PILOT PROTOCOL A PROTOCOL FOR THE PILOT STUDY TO ASSESS THE FEASBILITY OF DELIVERING AAC SERVICES REMOTELY Initial version: 12.01.2013 RemotePilotPROTOCOLV1 Remote Delivery of AAC Services Pilot Protocol Page ii Version: 1 Table of Contents PILOT SUMMARY ............................................................................................................................................................... 1 1 2 3 INTRODUCTION ........................................................................................................................................................ 2 1.1 BACKGROUND ............................................................................................................................................................. 2 1.2 VIDEO CONFERENCING TECHNOLOGY .............................................................................................................................. 2 1.3 REMOTE ACCESS TECHNOLOGY....................................................................................................................................... 3 PILOT OBJECTIVES .................................................................................................................................................... 3 2.1 PRIMARY OBJECTIVE..................................................................................................................................................... 3 2.2 SECONDARY OBJECTIVES ............................................................................................................................................... 4 PILOT DESIGN ........................................................................................................................................................... 4 3.1 4 5 6 GENERAL DESIGN ........................................................................................................................................................ 4 SUBJECT SELECTION .................................................................................................................................................. 6 4.1 INCLUSION CRITERIA..................................................................................................................................................... 6 4.2 EXCLUSION CRITERIA .................................................................................................................................................... 6 4.3 SUBJECT RECRUITMENT AND SCREENING .......................................................................................................................... 6 STUDY PROCEDURES ................................................................................................................................................ 7 5.1 VIDEO CONFERENCING PILOTS ....................................................................................................................................... 7 5.2 REMOTE ACCESS PILOTS................................................................................................................................................ 7 DATA HANDLING AND RECORD KEEPING .................................................................................................................. 8 6.1 RECORDS MANAGEMENT AND CONFIDENTIALITY ............................................................................................................... 8 6.2 FEEDBACK FORMS ........................................................................................................................................................ 8 6.3 RECORDS RETENTION ................................................................................................................................................... 9 7 ETHICAL CONSIDERATIONS ....................................................................................................................................... 9 8 REFERENCES ............................................................................................................................................................. 9 9 APPENDIX ............................................................................................................................................................... 10 Remote Delivery of AAC Services Pilot Protocol Page iii Version: 1 Glossary of terms and abbreviations Aided Communication: Aided communication is a subset of AAC which refers to those methods of communication which involve using additional equipment, such as picture, letter or word boards or books and technology based systems such as voice output communication aids. Augmentative and Alternative Communication (AAC): AAC covers a range of techniques which support or replace spoken communication. It includes gesture, signing, symbols, picture, letter or word boards or books and technology based systems such as voice output communication aids. Video Conferencing: A video conference is a tool which allows two or more people to participate in a virtual meeting with video and audio links – it is like a telephone call with the addition of live pictures. Remote Access: Remote access tools allow someone, in this case a therapist, technician or equipment supplier to connect to a suitable device for example a computer or high tech communication aid, remote to make small changes to the software or hardware configuration of your device. This can often alleviate issues quickly without you having to leave your home. Communication aid: A communication aid is a piece of equipment which helps a person to communicate. These aids range from letter, word or picture boards to any technology based system such as a voice output communication aid. Pan Tilt Zoom (PTZ) Camera: A camera that is capable of remote directional and zoom control Training for people who use AAC: Training involves a period of time potentially over multiple sessions to help those involved learn about using the device with an expected outcome of an awareness of how to operate the device and integrate it with their current communication strategies to the extent which is useful for them. Training for professionals working with AAC: Training for professionals includes raising awareness and updating knowledge of AAC. This may include some or all of: information on AAC strategies, research and practice; AAC equipment and potential customisation and access options; and how to use and prepare the equipment for use. Training may also include information on any other aspects of providing a service for AAC and people who use AAC. Follow up AAC reviews: Review occurs in a separate period after an initial intervention. It is a process where a communication strategy employed since the previous intervention is considered and evaluated. The review will consider if this strategy is still appropriate and meets the needs of the person who uses AAC. A review may involve further assessments of the person’s communication strategies, abilities and access methods and address any changes that have occurred in the person’s situation. Remote Delivery of AAC Services Pilot Protocol Page iv Version: 1 Ongoing support for people who use AAC: The provision of any type of support for the person who uses AAC after the provision of the equipment or strategy. This could include further customisation, information or advice on effectiveness of use or suggestions of alterations to meet minor changes in the needs. Where there are more distinct changes in the needs of the person a review may be required. Assessment for aided communication: Assessment is an evaluation of the suitability of aided communication to match a person’s skills and capabilities for use. The assessment takes into account some or all of the cognitive, communicative, language, speech, physical and sensory abilities and needs including those that affect the method of accessing the devices for the person. It may also include equipment loan and trial. Remote Delivery of AAC Services Pilot Protocol page 1 Version 1 PILOT SUMMARY Title Protocol for pilots in the use of Video Conferencing and Remote Access to deliver AAC services remotely Methodology Design attributes such as single blind, double blind or open label; Randomized, placebo or active placebo control; cross-over design, etc. Study Duration December 2012 – March 2013 Study Centres Multi-centre study – North Bristol NHS Trust, ACE Centre South, Kent Communication and Assistive Technology Ashford and Canterbury, Chailey Heritage Clinical Services Objectives To pilot the use of appropriate Video Conferencing and Remote Access technology to perform end to end pilots from a variety of organisations with professionals and users. Main Inclusion Criteria Study Design Subject or proxy able to give informed consent Services and users meet technology eligibility criteria The remote service delivery pilots are non-randomised trials with two parallel streams to systematically evaluate the use of video conferencing and remote access tools in AAC services. The pilots will evaluate a range of session scenarios with a variety of network connections. RemotePilotPROTOCOLV1 Remote Delivery of AAC Services Pilot Protocol Page 2 Version: 1 1 INTRODUCTION This document is a protocol for pilots in the use of video conferencing and remote access technology to deliver Alternative and Augmentative Communication (AAC) services remotely. The pilots are being undertaken by the South Consortium partners as part of the Department for Education Project Objective 7, assessing the feasibility of delivering AAC services remotely. 1.1 B ACKGROUND The Department for Education is funding a national project to develop a model of AAC service provision fit for the future. Eight key objectives have been created for the project which will inform the commissioning of the 'hub and spoke' model of AAC services as recommended by the Office of the Communication Champion and Council (ref). Four regions, North, Midlands and East, London and South will work together to achieve the objectives. The consortium partners for the South, who are leading on objective 7, are Bristol Communication Aid Services, ACE South, Kent Communication and Assistive Technology (CAT), Chailey Heritage Clinical Services, and Dame Hannah Rogers Trust. The goal of objective 7 is to assess the feasibility of using technology to deliver AAC services remotely to those who have most difficulty accessing AAC services. The use of technology in this way is often referenced within the field of Telehealth and more specifically Telerehabilitation which describes the use of technology to deliver traditional rehabilitation services remotely (ref). The use of telerehabilitation tools has the potential to provide benefits for key stakeholders involved in AAC services including users, professionals and organisations. The use of technology in this way could be a useful tool for some users and organisations to enhance the way AAC services are currently delivered. Being able to deliver some services remotely could provide improved equity to services for those who have difficulty accessing services due to distance, time, cost and transport issues. This pilot will investigate the use of video conferencing and remote access technology to provide remote service delivery. 1.2 V IDEO C ONFERENCING T ECHNOLOGY Videoconferencing can be described as interactive communication using video and audio to communicate over long distances. It combines the interactivity of the telephone with the visual stimulation of video. Videoconferencing may also include graphics and data exchange. A large range of commercial systems are available, an evaluation tool was developed to identify suitable technology for use within AAC services. Following this evaluation Iocom’s Visimeet was deemed an appropriate software application. Iocom’s Visimeet has already been installed in many NHS sites across Remote Delivery of AAC Services Pilot Protocol Page 3 Version: 1 the country. (IOCOM, 2009) An important aspect for the trials is for the product to work within the N3 NHS network and external to this, Visimeet meets this criterion. Hardware requirements for video conferencing are of equal importance to ensure it meets the needs of AAC services. For the pilots appropriate hardware was selected: Pan Tilt Zoom (PTZ) camera (Misco) PTZ adapter High Definition USB camera (Logitech C920) USB Headset (Logitech) Echo cancellation microphone and speaker (Jabra) Laptop (Laptop (Acer Aspire M) 1.3 R EMOTE A CCESS T ECHNOLOGY Remote access or remote support can broadly be defined as the ability