Clinical trial NCT06104605: Improving Access to Chiropractic Care in Community Health Centers
Official title: Improving Access to Chiropractic Care for Low Back Pain in Underserved Primary Care Settings: A Protocol for a Pilot Study of a Multi-level Implementation Strategy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lower Back Pain
Keywords: Chiropractic care
Primary care provider
Chiropractor referrals
Chronic pain
Non-pharmacologic treatment
Community health centers
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-10-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a stepped-wedge design. 3 CHCs will be randomized to receive the intervention either first, second, or third two months apart.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. The investigators plan to pilot the strategies in three qualified community health centers (CHCs) and compare the number of LBP patients who receive referrals before and after implementation. The implementation strategies involve PCP, patient, and organizational interventions.

Patients presenting with LBP will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for LBP. Materials will be available in CHC common areas and may be sent to patients by their PCP via patient portal.

PCPs will participate in interactive lunch seminars to allow for inter-professional learning for PCPs. They will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. Currently, many PCPs cannot make chiropractic care referrals in the electronic health record (EHR). The investigators plan to add this option, or make it easier if the referral is already available.

This multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. The ordering of clinics will be random.

The primary outcome is the proportion of patients with LBP who received a referral to chiropractic care before and after the intervention. Secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications.


Eligibility criteria: Inclusion criteria for CHCs:

* Be a CHC in the Boston area with primary care
* Agree to participate in study

Inclusion criteria for PCPs:

* Work at a participating CHC
* Be an MD, doctor of osteopathy (DO), nurse practitioner (NP), or physician assistant (PA)

Inclusion criteria for patients with LBP:

* Has PCP at participating CHC
* Has LBP diagnosis
* Is 18 years of age or older

Exclusion criteria for CHCs:

* There are no exclusion criteria

Exclusion criteria for PCPs:

* There are no exclusion criteria

Exclusion criteria for patients with LBP:

* There are no exclusion criteria for adult patients with LBP

Primary outcomes:
measure: Change in PCP Chiropractor Referrals for LBP
timeFrame: During the fourteen month study period
Secondary outcomes:
measure: Percentage of patient participants referred to physical therapy
timeFrame: 15 months
measure: Percentage of patient participants referred to acupuncture
timeFrame: 15 months
measure: Percentage of patient participants prescribed opioids
timeFrame: 15 months
measure: Percentage of patient participants referred to magnetic resonance imaging (MRI)
timeFrame: 15 months
measure: Percentage of patient participants that receive epidural injections
timeFrame: 15 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Eric J Roseen, DC
role: PRINCIPAL_INVESTIGATOR
References: