SAGE Journals
Reinforce chapter themes with free access to two journal articles for each chapter and further online readings. Select chapters will also include suggested weblinks.
Discussion Points: What do you make of the randomized controlled trial in terms of how it was set up?
Journal Article 14.2: Sturkenboom, I., Graff, M., Borm, G., et al. (2012) ‘The impact of occupational therapy in Parkinson’s disease: A randomized controlled feasibility study’, Clinical Rehabilitation 27(2): 99–112.
Discussion Points: Critically evaluate the paper in light of what you have read.
Description: Randomised controlled trials (RCTs) involving diverse population groups in complex health care settings can be difficult to successfully undertake and pose practical and methodological challenges. For this reason, undertaking a pilot study is recommended by the Medical Research Council prior to conducting a definitive trial. This paper reports a pragmatic review of the challenges encountered by the research team during a single-centre pilot RCT and discusses how feasible it was to deliver and evaluate a complex intervention in practice. The psycho-social intervention designed for this trial was a ‘user-centred critical care discharge information pack’. The pack was designed to support patients and their families during and after their discharge from a critical care unit. It consisted of two written booklets, one for the patient and one for the family member. In total, 221 patients met our inclusion criteria, of whom 158 (71%) were recruited. The pilot RCT identified important lessons for the design of future trials. Challenges included those associated with the recruitment of potential participants, assessing capacity and obtaining informed consent. Problems with attrition, intervention delivery and the choice of data collection tools and time-points were also apparent. Our findings demonstrate that the evaluation of complex interventions is feasible in clinical practice. The importance of adhering to a robust research protocol, maintaining efficient and effective communication between researchers and clinical staff is emphasized. Findings further support the importance of conducting a pilot study prior to embarking on a definitive RCT.
Description: Innovative, culturally tailored strategies are needed to extend diabetes education and support efforts in lower-resourced primary care practices serving racial/ethnic minority groups. A randomized controlled trial (RCT) examined the effect of a diabetes self-care coaching intervention delivered by medical assistants and the joint effect of intervention and ethnicity over time. The randomized repeated-measures design included 270 low-income African American and Hispanic/Latino patients with type 2 diabetes. The 1-year clinic- and telephone-based medical assistant coaching intervention was culturally tailored and guided by theoretical frameworks. A1C was obtained, and a self-care measure was completed at baseline, 6 months, and 12 months. Data were analyzed using mixed-effects models with and without adjustment for covariates. There was a significant overall improvement in mean self-care scores across time, but no intervention effect. Results revealed differences in self-care patterns across racial/ethnic subgroups. No differences were found for A1C levels across time or group.