Implementation of the ACP Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)

Overview

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).

Full Title of Study: “Implementation of the American College of Physicians Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2025

Detailed Description

This study is a pragmatic, multi-site, two-arm cluster-randomized trial with the unit of randomization at the primary care clinic level. The overall goal is to evaluate implementation of the American College of Physicians (ACP) guideline for LBP by assessing the comparative effectiveness of the PSP model, which involves first contact care for LBP patients from either a physical therapist (PT) or a doctor of chiropractic (DC), versus usual care, which involves first contact care with primary care physicians. The study includes patients aged 18 years and older with a chief complaint of LBP. Co-primary endpoints to be assessed are changes in Patient- Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Physical Function from baseline to 3 months. The Investigators have chosen to use these co-primary endpoints as they represent two domains that are important factors related to patient improvement. Secondary endpoints collected at baseline, 3, 6 and 12 months include Pain Catastrophizing Scale – 4-item short form, PROMIS Global-10 (v1.2), total prescribed opioid dosage, imaging and diagnostic testing, provider visits, and LBP-associated procedures and treatments: surgical procedures, medication prescriptions, hospital admissions and emergency room visits. Additional exploratory analyses among enrolled patients will assess whether the PSP model leads to 1) long-term improvement compared to usual care using the PROMIS Pain Interference and Physical Function at 6, 12, and 24 months; and 2) lower healthcare utilization and costs for LBP at 12 and 24 months. Patients enrolled within the first 18 months of the data collection phase will be included in the 24-month exploratory analyses. Additional analyses will evaluate LBP-related utilization within the academic healthcare systems among all patients seen in intervention versus control primary care clinics utilizing de-identified clinic level data extracted from the EHR. A total of approximately 1,800 patients who seek care at a participating primary care clinic with a complaint of LBP and meet study eligibility criteria will be enrolled.

Interventions

  • Other: Primary Spine Provider Model
    • Patients with LBP seeking care at intervention clinics will be offered an appointment with a DC or PT at the initial point of contact.
  • Other: Usual Care
    • Patients in this arm will receive usual care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).

Arms, Groups and Cohorts

  • Active Comparator: Usual Medical Care
    • 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).
  • Experimental: Primary Spine Provider Model
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
    • Time Frame: Baseline, 3 Months
    • The Investigators will compare the change in PROMIS Pain Interference scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.
  • Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
    • Time Frame: Baseline, 3 Months
    • The Investigators will compare the change in PROMIS Physical Function scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.

Secondary Measures

  • NIH Low Back Pain Questions
    • Time Frame: Baseline, 12 Months
    • The NIH LBP questions consist of 2-items that were developed by the NIH Task Force and are used determined patients’ chronicity with LBP
  • Patient Satisfaction
    • Time Frame: 3 Months
    • The Investigators will assess patient satisfaction with care using a single item used in prior spine studies including SPORT: “Overall, how satisfied are you with the care you received for your back pain? Very satisfied, Somewhat satisfied, Neutral, Somewhat dissatisfied, Very dissatisfied.
  • Perceived Improvement
    • Time Frame: 3 Months
    • The Investigators will measure global improvement using a one-item scale that has been used in prior pragmatic trials of low back pain: “Compared to your first visit, your low back pain is much worse, a little worse, about the same, a little better, moderately better, much better or completely gone.
  • Patient Experience
    • Time Frame: 3 Months
    • The Investigators will compare patient experience with the clinical care between groups at 3 months using a modified satisfaction with outpatient physiotherapy instrument (Hills & Kitchen, 2007). Domains compared will include expectations, clinician, communication, health organization, and treatment satisfaction.
  • Total Prescribed Opioid Dosage
    • Time Frame: Baseline, 3 Months, 6 Months, 12 Months, 24 Months
    • The Investigators will compare total opioid dosage (morphine equivalents) in the 12 months after baseline. In order to be able to compare opioid doses across classes, the Investigators will use a standard formula to calculate morphine equivalents from the CDC Morphine Equivalent Factors. Within 12 months after baseline, the Investigators will determine morphine equivalent dose.
  • PROMIS Global 10 (v1.2) – Physical Health
    • Time Frame: Baseline, 3 Months, 6 Months, 12 Months, 24 Months
    • The PROMIS Global-10 is a 10 item PRO questionnaire which has response options presented as 5-point rating scales; Results are used to calculate a global physical health score and global mental health score with higher scores indicating better health.Patient Reported Outcomes Measurement Information System Global Health Short Form Range: 0 – 100
  • PROMIS Global 10 (v1.2) – Mental Health
    • Time Frame: Baseline, 3 Months, 6 Months, 12 Months, 24 Months
    • The PROMIS Global-10 is a 10 item PRO questionnaire which has response options presented as 5-point rating scales; Results are used to calculate a global physical health score and global mental health score with higher scores indicating better health.Patient Reported Outcomes Measurement Information System Global Health Short Form Range: 0 – 100
  • Number of LBP-related Imaging and Diagnostic Tests
    • Time Frame: Up to approximately 24 Months
    • The Investigators will collect any imaging and diagnostic tests from the time from enrollment through 24 months or study end. These measures will be extracted from the electronic health record using ICD and CPT codes. The imaging and diagnostics include magnetic resonance imaging, computed tomography, plain film x-rays, discography, electromyography, and nerve conduction studies.
  • Number of LBP-related Injection Procedures
    • Time Frame: Up to approximately 24 Months
    • The Investigators will collect any LBP-related injection procedures conducted from the time from enrollment until 24 months or study end. These procedures will be extracted by the electronic health record using ICD and CPT codes. The injection procedure types include fascia, facet joint, intervertebral disc, and muscle.
  • Number of LBP-related Surgical Procedures
    • Time Frame: Up to approximately 24 Months
    • The Investigators will collect any LBP-related surgical procedures conducted from the time from enrollment until 24 months or study end. These surgical procedures will be extracted by the electronic health record using ICD and CPT codes. The surgical procedure types include discectomy, fusion, and decompression.
  • Number of LBP-related Medical Prescriptions
    • Time Frame: Up to approximately 24 Months
    • The Investigators will collect any LBP-related medication prescriptions from the time from enrollment until 24 months or study end. These medication prescriptions will be extracted from the electronic health record using commonly used codes during routine clinical practice. The medication types include opioids, NSAIDS, muscle relaxers, anticonvulsants, and SNRIs.
  • Number of LBP-related Provider Visits
    • Time Frame: Up to approximately 24 Months
    • The Investigators will collect any provider visits from the time from enrollment until 24 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes
  • Number of Hospital Admissions
    • Time Frame: Up to approximately 24 Months
    • The Investigators will collect any hospital admissions from the time from enrollment through 24 months or study end. These admissions will be extracted by the electronic health record using ICD and CPT codes. The admission types include routine, emergency, and elective.
  • Number of Emergency Room Visits
    • Time Frame: Up to approximately 24 Months
    • The Investigators will collect any emergency room visits from the time from enrollment until 24 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes.

Participating in This Clinical Trial

Inclusion Criteria

1. aged 18 years and older 2. initiating an outpatient visit for LBP at a participating PCP clinic 3. agree to participate and complete baseline questionnaire (in lieu of formal written documentation of consent) Exclusion Criteria:

1. inability to provide consent or complete outcome questionnaires 2. positive screening for cauda equina symptoms (loss of bowel/bladder control, progressive muscle weakness)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Collaborator
    • Dartmouth-Hitchcock Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christine Goertz, PhD, Principal Investigator, Duke Clinical Research Institute
  • Overall Contact(s)
    • Kelley Ryan, 919-668-7519, kelley.ryan@duke.edu

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