Clinical trial NCT05626049: Implementation of the ACP Guideline for Low Back Pain (IMPACt-LBP)
Official title: Implementation of the American College of Physicians Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Back
Keywords: pain
back pain
low back pain
primary spine provider
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
name: University of Iowa
name: Duke Health
name: Palmer College of Chiropractic
name: National Center for Complementary and Integrative Health (NCCIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2022-11-23
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary care clinics across three academic HCS will be allocated 1:1 to each arm (PSP model versus usual care) of the study. Clinics randomized to provide the PSP model will provide patient information regarding the ACP guideline for LBP and an LBP scheduling assistant will help patients make an appointment with either a DC or PT at the initial point of contact.
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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 )

Primary outcomes:
measure: Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
timeFrame: Baseline, 3 Months
measure: Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
timeFrame: Baseline, 3 Months
Secondary outcomes:
measure: NIH Low Back Pain Questions
timeFrame: Baseline, 12 Months
measure: Patient Satisfaction
timeFrame: 3 Months
measure: Perceived Improvement
timeFrame: 3 Months
measure: Patient Experience
timeFrame: 3 Months
measure: Total Prescribed Opioid Dosage
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: PROMIS Global 10 (v1.2) - Physical Health
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: PROMIS Global 10 (v1.2) - Mental Health
timeFrame: Baseline, 3 Months, 6 Months, 12 Months
measure: Number of LBP-related Imaging and Diagnostic Tests
timeFrame: Up to approximately 12 Months
measure: Number of LBP-related Injection Procedures
timeFrame: Up to approximately 12 Months
measure: Number of LBP-related Surgical Procedures
timeFrame: Up to approximately 12 Months
measure: Number of LBP-related Medical Prescriptions
timeFrame: Up to approximately 12 Months
measure: Number of LBP-related Provider Visits
timeFrame: Up to approximately 12 Months
measure: Number of Hospital Admissions
timeFrame: Up to approximately 12 Months
measure: Number of Emergency Room Visits
timeFrame: Up to approximately 12 Months
Other outcomes:
measure: Total Prescribed Opioid Dosage
timeFrame: Up to approximately 24 Months
measure: PROMIS Global 10 (v1.2) - Physical Health
timeFrame: Up to approximately 24 Months
measure: PROMIS Global 10 (v1.2) - Mental Health
timeFrame: Up to approximately 24 Months
measure: Number of LBP-related Imaging and Diagnostic Tests
timeFrame: Up to approximately 24 Months
measure: Number of LBP-related Injection Procedures
timeFrame: Up to approximately 24 Months
measure: Number of LBP-related Surgical Procedures
timeFrame: Up to approximately 24 Months
measure: Number of LBP-related Medical Prescriptions
timeFrame: Up to approximately 24 Months
measure: Number of LBP-related Provider Visits
timeFrame: Up to approximately 24 Months
measure: Number of Hospital Admissions
timeFrame: Up to approximately 24 Months
measure: Number of Emergency Room Visits
timeFrame: Up to approximately 24 Months
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lebanon
country: United States
facility: Dartmouth Health
state: New Hampshire
city: Durham
country: United States
facility: Duke Health
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute
name: Christine Goertz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goode AP, Goertz C, Chakraborty H, Salsbury SA, Broderick S, Levy BT, Ryan K, Settles S, Hort S, Dolor RJ, Chrischilles EA, Kasper S, Stahl JE, Almond C, Reed SD, Shannon Z, Harris D, Daly J, Winokur P, Lurie JD. Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial. BMJ Open. 2025 Mar 26;15(3):e097133. doi: 10.1136/bmjopen-2024-097133.