Design of a multi-site multi-state clinical trial of home monitoring of chronic disease in the community in Australia

Celler, Branko G.; Sparks, Ross; Nepal, Surya; Alem, Leila; Varnfield, Marlien; Li, Jane; Jang-Jaccard, Julian; McBride, Simon; Jayasena, Rajiv

doi:10.1186/1471-2458-14-1270

Cited by 35 publications

(38 citation statements)

References 23 publications

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“…The clinical trial protocol for this study was approved by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Research Ethics Committee (HREC) (Approval Number 13/04, March 25, 2013) as well as 5 other local HRECs. A journal article on the clinical trial design has been previously published [ 13 ].…”

Section: Methodsmentioning

confidence: 99%

“…A before and after control intervention (BACI) design was used where control patients were matched to each test patient. This design [ 13 - 16 ] is well known in environmental intervention studies but is less known for health interventions. However, it has theoretical justifications for studies involving heterogeneous populations and has been successfully applied in many environmental intervention studies [ 14 - 16 ].…”

Section: Methodsmentioning

confidence: 99%

“…Candidates were eligible to participate in the study if they met inclusion criteria which were comprehensively described in an earlier publication [ 13 ] but are mentioned here briefly for convenience: age 50 years and older; 2 or more unplanned acute admissions during the last 12 months or 4 or more unplanned acute admissions during the previous 5 years, with a principal diagnosis of chronic obstructive pulmonary disease, coronary artery disease, hypertensive diseases, congestive heart failure, diabetes, or asthma. Eligible patients could be under the care of a community nurse or PCP or participants in a government care program other than special targeted programs to support individuals with high-care needs.…”

Section: Methodsmentioning

confidence: 99%

“…However, experience in Australia with the deployment of at-home telemonitoring services is very limited [ 11 - 12 ]. Most trials are small scale and lack detailed analysis of key success factors such as health care outcomes, health economic benefits, impact on clinical work force availability, and acceptability by patients, carers, nurses, primary care physicians (PCP), and health care managers as well as the effect of workplace culture and capacity for organizational change management [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

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Impact of At-Home Telemonitoring on Health Services Expenditure and Hospital Admissions in Patients With Chronic Conditions: Before and After Control Intervention Analysis

et al. 2017

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BackgroundTelemonitoring is becoming increasingly important for the management of patients with chronic conditions, especially in countries with large distances such as Australia. However, despite large national investments in health information technology, little policy work has been undertaken in Australia in deploying telehealth in the home as a solution to the increasing demands and costs of managing chronic disease.ObjectiveThe objective of this trial was to evaluate the impact of introducing at-home telemonitoring to patients living with chronic conditions on health care expenditure, number of admissions to hospital, and length of stay (LOS).MethodsA before and after control intervention analysis model was adopted whereby at each location patients were selected from a list of eligible patients living with a range of chronic conditions. Each test patient was case matched with at least one control patient. Test patients were supplied with a telehealth vital signs monitor and were remotely managed by a trained clinical care coordinator, while control patients continued to receive usual care. A total of 100 test patients and 137 control patients were analyzed. Primary health care benefits provided to Australian patients were investigated for the trial cohort. Time series data were analyzed using linear regression and analysis of covariance for a period of 3 years before the intervention and 1 year after.ResultsThere were no significant differences between test and control patients at baseline. Test patients were monitored for an average of 276 days with 75% of patients monitored for more than 6 months. Test patients 1 year after the start of their intervention showed a 46.3% reduction in rate of predicted medical expenditure, a 25.5% reduction in the rate of predicted pharmaceutical expenditure, a 53.2% reduction in the rate of predicted unscheduled admission to hospital, a 67.9% reduction in the predicted rate of LOS when admitted to hospital, and a reduction in mortality of between 41.3% and 44.5% relative to control patients. Control patients did not demonstrate any significant change in their predicted trajectory for any of the above variables.ConclusionsAt-home telemonitoring of chronically ill patients showed a statistically robust positive impact increasing over time on health care expenditure, number of admissions to hospital, and LOS as well as a reduction in mortality.Trial RegistrationRetrospectively registered with the Australian and New Zealand Clinical Trial Registry ACTRN12613000635763; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364030 (Archived by WebCite at http://www.webcitation.org/6sxqjkJHW)

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Impact of At-Home Telemonitoring on Health Services Expenditure and Hospital Admissions in Patients With Chronic Conditions: Before and After Control Intervention Analysis

et al. 2017

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“…Relatively few randomized control trials on at-home telemonitoring of vital signs have been reported [3,11]. This paper reports findings on patient compliance in the recently completed Commonwealth Scientific and Industrial Research Organization (CSIRO) trial of home monitoring for chronic disease management, carried out at several locations along the east coast of Australia [12].…”

Section: Introductionmentioning

confidence: 99%

Patient Adherence to Scheduled Vital Sign Measurements During Home Telemonitoring: Analysis of the Intervention Arm in a Before and After Trial (Preprint)

Celler¹,

Argha²,

Varnfield³

et al. 2017

Preprint

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Background This paper presents findings on patient compliance with scheduled vital signs measurements in the recently completed Commonwealth Scientific and Industrial Research Organization (CSIRO) national trial of home telemonitoring of patients with chronic conditions, carried out at five locations along the east coast of Australia. ObjectivesTo investigate the ability of chronically ill patients to carry out a daily schedule of vital signs measurements as part of a chronic disease management care plan, over prolonged periods exceeding six months, and to explore different levels of compliance for different measurements, as a function of age, gender and supervisory models. MethodsPatients were required to monitor on a daily basis a range of vital signs determined by their chronic condition and co-morbidities. Vital signs included non-invasive blood pressure, pulse oximetry, spirometry, ECG, blood glucose level, body temperature and body weight.Compliance was calculated as the number days during which at least one measurement was taken over all days where measurements were scheduled. ResultsPatients were monitored on average for 302 days although some continued beyond 12 months. The overall compliance rate for all measurements was 64.8%. The compliance rates of patients monitored in hospital settings relative to those monitored in community settings were significantly higher for spirometry (69.3 versus 41.0%, p<0.001), body weight (64.5 versus 40.5%, p=<0.001) and body temperature (66.8 versus 55.2%, p=0.026), and the compliance rates for blood pressure (68.5 versus 59.7%, p=0.042), ECG (65.6 versus 56.5%, p=0.047) and pulse oximetry (67.0 versus 56.4%, p=0.018) were significantly higher in male relative to female subjects. Compliance with blood glucose measurements (58.1 versus 50.2%, p=0.237) was not significantly different overall. No statistical differences were observed between rates of compliance for younger patients group (≤70 years old) and older patient group (>70 yo). ConclusionsPatients with chronic conditions were able to record their vital signs at home at least once every two days over prolonged periods of time. Surprisingly, male patients maintained a higher compliance than female patients over time, and patients supervised by hospital based care coordinators reported higher levels of compliance with their measurement schedule relative to patients supervised in community settings. This was most noticeable for spirometry.

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Linking EWMA p Charts and the Risk Adjustment Control Charts

Sparks

2016

Quality & Reliability Eng

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This paper develops an adaptive exponentially weighted moving average (EWMA) chart that can be used as either a p chart for monitoring significant departures from in‐control non‐homogenous probabilities of failure or success or a risk‐adjusted control chart for success or failure of an event. An example of a risk adjustment process is monitoring the performance of a particular surgery over time where we need to adjust for the temporal changes in patient case mix. If the magnitude of this shift is known in advance, as would be the case in some hypothesis testing applications, then the paper offers a way of selecting the appropriate exponential weights to be efficient at detecting such a variable shift. The adaptive EWMA p chart is tested using extensive simulations. Processes for its efficient design are offered. The example application offers practitioners a means of evaluating a trial in real time rather than the traditional approach of evaluating the trial at the end of the study period. This is helpful in deciding how long the trial should run as well as potentially adapting the design over time as more is understood about the trial uncertainties. This may be particularly useful in evaluating expensive trials. Copyright © 2016 John Wiley & Sons, Ltd.

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Design of a multi-site multi-state clinical trial of home monitoring of chronic disease in the community in Australia

Cited by 35 publications

References 23 publications

Impact of At-Home Telemonitoring on Health Services Expenditure and Hospital Admissions in Patients With Chronic Conditions: Before and After Control Intervention Analysis

Impact of At-Home Telemonitoring on Health Services Expenditure and Hospital Admissions in Patients With Chronic Conditions: Before and After Control Intervention Analysis

Patient Adherence to Scheduled Vital Sign Measurements During Home Telemonitoring: Analysis of the Intervention Arm in a Before and After Trial (Preprint)

Linking EWMA p Charts and the Risk Adjustment Control Charts

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