Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial)

Allan Riis, Jan Hartvigsen, Michael Skovdal Rathleff, Tamana Afzali, Martin Bach Jensen, Allan Riis, Jan Hartvigsen, Michael Skovdal Rathleff, Tamana Afzali, Martin Bach Jensen

Abstract

Background: Low back pain (LBP) is the most common musculoskeletal disorder and a leading cause of disability worldwide. It impacts daily life and work capacity and is the most common reason for consulting a general practitioner (GP). According to international guidelines, information, reassurance, and advice are key components in the management of people with LBP; however, the consultation time available in general practice for each patient is often limited. Therefore, new methods to support the delivery of information and advice are needed and online technologies provide new opportunities to extend the consultation beyond the GP's office. However, it is not known whether GPs and people consulting their GP because of LBP will accept online technologies as part of the consultation. By involving patients in the development of online information, we may produce more user-friendly content and design, and improve patient acceptance and usage, optimising satisfaction and clinical outcomes. The purpose is to study satisfaction in people consulting their GP with LBP depending on whether they are randomised to receive supporting information through a new participant-driven web application or a standard reference website containing guideline-based information on LBP. It is hypothesised that patients offered information in a new web application will be more satisfied with the online information after 12 weeks compared to patients allocated to a standard website.

Methods: Two hundred patients with LBP aged ≥ 18 years consulting Danish general practice will be randomly allocated 1:1 to either the new web application or standard online information in permuted blocks of two, four, and six. Patients with serious spinal diseases (cancer, fractures, spinal stenosis, spondyloarthritis), those without Danish reading skills or without online access, and pregnant women will not be included in the trial. Patient satisfaction measured by the Net Promotor Score after 12 weeks is the primary outcome. Patients will be aware of their allocation. GPs will be blinded unless informed by the patient. Assessors are blinded.

Discussion: To our knowledge, this is the first trial evaluating whether involving LBP patients in the development of an online web application will result in higher patient satisfaction.

Trial registration: ClinicalTrials.gov NCT03088774 . Registered on 23 March 2017. Last updated on 14 March 2018.

Keywords: Advice; General practice; Health information technology; Low back pain; Participatory design; Patient education; Patient satisfaction.

Conflict of interest statement

Ethics approval and consent to participate

This study is registered at the Danish Data Protection Agency (number: 2017–41-5150) and is recommended by The Committee of Multipractice Studies in General Practice in Denmark (MPU 09–2017). The North Denmark Region Health Ethics Committee has decided that this study does not need their approval (N-20170038). Patients will be informed of the study by their GP and will provide informed electronic consent online before being directed to the baseline questionnaire and being assigned to their allocation group. Patients may at any time and without any consequences for the usual treatment of LBP, discontinue participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Timeline of the study. NOTE: Data from questionnaires integrated in the web application. Patients are asked to fill in questions following login at the given time point and before accessing the information on the homepage. In addition, number of entries at homepages will be collected
Fig. 2
Fig. 2
Flowchart
Fig. 3
Fig. 3
Participatory design of a new web application

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