to connect to a host device or network from another device (the client) without being physically at the location of the host device. Once connected, remote access technology can enable various levels of control and access to data on the host device. This can range from full control to the ability to only view the host device. Remote access can be set up using a local area network (LAN), a virtual private network (VPN) or wide area network (WAN) such as the internet so that resources and systems can be accessed remotely. Typically remote access is utilised by IT professionals to connect to desktops and servers to manage networks and provide support. It has generally been established that organisations taking advantage of remote control technology have saved time, money and resources eliminating the need for IT staff to travel, reducing system down time and improving the efficiency of the IT organisation. If a model for using remote technology with high-tech communication aids can be established it could provide a useful tool for harnessing some of these advantages for services across the country. A large range of commercial systems are available, an evaluation tool was developed to identify suitable technology for use within AAC services. All the systems evaluated use the internet to establish the connection over a wide area network. Bomgar, Teamviewer and LogMeIn were three systems identified as suitable for the pilot. 2 PILOT OBJECTIVES 2.1 P RI MARY O BJECTIVE To assess the feasibility of delivering a range of AAC services remotely using appropriate technology. Remote Delivery of AAC Services Pilot Protocol Page 4 Version: 1 2.2 S ECONDARY O BJECTIVES To assess suitability of services and users for remote sessions To assess professional and service user acceptance of remote service delivery To identify barriers, limitations and solutions for remote service delivery in AAC services To assess cost comparisons of remote sessions and face to face appointments. 3 PILOT DESIGN 3.1 G ENERAL D ESIGN The remote service delivery pilots are non-randomised trials with two parallel streams to systematically evaluate the use of video conferencing and remote access tools in AAC services. The pilots will evaluate a range of session scenarios with a variety of network connections. Table 1 outlines the range of trial scenarios for video conferencing. Table 2 outlines the range of trial scenarios for remote access. Tables 1 and 2 summarise the potential activities for remote service delivery within AAC services. Due to the variety of activities AAC services provide these may not be an exhaustive list in terms of the type of session and interaction type. The pilots will involve several stages: 1. Identify services and users to participate in trials 2. Screen to ensure eligibility criteria for users, services and technology are met 3. Deliver trial packs to gain consent and deliver training 4. Undertake pre-trial testing for technical setup 5. Undertake trial according to trial procedures 6. Collect results for analysis Remote Delivery of AAC Services Pilot Protocol Page 5 Version: 1 Table 1: Trial scenarios for video conferencing pilots Interaction Type Type of Session Network Connections Training Organisation1 LAN - Organisation1 LAN - Single point session Meetings - catch up, client review etc Organisation1 - Organisation2 - Single point session Organisation1 - Home BB - Single point session Professional to Professional Home BB - Home BB - Single point session Organisation1 LAN - Organisation1 LAN - Multipoint session Organisation1 - Organisation2 - Multipoint session Organisation1 - Home BB - Multipoint session Organisation1 LAN - Organisation1 LAN - Single point session Organisation1 - Organisation2 - Single point session Organisation1 - Home BB - Single point session Professional(s) to Service User Initial Assessment Home BB - Home BB - Single point session Organisation1 LAN - Organisation1 LAN - Multipoint session Organisation1 - Organisation2 - Multipoint session Organisation1 - Home BB - Multipoint session Organisation1 LAN - Organisation1 LAN - Single point session Organisation1 - Organisation2 - Single point session Organisation1 - Home BB - Single point session Professional(s) to Service User Review Appointment/Follow Up Session Home BB - Home BB - Single point session Organisation1 LAN - Organisation1 LAN - Multipoint session Organisation1 - Organisation2 - Multipoint session Organisation1 - Home BB - Multipoint session Organisation1 LAN - Organisation1 LAN - Single point session Organisation1 - Organisation2 - Single point session Organisation1 - Home BB - Single point session Professional(s) to Service User Training Home BB - Home BB - Single point session Organisation1 LAN - Organisation1 LAN - Multipoint session Organisation1 - Organisation2 - Multipoint session Organisation1 - Home BB - Multipoint session Remote Delivery of AAC Services Pilot Protocol Page 6 Version: 1 Table 2: Trial scenarios for remote access pilots Type of Session Network Connections Organisation1 LAN - Organisation1 LAN - Single point session Service User Training Organisation1 - Organisation2 - Single point session Organisation1 - Home BB - Single point session Home BB - Home BB - Single point session Organisation1 LAN - Organisation1 LAN - Single point session Troubleshooting Organisation1 - Organisation2 - Single point session Organisation1 - Home BB - Single point session Home BB - Home BB - Single point session Organisation1 LAN - Organisation1 LAN - Single point session Software change/update Organisation1 - Organisation2 - Single point session Organisation1 - Home BB - Single point session Home BB - Home BB - Single point session Organisation1 LAN - Organisation1 LAN - Single point session Configuration Changes Organisation1 - Organisation2 - Single point session Organisation1 - Home BB - Single point session Home BB - Home BB - Single point session 4 SUBJECT SELECTION 4.1 I NCLUSION C RITERIA 1. Subjects capable of giving informed consent 2. Subjects who have an acceptable surrogate capable of giving consent on behalf of the subject 4.2 E XCLUSION C RITERIA 1. Services and users who do not meet technology eligibility criteria 2. Subjects declining remote service delivery 4.3 S UBJECT R ECRUITMENT AND S CREENING Users and services were recruited from investigating centres and through stakeholder days and questionnaires distributed as part of the wider project. Services and users were given trial packs with consent forms, handouts on equipment and training, and questionnaires for feedback and cost analysis. Remote Delivery of AAC Services Pilot Protocol Page 7 Version: 1 (See Appendix #). Services and users are required to meet eligibility criteria for network and data requirements in order to participate. 