Implementation of Telemonitoring in Chronic Heart or Lung Failure
Implementation of Telemonitoring in Chronic Heart or Lung Failure
The aims of the study are to:

 1. Implement a telemonitoring programme in heart failure and obstructive pulmonary disease
 (COPD) /chronic respiratory patients by assessing the real world impact of on
 readmissions, consults, home visits, quality of life and economic endpoints.

 2. Explore the effects of telemonitoring across heart and respiratory groups with respect
 to i) factors that influence how patients integrate telemonitoring into their daily
 routines and self care behaviour and ii) how healthcare professionals use telemonitoring
 to aid decision- making.

 3. Understand the impact of telemonitoring on a variety of care pathways.
BACKGROUND

 Heart failure exacerbations consume 60-70% of costs for the condition and COPD exacerbations
 lead to 1:8 admissions so are costly to the NHS. The roll-out of telemonitoring in chronic
 disease is in line with NHS policy (Building Telecare in England; High Quality Care for All,
 national health service (NHS) next stage Darzi review).

 Despite systematic reviews, the Whole System Demonstrator programme and randomised control
 trial (RCT) evidence in heart failure, the outcome of implementing telemonitoring is unclear,
 the evidence base in COPD is less consistent, and few studies have included economic analysis
 or investigated cross speciality implementation. An Italian trial found that telemedicine
 reduces chronic respiratory admissions by a third, but the Italian health service differs
 from the united kingdom (UK) system. The european union (EU) Commission Communication on
 telemedicine 2009 has stressed the need for new deployments to contribute to the evidence
 base in respiratory disease, and include a detailed analysis of the process changes that
 determine success. Our group has previously shown that telemonitoring reduces unplanned
 admissions in heart failure patients, and that elderly patients were able to cope well with
 the equipment. The investigators have also had experience with telesupport in chronic
 respiratory patients.

 RATIONALE FOR CURRENT STUDY

 The study will assess the implementation of a telemonitoring programme to demonstrate

 1. whether home telemonitoring alerts patients and health professionals to exacerbations
 and reduces admissions,

 2. if it can be reasonably implemented cross specialty,

 3. the impact on quality of life of patients,

 4. interaction between healthcare professionals, robustness of algorithms and self efficacy
 in patients.

 The cross-over design allows sustained effects on self care and admissions to be assessed
 after removal of telemonitoring at 6 months in first groups treated. The acceptability of
 telemonitoring to healthcare workers and factors aiding and limiting integration into care
 pathways will be explored. Results should inform the commissioning of telemonitoring
 locally/nationally, facilitate buy-in from secondary and primary care teams, and optimise
 cost.

 OVERALL DESIGN

 Design: Crossover implementation study with patients allocated randomly 1:1 to telemonitoring
 or delayed entry to telemonitoring (after 6 months). All patients with receive standard
 optimal medical care according to European Society of Cardiology (ESC) Heart Failure
 guidelines, National Institute for Health and Care Excellence (NICE) COPD guidelines or other
 best practice care pathways as relevant to their condition. Each patient will receive home
 telemonitoring for 6 months. Comparisons will be carried out between patients with delayed
 entry (controls) and active telemonitoring. In the group receiving telemonitoring in first 6
 month period the investigators will be able to assess impact of withdrawal in subsequent 6
 months ie longer term benefit.

 TELEMONITORING

 Data from the monitors are delivered to the health care team members personal computer (PCs)
 using a dedicated broad band line which is installed in the patients home and is routed via a
 secure Philips Server. Each patient receives education in using the device until he or she
 and/or family/carer are fully confident. Via information displayed on their television screen
 each day patients are requested to answer interactive questions on level of breathlessness,
 sleep quality, phlegm production, wheeze. These results from each patient is used to create a
 warning system such that if all parameters are satisfactory this will appear as a green
 light; or for example, if a drop in arterial oxygen saturation and increase in wheeze, or
 increase in weight and increased breathlessness is seen the Motiva system will generate a red
 light for that patient which needs to be acted upon. It is an interactive system and
 therefore the healthcare team member can advise the patient through their screen (eg.
 increase dose of diuretic or oxygen flow rate, start antibiotic and steroids), or provide
 educational material eg. on inhaler use or exercise, and patients can respond. Patients will
 also be asked several questions once a week on whether they have consulted their general
 practitioner (GP), visited an Accident and Emergency Dept or been admitted to hospital.
Inclusion Criteria:

 -  Heart failure patients: age > 18 years who were in New York Heart Association class
 II-IV at time of discharge diagnosed by ESC guidelines.

 -  Respiratory patients: age > 18 years with diagnosis of COPD or respiratory
 insufficiency due to chronic respiratory disorder diagnosed by Consultant Respiratory
 Physician (eg. bronchiectasis, chest wall disease, neuromuscular disorder) and
 arterial oxygen saturation value during most recent admission for exacerbation of 90%
 or below (or partial pressure of oxygen in arterial blood (PaO2) 8.0 kilopascal (kPa)
 or below) on air, or who fulfill criteria for, and receive long term oxygen therapy.

 Exclusion Criteria:

 -  Age <18 years.

 -  Cognitive impairment sufficient to interfere with use of telemonitoring system.