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Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care.

ABSTRACT: BACKGROUND:The STarT Back strategy for categorizing and treating patients with low back pain (LBP) improved patients' function while reducing costs in England. OBJECTIVE:This trial evaluated the effect of implementing an adaptation of this approach in a US setting. DESIGN:The Matching Appropriate Treatments to Consumer Healthcare needs (MATCH) trial was a pragmatic cluster randomized trial with a pre-intervention baseline period. Six primary care clinics were pair randomized, three to training in the STarT Back strategy and three to serve as controls. PARTICIPANTS:Adults receiving primary care for non-specific LBP were invited to provide data 2 weeks after their primary care visit and follow-up data 2 and 6 months (primary endpoint) later. INTERVENTIONS:The STarT Back risk-stratification strategy matches treatments for LBP to physical and psychosocial obstacles to recovery using patient-reported data (the STarT Back Tool) to categorize patients' risk of persistent disabling pain. Primary care clinicians in the intervention clinics attended six didactic sessions to improve their understanding LBP management and received in-person training in the use of the tool that had been incorporated into the electronic health record (EHR). Physical therapists received 5 days of intensive training. Control clinics received no training. MAIN MEASURES:Primary outcomes were back-related physical function and pain severity. Intervention effects were estimated by comparing mean changes in patient outcomes after 2 and 6 months between intervention and control clinics. Differences in change scores by trial arm and time period were estimated using linear mixed effect models. Secondary outcomes included healthcare utilization. KEY RESULTS:Although clinicians used the tool for about half of their patients, they did not change the treatments they recommended. The intervention had no significant effect on patient outcomes or healthcare use. CONCLUSIONS:A resource-intensive intervention to support stratified care for LBP in a US healthcare setting had no effect on patient outcomes or healthcare use. TRIAL REGISTRATION:National Clinical Trial Number NCT02286141.

SUBMITTER: Cherkin D

PROVIDER: S-EPMC6082187 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care.

Cherkin Dan D Balderson Benjamin B Wellman Rob R Hsu Clarissa C Sherman Karen J KJ Evers Sarah C SC Hawkes Rene R Cook Andrea A Levine Martin D MD Piekara Diane D Rock Pam P Estlin Katherine Talbert KT Brewer Georgie G Jensen Mark M LaPorte Anne-Marie AM Yeoman John J Sowden Gail G Hill Jonathan C JC Foster Nadine E NE

Journal of general internal medicine 20180522 8

<h4>Background</h4>The STarT Back strategy for categorizing and treating patients with low back pain (LBP) improved patients' function while reducing costs in England.<h4>Objective</h4>This trial evaluated the effect of implementing an adaptation of this approach in a US setting.<h4>Design</h4>The Matching Appropriate Treatments to Consumer Healthcare needs (MATCH) trial was a pragmatic cluster randomized trial with a pre-intervention baseline period. Six primary care clinics were pair randomize ...[more]

PMID: 29790073

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Project description:BackgroundInappropriate imaging and low-value care for low back pain (LBP) are common. A new patient-education booklet was created to overcome identified barriers to the delivery of recommended care, including the use of inappropriate imaging. Our aim was to assess the effectiveness of this booklet as part of primary care for LBP patients in comparison to usual care.MethodsA cluster-randomized trial was performed. The intervention involved providing practitioners with the new patient-education booklet and a 30-min training session on its use. The booklet was provided during the clinical consult to all consenting LBP patients in the intervention group. Primary outcomes were the proportion of patients presenting with LBP who underwent imaging examinations during the first three months of follow-up and PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) change between baseline and three-month follow-up. Secondary outcomes, including sick leave and imaging examinations at 12 months, were investigated. Logistic regression using GEE-estimation was used for dichotomous outcomes, Poisson regression using GEE-estimation for count outcomes, and linear mixed models for continuous outcomes.ResultsUsing the patient education booklet appeared to substantially reduce the proportion of LBP patients who underwent an imaging examination at three months, but the result was not statistically significant (OR 0.57, 95% confidence interval (Cl) 0.27 to 1.22). At 12 months, the effect was slightly larger and statistically significant (OR 0.50, 95%Cl 0.30 to 0.83, p = 0.008). No difference was observed in the PROMIS PF-20 T-score change between baseline and 3 months or 12 months (p = 0.365 and p = 0.923, respectively). The number of sick leave days in the intervention group was less than that in the control group at 3 months (RR 0.47, 95%Cl 0.26 to 0.83, p = 0.010) and at 12 months (RR 0.36, 95%Cl 0.18 to 0.72, p = 0.004).ConclusionsThe booklet appeared to be effective in reducing the proportion of LBP patients who underwent imaging examinations over 12 months. The intervention had no discernible effect on the PROMIS PF20 T-score change. The number of sick leave days was substantially lower in the intervention group.Trial registrationISRCTN, ISRCTN14389368 , Registered 4 April 2019-Retrospectively registered.

Project description:BackgroundNon-specific low back pain (NSLBP) is the most prevalent musculoskeletal condition in western countries and is associated with persistent disability and high consumption of health care resources. NSLBP patients first seek primary health care services but the outcomes are often uncertain. This study aimed to examine the clinical course of the outcomes and to identify prognostic indicators for poor outcomes in NSLBP patients who consulted primary care.MethodsA prospective cohort study of 115 patients seeking treatment for NSLBP in primary care was conducted. Participants were consecutively recruited by their General Practitioners (GPs) and then assessed at baseline and 2 and 6 months later. Baseline assessment included socio-demographic and clinical data, psychosocial factors, pain, disability, and health related quality of life (HRQoL). Pain, disability, HRQoL and global perception of change were also assessed at 2 and 6-months' follow-up. In addition, information regarding the GP' practice was collected. Poor outcomes were determined according to the cut-off point used to define a persistent disabling condition and the minimal important change established for disability, pain and for global perception of change. The relationship between variables on baseline and poor outcomes was modulated through binary logistic regression analysis. The significance of associations was evaluated at ≤ 0.05 p-value with 95% confidence intervals (CI) and adjusted odds ratios (AOR).Results110 (94.8%) and 104 (89.7%) participants completed the follow-up assessment at 2 and 6 months, respectively. The mean age (±SD) was 48.06 ± 11.41, with 53.9%, (N = 62) reporting an acute presentation of NSLBP. Six months after GP consultation, 53.8% (N = 56) of the participants reported a persistent disabling condition. An "LBP episode of less than 12 weeks" [AOR: 0.26; 95% CI (0.10, 0.65); AOR: 0.34; 95% CI (0.14, 0.81); AOR: 0.21; 95% CI (0.09, 0.53)],"maladaptive psychosocial factors" [AOR: 2.06; 95% CI (1.40, 3.04); AOR: 1.82; 95% CI (1.27, 2.59); AOR: 1.72; 95% CI (1.20, 2.47)] were significantly associated with poor outcomes on disability, pain and global perception of change, respectively. Besides these factors, being employed reduces the chances of poor outcomes on disability [AOR 0.31; 95% CI (0.11, 0.92)].ConclusionsA large proportion of LBP patients seeking primary health care reported poor outcomes 6 months after GP consultation. Patients who report chronic LBP, maladaptive psychosocial factors and are unemployed have a significant increase in the risk of poor outcome. These findings suggest the need of implementing effective models of care able to provide early screening and appropriate treatment to those at greatest risk of a poor outcome.Trial registrationCurrent Controlled Trials NCT04046874 (August 6, 2019). Retrospectively registered.

Project description:IntroductionLow back pain (LBP) is the most prevalent musculoskeletal condition worldwide and it is responsible for high healthcare costs and resources consumption. It represents a challenge for primary care services that struggle to implement evidence-based practice. Models of care (MoCs) are arising as effective solutions to overcome this problem, leading to better health outcomes. Although there is growing evidence regarding MoCs for the management of LBP patients, an analysis of the existing body of evidence has not yet been carried out. Therefore, this scoping review aims to identify and map the current evidence about the implementation of MoCs for LBP in primary healthcare. Findings from this study will inform policy makers, health professionals and researchers about their characteristics and outcomes, guiding future research and best practice models.Methods and analysisThis protocol will follow the Joanna Briggs Institute methodological guidelines for scoping reviews. Studies that implemented an MoC for LBP patients in primary healthcare will be included. Searches will be conducted on PubMed, EMBASE, Cochrane Central Register of Controlled Trials, PEDro, Scopus, Web of Science, grey literature databases and relevant organisations websites. This review will consider records from 2000, written in English, Portuguese or Spanish. Two researchers will independently screen all citations and full-text articles and abstract data. Data extracted will include the identification of the MoC, key elements of the intervention, organisational components, context-specific factors and patient-related, system-related and implementation-related outcomes.Ethics and disseminationAs a secondary analysis, this study does not require ethical approval. It will provide a comprehensive understanding on existing MoCs for LBP, outcomes and context-related challenges that may influence implementation in primary healthcare, which is meaningful knowledge to inform future research in this field. Findings will be disseminated through research papers in peer-reviewed journals, presentations at relevant conferences and documentation for professional organisations and stakeholders.

