Dataset Information

Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach.

ABSTRACT: INTRODUCTION:This protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. The intervention supports general practitioners (GPs) to gain an understanding of the best management options available through online professional development. Their patients receive telephone advice and support for OA management by a centralised, multidisciplinary 'Care Support Team'. We will conduct concurrent process and feasibility evaluations to understand the implementation of this new complex health intervention, identify issues for consideration when interpreting the effectiveness outcomes and develop recommendations for future implementation, cost effectiveness and scalability. METHODS AND ANALYSIS:The UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of 'usual care'. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model. ETHICS AND DISSEMINATION:The primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context. TRIAL REGISTRATION NUMBER:ACTRN12617001595303; Pre-results.

SUBMITTER: Bowden JL

PROVIDER: S-EPMC7045031 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach.

Bowden Jocelyn L JL Egerton Thorlene T Hinman Rana S RS Bennell Kim L KL Briggs Andrew M AM Bunker Stephen J SJ Kasza Jessica J French Simon D SD Pirotta Marie M Schofield Deborah J DJ Zwar Nicholas A NA Hunter David J DJ

BMJ open 20200204 2

<h4>Introduction</h4>This protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. ...[more]

PMID: 32024793

Similar Datasets

Project description:ObjectiveImplementation strategies, such as new models of service delivery, are needed to address evidence practice gaps. This paper describes the process of developing and operationalising a new model of service delivery to implement recommended care for people with knee osteoarthritis (OA) in a primary care setting.MethodsThree development stages occurred concurrently and iteratively. Each stage considered the healthcare context and was informed by stakeholder input. Stage 1 involved the design of a new model of service delivery (PARTNER). Stage 2 developed a behavioural change intervention targeting general practitioners (GPs) using the behavioural change wheel framework. In stage 3, the 'Care Support Team' component of the service delivery model was operationalised.ResultsThe focus of PARTNER is to provide patients with education, exercise and/or weight loss advice, and facilitate effective self-management through behavioural change support. Stage 1 model design: based on clinical practice guidelines, known evidence practice gaps in current care, chronic disease management frameworks, input from stakeholders and the opportunities and constraints afforded by the Australian primary care context, we developed the PARTNER service-delivery model. The key components are: (1) an effective GP consultation and (2) follow-up and ongoing care provided remotely (telephone/email/online resources) by a 'Care Support Team'. Stage 2 GP behavioural change intervention: a multimodal behavioural change intervention was developed comprising a self-audit/feedback activity, online professional development and desktop software to provide decision support, patient information resources and a referral mechanism to the 'Care Support Team'. Stage 3 operationalising the 'care support team'-staff recruited and trained in evidence-based knee OA management and behavioural change methodology.ConclusionThe PARTNER model is the result of a comprehensive implementation strategy development process using evidence, behavioural change theory and intervention development guidelines. Technologies for scalable delivery were harnessed and new primary evidence was generated as part of the process.Trial registration number ACTRN12617001595303 (UTN U1111-1197-4809).

Project description:ObjectiveTo evaluate the effectiveness and health costs of a new primary care service delivery model (the Optimising Primary Care Management of Knee Osteoarthritis [PARTNER] model) to improve health outcomes for patients with knee osteoarthritis (OA) compared to usual care.MethodsThis study was a 2-arm, cluster, superiority, randomized controlled trial with randomization at the general practice level, undertaken in Victoria and New South Wales, Australia. We aimed to recruit 44 practices and 572 patients age ≥45 years with knee pain for >3 months. Professional development opportunities on best practice OA care were provided to intervention group general practitioners (GPs). All recruited patients had an initial GP visit to confirm knee OA diagnosis. Control patients continued usual GP care, and intervention patients were referred to a centralized care support team (CST) for 12-months. Via telehealth, the CST provided OA education and an agreed OA action plan focused on muscle strengthening, physical activity, and weight management. Primary outcomes were patient self-reported change in knee pain (Numerical Rating Scale [range 0-10; higher score = worse]) and physical function (Knee Injury and Osteoarthritis Outcome Score activities of daily living subscale [range 0-100; higher score = better] at 12 months. Health care cost outcomes included costs of medical visits and prescription medications over the 12-month period.ResultsRecruitment targets were not reached. A total of 38 practices and 217 patients were recruited. The intervention improved pain by 0.8 of 10 points (95% confidence interval [95% CI] 0.2, 1.4) and function by 6.5 of 100 points (95% CI 2.3, 10.7), more than usual care at 12 months. Total costs of medical visits and prescriptions were $3,940 (Australian) for the intervention group versus $4,161 for usual care. This difference was not statistically significant.ConclusionThe PARTNER model improved knee pain and function more than usual GP care. The magnitude of improvement is unlikely to be clinically meaningful for pain but is uncertain for function.

