Background
Trauma injuries, including traumatic brain injuries (TBI) and spinal cord injuries (SCI) are a leading cause of disability (Vos et al., Reference Vos T, Naghavi, Lozano, Michaud, Ezzati, Shibuya and Abraham2013). Community participation is a common goal of rehabilitation following traumatic injuries (TI), enabling a resumption of life patterns and meaningful engagement in chosen activities (Barclay, McDonald, & Lentin, Reference Barclay, McDonald and Lentin2015; Liddle, Hayes, Gustafsson, & Fleming, 2014; Williams, Rapport, Millis, & Hanks, Reference Williams, Rapport, Millis and Hanks2014). The International Classification of Functioning and Disability (ICF) (World Health Organization, 2001) provides a framework in which community participation can be considered. Activities are the execution of a task or action by an individual. Participation is defined as the performance of people in activities across social life domains, through interaction with others. Community participation, considered in the ICF framework, is the performance of an individual in activities across the domains of (1) domestic life; (2) interpersonal life (consisting of formal and informal social relationships, family relationships and intimate relationships); (3) major life activities including education (informal, vocational training and higher education) and employment (remunerative and non‐remunerative, excluding domestic work); and (4) community, civic and social life (including religion, politics, recreation and leisure, hobbies, socialising, sports, arts and culture); in the context of the community in which they live.
Community mobility and transportation is one of the factors that has an influence on the success of community participation through access to health care services, independence and participation in daily activities (Classen et al., Reference Classen, Levy, McCarthy, Mann, Lanford and Waid-Ebbs2009; Norweg, Reference Norweg2011; Rapport, Hanks, & Bryer, Reference Rapport, Hanks and Bryer2006). Driving, a form of transportation, has been identified by people with TBI and SCI, as a key activity to maximising community participation (Liddle et al., Reference Liddle, Fleming, McKenna, Turpin, Whitelaw and Allen2012; Norweg, Reference Norweg2011). Commonly driving is the most accessible and highly valued form of transport, particularly so for the generally younger and male demographic of people acquiring a TBI or SCI injury (Cairns, Harmer, Hopkin, & Skippon, Reference Cairns, Harmer, Hopkin and Skippon2014).
Driving is a complex task involving a high level of physical, sensory, perceptual and cognitive functions integrated in an unpredictable and challenging environment. The ability to drive safely can be compromised after TI, with changes in physical functions, visual abilities (Ross, Ponsford, Di Stefano, & Spitz, Reference Ross, Ponsford, Di Stefano and Spitz2015), judgement and attention in TBI (McCrea et al., Reference McCrea, Iverson, McAllister, Hammeke, Powell, Barr and Kelly2009), and sensory awareness and muscle strength in SCI. Research indicates that a proportion of people will return to driving at some stage post-trauma injury, with rates of between 36 (Hawley, Reference Hawley2001) and 50% (Pietrapiana et al., Reference Pietrapiana, Tamietto, Torrini, Mezzanato, Rago and Perino2005) following TBI and 36.5% (Norweg, Reference Norweg2011) following SCI. Thus, at least half of the population who sustain severe TBI and 63% of people following SCI are unable to return to driving.
Stopping driving following complex trauma injuries is associated with emotional, identity, transport and participation related needs (Liddle et al., Reference Liddle, Fleming, McKenna, Turpin, Whitelaw and Allen2012). Furthermore, driving cessation leads to a reduced quality of life for not only the individual who has stopped driving, but also for carers or family members (Liddle et al., Reference Liddle, Fleming, McKenna, Turpin, Whitelaw and Allen2012). Following a significant life event such as TBI and SCI, adjustment to resume life roles is required by the individual to their changed circumstances (Liddle, Turpin, Carlson, & McKenna, Reference Liddle, Turpin, Carlson and McKenna2008). Adjustment to driving cessation has been demonstrated to be an important component to successful community participation, and a unique and continuing experience for individuals with trauma injuries (Liddle et al., Reference Liddle, Fleming, McKenna, Turpin, Whitelaw and Allen2012).
