Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care - the Management of OsteoArthritis In Consultations (MOSAICS) study protocol

Abstract

BackgroundThere is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving ‘quality markers’ of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain.DesignA mixed methods study with a nested cluster randomised controlled trial.MethodThis study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive ‘whole-system’ evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations.DiscussionThe main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance.Trial registrationISRCTN number: ISRCTN06984617.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-014-0095-y) contains supplementary material, which is available to authorized users.

Research “push”, long term-change, and general practice

“…Ten potential general practices (GPs), who fulfilled the eligibility criteria (see protocol, Dziedzic et al, 2014), were identified through the English West Midlands North and North West Primary Care Research Networks. The practices were introduced to the trial by the study research team at a "roadshow" meeting where they were given information about the study rationale and an overview of its design, the main research questions, what was required from their teams, potential benefits of participation and details of remuneration for clinical time.…”

Non-operative treatment options for knee osteoarthritis: current concepts

“…The care coordinator should conduct a thorough needs analysis, including a standardised assessment of pain and functional disability, in order to be an active and decision-making member of the model 61. From the patient’s clinical profile, the priority symptoms will be targeted in order to obtain a patient-specific model of care 62. As the patient’s expectations evolve with the progression of the disease, the care coordinator will have to perform a thorough reassessment and carry out regular evaluations at appropriate follow-ups.…”

Optimal primary care management of clinical osteoarthritis and joint pain in older people: a mixed-methods programme of systematic reviews, observational and qualitative studies, and randomised controlled trials

“…Randomisation was by practice, so the sample size calculation was inflated to correct for an intracluster correlation coefficient (ICC) (adjusted ICC of 0.005). Varying practice size recruitment was taken into account (including coefficient of variation of 0.5) 131 and included (× 0.67 and × 1.25, respectively for intervention and control practices) adjustments for repeated-measures design.…”