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��ࡱ�>��	���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������y�	��(�bjbj��	*r�{�{����������<<<<<����PPP8�,�tP�<�(p����BBB<	<	<	<	<	<	<$p?�"B`-<<BBBBB-<<<���B<80/0/0/B�
<�<�<0/B<0/0/r#9T#:������]>��G�����*"w9�;z<<�<�9��B6-*�B#:#:�B<7:�0/BBB-<-<`.�BBB�<BBBB���������������������������������������������������������������������BBBBBBBBBB� :	A Cost Analysis of a Remote Home Support Programme for Infants with Major Congenital Heart Disease: evidence from 
a Randomised Controlled Trial.

Brian A. McCrossan1,2, Ashley M. Agus 3, Gareth J. Morgan1, Brian Grant1, Andrew J. Sands1, Brian G. Craig1, Grainne E. Crealey1, & Frank A. Casey1,2
1. Department of Paediatric Cardiology, Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland, UK.
2. Dept of Child Health,Queen�s University, Belfast, Northern Ireland, UK
3. Northern Ireland Clinical Trials Unit, The Royal Hospitals, Northern Ireland, UK.

Corresponding Author:
Dr. Brian A. McCrossan
Department of Paediatric Cardiology,
Royal Belfast Hospital for Sick Children,
Falls Road, Belfast,
BT 12 6BE

Tel:		0044 (0)28 90632001
Fax:		0044 (0)28 90632878
E-mail:	brianmccrossan@doctors.org.uk

Word Count
Body = 2,675
Abstract = 246
Tables = 5
Key words: Congenital Heart Disease, Telemedicine, Home Support, Economic Analysis

Email addresses:
 HYPERLINK "mailto:Ashley.Agus@nictu.hscni.net" Ashley.Agus@nictu.hscni.net
 HYPERLINK "mailto:hotmorgan@doctors.org.uk" hotmorgan@doctors.org.uk
 HYPERLINK "mailto:briangrant@doctors.org.uk" briangrant@doctors.org.uk
 HYPERLINK "mailto:hotmorgan@doctors.org.uk" hotmorgan@doctors.org.uk
 HYPERLINK "mailto:andrew.sands@belfasttrust.hscni.net" andrew.sands@belfasttrust.hscni.net
brian.craig@belfasttrust.hscni.net
 HYPERLINK "mailto:G.Crealey@qub.ac.uk" G.Crealey@qub.ac.uk
frank.casey@belfasttrust.hscni.net 


ABSTRACT

Objective
Paediatric cardiology is a highly centralised subspecialty with patients living often living large distances from the tertiary care centre. A tele homecare programme for infants with major congenital heart disease (CHD) was devised to support patients and families during the stressful and vulnerable period following discharge from hospital. This study aimed to describe the costs and potential savings of a telemedicine home support programme for infants with major congenital heart disease (CHD).
Methods
A randomized controlled trial was performed at a UK tertiary paediatric cardiology centre. Infants with major CHD discharged home were randomized to one of three groups: Two intervention groups (Video support and Telephone support) and one control group (standard care). Patients in the two intervention groups received regular, standardised remote consultations. Video support initially provided by ISDN lines and later by a home broadband (IP) connection. The main outcome measure was a comparison of total cost to NHS of  participants including cost of study interventions and health service utilisation.
Results
Significantly lower healthcare resource use, and therefore cost per patient, in the video group (�822) compared with telephone (�2,382) and control groups (�3,683). Mean difference/patient between video and telephone support groups was �1,563 (95% CI, �2624 to -�496). Mean difference/ patient between the video and control groups was �2,760 (95% CI, �5219 to �660). Mean difference/patient between the telephone and control group was �1197 (95% CI, �3843 to �1070). Providing video support was significantly more expensive by ISDN (�2,850) compared with IP (�1,372). The mean total cost to the health service (includng intervention costs) during the study period was lowest in the video group, when using an IP connection, (�2,271) compared with both telephone support (�2,447) and the control groups (�3,582).
Conclusions
 A home support programme facilitated by videoconferencing is associated with lower health care utilisation. The consequent reduction in healthcare costs offsets the set-up and running costs of the tele-homecare programme and may be cost saving to the health service.











BACKGROUND
Improvements in survival for a range of conditions across the paediatric spectrum e.g. congenital heart disease (CHD), cystic fibrosis, ex-premature infants and severe congenital gastro-intestinal defects have produced a cohort of patients requiring ongoing specialist care beyond discharge from hospital.1-4 Parental expectations have increased regarding the quality of life experienced by their child and the level of specialist input that should be provided. These expectations are unlikely to decline but rather to increase with time.  This is especially true of paediatric cardiology. 4, 5 In particular children with complex CHD, typified by single ventricle physiology, now have the possibility of life beyond the neonatal period.6 However, such patients are not �cured� but receive long-term palliation in the form of a staged surgical programme over several years. This patient group require particularly careful follow-up in early infancy and it seems logical that home support / monitoring could potentially contribute to the quality of care delivered.
Although there is good evidence that home monitoring is beneficial for adults with particular chronic illnesses7,8 there is a paucity of paediatric trials. For telemedicine to become widely disseminated and incorporated into routine practice, decision makers in healthcare (those who deliver and fund health services) require assurance that telemedicine provides good value for money.9 However, to date there has not been enough conclusive proof to convince decision makers that telemedicine will generate rates of return on investments.10
We conducted a randomised controlled trial of a telemedicine home support programme for infants with major CHD. This demonstrated that a telemedicine home support programme facilitated by videoconferencing was reliable, effective and associated with reduced healthcare utilisation.11 The cost analysis  was also touched upon in that publication. In this study we hope to describe the costs of implementing and running a telemedicine home support programme for infants with major CHD, to evaluate the cost of patient episodes and compare the overall cost to the health service from involvement in the home support programme.



METHODS
This study was performed at the department of paediatric cardiology, Royal Belfast Hospital for Sick Children (RBHSC). Ethical approval was granted from the Queen�s University Belfast Research Ethics� Committee. Informed consent was obtained from all participants. All paediatric cardiology admissions between August 2005 and October 2008 were considered for inclusion in the study. Patients were included if the attending paediatric cardiologist felt that the clinical condition of the patient would require significant support following discharge from hospital. The only exclusion criterion was if there was no fixed address in which to install the equipment. 
Study Groups & Randomisation Process
There were three study groups: two intervention- videoconference group and telephone group, and one control group. Participants were randomly allocated to one of the three study groups depending on the availability of videoconferencing equipment. If a videoconferencing codec was available, a 2: 1: 1 randomisation weighted towards the videoconferencing group was employed. If no codec was available, then participants were randomised on a 1: 1 basis between the telephone and control groups. Patients were enrolled for a predicted period of 10 weeks. However, there was some flexibility permitted depending on the clinical status of the patient.
Interventions
The intervention took the form of clinical consultations performed remotely by either videoconference or telephone. The videoconference consultation consisted of a clinical history and visual assessment of the patient. Pulse oximetry was obtained from patients whom variations in oxygen saturation were felt to indicate deviations in their cardiac status. Video consultations were arranged on a weekly or twice weekly basis depending on the wishes of the parents or clinician. The telephone consultations followed a parallel schedule and format to the videoconferences. The only difference was that the clinician was unable to visually assess the patient. Parents in this group were informed that they had been randomised to the control group and would still receive the same level of care from the paediatric cardiology team as if they were not involved in the study. 
Equipment
Commercially available telemedicine equipment was utilised. A Tandberg 880TM codec (Lysaker, Norway) in the hospital and a Tandberg 1000TM �Classic� (Lysaker, Norway) in the homes. The pulse oximeter distributed to selected patients was the  Masimo SET� (Neuchatel, Switzerland).
Transmission modality
Videoconferences were performed across standard telemedicine links. Initially, Integrated Systems Digital Network lines (ISDN 6, 384Kbps) were utilised as we had experience using this connection. During the latter 12 months of the study following pilot testing, the tele-link was changed to an Asynchronous Digital Subscriber Loop (256Kbps) which is a form of internet connection (IP). As the video group comprises patients receiving either ISDN or IP transmission, the costs of delivering each modality have been calculated separately. In a previous publication, the authors demonstrated equivalent effectiveness of ISDN and IP transmission in facilitating the home support programme.12 
Data collection
The perspective of the cost analysis was that of the payer (ie, the National Health Service; NHS), out-of-pocket costs borne by the family (such as travel costs) were not included. Each patient�s healthcare resource use (hospital bed days, accident and emergency department visits, general practitioner visits, paediatric outpatient visits, paediatric cardiology outpatient visits and specialist nurse contact (visits and telephone contact), whilst actively involved in the study, 
Resource use was valued in UK Sterling (�) by multiplying the quantity of each resource by its unit cost obtained from either the Unit Costs of Health and Social Care 200713 or the Department of Health National Schedule of Reference Costs (2006/2007) (Table 1).14 
The latter does not specify an individual cost for paediatric cardiology or general paediatric inpatient bed days. In view of the level of monitoring afforded to infants with major CHD in hospital (oxygen saturation, ECG and blood pressure monitoring), the most suitable bed type quoted was for a Special Care Baby Unit bed.  The cost of this bed type correlated with the actual cost of paediatric inpatient beds in district general hospitals in Northern Ireland. 



