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Effectiveness and Quality of Implementing a Best Practice Model of Care for Low Back Pain (BetterBack) Compared with Routine Care in Physiotherapy: A Hybrid Type 2 Trial.

ABSTRACT: Low back pain (LBP) occurs in all ages and first-line treatment by physiotherapists is common. The main aim of the current study was to evaluate the effectiveness of implementing a best practice model of care for LBP (intervention group-BetterBack☺ MoC) compared to routine physiotherapy care (control group) regarding longitudinal patient reported outcomes. The BetterBack☺ MoC contains clinical guideline recommendations and support tools to facilitate clinician adherence to guidelines. A secondary exploratory aim was to compare patient outcomes based on the fidelity of fulfilling a clinical practice quality index regarding physiotherapist care. A stepped cluster randomized design nested patients with LBP in the three clusters which were allocated to control (n = 203) or intervention (n = 264). Patient reported measures were collected at baseline, 3, 6 and 12 months and analyzed with mixed model regression. The primary outcome was between-group changes from baseline to 3 months for pain intensity and disability. Implementation of the BetterBack☺ MoC did not show any between-group differences in the primary outcomes compared with routine care. However, the intervention group showed significantly higher satisfaction at 3 months and clinically meaningful greater improvement in LBP illness perception at 3 months and quality of life at 3 and 6 months but not in patient enablement and global impression of change compared with the control group. Physiotherapists' care that adhered to all clinical practice quality indices resulted in an improvement of most patient reported outcomes with a clinically meaningful greater improved LBP illness perception at 3 months and quality of life at 3 and 6 months, significantly greater improvement in LBP illness perception, pain and satisfaction at 3 and 6 months and significantly better enablement at all time points as well as better global improvement outcomes at 3 months compared with non-adherent care. This highlights the importance of clinical guideline based primary care for improving patient reported LBP outcomes.

SUBMITTER: Schroder K

PROVIDER: S-EPMC8002355 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:Low back pain (LBP) is a major health problem commonly requiring healthcare. In Sweden, there is a call from healthcare practitioners (HCPs) for the development, implementation and evaluation of a best practice primary healthcare model for LBP. AIMS:(1) To improve and understand the mechanisms underlying changes in HCP confidence, attitudes and beliefs for providing best practice coherent primary healthcare for patients with LBP; (2) to improve and understand the mechanisms underlying illness beliefs, self-care enablement, pain, disability and quality of life in patients with LBP; and (3) to evaluate a multifaceted and sustained implementation strategy and the cost-effectiveness of the BetterBack☺ model of care (MOC) for LBP from the perspective of the Swedish primary healthcare context. METHODS:This study is an effectiveness-implementation hybrid type 2 trial testing the hypothesised superiority of the BetterBack☺ MOC compared with current routine care. The trial involves simultaneous testing of MOC effects at the HCP, patient and implementation process levels. This involves a prospective cohort study investigating implementation at the HCP level and a patient-blinded, pragmatic, cluster, randomised controlled trial with longitudinal follow-up at 3, 6 and 12 months post baseline for effectiveness at the patient level. A parallel process and economic analysis from a healthcare sector perspective will also be performed. Patients will be allocated to routine care (control group) or the BetterBack☺ MOC (intervention group) according to a stepped cluster dogleg structure with two assessments in routine care. Experimental conditions will be compared and causal mediation analysis investigated. Qualitative HCP and patient experiences of the BetterBack☺ MOC will also be investigated. DISSEMINATION:The findings will be published in peer-reviewed journals and presented at national and international conferences. Further national dissemination and implementation in Sweden and associated national quality register data collection are potential future developments of the project. DATE AND VERSION IDENTIFIER:13 December 2017, protocol version 3. TRIAL REGISTRATION NUMBER:NCT03147300; Pre-results.

Project description:BackgroundInherited epidermolysis bullosa (EB) comprises a group of rare disorders that have multi-system effects and patients present with a number of both acute and chronic pain care needs. Effects on quality of life are substantial. Pain and itching are burdensome daily problems. Experience with, and knowledge of, the best pain and itch care for these patients is minimal. Evidence-based best care practice guidelines are needed to establish a base of knowledge and practice for practitioners of many disciplines to improve the quality of life for both adult and pediatric patients with EB.MethodsThe process was begun at the request of Dystrophic Epidermolysis Bullosa Research Association International (DEBRA International), an organization dedicated to improvement of care, research and dissemination of knowledge for EB patients worldwide. An international panel of experts in pain and palliative care who have extensive experience caring for patients with EB was assembled. Literature was reviewed and systematically evaluated. For areas of care without direct evidence, clinically relevant literature was assessed, and rounds of consensus building were conducted. The process involved a face-to-face consensus meeting that involved a family representative and methodologist, as well as the panel of clinical experts. During development, EB family input was obtained and the document was reviewed by a wide variety of experts representing several disciplines related to the care of patients with EB.ResultsThe first evidence-based care guidelines for the care of pain in EB were produced. The guidelines are clinically relevant for care of patients of all subtypes and ages, and apply to practitioners of all disciplines involved in the care of patients with EB. When the evidence suggests that the diagnosis or treatment of painful conditions differs between adults and children, it will be so noted.ConclusionsEvidence-based care guidelines are a means of standardizing optimal care for EB patients, whose disease is often times horrific in its effects on quality of life, and whose care is resource-intensive and difficult. The guideline development process also highlighted areas for research in order to improve further the evidence base for future care.

