East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol

Abstract

IntroductionKnee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.Methods and analysisIn phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.Ethics and disseminationThis protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.Trial registration numberNCT03670706

Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences

“…These factors increase the transferability of the findings to clinical settings. Secondly, the main interviewer (PAN) also evaluated the fidelity of intervention delivery using video-recordings of individual treatment sessions [20], which may have affected the line of questioning with participants. However, any risk of bias or judgement in questioning was minimised by conducting interviews at least one week after fidelity assessments and with the use of a pre-specified semi-structured interview.…”

“…Behaviour change strategies [23] such as SMART goal setting, action planning, assessment of participant confidence to achieve goals, discussion of barriers and facilitators and the use of exercise diaries were used to improve adherence. The intervention is described fully in the study protocol [20].…”

Fidelity assessment of nurse-led non-pharmacological package of care for knee pain in the package development phase of a feasibility randomised controlled trial based in secondary care: a mixed methods study

“…A training programme to enable a nurse to deliver the current NICE guidelines for OA management was developed and an educational manual produced. 26 The training included face-to-face learning, case-studies, on-line resources and simulated patients. Practical sessions on assessing the participant, delivering and modifying exercise, weight loss advice and use of strategies to encourage adherence were also included.…”

“…The intervention is described in more detail in the protocol. 26 After the training period, the nurse delivered the intervention in four sessions over a 5-week period.…”

“…24 For this reason, a mixed methods approach was used. 25 The present study is part of the East-Midlands Knee Pain Cohort RCT study, 26 the overall purpose of which is to evaluate the feasibility of a nurse-led package of care for knee pain due to OA. The objective of the present study was to evaluate the fidelity of delivery of a nurse-led non-pharmacological package of care for knee pain during the package development phase of the RCT.…”