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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2026-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Pain, Back

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Patients, clinicians delivering care, LBP schedulers and site research coordinators will not be blinded to clinic intervention assignment in this pragmatic clinical trial. There will be both blinded and unblinded analysis teams.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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).

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.

Group Type EXPERIMENTAL

Primary Spine Provider Model

Intervention Type OTHER

Patients with LBP seeking care at intervention clinics will be offered an appointment with a DC or PT at the initial point of contact.

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

Other Intervention Names

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PSP Model

Eligibility Criteria

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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 )

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No