Implementation of the ACP Guideline for Low Back Pain (IMPACt-LBP) (IMPACt-LBP)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Pain, Back
• Intervention / Treatment: Other: Usual Care; Other: Primary Spine Provider Model

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), opioid use, 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 12 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.

• Study Type: Interventional
• Enrollment (Estimated): 1800
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kelley Ryan; Phone Number: 919-668-7519; Email: kelley.ryan@duke.edu
• Study Contact Backup: Name: Adam Goode, PhD; Phone Number: 919-681-6154; Email: adam.goode@duke.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Barcey T Levy, MD, PhD; Phone Number: 319-384-7622; Email: barcey-levy@uiowa.edu
      • Contact: Jeanette M Daly, PhD; Phone Number: 319-3984-8995; Email: jeanette-daly@uiowa.edu
      • Principal Investigator: Barcey T Levy, MD, PhD
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03755
      • Recruiting
      • Dartmouth Health
      • Contact: Jon D Lurie, MD, MS; Phone Number: 603-650-8303; Email: jon.d.lurie@dartmouth.edu
      • Principal Investigator: Jon D Lurie, MD, MS
      • Contact: Corie L Lynn; Phone Number: 843-251-8956; Email: corie.l.lynn@hitchcock.org
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Recruiting
      • Duke Health
      • Principal Investigator: Rowena J Dolor, MD, MHS
      • Contact: Morgan Mangum; Phone Number: 919-660-2062; Email: morgan.mangum1@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 total control of bowel/bladder associated with this episode of LBP )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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).
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.	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 Names: PSP Model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	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.	Baseline, 3 Months
Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	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.	Baseline, 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH Low Back Pain Questions	The NIH LBP questions consist of 2-items that were developed by the NIH Task Force and are used determined patients' chronicity with LBP	Baseline, 12 Months
Patient Satisfaction	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.	3 Months
Perceived Improvement	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.	3 Months
Patient Experience	The Investigators will compare patient experience with the clinical care between groups at 3 months using a modified satisfaction with outpatient physiotherapy instrument. Domains compared will include expectations, clinician, communication, health organization, and treatment satisfaction. Physiotherapy outpatient satisfaction questionnaire (modified), score range: 32 to 160. Higher score indicates a better outcome.	3 Months
Total Prescribed Opioid Dosage	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.	Baseline, 3 Months, 6 Months, 12 Months
PROMIS Global 10 (v1.2) - Physical Health	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	Baseline, 3 Months, 6 Months, 12 Months
PROMIS Global 10 (v1.2) - Mental Health	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	Baseline, 3 Months, 6 Months, 12 Months
Number of LBP-related Imaging and Diagnostic Tests	The Investigators will collect any imaging and diagnostic tests from the time from enrollment through 12 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.	Up to approximately 12 Months
Number of LBP-related Injection Procedures	The Investigators will collect any LBP-related injection procedures conducted from the time from enrollment until 12 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.	Up to approximately 12 Months
Number of LBP-related Surgical Procedures	The Investigators will collect any LBP-related surgical procedures conducted from the time from enrollment until 12 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.	Up to approximately 12 Months
Number of LBP-related Medical Prescriptions	The Investigators will collect any LBP-related medication prescriptions from the time from enrollment until 12 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.	Up to approximately 12 Months
Number of LBP-related Provider Visits	The Investigators will collect any provider visits from the time from enrollment until 12 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes	Up to approximately 12 Months
Number of Hospital Admissions	The Investigators will collect any hospital admissions from the time from enrollment through 12 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.	Up to approximately 12 Months
Number of Emergency Room Visits	The Investigators will collect any emergency room visits from the time from enrollment until 12 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes.	Up to approximately 12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of LBP-related Imaging and Diagnostic Tests	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.	Up to approximately 24 Months
Number of LBP-related Injection Procedures	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.	Up to approximately 24 Months
Number of LBP-related Surgical Procedures	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.	Up to approximately 24 Months
Number of LBP-related Provider Visits	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	Up to approximately 24 Months
Number of Hospital Admissions	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.	Up to approximately 24 Months
Number of Emergency Room Visits	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.	Up to approximately 24 Months
Total Prescribed Opioid Dosage	The Investigators will compare total opioid dosage (morphine equivalents) in the 24 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 24 months after baseline, the Investigators will determine morphine equivalent dose.	Up to approximately 24 Months
PROMIS Global 10 (v1.2) - Physical Health	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	Up to approximately 24 Months
PROMIS Global 10 (v1.2) - Mental Health	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	Up to approximately 24 Months
Number of LBP-related Medical Prescriptions	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	Up to approximately 24 Months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); University of Iowa; Dartmouth-Hitchcock Medical Center; National Center for Complementary and Integrative Health (NCCIH); Duke Health; Palmer College of Chiropractic
• Investigators: Principal Investigator: Christine Goertz, PhD, Duke Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pain; low back pain; back pain; primary spine provider
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Pro00109780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

In collaboration with the NCCIH, the Investigators will develop a process to facilitate access to study data and will follow the Department of Health and Human Services guidance regarding HIPAA-compliant data sharing.

Access to the limited dataset (Enrolled Cohort) will require a Data Use Agreement and IRB approval. This is a custom dataset created to include just the subset of data needed.

Access to the de-identified dataset (Longitudinal Cohort) does not require a Data Use Agreement or IRB approval and is not subject to HIPAA's minimum necessary standards.

• IPD Sharing Time Frame: Data will not be shared until the end of the grant period (June 30, 2026).
• IPD Sharing Access Criteria: De-identified data or limited datasets for proposed use, with appropriate documentation, will be provided via secure transfer methods to the requestor following institutional approval and data use agreements as appropriate.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No