Project description:BackgroundOsteoarthritis (OA) is a common problem in older women that is associated with pain and disabilities. Although yoga is recommended as an exercise intervention to manage arthritis, there is limited evidence documenting its effectiveness, with little known about its long term benefits. This study's aims were to assess the feasibility and potential efficacy of a Hatha yoga exercise program in managing OA-related symptoms in older women with knee OA.MethodsEligible participants (N=36; mean age 72 years) were randomly assigned to 8-week yoga program involving group and home-based sessions or wait-list control. The yoga intervention program was developed by a group of yoga experts (N=5). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score that measures knee OA pain, stiffness, and function at 8 weeks. The secondary outcomes, physical function of the lower extremities, body mass index (BMI), quality of sleep (QOS), and quality of life (QOL), were measured using weight, height, the short physical performance battery (SPPB), the Pittsburgh Sleep Quality Index (PSQI), the Cantril Self-Anchoring Ladder, and the SF12v2 Health Survey. Data were collected at baseline, 4 weeks and 8 weeks, and 20 weeks.ResultsThe recruitment target was met, with study retention at 95%. Based on ANCOVAs, participants in the treatment group exhibited significantly greater improvement in WOMAC pain (adjusted means [SE]) (8.3 [.67], 5.8 [.67]; p=.01), stiffness (4.7 [.28], 3.4 [.28]; p=.002) and SPPB (repeated chair stands) (2.0 [.23], 2.8 [.23]; p=.03) at 8 weeks. Significant treatment and time effects were seen in WOMAC pain (7.0 [.46], 5.4 [.54]; p=.03), function (24.5 [1.8], 19.9 [1.6]; p=.01) and total scores (35.4 [2.3], 28.6 [2.1]; p=.01) from 4 to 20 weeks. Sleep disturbance was improved but the PSQI total score declined significantly at 20 weeks. Changes in BMI and QOL were not significant. No yoga related adverse events were observed.ConclusionsA weekly yoga program with home practice is feasible, acceptable, and safe for older women with knee OA, and shows therapeutic benefits.Trial registrationClinicalTrials.gov: NCT01832155.

Project description:BackgroundNormalization Process Theory (NPT) identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions. A large body of literature that employs NPT to inform feasibility studies and process evaluations of complex healthcare interventions has now emerged. The aims of this review were to review this literature; to identify and characterise the uses and limits of NPT in research on the implementation and integration of healthcare interventions; and to explore NPT's contribution to understanding the dynamics of these processes.MethodsA qualitative systematic review was conducted. We searched Web of Science, Scopus and Google Scholar for articles with empirical data in peer-reviewed journals that cited either key papers presenting and developing NPT, or the NPT Online Toolkit ( www.normalizationprocess.org ). We included in the review only articles that used NPT as the primary approach to collection, analysis or reporting of data in studies of the implementation of healthcare techniques, technologies or other interventions. A structured data extraction instrument was used, and data were analysed qualitatively.ResultsSearches revealed 3322 citations. We show that after eliminating 2337 duplicates and broken or junk URLs, 985 were screened as titles and abstracts. Of these, 101 were excluded because they did not fit the inclusion criteria for the review. This left 884 articles for full-text screening. Of these, 754 did not fit the inclusion criteria for the review. This left 130 papers presenting results from 108 identifiable studies to be included in the review. NPT appears to provide researchers and practitioners with a conceptual vocabulary for rigorous studies of implementation processes. It identifies, characterises and explains empirically identifiable mechanisms that motivate and shape implementation processes. Taken together, these mean that analyses using NPT can effectively assist in the explanation of the success or failure of specific implementation projects. Ten percent of papers included critiques of some aspect of NPT, with those that did mainly focusing on its terminology. However, two studies critiqued NPT emphasis on agency, and one study critiqued NPT for its normative focus.ConclusionsThis review demonstrates that researchers found NPT useful and applied it across a wide range of interventions. It has been effectively used to aid intervention development and implementation planning as well as evaluating and understanding implementation processes themselves. In particular, NPT appears to have offered a valuable set of conceptual tools to aid understanding of implementation as a dynamic process.

Project description:BackgroundKnee osteoarthritis has an inflammatory component that is linked to pain and joint pathology, yet common non-surgical and non-pharmacological interventions (e.g., exercise, calorie restricting diets) do not typically target inflammation. We aimed to evaluate the feasibility of a telehealth delivered anti-inflammatory diet intervention for knee osteoarthritis.MethodsThis 9-week single-arm feasibility study recruited participants aged 40-85 years with symptomatic knee osteoarthritis (inclusion criteria: average pain ≥4/10 or maximal pain ≥5/10 during past week). All participants received a telehealth-delivered anti-inflammatory dietary education intervention involving 1:1 consultations at baseline, 3- and 6-week follow-up. The diet emphasised nutrient-dense wholefoods and minimally processed anti-inflammatory foods and discouraged processed foods considered to be pro-inflammatory. The primary outcome of feasibility was assessed via: i) eligibility, recruitment and retention rates; ii) self-reported dietary adherence; iii) adverse events; and iv) treatment satisfaction. Post-intervention interviews evaluated the acceptability of the dietary intervention delivered via telehealth. Secondary outcomes included changes in self-reported body mass, Knee injury and Osteoarthritis Outcome Score (KOOS), health-related quality of life (EuroQoL-5D), analgesic use and global rating of change. Worthwhile effects were determined by the minimal detectable change (MDC) for all five KOOS-subscales (pain, symptoms, activities of daily living, sport/recreation, quality of life) being contained within the 95% confidence interval.ResultsForty-eight of seventy-three (66%) individuals screened were eligible and 28 enrolled over 2 months (82% female, mean age 66 ± 8 years, body mass index 30.7 ± 4.8 kg.m-2). Six participants withdrew prior to final follow-up (21% drop-out). Of those with final follow-up data, attendance at scheduled telehealth consultations was 99%. Self-reported adherence to diet during the 9-week intervention period: everyday = 27%, most of time = 68% and some of time = 5%. Two minor adverse events were reported. Change scores contained the MDC within the 95% confidence interval for all five KOOS subscales. Suggestions to improve study design and limit drop-out included an initial face-to-face consultation and more comprehensive habitual dietary intake data collection.ConclusionThis study supports the feasibility of a full-scale randomised controlled trial to determine the efficacy of a primarily telehealth-delivered anti-inflammatory dietary education intervention in adults with symptomatic knee osteoarthritis.Trial registrationACTRN12620000229976 prospectively on 25/2/2020.

Dataset Information

Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach.

Publications

Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets