Contextual Expereicnes of Participating in a Randomised Controlled Trial: Scottish Experience

Willaim Reynolds, PhD, MPhil, RMN, RGN, RNT, Turku Polytechnic, Turku Polytechnic, Salo, Finland, Siobhan Sharkey, PhD, RMN, Department of Nursing and Midwifery, Department of Nursing and Midwifery, Unviersity of Stirling, Inverness, United Kingdom, and Terry Veitch, RMN, University of Stirling (United Kingdom), United Kingdom.

Design & Sample: This aspect of the study was designed using mixed methods (Robson, 1993) to optimise feedback from qualified staff contributing to the study. All nursing and social work staff participating were invited to feedback on their perceptions about and experiences of the study. Participation was voluntary.

Methods: Data was collected using focus group technique and self-completed diaries. Data was analysed using thematic content analysis. (Miles & Huberman, 1984)

Results: Results identified a variety of themes: preparation and training for trial participation and procedures to improve communication. Results not directly relating to the trial revealed differences in perspectives about nursing roles between community and inpatient staff.

Conclusions/Implications: Information about the context within which RCT’s are carried out is important to open up questions relating to external validity. Given the often complex nature of RCTs it is particularly important in a pilot study to provide information on which aspects of the study design were successful or otherwise in achieving the objectives of the pilot. This can provide crucial information for the design of future RCTs.

Researchers designing RCTs involving human interventions have to be both alert and responsive to the fact that being a participant delivering interventions within a study will have an impact on outcomes. The paper introduces an RCT measuring the impact of a Transitional Discharge Model and goes on to focus on the exploration of experiences and benefits of undertaking this kind of parallel enquiry within trials.

References: Miles MB & Huberman AM (1984) Qualitative Data Analysis: A Sourcebook of New Methods. Newbury Park, California. Sage Robson C (1993) Real World Research. Oxford. Blackwell