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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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, DO, NP, or 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a stepped-wedge design. CHCs will be randomized to receive the intervention either first, second, or third two months apart.
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Implementation 		Implementation will be deployed at the CHC, PCP, and patient level.
  • Other: Institutional interventions
    Intervention will include, but not be limited to, the following: adding a referral option to chiropractic care in the electronic health record (EHR), optimizing referral option, e.g., creating a list of preferred providers. Additional strategies may be added depending on community health center staff engagement prior to implementation.
  • Other: PCPs interventions
    Two one-hour interactive grand rounds/lunch seminars that allow for inter-professional learning for PCPs with optional continuing education credits for PCPs. Short teaching cases involving clinical vignettes developed with local DCs, information about DCs (e.g., evidence-base for treatments), and logistics of the referral process (e.g., geographic location of community-based DCs who accept Medicaid) sent to participating providers unable to attend the seminars. Additional strategies may be added depending on primary care provider engagement prior to implementation.
  • Other: Patient interventions
    Printed and electronic educational materials (e.g., brochures) written at a sixth grade reading level in English and Spanish that present chiropractic as a safe and effective evidence-based treatment for LBP. These materials will be written, reviewed, and revised by the researchers with CHC patient input. Additional strategies may be added depending on patient engagement prior to implementation.
No Intervention
Standard of care 		Usual patient care without deployment of intervention.

More Details

Status
Enrolling by invitation
Sponsor
Boston Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.