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Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial.

ABSTRACT: INTRODUCTION:Chronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients' compliance, and associated health and economic outcomes. METHODS AND ANALYSIS:An open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits. ETHICS AND DISSEMINATION:The clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees. TRIAL REGISTRATION NUMBER:Registered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640).

SUBMITTER: Ding H

PROVIDER: S-EPMC5640081 | biostudies-other | 2017 Oct

REPOSITORIES: biostudies-other

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Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial.

Ding Hang H Jayasena Rajiv R Maiorana Andrew A Dowling Alison A Chen Sheau Huey SH Karunanithi Mohan M Layland Jamie J Edwards Iain I

BMJ open 20171008 10

<h4>Introduction</h4>Chronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients' compliance, and associated health and economic outcomes.<h4>Method ...[more]

PMID: 28993389

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Project description:PurposeSupporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany.MethodsWe conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447).ResultsBetween September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for "sedation, analgesia and delirium" (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395-8.358), "ventilation" (OR 2.248, 1.198-4.217), "weaning from ventilation" (OR 9.049, 2.707-30.247), "infection management" (OR 4.397, 1.482-13.037), "enteral nutrition" (OR 1.579, 1.032-2.416), "patient and family communication" (OR 6.787, 3.976-11.589), and "early mobilisation" (OR 3.161, 2.160-4.624). No evidence for a difference in adherence to "daily multi-professional and interdisciplinary clinical visits" between both conditions was found (OR 1.606, 0.780-3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition).ConclusionA telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems.

Project description:IntroductionGlobally, children are not meeting the recommended serves of the five food group foods, particularly vegetables. Childcare is an opportune setting to improve children's diet quality. This study aims to assess the effectiveness of a menu box delivery service tailored to the long day care setting to improve menu compliance with recommendations and improve children's food intake while in care.Methods and analysisThis study will employ a cluster randomised controlled trial and will recruit eight long day care centres, randomly allocated to the intervention or comparison groups. The intervention group will trial the delivery of a weekly menu box service that includes all ingredients and recipes required to provide morning snack, lunch and afternoon snack. The menu boxes are underpinned by a 4-week menu developed by dietitians and meet menu planning guidelines. The comparison group will receive access to online menu planning training and a menu assessment tool for cooks. The primary outcomes are child dietary intake and menu guideline compliance. Secondary outcomes include within-trial cost-effectiveness and process evaluation measures including intervention acceptability, usability and fidelity. If effective, the menu box delivery will provide an easy strategy for childcare cooks to implement a centre menu that meets menu planning guidelines and improves child intake of five food group foods, including vegetables.Ethics and disseminationThis study was approved by the Flinders University Social and Behavioural Research Ethics Committee. Study outcomes will be disseminated in peer-reviewed publications, via local, national and international presentations. Non-traditional outputs including evidence summaries and development of a business case will be used to disseminate study findings to relevant stakeholder groups. Data will be used in a doctoral thesis.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12620000296932).

Project description:BackgroundTelemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but little is known about the usability and patients' willingness to engage with this technology.ObjectiveThis study aims to evaluate feedback from patients with CHF following participation in the Innovative Telemonitoring Enhanced Care program for CHF (ITEC-CHF) study.MethodsThe telemonitoring intervention consisted of three components: remote weight monitoring, structured telephone support, and nurse-led collaborative care. Participants were provided with electronic weighing scales (W550; ForaCare), and a computer tablet (Galaxy Tab A; Samsung). They were asked to weigh themselves on the provided scales daily. Telemonitoring was integrated with a personal assistance call service and a nurse care service according to their workflows in usual care. Feedback on the usability of ITEC-CHF was collected via survey from study participants following 6 months of receiving telemonitoring care for their body weight. Survey responses were provided on a 5-point Likert scale and through open-ended questions to determine participants' perceived benefits and barriers to using ITEC-CHF.ResultsA total of 67 participants (49/67, 73% male), with a mean age of 69.8 (SD 12.4) years completed the survey. The majority of participants agreed or strongly agreed that the ITEC-CHF program was easy to use (61/67, 91%), easy to navigate (51/65, 78%), useful (59/65, 91%), and made them feel more confident in managing their weight (57/67, 85%). Themes related to participants' perceptions of telemonitoring included increased support for early intervention of clinical deterioration, improved compliance to daily weighing, a sense of reassurance, and improved self-care and accountability, among others.ConclusionsITEC-CHF was rated highly on usability and was well accepted by users as part of their routine self-management activities. Participants were willing to use telemonitoring because they perceived a broad spectrum of benefits for CHF management.Trial registrationAustralian New Zealand Clinical Trial Registry ID ACTRN 12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691.

Project description:ObjectivesTo study the cost-effectiveness of a care manager organization for patients with mild to moderate depression in Swedish primary care in a 12-month perspective.MethodsCost-effectiveness analysis of the care manager organization compared to care as usual (CAU) in a pragmatic cluster randomised controlled trial including 192 individuals in the care manager group and 184 in the CAU group. Cost-effectiveness was assessed from a health care and societal perspectives. Costs were assessed in relation to two different health outcome measures: depression free days (DFDs) and quality adjusted life years (QALYs).ResultsAt the 12-month follow-up, patients treated at the intervention Primary Care Centres (PCCs) with a care manager organization had larger health benefits than the group receiving usual care only at control PCCs. Mean QALY per patient was 0.73 (95% CI 0.7; 0.75) in the care manager group compared to 0.70 (95% CI 0.66; 0.73) in the CAU group. Mean DFDs was 203 (95% CI 178; 229) in the care manager group and 155 (95% CI 131; 179) in the CAU group. Further, from a societal perspective, care manager care was associated with a lower cost than care as usual, resulting in a dominant incremental cost-effectiveness ratio (ICER) for both QALYs and DFDs. From a health care perspective care manager care was related to a low cost per QALY (36,500 SEK / €3,379) and DFD (31 SEK/€3).LimitationsA limitation is the fact that QALY data was impaired by insufficient EQ-5D data for some patients.ConclusionsA care manager organization at the PCC to increase quality of care for patients with mild-moderate depression shows high health benefits, with no decay over time, and high cost-effectiveness both from a health care and a societal perspective. Trial registration details: The trial was registered in ClinicalTrials.com ( https://clinicaltrials.gov/ct2/show/NCT02378272 ) in 02/02/2015 with the registration number NCT02378272. The first patient was enrolled in 11/20/2014.

Project description:ObjectivesTo determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes.DesignMulticentre, parallel, cluster randomised controlled trial.SettingLong term care homes in the UK, registered to care for older people or those with dementia.Participants1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care.InterventionsGuide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care.Main outcome measuresPrimary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation.ResultsMean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000). Barthel activities of daily living indices and PAM-RC scores were similar between groups at all time points. The incremental cost was £108 (95% confidence interval -£271.06 to 487.58), incremental QALYs gained for EQ-5D-5L-P was 0.024 (95% confidence interval 0.004 to 0.044) and for DEMQOL-P-U was 0.005 (-0.019 to 0.03). The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4544 and £20 889, respectively.ConclusionsThe GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency.Trial registrationISRCTN34353836.

Dataset Information

Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial.

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Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial.

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