Project description:The purpose of this study was to define and select a core set of outcome-based quality indicators, accepted by stakeholders on usability and perceived added value as a quality improvement tool, and to formulate recommendations for the next implementation step. In phase 1, 15 potential quality indicators were defined for patient-reported outcome measures and associated domains, namely the Numeric Pain Rating Scale (NPRS) for pain intensity, the Patient Specific Functioning Scale (PSFS) for physical activity, the Quebec Back Pain Disability Scale for physical functioning, and the Global Perceived Effect-Dutch Version for perceived effect. Their comparability and discriminatory characteristics were described using cohort data. In phase 2, a core set of quality indicators was selected based on consensus among stakeholders in focus group meetings. In total, 65,815 completed treatment episodes for patients with nonspecific low back pain were provided by 1009 physical therapists from 219 physical therapist practices. The discriminability between physical therapists of all potential 15 quality indicators was adequate, with intraclass correlation coefficients between 0.08 and 0.30. Stakeholders selected a final core set of 6 quality indicators: 2 process indicators (the routine measurement of NPRS and the PSFS) and 4 outcome indicators (pretreatment and posttreatment change scores for the NPRS, PSFS, Quebec Back Pain Disability Scale, and the minimal clinically important difference of the Global Perceived Effect-Dutch Version). This study described and selected a core set of outcome-based quality indicators for physical therapy in patients with nonspecific low back pain. The set was accepted by stakeholders for having added value for daily practice in physical therapy primary care and was found useful for quality improvement initiatives. Further studies need to focus on improvement of using the core set of outcome-based quality indicators as a quality monitoring and evaluation instrument. Patient-reported outcome-based quality indicators developed from routinely collected clinical data are promising for use in quality improvement in daily practice.

Project description:ObjectiveIdentifying subgroups of low back pain (LBP) has the potential to improve prediction of clinical outcomes. Risk stratification is one such strategy that identifies similar characteristics indicative of a common clinical outcome trajectory. The purpose of this study was to determine if an empirically derived subgrouping approach based on physical impairment measures improves information provided from the STarT Back Tool (SBT).MethodsAt baseline in this secondary analysis of a cohort study, patients (N = 144) receiving physical therapy for LBP completed the SBT and tests (active lumbar flexion, extension, lateral bending, and passive straight-leg raise) from a validated physical impairment index. Clinical outcomes were assessed at 4 weeks and included the Numerical Pain Rating Scale and Oswestry Disability Index. Exploratory hierarchical agglomerative cluster analysis identified empirically derived subgroups based on physical impairment measures. Independent samples t testing and chi-square analysis were used to assess baseline subgroup differences in demographic and clinical measures. Spearman rho correlation coefficient was used to assess baseline SBT risk and impairment subgroup relationships, and a 3-way mixed-model ANOVA was used to assessed SBT risk and impairment subgroup relationships with clinical outcomes at 4 weeks.ResultsTwo physical impairment-based subgroups emerged from cluster analysis: (1) low-risk impairment (n = 119, 81.5%), characterized by greater lumbar mobility; and (2) high-risk impairment (n = 25, 17.1%), characterized by less lumbar mobility. A weak, positive relationship was observed between baseline SBT risk and impairment subgroups (rs = .170). An impairment-by-SBT risk-by-time interaction effect was observed for Oswestry Disability Index scores but not for Numerical Pain Rating Scale scores at 4 weeks.ConclusionsPhysical impairment subgroups were not redundant with SBT risk categories and could improve prediction of 4-week LBP disability outcomes. Physical impairment subgroups did not improve the prediction of 4-week pain intensity scores.ImpactSubgroups based on physical impairment and psychosocial risk could lead to better prediction of LBP disability outcomes and eventually allow for treatment options tailored to physical and psychosocial risk.

Dataset Information

Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care.

Publications

Effect of Low Back Pain Risk-Stratification Strategy on Patient Outcomes and Care Processes: the MATCH Randomized Trial in Primary Care.

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