5 STUDY PROCEDURES 5.1 V IDEO C ONFERENCING P ILOTS 1. The service provider identifies an opportunity to deliver a session remotely. 2. The project worker from the South region arranges a time to discuss with the service provider the details of the project and the video conferencing system. The project worker assesses the technical eligibility of the proposed remote session. The service provider assess the suitability of delivering the session using video conferencing tools considering where applicable the user suitability. 3. Following initial screening the project worker delivers trial pack information to service provider to seek necessary consent from services and users. The trial pack also contains information for training for the session and equipment. 4. Once the necessary permissions and consent has been granted a date for the trial session is arranged. Prior to the trial date the project worker will work with local teams to setup and test Visimeet and where necessary hardware for both the host and remote sites. The project worker will document and record hardware details and network connections used. 5. On the day of the video conference session the project worker will act as administrator and technical support for the session. The project worker will ensure accurate and optimal setup of equipment and provide support for technical issues. The service provider will control functional aspects of the video conferencing system e.g. camera zoom and be responsible for the content of a session. During a session the project worker will record network statistics using tools provided by Visimeet. 6. Following the session the project worker will gather completed feedback forms from the lead participant at the remote and host sites. 5.2 R EMOTE A CCESS P ILOTS 1. The service provider identifies an opportunity to deliver a session remotely. 2. The project worker from the South region arranges a time to discuss with the service provider the details of the project and the video conferencing system. The project worker assesses the technical eligibility of the proposed remote session. The service provider assess the suitability of delivering the session using video conferencing tools considering where applicable the user suitability. Remote Delivery of AAC Services Pilot Protocol Page 8 Version: 1 3. Following initial screening the project worker delivers trial pack information to service provider to seek necessary consent from services and users. The trial pack also contains information for training for the session and equipment. This includes aspects of user authentication and security for approving remote access to a device. 4. The project worker will work with local teams to establish which software solution is to be trialled. The project worker will work with the local team to where necessary install trial applications on existing hardware and the device to be accessed remotely. The project worker will document and record hardware details and network connections used. 5. The service provider will determine suitable users and sessions for use of the remote access software. Often it is anticipated remote access sessions will take place on ad hoc basis e.g. troubleshooting an issue with a device. The project worker will provide technical assistance for setup and support prior and during sessions where required. The service provider will control functional aspects of the remote access session e.g. screen sharing and be responsible for the content of the session. 6. The project worker will gather completed feedback forms from the lead participant at the remote and host sites. 6 DATA HANDLING AND RECORD KEEPING 6.1 R ECORDS M ANAGEMENT AND C ONFI DENTIALITY Information about trial subjects will be kept confidential and managed according to the requirements of the Data Protection Act (1998). Data should be stored in line with local organisation policies taking part in the pilot. Data should be stored in a way that permits a complete retrospective audit if necessary. In line with local information governance guidance video and audio recording of remote sessions will be disabled for pilots in order to ensure compliance with guidelines of medical record policy. 6.2 F EEDBACK F O RMS The pilot feedback forms are the primary data collection instrument for the study. All data requested on the feedback forms must be recorded. All missing data must be explained. If a space on the feedback form is left blank because it is not applicable for this case, write “N/D”. Remote Delivery of AAC Services Pilot Protocol Page 9 Version: 1 6.3 R ECORDS R ETENTION Records recorded in the study will be retained in accordance to the local service provider policy and procedures. 7 ETHICAL CONSIDERATIONS In accordance with guidelines set out by the NHS National Patient Safety Agency, the pilots are part of a service evaluation and do not require Research Ethics Committee review. The pilots involve an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference. (National Research Ethics Service, 2010) The pilots are carried out in accordance with national regulations and local institutional policies and procedures. All subjects for this pilot will be provided a consent form describing this study and providing sufficient information for subjects to make an informed decision about their participation in this pilot. See Trial pack within appendix # for a copy of the Subject Informed Consent Form. 8 REFERENCES IOCOM, 2009. ICOM Case Study: Extending the Reach of Stroke Care: NHS use of Visimeet in the East of England. [Online] Available at: www.iocom.com/docs/EOE_nhs_case_study2.pdf [Accessed 14 February 2013]. National Research Ethics Service, 2010. Defining Research, London: NHS National Patient Safety Agency. 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