JMIR Publications

ABSTRACT

Background:

Over 135 million people worldwide currently live with acquired brain injury (ABI), and this large and growing burden increasingly surpasses global rehabilitation service capacity. ABIs commonly cause cognitive-communication disorders, which can subsequently affect a person’s social participation and relationships, employment, and mental health. The scale of this psychosocial impact demands consideration of service delivery models to meet this escalating need, with online service delivery offering one such model. The Social Brain Toolkit is a co-designed and evidence-based suite of three online communication training interventions for people with ABI and their communication partners. Research of online interventions such as the Social Brain Toolkit must investigate implementation, in addition to efficacy and effectiveness, to ensure this service delivery model is possible in real-world settings.

Objective:

To investigate the effectiveness and implementation of the Social Brain Toolkit as an online service delivery model.

Methods:

A mixed-methods, prospective, Hybrid II effectiveness-implementation study theoretically underpinned by the Non-Adoption, Abandonment, Scale-Up, Spread and Sustainability (NASSS) framework of digital health implementation. We will deploy pre-emptive strategies to support the implementation of the Social Brain Toolkit interventions at launch. We will also document user-identified strategies to improve implementation of the Social Brain Toolkit through formative evaluation by end-users, and employ these where possible. We will prospectively observe implementation outcomes through (i) qualitative interviews with a subset of users of the interventions, (ii) qualitative and quantitative pre- and post-intervention survey data from all users within a specified sample frame, and (iii) quantitative online analytics of intervention usage, selected based on the NASSS framework. Qualitative implementation data will be analysed using framework analysis based on the NASSS framework. Quantitative implementation data will be analysed descriptively. We will obtain effectiveness outcomes through custom user questionnaires and formal clinical tools. Quantitative effectiveness outcomes will be analysed through descriptive statistics and the reliable change index, with repeated analysis of variance (pre-training, post-training and follow-up), to determine whether there is any significant improvement within this participant sample.

Results:

This research protocol has been submitted before the completion of data collection or analysis.

Conclusions:

The direct evaluation of the implementation of the interventions by end-users aims to ensure these interventions reach and meet community needs in a feasible, scalable, sustainable and acceptable manner. Problems identified and recommendations made by users will be directly incorporated and addressed wherever possible in the next version of the Social Brain Toolkit interventions. Learnings from these findings will benefit the implementation of this and future online psychosocial interventions for people with ABI and other populations. Clinical Trial: Australia and New Zealand Clinical Trials Registry (ANZCTRN Pending. JMIR does not currently require registration for non-randomized studies (although registration as registered report, i.e. publishing a protocol before data are collected, is best practice and highly encouraged for any project), i.e. only randomized studies require registration. https://support.jmir.org/hc/en-us/articles/115001389307-Does-my-trial-RCT-have-to-be-registered- ). Universal Trial Number (UTN: U1111-1266-6628).