Dataset Information

Pragmatic Implementation of a Stratified Primary Care Model for Low Back Pain Management in Outpatient Physical Therapy Settings: Two-Phase, Sequential Preliminary Study.

ABSTRACT:

Background

The effectiveness of risk stratification for low back pain (LBP) management has not been demonstrated in outpatient physical therapy settings.

Objective

The purposes of this study were: (1) to assess implementation of a stratified care approach for LBP management by evaluating short-term treatment effects and (2) to determine feasibility of conducting a larger-scale study.

Design

This was a 2-phase, preliminary study.

Methods

In phase 1, clinicians were randomly assigned to receive standard (n=6) or stratified care (n=6) training. Stratified care training included 8 hours of content focusing on psychologically informed practice. Changes in LBP attitudes and beliefs were assessed using the Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) and the Health Care Providers Pain and Impairment Relationship Scale (HC-PAIRS). In phase 2, clinicians receiving the stratified care training were instructed to incorporate those strategies in their practice and 4-week patient outcomes were collected using a numerical pain rating scale (NPRS), and the Oswestry Disability Index (ODI). Study feasibility was assessed to identify potential barriers for completion of a larger-scale study.

Results

In phase 1, minimal changes were observed for PABS-PT and HC-PAIRS scores for standard care clinicians (Cohen d=0.00-0.28). Decreased biomedical (-4.5±2.5 points, d=1.08) and increased biopsychosocial (+5.5±2.0 points, d=2.86) treatment orientations were observed for stratified care clinicians, with these changes sustained 6 months later on the PABS-PT. In phase 2, patients receiving stratified care (n=67) had greater between-group improvements in NPRS (0.8 points; 95% confidence interval=0.1, 1.5; d=0.40) and ODI (8.9% points; 95% confidence interval=4.1, 13.6; d=0.76) scores compared with patients receiving standard physical therapy care (n=33).

Limitations

In phase 2, treatment was not randomly assigned, and therapist adherence to treatment recommendations was not monitored. This study was not adequately powered to conduct subgroup analyses.

Conclusions

In physical therapy settings, biomedical orientation can be modified, and risk-stratified care for LBP can be effectively implemented. Findings from this study can be used for planning of larger studies.

SUBMITTER: Beneciuk JM

PROVIDER: S-EPMC4528015 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Publications

Pragmatic Implementation of a Stratified Primary Care Model for Low Back Pain Management in Outpatient Physical Therapy Settings: Two-Phase, Sequential Preliminary Study.

Beneciuk Jason M JM George Steven Z SZ

Physical therapy 20150409 8

<h4>Background</h4>The effectiveness of risk stratification for low back pain (LBP) management has not been demonstrated in outpatient physical therapy settings.<h4>Objective</h4>The purposes of this study were: (1) to assess implementation of a stratified care approach for LBP management by evaluating short-term treatment effects and (2) to determine feasibility of conducting a larger-scale study.<h4>Design</h4>This was a 2-phase, preliminary study.<h4>Methods</h4>In phase 1, clinicians were ra ...[more]

PMID: 25858972

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Project description:BackgroundMany patients with acute low back pain (LBP) first seek care from primary care physicians. Evidence is lacking for interventions to prevent transition to chronic LBP in this setting. We aimed to test if implementation of a risk-stratified approach to care would result in lower rates of chronic LBP and improved self-reported disability.MethodsWe conducted a pragmatic, cluster randomized trial using 77 primary care clinics in four health care systems across the United States. Practices were randomly assigned to a stratified approach to care (intervention) or usual care (control). Using the STarTBack screening tool, adults with acute LBP were screened low, medium, and high-risk. Patients screened as high-risk were eligible. The intervention included electronic best practice alerts triggering referrals for psychologically informed physical therapy (PIPT). PIPT education was targeted to community clinics geographically close to intervention primary care clinics. Primary outcomes were transition to chronic LBP and self-reported disability at six months. Trial Registry: ClinicalTrials.gov NCT02647658.FindingsBetween May 2016 and June 2018, 1207 patients from 38 intervention and 1093 from 37 control practices were followed. In the intervention arm, around 50% of patients were referred for physical therapy (36% for PIPT) compared to 30% in the control. At 6 months, 47% of patients reported transition to chronic LBP in the intervention arm (38 practices, n = 658) versus 51% of patients in the control arm (35 practices, n = 635; OR=0.83 95% CI 0.64, 1.09; p = 0.18). No differences in disability were detected (difference -2·1, 95% CI -4.9-0.6; p = 0.12). Opioids and imaging were prescribed in 22%-25% and 23%-26% of initial visits, for intervention and control, respectively. Twelve-month LBP utilization was similar in the two groups.InterpretationThere were no differences detected in transition to chronic LBP among patients presenting with acute LBP using a stratified approach to care. Opioid and imaging prescribing rates were non-concordant with clinical guidelines.FundingPatient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402-10867.

