Telemedicine for the support of parents of high risk newborn infants
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To evaluate if the use of telemedicine technology to provide education and support for the families of newborn infants receiving intensive care effects the length of hospital stay.
Background
Telemedicine enables the practitioner or physician to deliver healthcare without being in the same physical location as the patient (Strehle 2006). One definition relevant to the pediatric population is provided by Spooner and Gottlieb is "the use of electronic communications technology to provide and support health care for infants, children, adolescents, and young adults when distance separates the practitioner from the patient, parent, guardian or referring practitioner" (Spooner 2004). In earlier usages of the term, telemedicine (which means "medicine at a distance") implies communication between doctors and patient in different physical locations where direct face‐to‐face consultation is not feasible using ancillary means of communication like telephone and radio (McLaren 1995).
More recently, the meaning of telemedicine has been expanded following the introduction of the Internet and other advances in electronic and information technologies (Currell 2000). The newer applications in telemedicine range from web‐based interactive image‐enriched patient‐specific information resources (Chan 2003) and teleconferencing with audio and video capabilities (Weiner 2001) to the use of electronic accessories in the operating room (Whitten 2004).Telemedicine can thus be seen as a subset within the wider field of medical informatics (Nagendran 2000). The terms "telehealth", "online health" and "e‐health" are now also being used interchangeably with telemedicine (Wootton 2001).
The two main forms of telemedicine are the synchronous or realtime variety (face‐to‐face) and the asynchronous variety where the information is recorded (Jaatinen 2002). In the synchronous variety, data, images and sound are transmitted live and the health professional may have direct video contact with the patient. In the asynchronous (store and forward technique), information like X‐Ray images may be acquired in one location and then reviewed in another at a later stage (Strehle 2006).
Telemedicine has been developed in countries like Canada (Roine 2001) and Norway (Pettersen 1999) where a relatively small rural population is spread over a large area, making face‐to‐face medical consultations difficult. The application of telemedicine has been reported in the delivery of primary care (Marcin 2004a; Marcin 2004b), child health (Shiffman 2001), specialist care in cardiology (Sable 2002) and home monitoring of stable chronic patients (Brennan 1997). However, the overall cost effectiveness of telemedicine in child health is still largely unproven (Strehle 2006a). In fact, a recent evaluation suggest that telemedicine is not a cost effective way of delivering healthcare (Whitten 2002)
Telemedicine applications for remote monitoring of infants in the Neonatal Intensive Care Unit (NICU) is technically feasible. A web‐based monitoring application for infants in the NICU (Shin 2003) has been described. However, in this study, the monitoring station was located within the NICU, although it would have been feasible for monitoring to be performed at some distance away from the NICU. The current model of delivery of care in the NICU is for the neonatologists to deliver care in person. However, telemedicine applications for adult intensive care units allow intensivists to deliver consultation when they are not physically at the patient's bedside (Rosenfeld 2000).
Currently the development of telemedicine in neonatal care has a different focus, targeting mainly the parents or family. Telemedicine support is needed in neonatal care because of the vast amount of specialised information available regarding the care of the sick newborn, the prognosis of these newborns and the roles and skills expected of the parents at discharge, given the limitations of what most parents can realistically absorb within their visiting time in the neonatal unit. Telemedicine should, therefore, aim not to lessen the parents' need to travel to the hospital, but to provide a portal through which they can access information pertinent to the care of their newborn infants at their own time and place of choice. Hopefully, better understanding by the parents regarding the care of their infants can contribute to improved outcomes. Daily updates may come in the form of "infant's diary" in an attempt to personalize the progress of the infants for the family. An example of this use of telemedicine is the "BabyLink" program, a web‐based program that automatically generates a daily update summarising the infant's clinical progress through a secure web‐based server (Freer 2005). An observational study (comparing two NICUs) has shown that telemedicine used to aid the turnaround time of neonatal echocardiography interpretation may reduce the length of hospital stay of very low birthweight infants (Rendina 1998). This may translate into benefits such as cost reduction from early neonatal discharges (Speer 1998; Spinner 1998).
A Cochrane review on the effectiveness of telemedicine versus face to face patient care found variable and inconclusive results, but pointed out the feasibility of conducting randomised‐controlled trials of telemedicine applications (Currell 2000). However, a lack of uniformity in the definitions of telemedicine has complicated the assessment of its effectiveness. For example, opinions vary on whether the use of telephone in a health care setting constitutes telemedicine (McLaren 1995; Wootton 2006; Currell 2000; Spooner 2004; Thrall 1998; Hersh 2001). The evolving characteristics and applications in telemedicine serve only to further broaden its definition. To derive a practical message on the effectiveness of telemedicine, systematic reviews may have to focus on a specific application or setting. This review examines one such application of telemedicine in the NICU that provides information, education and support to the families of sick newborns in the unit. This review will assess whether telemedicine, when applied as an additional resource, can enhance standard parental support.
Objectives
To evaluate if the use of telemedicine technology to provide education and support for the families of newborn infants receiving intensive care effects the length of hospital stay.
Methods
Criteria for considering studies for this review
Types of studies
Randomised and quasi‐randomised trials will be included. The unit of allocation can be either the individual parental set or centres.
Types of participants
Parents or caretakers of high‐risk newborn infants receiving intensive care (not depending on the distance from the NICU).
Types of interventions
Telemedicine technology focused on education and support to the parents or caretakers of newborn infants receiving intensive care
Essential requirements that defines the use of telemedicine.
i) The use of information and communication technology, such as Internet.
ii) The provision of dedicated information relevant to the care of the infants using the above technology.
iii) The information provided above must be tailored to the parents in the settings where the infant is cared for. A series of links to the commonly accessible health websites or search engines or simply an encouragement to use Internet will not be considered a telemedicine intervention.
iv) The intervention can include the use of non‐Internet based information technology (IT), such as regular access to interactive CD ROM on the care of the infants in the neonatal unit concerned.
v) The use of the telephone will be accepted as a "telemedicine" intervention only if it is used as an additional tool in providing information and education within a structured programme, run either by human or computer programmes, in conjunction with telemedicine applications as defined in points i) to iv), in addition to the standard telephone support given to the carers of the infants in the unit. For example, this could involve regular calls made by NICU staff to the carers at pre‐defined timing. Where applicable, subgroup analyses will be performed for studies using telephone only as intervention and for those using other forms of telemedicine applications.
The time of commencement and the duration of intervention will be accepted as variously specified by the authors of the included studies. However, subgroup analyses will be performed where applicable for studies with intervention applied during the following periods:
a) Only during the infant's primary hospitalisation
b) Only after the infant's discharge
c) Both during the infant's primary hospitalisation and after discharge
For comparison, studies will be considered that examine the following:
i) Comparison of telemedicine support intervention versus no support interventions
ii) Comparison of telemedicine support intervention versus standard support interventions
ii) Comparison between telemedicine and standard support versus standard support alone
For studies that fall into groups ii) and iii), the education and support measures for the control group will be accepted as variously defined by the authors of the included studies as long as these measures are clearly stated, are part of the standard educational and support measures for the unit/s concerned at the time of study, and thus are also applicable to the intervention group together with telemedicine.
Subgroup analyses will be performed where applicable for i) and ii).
Studies that compare only different types/forms of telemedicine against each other will not be included in this review.
Types of outcome measures
Primary outcome measures:
Length of hospital stay
Secondary outcome measures:
i. Families' knowledge on patient's condition, their satisfaction and confidence on the care of infants at discharge.
ii. Staff satisfaction on patient care
iii. Frequency of emergency hospital visits post‐discharge
iv. Breast feeding rate at discharge and duration of breast feeding
v. Frequency of access for infant health related resources by the families (including books, journal, CD ROM, Internet), taking into account the use of assigned telemedicine facilities
Search methods for identification of studies
The standard search strategy of the Cochrane Neonatal Review Group will be used. The following databases: MEDLINE (from 1966 ‐ present ), EMBASE (1980 ‐ present) using the search strategy below. The following Medical Subject Heading (MESH) terms will be used: "Telemedicine" and "Telemetry". Restriction terms; infants (0 ‐ 23 months), humans and clinical trials will be used. There will be no language restriction.
Search Strategy:
1 exp TELEMEDICINE
2 telemedicine.mp. [mp=title, original title, abstract, name of substance word, subject heading word]
3 exp TELEMETRY
4 telemetry.mp. [mp=title, original title, abstract, name of substance word, subject heading word]
5 telehealth.mp. [mp=title, original title, abstract, name of substance word, subject heading word]
6 1 or 2 or 3 or 4 or 5
7 limit 6 to (humans and "all infant (birth to 23 months)" and clinical trial)
The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) will also be searched.
The reference list of articles identified from the search will be reviewed. The authors will be approached and asked about ongoing trials and unpublished studies. Hand searching of the relevant journals will also be undertaken. Databases within ClinicalTrials.gov (http://www.clinicaltrials.gov) and the EudraCT (http://eudract.emea.eu.int/) websites will be searched.
The proceedings of conferences will be searched to identify relevant published abstracts of the Canadian Society of Telehealth, American Telemedicine Association, the International Society for Telemedicine, the Annual Conference of The International e‐Health Association, American Medical Informatics Association and MedInfo.
Data collection and analysis
The standard method of the Cochrane Collaboration as described in the Cochrane Neonatal Review Group guidelines will be used.
1. Eligible studies will independently selected by the investigators by applying predefined inclusion and exclusion criteria. Any disagreement will be resolved by discussion.
2. Data extraction and entry:
The review authors will separately extract, assess and code all data for each study using a proforma that was designed specifically for this review. For continuous data, any standard error of the mean will be replaced by the corresponding standard deviation.
3. Planned subgroup analyses:
Subgroup analyses are planned according to the setting of newborn care: neonatal intensive care unit, other in‐hospital setting, or community setting.
4. Criteria for assessing the methodological quality of the studies:
Each trial will be assessed for:
a) blinding of randomisation
b) blinding of intervention
c) whether there was complete follow‐up
d) blinding of outcome measurement and categorised them into "yes", "no" and "can't tell"
5. Statistical analyses:
Abstracted data will be entered into RevMan 4.2 software and the studies will be assessed for statistical heterogeneity. Meta‐analyses will be performed, if appropriate, using the fixed‐effect model. The standard methods of the Neonatal Review Group will be used to synthesise data using relative risk (RR), risk difference (RD) and number needed to treat (NNT) if there was a statistically significant reduction in RD and number needed to harm (NNH) if there was a statistically significant increase in the RD. The I2 test will be used to examine heterogeneity between trials. If heterogeneity is noted, sensitivity and subgroup analyses will be used to identify the source of heterogeneity.
For categorical data, relative risk, risk difference and NNT will be used with their respective 95% confidence intervals. For continuous data, weighted mean difference will be used with 95% confidence interval.
The methods described in Section 8.11. 2 of the Reviewers Handbook will be used to allow analysis at the level of the individual parent/infant while accounting for the clustering of the data. Such methods may include a 'multilevel model', a 'variance components analysis' or may use 'generalised estimating equations (GEEs)'. Effect estimates will be analysed using generic inverse variance method found in the RevMan 4.2 software.