Table 1: Unit costs of health care services 
ResourceUnit costDetails GP visit�34.00per surgery consultation*Cardiac Liaison Nurse  �58.00per hour specialist nurse*         phonecall�5.806 mins*         home visit�24.1725 mins*Specialist Registrar �41.00per hour*Hospital inpatient stay  (bed days)�405.00per special baby care unit bed day*Accident & Emergency visit�111.00per high cost investigation*Paediatric outpatient visit�140.00per paediatric consultant led follow up attendance outpatient (face to face) **Paediatric cardiology outpatient visit�179.00per paediatric cardiology consultant led follow up attendance outpatient (face to face) **
*Curtis L. Unit Costs of Health and Social Care 2007 2008;2012(04/01).12
** Department of Health. NHS Reference Costs 2006-7. London: Department of Health, 2008. Curtis L, ed. Unit Costs of Health and Social Care. Canterbury: University of Kent: Personal Social Services Research Unit.], 200713





Videoconferencing  & Telephone group costs
Telemedicine service costs were based on the actual cost paid to the equipment suppliers (Questmark) and the IP or ISDN provider. Costs associated with the provision of the telemedicine service included the telemedicine equipment (teleconferencing machines, saturation monitors and routers), annual hardware support, reprogramming of routers, installation and connection of the ISDN or IP line, ISDN or IP line rental, ISDN call charges and the specialist registrar time input required for video conference calls. Equipment costs were annuitized at a discount rate of 3.5% over the useful life of the equipment to obtain an annual equivalent cost. Cost per patient to avail of the telemedicine service was calculated.  Whilst ISDN was used for 20 patients and IP for 15 patients, for the purposes of comparing costs across the three study groups, the cost of providing home support for each modality is based upon the combined total of 35 patients. It is reasonable to assume equal healthcare outcomes for ISDN and IP on the basis of the similar outcomes using each modality as described in the results section and previous publication.12The costs associated with the provision of the telephone intervention included only the time input of the specialist registrar for telephone calls. Cost per patient to avail of the telephone service was calculated. 

All analyses were performed using performed using STATA 12.0/IC  for Windows�. Since healthcare costs are typically skewed non-parametric bootstrapping was also used to calculate 95% bootstrap confidence intervals of differential mean costs.15  Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med, 19 (23) 3219 � 3236], drawing 1000 samples of the same size as the original sample separately for each group with replacement. Significance (p<0.05) was judged where the percentile confidence intervals of differential means excluded zero.  

RESULTS 
Between 31st August 2005 and 31st October 2008, 85 patients and families were eligible for inclusion in the study. Two families refused consent leaving 83 patients and families recruited to the study.  Thirty-five patients were randomised to the videoconferencing group (20 ISDN followed by 15 IP), 24 to the telephone group and 24 to the control group. Over the 41 month study period, 370 video-consultations were conducted. Family involvement in the video support group lasted on average 12.1 weeks (s.d. 5.7 weeks) with a mean video-consultation time of 10.5 minutes (s.d. 2.0 minutes).  In the telephone group, 273 consultations were conducted. Family involvement in the telephone support group lasted on average 11.3 weeks (s.d. 3.5 weeks) with a mean consultation time of 8.0 minutes (s.d. 1.3 minutes). Table 3 shows the healthcare resource of patients in each of the groups whilst involved in the study. The main differences relate to the number of inpatient days with patients in the control groups using eight times as many on average than those in the video-conferencing group. The difference is largely due to a single patient in the control group who used 61 bed days. However, when they are excluded from the analysis the mean inpatient bed days for the control group is still considerably higher (5.00).  Separate analysis of patients receiving home support via ISDN compared with IP demonstrates similar health seeking behaviours. The median number of health episodes for ISDN home support patients = 8.5 (IQR = 6 � 11) and for IP home support patients = 7 (IQR = 6 - 10.75)  [p = 0.25].11

Table 3 summarises the cost to the NHS of healthcare resource use patterns for the three study groups, excluding intervention related contacts with the specialist registrar. There were large differences in associated costs between the three groups. The highest mean cost was observed in the control group (�3581.92), followed by the telephone (�2385) 94 (2346.94)) and video group (�822.32). Mean healthcare costs were significantly lower in the video group compared with both telephone and control groups with differential mean costs of    �1562.52 (95% CI �2624.14 to  �496.44) and �2759.60 (95% CI �5218.94 to  �659.74)  respectively. There was no significant difference between the telephone and control groups with a differential mean cost of  �1197.08 (95% C.I  �3843.00 to  �1069.79). The main cost driver was inpatient bed days.

Table 2: Use of healthcare resources across groups. Values are mean (SD) numbers of resource items per patient. 
Video Group (n=35)Telephone Group(n = 24)Control Group (n = 24)GP visit2.97 ( 2.98)5.75 (4.45) 2.29 (2.73)Cardiac Liaison nurse phone call2.17 (2.79)2.67 (2.66) 3.87 (2.35)Cardiac Liaison nurse home visit0.23 (0.55)0.5 (0.88)0.42 (0.76)Inpatient bed days0.89 (3.03)4.21 (5.35)7.29 (14.25)Accident & Emergency visit0.26 (0.51)1.08 (1.41)0.63 (1.01)Paediatric Outpatient visit0.69 (1.21)0.92 (2.60)1.88 (3.30)Paediatric Cardiology Outpatient visit 1.23 (0.91)1.17 (0.76)1.04 (1.04)

Table 3: Summary of mean (SD) and differential mean (95% CI) healthcare resource use costs (�) across three study groups. Costs are also presented as a percentage [%] of total health care costs. 

Video Group
(n=35)Telephone Group
(n=24)Control Group
(n=24)
Mean (SD)% total 
Mean (SD)% totalMean (SD)% totalGP visit101.06 (101.16) [12.3%]195.50 (151.14)[8.2%]77.92 (92.70)[2.2%]Cardiac Liaison nurse phone call12.60 (16.19)[1.5%]15.47 (15.46)[0.6%]22.48 (13.61)[0.6%]Cardiac Liaison nurse home visit5.52 (13.22)[0.7%]12.08 (21.38)[0.5%]10.07 (18.74)[0.3%]Inpatient bed days358.71(1225.96)[43.6%]1704.38 (2166.15)[71.5%]2953.12 (5770.34)[82.4%]Accident & Emergency attendance28.50 (56.10)[3.5%]120.25 (156.69)[5.0%]69.37 (112.50)[1.9%]Paediatric outpatient visit 96.00 (168.10)[11.7%]128.33 (364.41)[5.4%]262.50 (462.14)[7.3%]Paediatric cardiology outpatient visit 219.90 (162.94)[26.7%]208.83 (136.29)[8.8%]186.45 (186.46)[5.2%]Total healthcare costs 822.32 (1486.11)[100%]2384.84 (2346.94)[100%]3581.92 (5690.57) [100%]Differential mean costs (95% CI*)Video - Telephone-1562.52 (-2624.14 to -496.44)Telephone - Control-1197.08 (-3843.00 to 1069.79)Video-Control-2759.60 (-5218.94 to -659.75)* 95 % bootstrap percentile confidence intervals, based on1000 bootstrap resamples 