Research demonstrates that life roles, such as being a driver, are important for life satisfaction after injuries, such as TBI and SCI (Juengst et al., Reference Juengst, Adams, Bogner, Arenth, O'Neil-Pirozzi, Dreer and Wagner2015). Future studies need to examine participation in life roles; moreover, the personal importance and changes in these specific life roles (for example, driving and community mobility) after trauma injuries. Furthermore, the development of education and intervention programmes to address these specific life roles are critically important to life satisfaction after brain injury (Juengst et al., Reference Juengst, Adams, Bogner, Arenth, O'Neil-Pirozzi, Dreer and Wagner2015). Effective intervention to facilitate community mobility in the context of driving cessation needs to thus target the emotional, social and practical issues in a personalised way (Liddle et al., Reference Liddle, Fleming, McKenna, Turpin, Whitelaw and Allen2012), specifically in relation to the life role of driving and community mobility to be effective.
Currently in rehabilitation individualised community mobility intervention is not routinely provided (Liddle et al., Reference Liddle, Hayes, Gustafsson and Fleming2014a). Rehabilitation professionals generally offer community mobility interventions comprising of driving assessment, information detailing alternative forms of transport available and the coordination of multidisciplinary support (Liddle et al., Reference Liddle, Fleming, McKenna, Turpin, Whitelaw and Allen2012 , Reference Liddle, Hayes, Gustafsson and Fleming2014a). The requirements of a potentially successful intervention to maximise community mobility for people following trauma injuries, which addresses the criteria of both ongoing and individualised, would involve a combination of (1) information provision; (2) support to facilitate adjustment and decision making; (3) goal setting and (4) practical support to use alternative transport, in order to maximise participation in valued roles.
The CarFreeMe intervention (http://carfreeme.com.au/) is a community-based education and support programme, developed in Queensland, Australia, which has been demonstrated in a randomised controlled trial to increase community mobility and transport satisfaction in older adults following driving cessation (Liddle et al., Reference Liddle, Haynes, Pachana, Mitchell, McKenna and Gustafsson2014b). CarFreeMe TI, where the TI is Traumatic Injuries, a modified version of the programme, was developed following further research relating to the specific needs of people who are unable to drive, resulting from trauma injuries. The CarFreeMe TI intervention programme consists of seven modules run over six weeks, including sessions on adjusting to losses and changes (including mindfulness and relaxation techniques, coping with caregiving); experiences of stopping driving; alternative transport; lifestyle planning (how to stay involved without driving, planning for the future) and advocacy and support. Group activities take the form of information sharing, group discussion, speakers, practical sessions and outings facilitated by an occupational therapist and a peer leader (a person living with a TBI or SCI and no longer driving). The order and focus within modules are adapted depending on individual goals, which are set before the first session.
Currently, no intervention programmes, such as CarFreeMe TI regarding driving cessation and community mobility are available for people with complex trauma injuries in Australia in standard practice. There are high costs to the community for providing rehabilitation and community support to people following TBI and SCI (Access Economics, 2009; Scholten, Haagsma, Panneman, Van Beeck, & Polinder, Reference Scholten, Haagsma, Panneman, Van Beeck and Polinder2014). Currently, there are no published studies evaluating the clinical benefits or cost effectiveness of interventions targeting enhanced community mobility in people following trauma injuries (Alali et al., Reference Alali, Burton, Fowler, Naimark, Scales, Mainprize and Nathens2015; Grimby, Reference Grimby2010). There are also relatively few economic evaluations of rehabilitation strategies following severe trauma injuries (Oddy & da Silva Ramos, Reference Oddy and da Silva Ramos2013; van Heugten et al., Reference van Heugten, Geurtsen, Derksen, Martina, Geurts and Evers2011; Wood, McCrea, Wood, & Merriman, Reference Wood, McCrea, Wood and Merriman1999; Worthington, Matthews, Melia, & Oddy, Reference Worthington, Matthews, Melia and Oddy2006), with none using cost utility analysis methodology, the recommended economic evaluation for health technology assessment (Medical Services Committee in Australia, 2016; National Institute for Health and Care Excellence in the UK, 2013).
