Primary Spine Provider Model for Low Back Pain

(IMPACt-LBP Trial)

Recruiting at 2 trial locations

Overseen By Adam Goode, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Disqualifiers: Cauda equina symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 3 months

1800 Participants Needed

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).

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 11 12}

Research Team

Christine Goertz, PhD

Principal Investigator

Duke Clinical Research Institute

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.

Inclusion Criteria

Agree to participate and complete baseline questionnaire (in lieu of formal written documentation of consent)

I am starting treatment for lower back pain at a clinic.

Exclusion Criteria

Inability to provide consent or complete outcome questionnaires

I have lost total control of my bowel or bladder with this back pain episode.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive care based on the Primary Spine Provider model or usual medical care, with assessments at baseline and 3 months

3 months

Multiple visits as needed for care

Follow-up

Participants are monitored for changes in PROMIS Pain Interference and Physical Function, as well as other secondary outcomes

24 months

Assessments at 6, 12, and 24 months

Exploratory Analysis

Long-term improvement and healthcare utilization are assessed using PROMIS measures and healthcare data

24 months

Treatment Details

Interventions

• Primary Spine Provider Model
• Usual Care

Trial Overview 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.

Participant Groups

Group I: Primary Spine Provider Model Experimental Treatment 1 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 Care Active Control 1 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).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Duke Health

Collaborator

Trials

6

Recruited

3,100+

Palmer College of Chiropractic

Collaborator

Trials

19

Recruited

4,700+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

Patients receiving Primary Spine Care (PSC) experienced significantly lower rates of escalation of care (EoC) for spine-related disorders compared to those receiving conventional primary care, with fewer hospitalizations and specialist visits within 6 months.

The PSC model also resulted in reduced use of opioid prescriptions and spinal injections, suggesting it may provide a more efficient and safer approach to managing spine-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of primary spine care as compared to conventional primary care: a retrospective observational study at an Academic Medical Center. Bezdjian, S., Whedon, JM., Russell, R., et al.[2022]

The introduction of primary spine care services, led by primary spine practitioners (PSPs), aims to improve patient outcomes and satisfaction while reducing costs in the treatment of spine-related disorders.

This new model focuses on a patient-centered approach, integrating various healthcare professionals to better address specific patient needs, and has already been implemented in multiple healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary spine care services: responding to runaway costs and disappointing outcomes in spine care. Murphy, DR.[2014]

The Primary Spine Practitioner (PSP) model aims to improve the management of spine-related disorders by increasing efficiency and effectiveness in spine care, addressing the high costs and poor outcomes associated with these conditions.

Despite significant progress in integrating the PSP role into healthcare systems over the past decade, ongoing barriers remain, necessitating continued efforts and support from stakeholders to fully realize the benefits of this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The primary spine practitioner as a new role in healthcare systems in North America. Murphy, DR., Justice, B., Bise, CG., et al.[2022]

This scoping review aims to identify and map the current evidence on Models of Care (MoCs) for managing low back pain (LBP) in primary healthcare, which is crucial given LBP's prevalence and impact on healthcare resources.

The review will analyze various MoCs implemented since 2000, focusing on their characteristics, outcomes, and the challenges faced in their implementation, providing valuable insights for policymakers and healthcare professionals to improve LBP management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of care for low back pain patients in primary healthcare: a scoping review protocol. Duarte, ST., Nunes, C., Costa, D., et al.[2022]

Advanced practice physiotherapy (APP) models of care for adults with spinal pain show similar outcomes in pain, disability, and quality of life compared to usual medical care, based on a systematic review of 18 studies involving 9405 participants.

APP models significantly reduce wait times for consultations, with initial appointments occurring 1-9.4 weeks sooner than usual medical care, while also achieving high satisfaction rates among patients and stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced practice physiotherapy for adults with spinal pain: a systematic review with meta-analysis. Lafrance, S., Lapalme, JG., Méquignon, M., et al.[2021]

In a study of 10,037 citizens aged 40 and older in Germany, 14% reported experiencing patient safety problems (PSPs) in ambulatory care, with the most common issues arising from anamnesis/diagnostic procedures (61%) and medication (15%).