Cost of implementing and running videoconferencing home support
Table 4 summarises the cost of providing a home support programme to infants with major CHD via ISDN compared with IP. The cost of using ISDN is more than double that for internet transmission. The main cost driver in ISDN was the running costs � specifically the line rental. The line rental per patient for ISDN transmission costs �1,188 due to the high monthly rental charge and 12 month minimum contract. The corresponding cost for internet transmission is �52.


Table 4: Cost summary of providing home support via ISDN compared with IP (�)
ISDN (n = 35)IP (n = 35)HospitalHomeHospitalHome
Fixed CostsVideoconferencing
 equipment installation395395395395
Line installation395395154154Internet Router 
(re-programmed)n/an/a025Fixed costs per patient22.5779015.69574Total per patient812.57589.69
Capital Costs
(Annual cost)Videoconferencing
codec1,438.222,192.216,4952,475
Technical support for codec595595595595Pulse oximeter0442.870442.87Internet Routers (new)n/an/a236.870Annual capital costs 2,033.225,015.082,270.095,015.08Total Annual costs7,048.297,285.16Total per patient 
(10.17 patients per year)692.97716.26
Running CostsLine rental4,752.001,188.00483.0051.91
Phone calls020.3600Running costs per patient135.771,208.3613.8051.91Total per patient1,344.1365.71
Total cost per patientFixed costs
Capital costs
Running costs
2,849.67
1,371.66


Total cost to health service 
Table 5 summarises some of the most important results: the total cost to the health service during active involvement in the study. The costs are calculated by adding the cost of the intervention (none in the control group) and cost of investigator�s professional time and cost of health service use. The cost difference between ISDN 6 and ADSL transmission is highlighted in this analysis. If ISDN 6 transmission is used then videoconferencing care is the most expensive option. However, if internet transmission is employed then videoconferencing care becomes the least expensive option. A home support programme for infants with CHD facilitated by videoconferencing using IP  is cost saving. Total mean costs were lower in the video (IP) group compared to both the telephone and control groups with mean differences of �175.71 (95% CI; �1241.46 to �896.35) and �1310.65 (95% CI; �3774.93 to 793.55) respectively. Home support via telephone consultations was also cost saving compared with the control group with a significant difference in mean costs of �1134.94 (95% CI; �3778.63 to �1131.61)  
Table 5: Mean (SD) total cost (�) to health service of patients across the three study groups
GroupVideo (n=35)*Telephone(n=24)Control (n=24)ISDNIPMean cost of healthcare resource use / patient (see Table 3)822.32 (1486.11)822.32 (1486.11)2,384.84 (2346.94)3581.92 (5690.56)Mean cost of investigator time (Specialist registrar) / patient77.29 (43.20)77.29 (43.20)62.14 (27.16)0Mean cost of intervention delivery / patient (see Table 4)2,849.671,371.6600Total mean cost to NHS per  patient3,749.28 (1488.63))2,271.27 (1488.63)2,446.98 (2351.56)3581.92 (5690.57)Differential mean (95% CI**) costsVideo (ISDN) - Control167.36 (-2296.92 to 2271.57) Video (IP) - Control-1310.65 (-3774.93 to 793.55)Telephone - Control-1134.94 (-3778.63 to 1131.61)Video (ISDN)-Telephone1302.31 (236.55 to 2374.35)Video (IP) - Telephone-175.71 (-1241.46 to 896.34)*Cost to provide service per patient calculated as of all video patients (n=35) used either ISDN or IP connection.
** 95 % bootstrap percentile confidence intervals, based on1000 bootstrap resamples


