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Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

ABSTRACT: BACKGROUND:Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. METHODS/DESIGN:A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). DISCUSSION:The results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care. TRIAL REGISTRATION:ClinicalTrials.gov NCT02333656.

SUBMITTER: Osteras N

PROVIDER: S-EPMC4668617 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

Østerås Nina N van Bodegom-Vos Leti L Dziedzic Krysia K Moseng Tuva T Aas Eline E Andreassen Øyvor Ø Mdala Ibrahim I Natvig Bård B Røtterud Jan Harald JH Schjervheim Unni-Berit UB Vlieland Thea Vliet TV Hagen Kåre Birger KB

Implementation science : IS 20151202

<h4>Background</h4>Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibilit ...[more]

PMID: 26631224

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Project description:BackgroundTo improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international recommendations. The objective of this study was to assess the effectiveness of this model in primary care.Methods and findingsWe conducted a cluster-randomised controlled trial with stepped-wedge cohort design in 6 Norwegian municipalities (clusters) between January 2015 and October 2017. The randomised order was concealed to the clusters until the time of crossover from the control to the intervention phase. The intervention was implementation of the SAMBA model, facilitated by interactive workshops for general practitioners and physiotherapists with an update on OA treatment recommendations. Patients in the intervention group attended a physiotherapist-led OA education and individually tailored exercise programme for 8-12 weeks. The primary outcome was patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire; 0-100, 100 = optimal quality) at 6 months. Secondary outcomes included patient-reported referrals to physiotherapy, magnetic resonance imaging (MRI), and orthopaedic surgeon consultation; patients' satisfaction with care; physical activity level; and proportion of patients who were overweight or obese (body mass index ≥ 25 kg/m2). In all, 40 of 80 general practitioners (mean age [SD] 50 [12] years, 42% females) and 37 of 64 physiotherapists (mean age [SD] 42 [8] years, 65% females) participated. They identified 531 patients, of which 393 patients (mean age [SD] 64 [10] years, 71% females) with symptomatic hip or knee OA were included. Among these, 109 patients were recruited during the control periods (control group), and 284 patients were recruited during interventions periods (intervention group). The patients in the intervention group reported significantly higher quality of care (score of 60 versus 41, mean difference 18.9; 95% CI 12.7, 25.1; p < 0.001) and higher satisfaction with OA care (odds ratio [OR] 12.1; 95% CI 6.44, 22.72; p < 0.001) compared to patients in the control group. The increase in quality of care was close to, but below, the pre-specified minimal important change. In the intervention group, a higher proportion was referred to physiotherapy (OR 2.5; 95% CI 1.08, 5.73; p = 0.03), a higher proportion fulfilled physical activity recommendations (OR 9.3; 95% CI 2.87, 30.37; p < 0.001), and a lower proportion was referred to an orthopaedic surgeon (OR 0.3; 95% CI 0.08, 0.80; p = 0.02), as compared to the control group. There were no significant group differences regarding referral to MRI (OR 0.6; 95% CI 0.13, 2.38; p = 0.42) and proportion of patients who were overweight or obese (OR 1.3; 95% CI 0.70, 2.51; p = 0.34). Study limitations include the imbalance in patient group size, which may have been due to an increased attention to OA patients among the health professionals during the intervention phase, and a potential recruitment bias as the patient participants were identified by their health professionals.ConclusionsIn this study, a structured model in primary care resulted in higher quality of OA care as compared to usual care. Future studies should explore ways to implement the structured model for integrated OA care on a larger scale.Trial registrationClinicalTrials.gov NCT02333656.

