Improving quality of life by increasing outings after stroke: Study protocol for the Out-and-About trial

Abstract

Almost one third of Australians need help to travel outdoors after a stroke. Ambulation training and escorted outings are recommended as best practice in Australian clinical guidelines for stroke. Yet fewer than 20% of people with stroke receive enough of these sessions in their local community to change outcomes. The Out-And-About trial aims to determine the efficacy and cost-effectiveness of an implementation program to change team behaviour and increase outings by people with stroke. A two-group cluster-randomised trial will be conducted using concealed allocation, blinded assessors and intention-to-treat analysis. Twenty community teams and their stroke clients (n=300) will be recruited. Teams will be randomized to receive either the Out-And-About program or written guidelines only. The primary outcome is the proportion of people with stroke receiving multiple escorted outings during therapy sessions, measured at baseline and 13 months post-intervention. Secondary outcomes include number of outings and distance travelled, measured using a self report diary at baseline and six months post-baseline, and a global positioning system (GPS) after six months. Cost-effectiveness will measure quality-adjusted life years and health service use, measured at baseline and six months post-baseline. A potential outcome of this study will be evidence for a costed, transferable implementation program. If successful, the program will have international relevance and transferability. Another potential outcome will be validation of a novel and objective method of measuring outdoor travel (GPS) to supplement self-report methods. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611000554965)