DISCUSSION
The results of this study demonstrate that a remote home support programme, facilitated by videoconferencing, for infants with major CHD may be cost saving. This is despite relatively high start-up costs. The price difference in transmission modality is clearly highlighted as the main cost driver. However, telemedicine hardware and transmission costs have decreased since this study was conducted. The savings are derived from significant reductions in health service use. The costs and savings of developing similar programmes in different health systems will obviously vary, depending largely on health care costs. The focus of this study is the economic evaluation of tele-homecare. However, there are obvious additional benefits to families and patients in decreasing hospital admission and attendance at clinics, for example, reduced family disruption and less exposure to infection. 
Improvements in diagnostic imaging and innovations in surgical technique along with intensive care, have revolutionised the prognosis for children with major congenital heart disease.4, 5 However, many patients, in particular those with single ventricle physiology, are not �cured� but receive long-term palliation in the form of a staged surgical programme over several years. The most vulnerable period for these patients is between the first and second surgical stages.16 At discharge there may be ongoing clinical issues which may not require medical attention but are an added stress to parents e.g. feeding difficulties, ongoing cyanosis and inter-current viral infections. In this setting, it is understandable that parents are extremely anxious and in want of support and reassurance. It seems logical that members of the paediatric cardiology team who have been involved in the daily management of these patients are ideally placed to monitor the patient�s progress and deal with any problems as they arise.
The arguments for tele-homecare in pediatric cardiology are readily transferrable to other pediatric specialities. By their very nature, patients under the care of a pediatric subspecialist have complex problems requiring expertise provided by a small cadre of professionals and are, geographically, widely spread. We believe that many subgroups of pediatric patients could benefit from tele-homecare programmes. For example infants born very prematurely or with severe gastro-intestinal defects, children with severe respiratory conditions such as brittle asthma or cystic fibrosis and patients with life limiting illnesses such as neuro-degenerative disorders, severe epilepsy, home ventilation and children receiving palliative care.
However, in order to implement a new method of delivering health care evidence is necessary to demonstrate its safety, clinical benefit and increasingly its cost. 17 Whilst tele-homecare and home monitoring has become established in some adult specialties with a growing evidence base, to date there have been no good quality research in a paediatric setting.8,18-24 Systematic reviews of pediatric tele-homecare trials conclude that most studies are small and / or methodologically flawed.25 Miyasaka et al published a promising pilot study of a tele-homecare project involving 10 patients receiving home ventilation. The intervention was associated with a reduction in unscheduled medical care.26 A group from Boston reported a randomised control trial of a pre-discharge, e-learning package, along with scheduled audio-visual connections between cot and home, for very low birth weight babies. Unfortunately, there was no significant difference in discharge timing and the study was not developed to incorporate post-discharge support.27 Perhaps the most effective home monitoring programme in paediatrics was developed by a Wisconsin group. Ghanayem et al postulated that mortality risk could be predicted between first and second surgical stages of infants with hypoplastic left heart syndrome, by identifying a deterioration in physiological status from daily monitoring of weight and pulse oximetry. There was significantly less mortality observed during the 15 month intervention period compared with the preceding 50 month control period (0% vs 16%, p = 0.039).28-30
The results of this study are somewhat limited by a lack of cost-utility/ effectiveness data and the interval between study completion (October 2008) and publication. However, as telemedicine costs have reduced and health service costs have increased in the interval, the conclusions remain valid. Recent advances in voice-over IP services such as SkypeTM and FaceTimeTM are exciting opportunities for tele-homecare but issues around security and picture quality require formal evaluation before being rolled out into routine practice. 

Conclusion
A telemedicine home support programme for infants with major CHD is known to be associated with high levels of parental / professional satisfaction and reduces health service utilisation. This study also indicates that such a programme may be cost saving to the health service. Further similar research across other paediatric subspecialties is important to persuade health commissioners to invest in tele-homecare for children.

	








Funding: This work was supported by: (1) The Paediatric Cardiology Charitable Funds of
the Royal Belfast Hospital for Sick Children; was paid the research salary. (2) Questmark
Limited video-conferencing company. This took the form of not charging for the use of the
video-conferencing equipment and technical support. It also included paying the cost of
phone line rental. None of the researchers have received any payments from this company.
Competing interests: This study was partially funded by a videoconferencing
company Questmark limited.
Ethics approval: This study was conducted with the approval of the research ethics
committee of Queen�s University, Belfast.



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