We hypothesise that the community mobility intervention (CarFreeMe TI) will result in increased community participation compared to the control group. The main objective of this study is to compare the effectiveness of the CarFreeMe TI intervention versus standard intervention, in people following TI in community participation. Secondary objectives are to compare the effectiveness of the CarFreeMe TI intervention versus standard intervention on quality of life, community mobility self-efficacy, types of transport used and satisfaction for people following trauma injuries; community mobility self-efficacy and strain for carers; and to undertake a preliminary assessment of the potential resource use associated with the intervention.
Methods and Design
Study Design
A prospective randomised crossover trial will be conducted over 1 year (Figure 1).
Study design.
Participant Selection
Inclusion criteria (a) have had a trauma injury, that is a TBI and/or a SCI, which precludes returning to full driving; (b) aged over 18 years of age; (c) adequate cognition/behavioural abilities to participate in sessions; (d) mobile, either walking or in a wheelchair independently or with carer assistance. If there is concern about the participant's ability to make decisions, capacity to consent will be confirmed from the treating doctor, with permission from the client. The exclusion criteria is (a) evidence of aphasia or poor English language skills that significantly impact on the understanding of information and reduces engagement in a group setting; (b) living in residential care settings (or anywhere where transport would be provided); (c) driving with no restrictions. All volunteers will be screened by a research occupational therapist.
Settings/Locations
Participants will be recruited from all rehabilitation facilities in Adelaide and the community, South Australia.
Procedures/Measurements
All participants will undergo measurements of primary and secondary outcomes at three time points during the study, performed face to face with participants by assessors who are blinded to the group allocation. The outcome assessments will be performed by research occupational therapists who have received training in the standardised use of the outcome tools. These time points will be at Week 1–2 (baseline assessment, prior to randomisation), Week 9 (following completion of first CarFreeMe TI intervention group) and week 16 (following completion of second CarFreeMe TI intervention group).
Randomisation
After completion of the baseline assessment, participants will be randomly assigned to either Phase 1 or Phase 2 groups with a 1:1 allocation as per a computer generated randomisation schedule by an investigator not involved in recruitment or assessments.
Phase One
This group will participate in a CarFreeMe TI support and education group, which will be delivered and evaluated in community settings in South Australia. The intervention will include up to eight participants per group and involve six sessions, facilitated by an occupational therapist. Sessions will be conducted once a week and each session will be 2.5 hours in duration. Session content will include adjusting to loss and change; experiences of stopping driving; alternative transport; lifestyle planning; and advocacy and support. The researchers can be contacted to provide more details of the content provided within sessions, which follows an established protocol. Session content will be adapted from the established protocol to be relevant to the goals identified by group members, and additional individual sessions will be considered, if required for specific goals. Group sessions will be interactive and encourage information sharing, using peer leaders and guest speakers where appropriate. Practical outings will provide an opportunity to trial alternate transport methods, for example, public transport, and this will be included within the designated weekly sessions. A record of attendance will be completed at each session and treatment adherence recorded and monitored by the occupational therapist.
Phase 2 Group
The Phase 2 group will receive standard information related to transport options available. This will be in the form of a one page written information sheet sent to them.
Outcome Measures
The primary outcome measure will be community participation after the completion of the intervention at week 9 and week 16. Community participation will be measured with a Global Positioning System (GPS) to record the location and number of outings from home. Hordacre, Barr and Crotty (Reference Hordacre, Barr and Crotty2014) were able to accurately record a range of categorised community participation events using wearable GPS devices integrated with geographic information systems. The GPS units will be worn for a 7-day period at each time point of the study. Participants will be provided with a GPS device, as used in our previous studies in amputees (Hordacre, Barr, & Crotty, Reference Hordacre, Barr and Crotty2014). The device will be worn on a lanyard or belt hook for a period of seven consecutive days and will show location during daily community activities. The particular model we wish to use is the QSTARZ BT-Q1000XT. The device measures 72.2 mm (L) × 46.5 mm (W) × 20.0 mm (H), weighs 8.5 grams. Battery life of the device is 42 hours, and participants will be instructed to charge the device each night. The occupational therapist will be regularly checking in with participants via phone to remind participant to wear the tracker and instructions/education will be provided to participants and carers. The data collected provide longitude and latitude coordinates time stamped for every 5 seconds. Data will be linked to Google Maps for a graphic representation of where participants travel within the community. Participants will be made aware of the nature of the data that are obtained from the GPS device prior to giving consent to participate in the study.
