Rheumatoid arthritis is a long-term, progressive, autoimmune disease where the immune system attacks the membranes which line the joints causing them to become inflamed. It is also a systemic disease, affecting the body’s tissues and organs. Rheumatoid arthritis can lead to decreased quality of life, disability, co-morbidity (e.g. heart disease, diabetes) and reduced life expectancy.
The TITRATE trial is a randomised controlled trial which will compare the effectiveness of intensive management with standard care in patients (n=335) with moderate rheumatoid arthritis. The intensive management intervention is currently being delivered in 39 rheumatology outpatient departments across England. As part of the intensive management intervention patients attend monthly sessions across 12 months, which can last for up to one hour.
Intensive management is a complex intervention which includes treating patients more intensively with medication and providing ‘treatment support’ based on motivational interviewing (MI: Rollnick, Miller, & Butler, 2008) techniques. The treatment support aims to help patients identify and work on key areas where they may be challenged, including adherence to medication, pain, fatigue, physical activity, weight-management and smoking.
Rheumatology practitioners (who are mostly nurses) deliver the treatment support. All attended a two-day, developed and manualised, training course. Day-one focused on MI including the spirit of MI and its principles. Rheumatology practitioners were taught MI techniques including open-ended questions, affirmations, reflections, and summaries. On day-two the training focused on illness perceptions and psychoeducation for patients with rheumatoid arthritis. The training course included role play with constructive feedback.
Intervention fidelity is the use of methodological strategies to monitor and enhance the reliability and validity of behavioural interventions. (Bellg et al., 2004), Examining fidelity may be especially necessary in multi-site trials where the “same” intervention may be implemented and received by patients in different ways (Oakley et al., 2006). Intervention fidelity can also lead to greater confidence in results and supports research dissemination. The aim of the fidelity assessment, conducted as part of the TITRATE trial, was to assess delivery of the treatment support across 5% of all TITRATE intensive management sessions.
Delivery of the treatment support was rated according to a 15-item fidelity assessment tool which focuses on key MI techniques such as open-ended questions and reflections. It also includes statements relating to the rheumatology practitioners’ general approach to the consultation. The fidelity assessment tool was based on the techniques and approaches taught during the two-day training.
Rating of audio recorded sessions was conducted within a team of four researchers. Establishing inter-rater reliability took a period of six months from September 2015 to March 2016. Rating of the treatment support delivery commenced in March 2016 and continued for one year. To date, 126 intensive management sessions have been rated and analysis of this data is in progress.
Bellg, A. J., Borrelli, B., Resnick, B., Hecht, J., Minicucci, D. S., Ory, M., … Czajkowski, S. (2004). Enhancing treatment fidelity in health behavior change studies: Best practices and recommendations from the NIH Behavior Change Consortium. Health Psychology, 23(5), 443–451. https://doi.org/10.1037/0278-6126.96.36.1993
Oakley, A., Strange, V., Bonell, C., Allen, E., Stephenson, J., & Team, R. S. (2006). Complex Interventions. British Medical Journal, 332(7538), 413–416. https://doi.org/10.1136/bmj.332.7538.413
Rollnick, S., Miller, W. R. (William R., & Butler, C. (2008). Motivational interviewing in health care : helping patients change behavior. Guilford Press.
Louise Prothero, Researcher/PhD Student, King’s College London