Date Presented 03/26/20
This poster describes how the Medical Research Council’s process-evaluation guidelines were applied in a clinical trial undertaken to evaluate a complex intervention designed to reduce falls among full-time wheelchair or scooter users with MS. Preliminary process-evaluation findings relevant to implementation and mechanisms of impact based on post-intervention surveys and interview data from both participants and interventionists will be presented.
Primary Author and Speaker: Toni Van Denend
Additional Authors and Speakers: Elizabeth Peterson, Laura Rice
Contributing Authors: JongHun Sung
PURPOSE: Fall prevention programs for people with MS who use wheeled mobility full time are only beginning to emerge (3). This poster illustrates a) how the Medical Research Council’s (MRC) guidelines (2) were applied to develop a process evaluation for a clinical trial to evaluate the iROLL intervention, a program designed to reduce falls and improve community participation among full-time wheelchair/scooter users; and b) key preliminary process evaluation findings, relevant to two categories identified by MRC guidelines: implementation, including fidelity, dose, adaptions and reach; and mechanisms of impact (MOI). iROLL is a 6-session, community based, self-management program delivered by OTs or PTs (1).
DESIGN: The process evaluation took place in conjunction with a multi-site clinical trial. Participants (N= 13 to date) were recruited primarily through the North American Research Committee on Multiple Sclerosis registry and have a self-reported diagnosis of MS, are >18 years, Patient Determined Disability Score of >7, transfer with moderate assistance or less, and reported >1 fall in past 12 months. A mixed method design was used in the process evaluation. All procedures were approved by IRB.
METHOD: To assess implementation, program fidelity, and dose, a fidelity form with a self-report survey completed by trainers after each session was used. Adaptions to the program and reach was calculated via review and summary of data logs. To assess MOI, separate interview guides, designed to yield insights about participants’ response to, and satisfaction with iROLL, were used for 1:1 post-intervention interviews with participants and trainers. Descriptive statistics were calculated to analyze quantitative data. For open ended survey data obtained from post-session and post-intervention surveys, responses were reviewed, categorized and summarized. Qualitative data from participant and trainer telephone interviews was analyzed via thematic analysis. Codes were compared and discussed by two authors until agreement was reached on major themes, as well as on plans for defining and labeling themes.
RESULTS: Participants (average age of 59.2 (± 10.3), 3 male, 10 female), lived with MS for 21.4 (± 8.6) years, 9.5 (± -4.1) years of wheelchair usage, and an average of 2 falls in the past 6 month. The contributing trainers include 3 OTs and 4 PTs, with an average of 8.5 years in practice. Implementation Findings: iROLL was delivered at 91% logistic fidelity and at 94% content fidelity. The average dose delivered/length of the 6 sessions was 112 minutes. Adaptation findings: The structure of the instructional manual used by the trainers was modified to simplify use, but no content was modified. Reach Findings: 7 failed the screening and 12 declined to participant due to challenges with time commitment, recent hospitalization/exacerbation, transportation or scheduling problems. Two participants dropped out due to transportation problems and another due to scheduling conflicts. MOI Findings (Participants): Performing/self-evaluating transfers and building wheelchair and home exercise skills were most important. Interview findings highlighted impact on “Things I think or feel” i.e., heightened safety awareness. Lowest satisfaction ratings included training on complex transfers. MOI (Trainers): Essential iROLL components were the small group, practice time, and repetition/reinforcement.
AREAS TO IMPROVE: homework and amount of content. Interview findings highlighted high value of the group context, action planning and overlearning.
CONCLUSION: Results indicate iROLL is being delivered as intended and highlight the importance of practice time. Findings will inform further development and refinement of the iROLL intervention.
References
Rice, L., Peterson, E., Backus, D., Sung, J., Yarnot, R., Libak, A., Van Denend, T., Shen, S. & Sosnoff, J. (2019). Validation of an individualized reduction of falls intervention program among wheelchair and scooter users with multiple sclerosis. Medicine: May 2019 - Volume 98 - Issue 19 - p e15418. doi: 10.1097/MD.0000000000015418
Moore, G., Audrey, A., Barker, M., Bond, L., Bonell, C., Hardeman, W., Moore, L., O’Cathain, A., Tinati, T., Wight, D., Baird, J. (2015). Process evaluation of complex interventions: Medical Research Council guidance. BMJ, 350, h1258. doi: https://doi.org/10.1136/bmj.h1258
Rice, L., Abou, L., Van Denend, T., Peterson, E. & Sosnoff, J. (2018). Falls among wheelchair and scooter users with multiple sclerosis – a review. US Neurology, 14 (2), 82-87. doi: 10.17925/USN.2018.14.2.82