Data from the GPS device will provide a clear picture of the person's ability to participate in the community. From the coordinate data, the following will be calculated: trips per day, furthest distance travelled, average daily distance and percentage of time at home. The types of places participants visit in the community will be categorised such as employment, residential, commercial, health services, recreational and social.
The secondary outcome measures will provide a wider picture of quality of life, health care resource use, transport use and confidence with participation without driving, for participants and confidence and strain for carers. For the participants with a trauma injury, this will include the Community Mobility Self-efficacy Scale and the CarFree Me TI Transport Questionnaire.
The Community Mobility Self-efficacy Scale measures participant confidence with participation in life roles and activities without driving. For example, ‘How confident do you feel about being able to stay in contact with friends and family without driving?’ This questionnaire will assess the level of confidence on a 10-point scale ranging from 1, not confident at all, to 10, very confident. This was developed from an adaptation of Lorig and colleagues (Reference Lorig, Stewart, Ritter, Gonzalez, Laurent and Lynch1996) scale for a study evaluating the effectiveness of the CarFreeMe intervention with older drivers (Liddle et al., Reference Liddle, Haynes, Pachana, Mitchell, McKenna and Gustafsson2014b). The results of this study were that some features of the Community Mobility Self-efficacy Scale demonstrated significant improvements following intervention including ‘How confident do you feel about being able to stay involved in the community without driving?’, Item 5: ‘How confident do you feel about finding alternative transport options to get to necessary community activities and appointments?’ and Item 6: How confident do you feel about staying involved in activities that are important to you without driving?’ (Liddle et al., Reference Liddle, Haynes, Pachana, Mitchell, McKenna and Gustafsson2014b).
The CarFree Me TI Transport Questionnaire includes data on modes of transport used and subjective satisfaction, as well as a diary record of community mobility in the last 7 days to support GPS data. This was also developed for the study evaluating the effectiveness of the CarFreeMe for older drivers (Liddle et al., Reference Liddle, Haynes, Pachana, Mitchell, McKenna and Gustafsson2014b) which found the intervention was significantly associated with a higher number of episodes away from home per week and an increased mode of transport and higher satisfaction with transport use.
The health-related quality of life of participants will be measured using generic preference-based instruments AQOL (Hawthorne, Richardson, & Osborne, Reference Hawthorne, Richardson and Osborne1999) and EQ-5D-5L (Herdman et al., Reference Herdman, Gudex, Lloyd, Janssen, Kind, Parkin and Badia2011). A health-system perspective will be adopted for analysis of the costs and resource use within the study. The costs of the intervention will be calculated using study-based records of therapist time, and resources used. Health and aged care service utilisation will be accessed from self-reported weekly records of service use. Participants will be asked to complete a calendar recording instances of health and social care services input such as care provided at home, visits from allied health professionals or to clinicians. Unit costs for the health and social care services included in the analysis will be derived from published data sets including Pharmaceutical Benefits Scheme, Medical Benefits Scheme, Australian Bureau of Statistics and Australian Refined Diagnosis Related Groups cost weights.
