Feasibility study on recruitment in general practice for a Health information technology trial

Allan Riis, Michael S Rathleff, Jan Hartvigsen, Janus L Thomsen, Tamana Afzali, Martin Bach Jensen

Keywords: Low back pain; feasibility study; general practice; recruitment; retention; medical informatics app; evidence-based-treatment

Background:

We plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application in a future randomised controlled trial (RCT). The web-application may facilitate the delivery of evidence-based advice and information to patients with low back pain (LBP) in general practice.

Research questions:

The aim was to conduct the main trial in a miniature setting with the purpose to report on the lessons learned from recruitment and report on reasons for loss to follow-up.

Method:

This is a feasibility study intended to inform the RCT. The GP invited adult patient with non-specific LBP to participate by handing out an envelope with a link to the project homepage. Patients were told that the purpose was to test the setup of the study, including the randomisation module and data collection. Patients were informed that the research team needed their phone number to discuss any challenges with access to the website or with using online information to read about their LBP and finally to fill out online questionnaires.

Results:

We recruited 12 women and 8 men from two general practices with each practice recruiting for three months. Reasons for dropping out: loss of envelope, forgot about the study, had become pain-free and the trial was not relevant to them, and the login procedures was too demanding. Full follow-up data was available in only three patients (15%).

Conclusions:

Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale RCT as planned.

Points for discussion:

Modifying inclusion criteria to patients expressing an interest in using online health information may improve follow-up rates

Letting patients respond with their immediate satisfaction directly after inclusion in the general practice may ensure follow-up data

The web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants

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