Project description:Background:Low back pain clinical practice guidelines consistently recommend against the routine ordering of spinal imaging; however, imaging is frequently requested in primary care, without evidence of benefit. Imaging reports frequently identify degenerative features which are likely to be interpreted as 'abnormal', despite their high prevalence in symptom-free individuals. The aim of this study was to investigate whether post-imaging back-related perceptions are influenced by providing prior information about normal findings, and to compare the effect of receiving imaging results with best practice care (without imaging). The impact of introducing novel, 'enhanced' reporting strategies was also explored. Methods:This study was a simulated-patient, randomised, multiple-arm experiment. Patient scenarios were presented to volunteer healthy adult participants via an online survey. In the scenarios, 'virtual' patients with low back pain were randomised to one of three groups. Group 1 received imaging and was pre-informed about normal findings. Group 2 received imaging (without pre-information). Group 3 received best practice care: quality information without imaging. Group 1 was further divided to receive either a standard report, or an 'enhanced' report (containing altered terminology and epidemiological information). The primary outcome was back-related perceptions (BRP), a composite score derived from three numeric rating scale scores exploring perceptions of spinal condition, recovery concerns and planned activity. The secondary outcomes were satisfaction and kinesiophobia. Results:Full data were available from 660 participants (68% female). Analysis of covariance revealed a significant effect of group after controlling for baseline BRP scores [Formula: see text]. Pairwise comparisons indicated that receiving best practice care resulted in more positive BRPs than receiving imaging results, and receiving prior information about normal findings had no impact. Enhanced reporting strategies also positively impacted BRPs [Formula: see text]. Significant relationships between group allocation and both satisfaction [Formula: see text] and kinaesiophobia [Formula: see text] were found, with statistically significant pairwise comparisions again in favour of best-practice care. Conclusion:Intervention strategies such as enhanced reporting methods and the provision of quality information (without imaging) have the potential to improve the outcome of patients with recent-onset LBP and should be further considered by primary care providers.

Project description:Malnutrition is prevalent in patients with head and neck cancer (HNC), impacting outcomes. Despite publication of nutrition care evidence-based guidelines (EBGs), evidence-practice gaps exist. This study aimed to implement and evaluate the integration of a patient-centred, best-practice dietetic model of care into an HNC multidisciplinary team (MDT) to minimise the detrimental sequelae of malnutrition. A mixed-methods, pre-post study design was used to deliver key interventions underpinned by evidence-based implementation strategies to address identified barriers and facilitators to change at individual, team and system levels. A data audit of medical records established baseline adherence to EBGs and clinical parameters prior to implementation in a prospective cohort. Key interventions included a weekly Supportive Care-Led Pre-Treatment Clinic and a Nutrition Care Dashboard highlighting nutrition outcome data integrated into MDT meetings. Focus groups provided team-level evaluation of the new model of care. Economic analysis determined system-level impact. The baseline clinical audit (n = 98) revealed barriers including reactive nutrition care, lack of familiarity with EBGs or awareness of intensive nutrition care needs as well as infrastructure and dietetic resource limitations. Post-implementation data (n = 34) demonstrated improved process and clinical outcomes: pre-treatment dietitian assessment; use of a validated nutrition assessment tool before, during and after treatment. Patients receiving the new model of care were significantly more likely to complete prescribed radiotherapy and systemic therapy. Differences in mean percentage weight change were clinically relevant. At the system level, the new model of care avoided 3.92 unplanned admissions and related costs of $AUD121K per annum. Focus groups confirmed clear support at the multidisciplinary team level for continuing the new model of care. Implementing an evidence-based nutrition model of care in patients with HNC is feasible and can improve outcomes. Benefits of this model of care may be transferrable to other patient groups within cancer settings.

Project description:BackgroundLiver cirrhosis is a leading cause of morbidity, premature mortality and acute care utilization in patients with digestive disease. In the province of Alberta, hospital readmission rates for patients with cirrhosis are estimated at 44% at 90 days. For hospitalized patients, multiple care gaps exist, the most notable stemming from i) the lack of a structured approach to best practice care for cirrhosis complications, ii) the lack of a structured approach to broader health needs and iii) suboptimal preparation for transition of care into the community. Cirrhosis Care Alberta (CCAB) is a 4-year multi-component pragmatic trial which aims to address these gaps. The proposed intervention is initiated at the time of hospitalization through implementation of a clinical information system embedded electronic order set for delivering evidence-based best practices under real-world conditions. The overarching objective of the CCAB trial is to demonstrate effectiveness and implementation feasibility for use of the order set in routine patient care within eight hospital sites in Alberta.MethodsA mixed methods hybrid type I effectiveness-implementation design will be used to evaluate the effectiveness of the order set intervention. The primary outcome is a reduction in 90-day cumulative length of stay. Implementation outcomes such as reach, adoption, fidelity and maintenance will also be evaluated alongside other patient and service outcomes such as readmission rates, quality of care and cost-effectiveness. This theory-based trial will be guided by Normalization Process Theory, Consolidated Framework on Implementation Research (CFIR) and the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Framework.DiscussionThe CCAB project is unique in its breadth, both in the comprehensiveness of the multi-component order set and also for the breadth of its roll-out. Lessons learned will ultimately inform the feasibility and effectiveness of this approach in "real-world" conditions as well as adoption and adaptation of these best practices within the rest of Alberta, other provinces in Canada, and beyond.Trial registrationClinicalTrials.gov: NCT04149223, November 4, 2019.

Project description:BackgroundEvidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting.AimThis study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation.Methods/designThis study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy. Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory. Investigators (not involved in the delivery of the intervention), patients, outcome assessors and the study statistician will be blinded to group allocation.

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Effectiveness and Quality of Implementing a Best Practice Model of Care for Low Back Pain (BetterBack) Compared with Routine Care in Physiotherapy: A Hybrid Type 2 Trial.

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