in cost-effectiveness across a set of comorbidities, age-groups, genders, resource patterns (resource use in the social care sector prior to randomization), and delivery sites. All subgroups were investigated post hoc. In analyzing cost-effectiveness, two separate linear mixed-effects models with treatment-by-covariate interactions were applied: one for quality-adjusted life-year (QALY) gain and one for total healthcare and social sector costs. Probabilistic sensitivity analysis was used for each subgroup result in order to quantify the uncertainty around the cost-effectiveness results. RESULTS:The study concludes that, across the COPD severities, patients with severe COPD (GOLD 3 classification) are likely to be the most cost-effective group. This is primarily due to lower hospital-admission and primary-care costs. Telehealthcare for patients younger than 60 years is also more likely to be cost-effective than for older COPD patients. Overall, results indicate that existing resource patterns of patients and variations in delivery-site practices might have a strong influence on cost-effectiveness, possibly stronger than the included health or sociodemographic sources of heterogeneity. CONCLUSION:Future research should focus more on sources of heterogeneity found in the implementation context and the way telehealthcare is adopted (eg, by integrating formative evaluation into cost-effectiveness analyses). TRIAL REGISTRATION:Clinicaltrials.gov, NCT01984840.

Project description:ImportancePulmonary rehabilitation (PR) after exacerbation of chronic obstructive pulmonary disease (COPD) is effective in reducing COPD hospitalizations and mortality while improving health-related quality of life, yet use of PR remains low. Estimates of the cost-effectiveness of PR in this setting could inform policies to improve uptake.ObjectiveTo estimate the cost-effectiveness of participation in PR after hospitalization for COPD.Design, setting, and participantsThis economic evaluation estimated the cost-effectiveness of participation in PR compared with no PR after COPD hospitalization in the US using a societal perspective analysis. A Markov microsimulation model was developed to estimate the cost-effectiveness in the US health care system with a lifetime horizon, 1-year cycle length, and a discounted rate of 3% per year for both costs and outcomes. Data sources included published literature from October 1, 2001, to April 1, 2021, with the primary source being an analysis of Medicare beneficiaries living with COPD between January 1, 2014, and December 31, 2015. The analysis was designed and conducted from October 1, 2019, to December 15, 2021. A base case microsimulation, univariate analyses, and a probabilistic sensitivity analysis were performed.InterventionsPulmonary rehabilitation compared with no PR after COPD hospitalization.Main outcomes and measuresNet cost in US dollars, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio.ResultsAmong the hypothetical cohort with a mean age of 76.9 (age range, 60-92) years and 58.6% women, the base case microsimulation from a societal perspective demonstrated that PR resulted in net cost savings per patient of $5721 (95% prediction interval, $3307-$8388) and improved quality-adjusted life expectancy (QALE) (gain of 0.53 [95% prediction interval, 0.43-0.63] years). The findings of net cost savings and improved QALE with PR did not change in univariate analyses of patient age, the Global Initiative for Obstructive Lung Disease stage, or number of PR sessions. In a probabilistic sensitivity analysis, PR resulted in net cost savings and improved QALE in every one of 1000 samples and was the dominant strategy in 100% of simulations at any willingness-to-pay threshold. In a 1-way sensitivity analysis of total cost, assuming completion of 36 sessions, a single PR session would remain cost saving to $171 per session and had an incremental cost-effectiveness ratio of $884 per session for $50 000/QALY and $1597 per session for $100 000/QALY.Conclusions and relevanceIn this economic evaluation, PR after COPD hospitalization appeared to result in net cost savings along with improvement in QALE. These findings suggest that stakeholders should identify policies to increase access and adherence to PR for patients with COPD.

Project description:ObjectiveMucoactive drugs should increase the ability to expectorate sputum and, ideally, have anti-inflammatory properties. The aim of the study was to evaluate the mucolytic activity of Tyloxapol compared to saline (0.9%) in COPD.DesignA randomized, placebo-controlled, double-blinded crossover, clinical trial was carried out. Patients were randomly assigned to either inhale 5 ml Tyloxapol 1% or saline 0.9% solution three times daily for 3 weeks and vice versa for another 3 weeks. 28 patients (18 male, 10 female, 47 to 73 years old, median age 63.50) were screened, 21 were treated and 19 patients completed the study per protocol.ResultsA comparison of the two treatment phases showed that the primary endpoint sputum weight was statistically significant higher when patients inhaled Tyloxapol (mean 4.03 g, 95% CI: 2.34-5.73 g at week 3) compared to saline (mean 2.63 g, 95% CI: 1.73-3.53 g at week 3). The p-value at three weeks of treatment was 0.041 between treatment arms. Sputum cells decreased during the Tyloxapol treatment after 3 weeks, indicating that Tyloxapol might have some anti-neutrophilic properties. Lung function parameters (FVC, FEV1, RV, and RV/TLC) remained stable during the study, and no treatment effect was shown. Interestingly, there was a mean increase in all inflammatory cytokines (IL-1β, IL-6, and IL-8) during the saline treatment from day 1 to week 3, whereas during the Tyloxapol treatment, all cytokines decreased. Due to the small sample size and the large individual variation in sputum cytokines, these differences were not significant. However, analyses confirmed that Tyloxapol has significant anti-inflammatory properties in vitro. Despite the high number of inhalations (more than 1000), only 27 adverse events (20 during the Tyloxapol and seven during saline) were recorded. Eleven patients experienced AEs under Tyloxapol and six under saline treatment, which indicates that inhalation of saline or Tyloxapol is a very safe procedure.ConclusionOur study demonstrated that inhalation of Tyloxapol by patients with COPD is safe and superior to saline and has some anti-inflammatory effects.Trial registrationClinicalTrials.gov NCT02515799.

Project description:ObjectiveTo assess the cost-effectiveness of a structured education pulmonary rehabilitation programme (SEPRP) for chronic obstructive pulmonary disease (COPD) relative to usual practice in primary care. The programme consisted of group-based sessions delivered jointly by practice nurses and physiotherapists over 8 weeks.DesignCost-effectiveness and cost-utility analysis alongside a cluster randomised controlled trial.Setting32 general practices in Ireland.Participants350 adults with COPD, 69% of whom were moderately affected.InterventionsIntervention arm (n=178) received a 2 h group-based SEPRP session per week over 8 weeks delivered jointly by a practice nurse and physiotherapist at the practice surgery or nearby venue. The control arm (n=172) received the usual practice in primary care.Main outcome measuresIncremental costs, Chronic Respiratory Questionnaire (CRQ) scores, quality-adjusted life years (QALYs) gained estimated using the generic EQ5D instrument, and expected cost-effectiveness at 22 weeks trial follow-up.ResultsThe intervention was associated with an increase of €944 (95% CIs 489 to 1400) in mean healthcare cost and €261 (95% CIs 226 to 296) in mean patient cost. The intervention was associated with a mean improvement of 1.11 (95% CIs 0.35 to 1.87) in CRQ Total score and 0.002 (95% CIs -0.006 to 0.011) in QALYs gained. These translated into incremental cost-effectiveness ratios of €850 per unit increase in CRQ Total score and €472 000 per additional QALY gained. The probability of the intervention being cost-effective at respective threshold values of €5000, €15 000, €25 000, €35 000 and €45 000 was 0.980, 0.992, 0.994, 0.994 and 0.994 in the CRQ Total score analysis compared to 0.000, 0.001, 0.001, 0.003 and 0.007 in the QALYs gained analysis.ConclusionsWhile analysis suggests that SEPRP was cost-effective if society is willing to pay at least €850 per one-point increase in disease-specific CRQ, no evidence exists when effectiveness was measured in QALYS gained.Trial registrationCurrent Controlled Trials ISRCTN52 403 063.

Project description:BackgroundExacerbations of chronic obstructive pulmonary disease (COPD) are the main cause for hospitalisation. These hospitalisations result in a high pressure on hospital beds and high health care costs. Because of the increasing prevalence of COPD this will only become worse. Hospital at home is one of the alternatives that has been proved to be a safe alternative for hospitalisation in COPD. Most schemes are early assisted discharge schemes with specialised respiratory nurses providing care at home. Whether this type of service is cost-effective depends on the setting in which it is delivered and the way in which it is organised.Methods/designGO AHEAD (Assessment Of Going Home under Early Assisted Discharge) is a 3-months, randomised controlled, multi-centre clinical trial. Patients admitted to hospital for a COPD exacerbation are either discharged on the fourth day of admission and further treated at home, or receive usual inpatient hospital care. Home treatment is supervised by general nurses. Primary outcome is the effectiveness and cost effectiveness of an early assisted discharge intervention in comparison with usual inpatient hospital care for patients hospitalised with a COPD exacerbation. Secondary outcomes include effects on quality of life, primary informal caregiver burden and patient and primary caregiver satisfaction. Additionally, a discrete choice experiment is performed to provide insight in patient and informal caregiver preferences for different treatment characteristics. Measurements are performed on the first day of admission and 3 days, 7 days, 1 month and 3 months thereafter. Ethical approval has been obtained and the study has been registered.DiscussionThis article describes the study protocol of the GO AHEAD study. Early assisted discharge could be an effective and cost-effective method to reduce length of hospital stay in the Netherlands which is beneficial for patients and society. If effectiveness and cost-effectiveness can be proven, implementation in the Dutch health care system should be considered.Trial registrationNetherlands Trial Register NTR1129.

Project description:BackgroundWorld-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders.Methods/designThis two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. orControl groupStandard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients.DiscussionForty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.Trial registration[ClinicalTrials.gov: Identifier NCT00945204].

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Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

Publications

Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

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