Trial Summary
What is the purpose of this trial?The purpose of this study is to assess whether the primary spine practitioner (PSP) model of care will lead to improvements in patient outcomes, as compared to usual care, based on change in patient-reported PROMIS Pain Interference and Physical Function from baseline to 3 months in patients aged 18 years and older with a primary complaint of low back pain (LBP).
Is the Primary Spine Provider Model a promising treatment for low back pain?Yes, the Primary Spine Provider Model is a promising treatment for low back pain. It aims to improve patient care by focusing on non-drug therapies and reducing unnecessary medical procedures. This model helps organize spine care, making it more efficient and cost-effective, while also improving patient satisfaction and outcomes.125910
What safety data is available for the Primary Spine Provider Model for Low Back Pain?The provided research does not contain specific safety data for the Primary Spine Provider Model for Low Back Pain or its variations. The studies focus on general patient safety in ambulatory and primary care, tools for improving safety, and issues like repeat prescribing and adverse events, but do not address the safety of the Primary Spine Provider Model directly.346812
What data supports the idea that Primary Spine Provider Model for Low Back Pain is an effective treatment?The available research shows that the Primary Spine Provider Model is effective for treating low back pain. One study found that patients who received care from a Primary Spine Care clinician had better outcomes compared to those who received usual care from a primary care clinician. Specifically, these patients had lower rates of needing additional treatments like spinal injections or hospital visits. This suggests that the Primary Spine Provider Model can help manage low back pain more efficiently and reduce the need for more intensive medical interventions.2791011
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults over 18 who are starting outpatient treatment for low back pain at a participating clinic. They must be able to give consent and fill out a baseline questionnaire. People with severe symptoms like loss of bowel/bladder control or worsening muscle weakness cannot join.Treatment Details
The study compares two ways to treat low back pain: the Primary Spine Provider Model, which focuses on spine care specialists, versus Usual Care, where patients see general healthcare providers. It measures changes in how much pain affects their life and physical function after three months.
2Treatment groups
Experimental Treatment
Active Control
Group I: Primary Spine Provider ModelExperimental Treatment1 Intervention
This group will consist of patients who contact clinics that have been randomized to the primary spine provider (PSP) model (intervention clinics). Patients seeking care at intervention clinics will be given the option of seeing either a DC or a PT as their first contact clinician for an initial trial of PSP care.
Group II: Usual Medical CareActive Control1 Intervention
This group will consist of patients who contact clinics that have been randomized to usual medical care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of IowaIowa City, IA
Dartmouth HealthLebanon, NH
Duke HealthDurham, NC
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Who is running the clinical trial?
Duke UniversityLead Sponsor
Dartmouth-Hitchcock Medical CenterCollaborator
University of IowaCollaborator
Duke HealthCollaborator
Palmer College of ChiropracticCollaborator
National Center for Complementary and Integrative Health (NCCIH)Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Collaborator
References
The establishment of a primary spine care practitioner and its benefits to health care reform in the United States. [2022]It is widely recognized that the dramatic increase in health care costs in the United States has not led to a corresponding improvement in the health care experience of patients or the clinical outcomes of medical care. In no area of medicine is this more true than in the area of spine related disorders (SRDs). Costs of medical care for SRDs have skyrocketed in recent years. Despite this, there is no evidence of improvement in the quality of this care. In fact, disability related to SRDs is on the rise. We argue that one of the key solutions to this is for the health care system to have a group of practitioners who are trained to function as primary care practitioners for the spine. We explain the reasons we think a primary spine care practitioner would be beneficial to patients, the health care system and society, some of the obstacles that will need to be overcome in establishing a primary spine care specialty and the ways in which these obstacles can be overcome.