Project description:BackgroundNowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates. Patients' adherence to both treatment and hygienic-dietary measures is mandatory to achieve these objectives. Adherence to immunosuppressive drugs is estimated to be only 70%. We hypothesized that the implementation of a personalized pharmaceutical plan (PPP) would increase adherence and therefore graft survival.Methods/designThis study is a stepped-wedge cluster randomized trial with transplantation units defining clusters. Twelve clusters from 10 university hospitals were recruited. All centres started on the same day in the control phase. Every 7 weeks, one centre will switch to the intervention phase and remain there until the end of inclusions. We plan to recruit 1716 kidney and/or liver transplant patients. The intervention phase consists in setting up the PPP: development of the patient's hospital and community pharmaceutical follow-up. In the hospital, the pharmacist will carry out drug reconciliation upon admission, daily pharmaceutical follow-up of prescriptions and pharmaceutical interviews with the patient in order to explain the modalities of taking immunosuppressive drugs and hygienic-dietary measures. After hospitalization, during the post-transplantation year, pharmaceutical meetings will take place, prior to medical consultations in order to check the patient's understanding of the prescription, his adherence, to remind them of hygienic-dietary measures and to look for adverse effects. The hospital pharmacist will also be in charge of establishing a close link with the community pharmacist (CP) and general practitioner, especially providing discharge medication reconciliation, an e-learning and a checklist. Moreover, prior to each pharmaceutical consultation, the hospital pharmacist will contact the CP to discuss patient adherence. The primary outcome is adherence to immunosuppressive treatments 1 year post-transplantation assessed by using the BAASIS questionnaire and the health insurance data from the national health data system. A medico-economic study will measure the efficiency of this plan.DiscussionGRePH aims to increase adherence of liver and/or kidney transplant patients to their immunosuppressive therapies in order to reduce transplant rejections. To this end, a new clinical pharmacy model, the PPP, will be set up in 10 university hospitals.Trial registrationClinicalTrials.gov NCT04295928 . Registered on 5 March 2020.

Project description:BACKGROUND:Systematic implementation of guidelines for opioid therapy management in chronic non-cancer pain can reduce opioid-related harms. However, implementation of guideline-recommended practices in routine care is subpar. The goal of this quality improvement (QI) project is to assess whether a clinic-tailored QI intervention improves the implementation of a health system-wide, guideline-driven policy on opioid prescribing in primary care. This manuscript describes the protocol for this QI project. METHODS:A health system with 28 primary care clinics caring for approximately 294,000 primary care patients developed and implemented a guideline-driven policy on long-term opioid therapy in adults with opioid-treated chronic non-cancer pain (estimated N = 3980). The policy provided multiple recommendations, including the universal use of treatment agreements, urine drug testing, depression and opioid misuse risk screening, and standardized documentation of the chronic pain diagnosis and treatment plan. The project team drew upon existing guidelines, feedback from end-users, experts and health system leadership to develop a robust QI intervention, targeting clinic-level implementation of policy-directed practices. The resulting multi-pronged QI intervention included clinic-wide and individual clinician-level educational interventions. The QI intervention will augment the health system's "routine rollout" method, consisting of a single educational presentation to clinicians in group settings and a separate presentation for staff. A stepped-wedge design will enable 9 primary care clinics to receive the intervention and assessment of within-clinic and between-clinic changes in adherence to the policy items measured by clinic-level electronic health record-based measures and process measures of the experience with the intervention. DISCUSSION:Developing methods for a health system-tailored QI intervention required a multi-step process to incorporate end-user feedback and account for the needs of targeted clinic team members. Delivery of such tailored QI interventions has the potential to enhance uptake of opioid therapy management policies in primary care. Results from this study are anticipated to elucidate the relative value of such QI activities.

Project description:BackgroundShared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made.MethodsThe study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations.DiscussionIn the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making.Trial registrationNetherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487.

Project description:BACKGROUND:Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. METHODS:This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ??18?years, and requiring a PIVC for >?24?h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. RESULTS:Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n?=?306, intervention n?=?313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference -?8%, 95% CI -?14 to -?1, p?=?0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. CONCLUSIONS:This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. TRIAL REGISTRATION:Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415 .

Dataset Information

Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

Publications

Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

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