A significant 75% of reported PSPs resulted in harm, with 35% leading to permanent damage, highlighting the urgent need for improved safety measures in outpatient care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in ambulatory care from the patient's perspective: a retrospective, representative telephone survey. Geraedts, M., Krause, S., Schneider, M., et al.[2023]

The review identified 114 tools for improving patient safety in primary care, with a significant focus on medication errors (55%), but highlighted a lack of specific tools for addressing diagnostic errors and results handling, which are critical areas for patient safety.

While many tools exist to measure patient safety, there is limited evidence on their effectiveness in actual quality improvement strategies, indicating a need for further research to validate their utility in enhancing safety in family practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tools for primary care patient safety: a narrative review. Spencer, R., Campbell, SM.[2021]

A study involving 48 general medical practices in NHS Lambeth identified 62 unique risks associated with repeat prescribing, highlighting significant safety concerns in medication management.

The implementation of a risk management model led to the recommendation of 767 system improvement actions, demonstrating a proactive approach to enhancing patient safety and reducing preventable harm from repeat prescriptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeat prescribing of medications: A system-centred risk management model for primary care organisations. Price, J., Man, SL., Bartlett, S., et al.[2021]

In a study of 10,037 citizens aged 40 and older in Germany, 72% of reported patient safety problems (PSPs) were communicated back to their general practitioner or specialist, indicating a high level of patient engagement in reporting safety issues.

The study found that 63% of those who reported PSPs experienced a loss of trust in their physician or filed complaints, highlighting the significant impact of PSPs on the physician-patient relationship and the need for improved safety measures in ambulatory care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do patients respond to safety problems in ambulatory care? Results of a retrospective cross-sectional telephone survey. Seufert, S., de Cruppé, W., Assheuer, M., et al.[2023]

In a study of 249 residents and practicing physicians, it was found that supportive leadership and physician engagement significantly reduced the rate of adverse events related to patient safety, while high workload increased these events.

Burnout, particularly emotional exhaustion and interpersonal disengagement, was identified as a mediator that influences how work conditions affect the rate of adverse events, highlighting the importance of addressing burnout to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital Work Conditions and the Mediation Role of Burnout: Residents and Practicing Physicians Reporting Adverse Events. Jarrar, M., Al-Bsheish, M., Albaker, W., et al.[2023]

The study aims to evaluate the effectiveness and implementation of the BetterBack model of care for low back pain (LBP) in Sweden, comparing it to routine care through a hybrid trial involving both healthcare practitioners and patients.

This trial will assess changes in healthcare provider confidence and patient outcomes, including pain and quality of life, over a 12-month period, providing insights into the cost-effectiveness and practical application of the new care model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Abbott, A., Schröder, K., Enthoven, P., et al.[2019]

Health care costs for spine-related disorders (SRDs) have significantly increased in the U.S., but there has been no improvement in patient care quality or clinical outcomes, with rising disability rates associated with SRDs.

The authors propose establishing primary spine care practitioners to improve patient outcomes and reduce costs, highlighting the need for specialized training and addressing potential obstacles to implementing this model in the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The establishment of a primary spine care practitioner and its benefits to health care reform in the United States. Murphy, DR., Justice, BD., Paskowski, IC., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficiency of primary spine care as compared to conventional primary care: a retrospective observational study at an Academic Medical Center. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Primary spine care services: responding to runaway costs and disappointing outcomes in spine care. [2014]

3. England pubmed.ncbi.nlm.nih.gov

The primary spine practitioner as a new role in healthcare systems in North America. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Models of care for low back pain patients in primary healthcare: a scoping review protocol. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Advanced practice physiotherapy for adults with spinal pain: a systematic review with meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Patient safety in ambulatory care from the patient's perspective: a retrospective, representative telephone survey. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Tools for primary care patient safety: a narrative review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Repeat prescribing of medications: A system-centred risk management model for primary care organisations. [2021]

9. England pubmed.ncbi.nlm.nih.gov

How do patients respond to safety problems in ambulatory care? Results of a retrospective cross-sectional telephone survey. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Hospital Work Conditions and the Mediation Role of Burnout: Residents and Practicing Physicians Reporting Adverse Events. [2023]

11. England pubmed.ncbi.nlm.nih.gov

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]

12. England pubmed.ncbi.nlm.nih.gov

The establishment of a primary spine care practitioner and its benefits to health care reform in the United States. [2022]