Primary spine care services: responding to runaway costs and disappointing outcomes in spine care. [2014]Efforts are underway to reform our health care system to improve efficiency, outcomes, patient satisfaction and costs. In no field is this more critical than that of spine- related disorders, where escalating costs combined with decreasing clinical benefits for patients has reached a breaking point. Traditionally, practitioners have grouped together based on their specialty (orthopedics, otolaryn- gology, etc.). There has been a recent movement to restructure health care delivery into a patient-centered model that teams professionals based on their ability to serve specific patient needs. This article introduces a new service line - primary spine care services - led by a new type of professional - the primary spine practitioner (PSP). This new practitioner type requires a refined and focused skill set and ideally functions within an integrated spine care pathway. The challenges and opportunities presented by primary spine care services are discussed. This service line has already been implemented in a variety of settings.
Tools for primary care patient safety: a narrative review. [2021]Patient safety in primary care is a developing field with an embryonic but evolving evidence base. This narrative review aims to identify tools that can be used by family practitioners as part of a patient safety toolkit to improve the safety of the care and services provided by their practices.
Repeat prescribing of medications: A system-centred risk management model for primary care organisations. [2021]Reducing preventable harm from repeat medication prescriptions is a patient safety priority worldwide. In the United Kingdom, repeat prescriptions items issued has doubled in the last 20 years from 5.8 to 13.3 items per patient per annum. This has significant resource implications and consequences for avoidable patient harms. Consequently, we aimed to test a risk management model to identify, measure, and reduce repeat prescribing system risks in primary care.
Effectiveness of implementing a best practice primary healthcare model for low back pain (BetterBack) compared with current routine care in the Swedish context: an internal pilot study informed protocol for an effectiveness-implementation hybrid type 2 trial. [2019]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.
Patient safety in ambulatory care from the patient's perspective: a retrospective, representative telephone survey. [2023]Data on patient safety problems (PSPs) in ambulatory care are scarce. The aim of the study was to record the frequency, type, severity and point of origin of PSPs in ambulatory care in Germany.
Advanced practice physiotherapy for adults with spinal pain: a systematic review with meta-analysis. [2021]To appraise the available evidence on advanced practice physiotherapy (APP) models of care (MoC) in specialized secondary care such as orthopaedic, rheumatology or neurosurgery outpatients' clinics for adults with spinal pain.
How do patients respond to safety problems in ambulatory care? Results of a retrospective cross-sectional telephone survey. [2023]Patients in German ambulatory care frequently report patient safety problems (PSP). It is unclear whether patients report PSP back to their general practitioner (GP) or specialist in charge. This study reports on how patients respond to experienced PSP.
Efficiency of primary spine care as compared to conventional primary care: a retrospective observational study at an Academic Medical Center. [2022]Primary Spine Care (PSC) is an innovative model for the primary management of patients with spine-related disorders (SRDs), with a focus on the use of non-pharmacological therapies which now constitute the recommended first-line approach to back pain. PSC clinicians serve as the initial or early point of contact for spine patients and utilize evidence-based spine care pathways to improve outcomes and reduce escalation of care (EoC; e.g., spinal injections, diagnostic imaging, hospitalizations, referrals to a specialist). The present study examined 6-month outcomes to evaluate the efficiency of care for patients who received PSC as compared to conventional primary care. We hypothesized that patients seen by a PSC clinician would have lower rates of EoC compared to patients who received usual care by a primary care (PC) clinician.
The primary spine practitioner as a new role in healthcare systems in North America. [2022]In an article published in 2011, we discussed the need for a new role in health care systems, referred to as the Primary Spine Practitioner (PSP). The PSP model was proposed to help bring order to the chaotic nature of spine care. Over the past decade, several efforts have applied the concepts presented in that article. The purpose of the present article is to discuss the ongoing need for the PSP role in health care systems, present persistent barriers, report several examples of the model in action, and propose future strategies.
Models of care for low back pain patients in primary healthcare: a scoping review protocol. [2022]Low 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.
Hospital Work Conditions and the Mediation Role of Burnout: Residents and Practicing Physicians Reporting Adverse Events. [2023]"Patient Safety" in everyday practices is a target of healthcare leaders, and adverse events reported by healthcare providers directly reflect patient safety in the health system. Recognising how residents and practising physicians rate adverse events concerning their work conditions and burnout must be explored.