Project description:BackgroundStratified care approach involving use of the STarT-Back tool to optimise care for patients with low back pain is gaining widespread attention in western countries. However, adoption and implementation of this approach in low-and-middle-income countries will be restricted by context-specific factors that need to be addressed. This study aimed to develop with physiotherapists, tailored intervention strategies for the implementation of stratified care for patients with low back pain.MethodsA two-round web-based Delphi survey was conducted among purposively sampled physiotherapists with a minimum of three years of clinical experience, with post-graduation certification or specialists. Thirty statements on barriers and enablers for implementation were extracted from the qualitative phase. Statements were rated by a Delphi panel with additional open-ended feedback. After each Delphi round, participants received feedback which informed their subsequent responses. Additional qualitative feedback were analysed using qualitative content analysis. The criteria for consensus and stability were pre-determined using percentage agreement (≥ 75%), median value (≥ 4), Inter-quartile range (≤ 1), and Wilcoxon matched-pairs test respectively.ResultsParticipants in the first round were 139 and 125 of them completed the study, yielding a response rate of 90%. Participants were aged 35.2 (SD6.6) years, and 55 (39.6%) were female. Consensus was achieved in 25/30 statements. Wilcoxon's test showed stability in responses after the 5 statements failed to reach consensus: 'translate the STarT-Back Tool to pidgin language' 71% (p = 0.76), 'begin implementation with government hospitals' 63% (p = 0.11), 'share knowledge with traditional bone setters' 35% (p = 0.67), 'get second opinion on clinician's advice' 63% (p = 0.24) and 'carry out online consultations' 65% (p = 0.41). Four statements strengthened by additional qualitative data achieved the highest consensus: 'patient education' (96%), 'quality improvement appraisals' (96%), 'undergraduate training on psychosocial care' (96%) and 'patient-clinician communication' (95%).ConclusionThere was concordance of opinion that patients should be educated to correct misplaced expectations and proper time for communication is vital to implementation. This communication should be learned at undergraduate level, and for already qualified clinicians, quality improvement appraisals are key to sustained and effective care. These recommendations provide a framework for future research on monitored implementation of stratified care in middle-income countries.

Project description:BackgroundPatient engagement in decisions regarding their health care may lead to improved outcomes and improved adherence to treatment plans. While there are several options for involving patients in their health care, goal setting is a readily accessible method for physical therapists to increase the involvement of patients in health care decisions. Physical therapy goals are often generated by health care providers based on subjective information or standardized, fixed-item, patient-reported outcome measures. However, these outcome measures may not fully reveal the activity and participation limitations of individual patients. Goal attainment scaling (GAS) is a patient-centered approach that allows patients to set meaningful goals. While GAS has been shown to be reliable, valid, and sensitive to change in various populations, there is limited evidence in the United States on utilizing GAS in physical therapy for patients with chronic low back pain (LBP).ObjectiveThe purpose of this paper is to describe the protocol for a study to (1) develop a way to apply GAS procedures for physical therapists treating patients with chronic LBP in the United States and (2) test the feasibility of applying GAS procedures for chronic LBP in an outpatient physical therapy setting.MethodsThis study used a mixed methods design with 2 phases: qualitative and quantitative. The qualitative phase of the study employed focus groups of patients with chronic LBP to identify an inventory of goals that were important and measurable. A series of prompts was developed from this inventory to assist physical therapists in collaboratively establishing goals with patients in a clinical setting. The quantitative phase of the study pilot-tested the inventory developed in the qualitative phase in patients with chronic LBP to determine feasibility, reliability, validity, and responsiveness. We also plan to compare how well GAS reveals change over time relative to traditional, fixed-item, patient-reported measures.ResultsPhase 1 data collection was completed in June 2020, while data collection for phase 2 was performed between March 2021 and December 2021. We anticipate that this study will demonstrate that GAS can be implemented successfully by outpatient physical therapists, and that it will demonstrate clinically important changes in patients with chronic LBP.ConclusionsGAS represents an opportunity for patient-centered care in the physical therapy management of chronic LBP. While GAS is not new, it has never been studied in real-world physical therapy for chronic LBP in a clinical setting. Due to unique time and productivity constraints, for GAS to be successfully implemented in this environment, we must demonstrate that clinicians can be trained efficiently and reliably, that GAS can be implemented in a clinical setting in under 15 minutes, and that GAS is able to detect clinically meaningful changes in patient outcomes.International registered report identifier (irrid)DERR1-10.2196/32457.

