FRI0628-HPR EVALUATING A COMPLEX PACKAGE OF CARE IN THE EAST-MIDLANDS KNEE PAIN FEASIBILITY COHORT RANDOMISED CONTROLLED TRIAL
Authors: P. A. Nomikos, A. Fuller, M. Hall, B. Millar, R. Ogollah, M. Doherty, R. Nair, D. Walsh, A. Valdes, A. Abhishek
Journal: Annals of the Rheumatic Diseases (2020)

Background: The role of nurses in managing painful knee OA has been advocated but whether nurses can deliver such interventions as a package of care is unknown.The overall aim of this research is to develop and test a nurse-led complex intervention for knee pain comprising non-pharmacological and pharmacological components. In the first study phase, we report on fidelity and acceptability of a non-pharmacological intervention, to resolve possible challenges to delivery. Objectives: To evaluate fidelity of delivery and acceptability of non-pharmacological components of a complex intervention. Methods: This was a mixed-methods study. Participants with chronic knee pain were recruited from the community to receive the intervention, delivered in 4-sessions over a 5-week period by a trained research nurse. The intervention consisted of holistic assessment, patient education and advice, aerobic and strengthening exercise and weight-loss advice if required. All sessions were video-recorded. Fidelity checklists were completed by the nurse (nurse-rated) and two researchers from the video-recordings (video-rated). Median fidelity scores (%) and interquartile ranges (IQR) were calculated for each component and each session. Semi-structured interviews were conducted with participants. These were audio recorded, transcribed and analysed following the framework approach. Results: 18 participants (34% women), with a mean (SD) age and BMI of 68.7 (9.0) years and 31.2 (8.4) kg/m 2 , took part in the study. Of these, 14 completed all visits. In total, 62 intervention sessions were assessed for fidelity. Overall fidelity was rated high by both nurse-rated scores (97.7%) and video-rated scores (84.2%). The level of agreement between nurse-rated and video-recorded methods was 73.3% (CI 71.3, 75.3) and the inter-rater agreement was 65.5% (CI 60.3, 70.5). Fidelity of delivery was lower for advice on footwear modification and walking aids in all sessions and moderate for education in session 1 and for exercise in session 4 (Table 1). Table 1. Fidelity scores of the components of the intervention for each session, Intervention components Session 1* Session 2* Session 3* Session 4* Education 78.1 (74.1, 93.7) 87.5 (50, 100) 87.5 (50, 100) 100 (93.7, 100) Exercise 94.4 (88.9, 100) 88.9 (75, 94) 86.1 (72, 100) 75 (67.6, 82.8) Adjunctive treatments 50 (45.83, 100) 0 (0, 50) 50 (0, 100) - *median (IQR) 17 participants were interviewed. Most found advice supplied straightforward. They were satisfied with the package, which changed their perception of managing knee pain, understanding it can be improved though self-management. However, too much information was provided in a short time-span and it was difficult to fit exercises into their daily routine. Conclusion: Delivery of a non-pharmacological intevention by a nurse is feasible within a research setting. Most components of the intervention were delivered as intended, except for advice about the use of adjunctive treatment. Acknowledgments: This research was funded by the NIHR Nottingham BRC and Pain Centre Versus Arthritis Disclosure of Interests: Polykarpos Angelos Nomikos: None declared, Amy Fuller: None declared, Michelle Hall: None declared, Bonnie Millar: None declared, Reuben Ogollah: None declared, Michael Doherty: None declared, Roshan Nair Speakers bureau: Financial support from pharmaceutical companies (Biogen and Novartis) to present lectures at events related to psychological support for people with multiple sclerosis (Speaker’s bureau)., David Walsh Grant/research support from: 2016: Investigator-led grant from Pfizer Ltd (ICRP) on Pain Phenotypes in RA; non-personal financial disclosure (payment to University)., Consultant of: DAW has undertaken paid consultancy to Pfizer Ltd, Eli Lilly and Company and GSK Consumer Healthcare., Paid instructor for: 2019: Consultancy to Love Productions; consultancy on programme design, contribution to programme content on self-management of chronic pain (payments to University) 2019: Consultancy to AbbVie Ltd; 13.06.19; presentation on RA pain at EULAR, Madrid, and webinar (payments to University). 2019: Consultancy to Eli Lilly and Company Ltd. 06.06.19 Centre for Collaborative Neuroscience, Windlesham, Surrey, UK (payment to University). 2019: Consultancy to Pfizer (payment to University). 2018: Consultancy to Pfizer. 07.12.18. USA. 1 day. Tanezumab (payment to University). 2018: Consultancy to Pfizer. 23.11.18. Manchester UK. 1 day. Tanezumab (payment to University). 2018: Consultancy to Pfizer. 1.11.18. Skype. 4h. Tanezumab (payment to University). 2018: Consultancy to GlaxoSmithKline Plc. 1 day. Pain in RA and anti-GM-CSF (payment to University). 2018: Consultancy to Pfizer Ltd; Presentation at OARSI; non-personal financial disclosure (payment to University) 2018: Consultancy to Pfizer Ltd; Patient preference study; non-personal financial disclosure (payment to University) 2017: Consultancy to Pfizer Ltd; personal financial disclosure 2017: Consultancy to Pfizer Ltd through Nottingham University; non-personal financial disclosure (payment to University). 2015: Consultancy to GSK Consumer Healthcare; personal financial disclosure., Speakers bureau: 2019: Irish Society of Rheumatology: speaker fees (personal pecuniary), Ana Valdes Grant/research support from: Awarded a grant from Pfizer, Abhishek Abhishek: None declared