Improving Quality of Life by Increasing Outings after Stroke: Study Protocol for the Out-and-About Trial

Abstract

Rationale 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. Aims The Out-and-About trial aims to determine the efficacy and cost effectiveness of an implementation program to change team behavior and increase outings by people with stroke. Design A two-group cluster-randomized 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. Study Outcomes The primary outcome is the proportion of people with stroke receiving multiple escorted outings during therapy sessions, measured at baseline and 13 months postintervention. Secondary outcomes include number of outings and distance traveled, measured using a self-report diary at baseline and six months postbaseline, and a global positioning system after six months. Cost effectiveness will measure quality-adjusted life years and health service use, measured at baseline and six months postbaseline. Discussion 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 (global positioning system) to supplement self-report methods.