Project description:BackgroundLow back pain is a prevalent condition that causes a substantial health burden. Despite intensive and expensive clinical efforts, its prevalence is growing. Nonpharmacologic treatments are effective at improving pain-related outcomes; however, treatment effect sizes are often modest. Physical therapy (PT) and cognitive behavioral therapy (CBT) have the most consistent evidence of effectiveness. Growing evidence also supports mindfulness-based approaches. Discussions with providers and patients highlight the importance of discussing and trying options to find the treatment that works for them and determining what to do when initial treatment is not successful. Herein, we present the protocol for a study that will evaluate evidence-based, protocol-driven treatments using PT, CBT, or mindfulness to examine comparative effectiveness and optimal sequencing for patients with chronic low back pain.MethodsThe Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE) Study will be a multisite, comparative effectiveness trial using a sequential multiple assessment randomized trial design enrolling 945 individuals with chronic low back pain. The co-primary outcomes will be disability (measured using the Oswestry Disability Index) and pain intensity (measured using the Numerical Pain Rating Scale). After baseline assessment, participants will be randomly assigned to PT or CBT. At week 10, participants who have not experienced at least 50% improvement in disability will be randomized to cross-over phase-1 treatments (e.g., PT to CBT) or to Mindfulness-Oriented Recovery Enhancement (MORE). Treatment will consist of 8 weekly sessions. Long-term outcome assessments will be performed at weeks 26 and 52.DiscussionResults of this study may inform referring providers and patients about the most effective nonoperative treatment and/or sequence of nonoperative treatments to treat chronic low back pain.Trial registrationThis study was prospectively registered on March 1, 2019, with Clinicaltrials.gov under the registration number NCT03859713 (https://clinicaltrials.gov/ct2/show/NCT03859713).

Project description:BackgroundImaging is overused in the management of low back pain (LBP). Interventions designed to decrease non-indicated imaging have predominantly targeted practitioner education alone; however, these are typically ineffective. Barriers to reducing imaging have been identified for both patients and practitioners. Interventions aimed at addressing barriers in both these groups concurrently may be more effective. The Behaviour Change Wheel provides a structured framework for developing implementation interventions to facilitate behavioural change. The aim of this study was to develop an implementation intervention aiming to reduce non-indicated imaging for LBP, by targeting both general medical practitioner (GP) and patient barriers concurrently.MethodsThe Behaviour Change Wheel was used to identify the behaviours requiring change, and guide initial development of an implementation intervention. Preliminary testing of the intervention was performed with: 1) content review by experts in the field; and 2) qualitative analysis of semi-structured interviews with 10 GPs and 10 healthcare consumers, to determine barriers and facilitators to successful implementation of the intervention in clinical practice. Results informed further development of the implementation intervention.ResultsPatient pressure on the GP to order imaging, and the inability of the GP to manage a clinical consult for LBP without imaging, were determined to be the primary behaviours leading to referral for non-indicated imaging. The developed implementation intervention consisted of a purpose-developed clinical resource for GPs to use with patients during a LBP consult, and a GP training session. The implementation intervention was designed to provide GP and patient education, remind GPs of preferred behaviour, provide clinical decision support, and facilitate GP-patient communication. Preliminary testing found experts, GPs, and healthcare consumers were supportive of most aspects of the developed resource, and thought use would likely decrease non-indicated imaging for LBP. Suggestions for improvement of the implementation intervention were incorporated into a final version.ConclusionsThe developed implementation intervention, aiming to reduce non-indicated imaging for LBP, was informed by behaviour change theory and preliminary testing. Further testing is required to assess feasibility of use in clinical practice, and the effectiveness of the implementation intervention in reducing imaging for LBP, before large-scale implementation can be considered.

Project description:BackgroundPost-operative pain is unpleasant for patients and may worsen surgical recovery. Peri-operative multimodal analgesia has been used for many years; however, its efficacy still needs improvement. In the present study, a thorough peri-operative pain counseling and stratified management program based on risk assessment was implemented, with the goal of improving post-operative analgesia and patient satisfaction.MethodsThis prospective, controlled, pilot study included 361 patients who underwent elective surgery. Of these 361 patients, 187 received peri-operative pain risk assessment and stratified analgesia and counseling (stratified analgesia group), while 174 received conventional multimodal analgesia (conventional group). The two groups were compared regarding the post-operative pain intensity, rescue analgesia administration, post-operative quality of recovery as assessed via the quality of recovery 40 questionnaire, total dosage of peri-operative opioids, analgesic satisfaction, and analgesic costs.ResultsCompared with the conventional group, the stratified analgesia group reported decreased pain intensity during motion at 24 h post-operatively and required lower dosages of rescue analgesia (P = 0.03). The total quality of recovery 40 questionnaire score and the scores for physical wellbeing and pain were significantly better in the stratified analgesia group than the conventional group (P = 0.04); the stratified analgesia group also reported better scores for analgesic satisfaction (P = 0.03) and received lower dosages of opioids (P = 0.03). Analgesic costs were lower in the stratified analgesia group than the conventional group; the cost-effective ratio was 109 in the conventional group and 62 in the stratified analgesia group.ConclusionsThe analgesic efficacy was improved by the implementation of stratified analgesia based on surgical pain risk assessment and counseling. This stratified analgesia protocol increased the patients' analgesic satisfaction and improved the quality of recovery without increasing healthcare costs. The present findings may help improve the efficacy of peri-operative multimodal analgesia in clinical practice.Clinical trial registryNCT02728973; https://clinicaltrials.gov/ct2/show/NCT02728973?term=NCT02728973&draw=2&rank=1.

Project description:BackgroundThe prevalence of chronic pain conditions is growing. Low back pain was the primary cause of disability worldwide out of 156 conditions assessed between 1990 and 2016, according to the Global Burden of Disease Study. Conventional medical approaches have failed to identify effective and long-lasting approaches for the management of chronic pain, and often fail to consider the multiple domains that influence overall health and can contribute to the pain experience. Leading international organizations that focus on pain research have stated the importance of considering these other domains within holistic and multidisciplinary frameworks for treating pain. While the research behind the theoretical link between these domains and chronic pain outcomes has expanded greatly over the last decade, there have been few practical and feasible methods to implement this type of care in normal clinical practice.MethodsThe purpose of this manuscript is to describe an implementation protocol that is being used to deliver a complex holistic health intervention at multiple sites within a large government health system, as part of a larger multisite trial for patients with chronic low back pain. The Move to Health program developed by the US Army Medical Command was tailored for specific application to patients with low back pain and begins by providing an empirical link between eight different health domains (that include physical, emotional, social, and psychological constructs) and chronic low back pain. Through a six-step process, a health coach leverages motivational interviewing and information from a personal health inventory to guide the patient through a series of conversations about behavioral lifestyle choices. The patient chooses which domains they want to prioritize, and the health coach helps implement the plan with the use of SMART (Specific, Measurable, Attainable, Realistic, Time-bound) goals and a series of resources for every domain, triaged from self-management to specialist referral.DiscussionComplex interventions described in clinical trials are often challenging to implement because they lack sufficient details. Implementation protocols can improve the ability to properly deliver trial interventions into regular clinical practice with increased fidelity.Trial registrationImplementation of this intervention protocol was developed for a clinical trial that was registered a priori (clinicaltrials.gov #NCT04172038).

Dataset Information

Pragmatic Implementation of a Stratified Primary Care Model for Low Back Pain Management in Outpatient Physical Therapy Settings: Two-Phase, Sequential Preliminary Study.

Background

Objective

Design

Methods

Results

Limitations

Conclusions

Publications

Pragmatic Implementation of a Stratified Primary Care Model for Low Back Pain Management in Outpatient Physical Therapy Settings: Two-Phase, Sequential Preliminary Study.

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