Patients' understanding and participation in a trial designed to improve the management of anti-psychotic medication: a qualitative study

Abstract

Background: Combining qualitative methods alongside randomised controlled trials in the health field has been advocated but has only been used rarely in mental health services research. The aim of this study was to illuminate patients' understanding of the nature and purpose and outcomes of a trial designed to improve the management of neuroleptic medication.

Methods: Qualitative interviews were carried out with a group of patients participating in a trial comparing a psycho-educational and therapeutic alliance intervention in managing anti-psychotic medication.

Results: Our findings highlighted aspects of the experience, process and outcome of the trial, which remain latent in the quantitative assessment. The issue of enlarged selfefficacy emerging when patients were involved in communications with professionals in the trial was important. Whilst the participants provided positive feedback about their involvement in the trial, they struggled to recall the details of the intervention to which they had been exposed. Patients did not readily identify the content and concepts characterising each condition; rather they prioritised the opportunity for communication and contact with the researchers.

Conclusions: Qualitative research accompanying trials illuminates and adds to the quantitative outcomes. The key to interpreting participants' accounts of the process and outcomes of this trial suggests the need to give greater emphasis to participants' past and current experience of service contact.