None listed
Conditions
Brief summary
This project will deploy, operate and evaluate a state of the art, NBN enabled telehealth system for the management of chronic disease in the community in five different states and six different clinical trial sites in partnership with a variety of public and private sector health care service providers, including Local Health Districts, Medicare Locals and not for profit health care service providers. New methods for the automated risk stratification of patients will be developed that will facilitate future large scale deployment of NBN enabled telehealth services. Each clinical trial site will operate as a statistically independent case matched control trial with 25 Test patients supplied with NBN enabled Telehealth services and 50 patients receiving normal care. The overall patient cohort of 150 test patients and 300 control patients provide sufficient statistical power to ensure reliable and reproducible results across the whole health care sector. This project will provide the clinical and health economic evidence on how NBN enabled telehealth services can be scaled up nationally to provide an alternative cost effective health service for the management of chronic disease in the community. As well as demonstrating effective deployment of NBN enabled healthcare services, a number of critical success factors will be analysed. These include; * Health care outcomes * Health economic benefits * Impact on clinical work force availability and deployment * Human factors (acceptability, usability by patients, carers, nurses, GPs and administrators, impact on workplace culture) * Organisational change management and business processes Large scale deployment will also require automated risk stratification of patients according to their health status to ensure that the best possible response is orchestrated at the right time to avoid unnecessary hospitalisation. In the first year of the trial, CSIRO and its partners will develop a range of sophisticated automated risk stratification algorithms based on sophisticated statistical analysis and advanced data analytics. These were intended to be deployed and tested in the second year and the outcomes with respect to a range of healthcare outcomes, and socio-economic variables analysed and reported. However with the trial period now effectively shortened to 16 months, we will now be able to deploy the new risk stratification and decision support algorithms and evaluate useability and clinical acceptance of the service, but there will be insufficient time to rigorously evaluate the impact of this new facility on health care or socio-economic outcomes. This would require an additional eight months as initially planned. The third major contribution that will be the development and testing of a data architecture and communication framework consistent with NeHTA National eHealth Architecture, capable of transferring telehealth data to and from the PCEHR. Since the PCEHR will ultimately synchronise with GP systems and receive data from multiple sources, this development will firmly embed telehealth data recorded by patients at home as an important adjunct to the patient electronic health record. In addition, this project will analyse and report comprehensive health care outcome, health economic, work force and organisational change management data to provide the evidence that Government and treasury need to develop the policy and funding framework to facilitate the development of a national public and private sector market for the provision of telehealth services.
Interventions
At home telehealth service including vital signs monitoring using the TMC Home device (TGA, FDA approved, CE marked) administration of clinical questionnaires and video conferencing capability. Vital signs recorded include auscultatory blood pressure, single lead ecg, spirometry, blood glucose, pulse oximetry, body temperature and body weight.) Data uploaded to clinical web site for processing and review by clinical staff. Capability for setting thresholds and automated alarms.
Patient is prompt
At home telehealth service including vital signs monitoring using the TMC Home device (TGA, FDA approved, CE marked) administration of clinical questionnaires and video conferencing capability. Vital signs recorded include auscultatory blood pressure, single lead ecg, spirometry, blood glucose, pulse oximetry, body temperature and body weight.) Data uploaded to clinical web site for processing and review by clinical staff. Capability for setting thresholds and automated alarms. Patient is prompted to take vital signs and answer questionnaires on a daily basis. The monitoring period is at least 12 months, subject to availability of NBN connectivity. Adherence is monitored through automated analysis of computerised logs and routine surveillance of incoming data by one or more clinical care coordinators Training Comprehensive training on installation and use of the TMC Telehealth system was undertaken off-site over a three day period to Project Officers and Clinical Care Coordinators nominated form each trial site. These train the trainer sessions were carried out by trained and experienced Telemedcare staff. Once patients consent and NBN connectivity to their home is provided, the TMC system is installed by the trained Project Officer with telephone support by TMC staff if necessary. Because of the intuitive patient interface and large graphical display, patient