For the carers of participants with trauma injuries that consent to participating in the trial and attend the CarFreeMe TI group sessions, outcomes will include the Carer's Community Mobility Self-efficacy Scale and the Modified Carer Strain Index. The Carer's Community Mobility Self-efficacy Scale is a 10-point Likert scale measuring perceived confidence of participants’ ability to maintain community mobility following driving cessation adapted from the Community Mobility Self Efficacy Scale (Liddle et al., Reference Liddle, Haynes, Pachana, Mitchell, McKenna and Gustafsson2014b); The Modified Carer Strain Index (Thornton & Travis, Reference Thornton and Travis2003) is a questionnaire of 13 items measuring perceived burden of carers rated on a Likert scale ranging from ‘experiencing on a regular basis, sometimes, to not at all’. This tool has been used with a range of caregivers, is brief and convenient and has high internal and test–retest reliability, and has been used across cultures and languages (Thornton & Travis, Reference Thornton and Travis2003). Outcome measures can be obtained by contacting the research team. Adverse effects will be monitored including unlicensed driving and any injuries related to community mobility, and referral to support services (physiotherapy, psychologist and social work) will be made if required, as determined by the senior occupational therapist. A steering committee consisting of the authors and representatives from Paraquad SA, Brain Injury SA will oversee the monitoring of data and dissemination.
Sample Size
Sample size has been calculated based on data reported in a study assessing community participation in amputees (Hordacre et al., Reference Hordacre, Barr and Crotty2014). In this study, the mean number of community participation visits over the course of a continuous week for amputees classified as having limited mobility was 7.2, and for those with basic to normal activity were 13.7. Using the group SD of 10.9, and assuming a power of 0.8 and alpha of 0.05, a sample size of 45 would be required to detect a similar difference. Assuming a 20% drop out, we will therefore recruit 54 participants.
Statistical Analysis
Data will be entered into an SPSS database with all identifying information removed. Statistical analysis will be undertaken using SPSS version 23 Statistical software (IBM, Chicago). All analyses will be on an intention to treat basis and will be blinded (i.e., groups identified by number only) to determine the baseline differences between the groups using independent t-tests, difference in community participation between groups at week 9 via a GLM ANOVA with allocation and time as factors, and the significance between groups using independent sample t-tests for all questionnaires. It is acknowledged that there may be a carry-over of learning of the intervention which could impact the comparison of the second intervention and control group, which will be assessed before final analysis. A preliminary exploratory study of the health-service resource use and costs associated with the intervention will be undertaken. Costs accrued over the 9-week intervention period will be estimated for each participant and presented for the two treatment groups separately. Descriptive statistics will be calculated for relevant categories of resource use, including the intervention costs, and various health and medical system costs.
Discussion
Maximising participation through community mobility following trauma injuries leads to an improved quality of life and health outcomes. In trauma injury rehabilitation, there is a need to offer individualised community mobility interventions targeting the emotional, practical and social components. This project will compare the effectiveness of an individualised community mobility intervention, the CarFreeMe TI intervention, to usual care, in people following TI for community participation. Outcomes of both the participants and carers in terms of community participation, community mobility self-efficacy and quality of life will be used to enable meaningful assessment of the community mobility intervention. It is acknowledged that there will be an expectation of carry-over of learning of the intervention which will impact the comparison of both the groups.
Furthermore, there are no published studies evaluating the clinical or cost effectiveness of interventions targeting community mobility in people following trauma injuries. This project will undertake a preliminary assessment of the costs and resource use associated with the intervention. This information will be used to inform future larger scale studies of the economic benefits to the health system and broader societal benefits of the CareFreeMe TI. The results of this study will provide proof of concept information establishing feasibility for a larger study to inform the allocation of resources in community rehabilitation post-trauma injuries.
Financial Support
This study is funded by the Lifetime Support Authority of South Australia.
Conflict of Interest
Jacki Liddle has participated in the development of the CarFreeMe intervention.
Ethical Standards
The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Ethics approval and consent to participate: The study protocol has been approved by the Southern Adelaide Clinical Health Research committee (OFR # 42.16 – HREC/16/SAC/47) and written informed consent will be obtained from all participants. Participants are free to withdraw at anytime.
Authors’ Contributions
All authors contributed to the design and conduct of the clinical trial. SG and JL conceived of the study and participated in its design/coordination and drafted the manuscript. CB participated in design of the trial process. MC and AB participated in oversight of the trial process. AN is involved in the recruitment and data acquisition of all participants and helped draft the manuscript. All authors read and approved the final manuscript.