training in use of the TMC system typically requires less than an hour. For the first week of monitoring, the quality of patient data being received is carefully reviewed and remedial action is taken via telephone and video conference to correct any problems with measurement technique. As the graphical data is recorded, it is easy to identify and remedy errors in measurement technique. Video Conferencing The TMC system provides video conferencing capability between the patient and any member of his/her care team. Video conferencing however is not a formal part of the intervention and is used on a as-needed basis to keep in touch with the patient, review patient data, manage any patient queries and improve measurement technique. Questionnaires A comprehensive questionnaire is delivered to Test and Control patients at the start and at the end of the trial. This questionnaire is a compendium of the standard CSIRO Screening Medical Questionnaire available on; http://my.csiro.au/Support-Services/Human-Research-Ethics-in-CSIRO/Health-and-Medical-Research-Ethics/Human-Research-Ethics-Committee.aspx#1 and a number of other validated questionnaires as described below; Section 1 Q1-13 *CSIRO Demographics Questionnaire + additional trial specific questions Section 2 Q1-5 CSIRO Demographics Questionnaire + additional trial specific questions Section 3 Q1-2 CSIRO Demographics Questionnaire Q3-7 *^Selected questions from Living with Diabetes Study1 Q8-12*^Selected questions from Fat and Fibre Barometer2 Section 4 Q1-9 Active Australia3 Section 5 Q1-10 Kessler 104 Section 6 Q1-16 Dimensions from HeiQ5 Section 7 Q1-6 EQ-5D6 Section 8 Q1-5 Dimensions from HeiQ5 Section 9 Q1-8 Morisky Medication Adherence7 *Additional questions were added relating to level of education, marital status, household earnings, social support computer skills, use of social media, NBN status, health care services utilised *^These questions will not be scored, but only used for comparison between groups. References 1. Donald M, Dower J, Ware R, Mukandi B, Parekh S, Bain C. Living with diabetes: Rationale, study design and baseline characteristics for an australian prospective cohort study. BMC Public Health. 2012;12:8 2. Wright JL. The fat and fibre barometer, a short food behaviour questionnaire: Reliability, relative validity and utility. Australian Journal of Nutrition and Dietetics. 2000;57:33-39 3. Australian Institute of Health & Welfare. The active australia survey: A guide and manual for implementation, analysis and reporting. Canberra; 2003. 4. Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychological medicine. 2002;32:959-976 5. Osborne RH, Elsworth GR, Whitfield K. The health education impact questionnaire (heiq): An outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions. Patient Educ Couns. 2007;66:192-201 6. Group EuroQoL: a new facility for the measurement of health-related quality of life. Health Policy, 1990. 16: p. 199-208. 7. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67-74 A career stress questionnaire will be administered to the carer of test patients at the start of the project, mid point and exit point. During the trial the following questionnaires are administered using the TMC device at the frequency indicated; A. Quality of Life ( EQ5D) on a weekly basis B. The Mental Health (K10) on a monthly basis C. Social Isolation, Medical Adherence, Self Care : administered @ mid point e.g 6 month. A CHF and COPD clinical questionnaire is also administered on a daily basis to appropriate patients, to assess the patient's own perception of their condition. These data are also used as part of the risk stratification research being undertaken in this trial. The 5-6 questions asked were developed by Clinicians at the Austin Hospital for an earlier trial and have been adopted for this trial.
Sponsors
CSIRO ICT Centre
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Potential subjects must be known to a Chronic Disease Management, Coordinated Care or Connected care program operating in the area and must be in the care of a carer, community nurse and GP. Patients on EACH packages are specifically excluded. 2. Patients will be identified by way of disease group (ICD Code), by age and by frequency of admission from Hospital Records from Hospitals in each catchment area. 3. Chronic conditions included: Diabetes, Congestive heart failure (CHF), Coronary Artery Disease (CAD), Chronic Obstructive Pulmonary Disease (COPD) and Hypertension (High blood pressure) as defined by the relevant ICD Codes. Exclusions: Cancer, Neuromuscular (MS, Parkinsons etc) or Psychiatric conditions are not classified as suitable chronic conditions for the purpose of this study. 4. Patients will be selected as potential participants in the program if they are: i. Aged as 50 years old and over ii. Have a cognitive capacity equivalent to an MMSE–2 score > 25. iii. Not on renal dialysis or chemo-therapy. Have had either iv. At least two unplanned acute admission in the last 12 months with one or more chronic conditions listed in (3) as their principal diagnosis: or v. At least four (4) unplanned acute hospital admission over the previous 5 years, with one or more chronic conditions listed in (3) as their principal diagnosis:
Exclusion criteria
Cancer, Neuromuscular Disease (MS, Parkinson’s etc) and Mental Health conditions are not classified as suitable chronic conditions for the purpose of this study
Outcome results
None listed