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Active, Not Recruiting

NCT Number: NCT06104605

Improving Access to Chiropractic Care in Community Health Centers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lower Back Pain Back Pain Chronic Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Institutional interventions

Other

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.

PCPs interventions

Other

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 doctors of chiropractic (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.

Patient interventions

Other

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.

Primary outcomes

  1. Change in PCP Chiropractor Referrals for LBP

    Time frame: During the fourteen month study period

    This outcome will be assessed by calculating the proportion of LBP patients receiving a chiropractic referral for the two timeframe periods will be calculated. The numerator will be those with a chiropractic referral, defined as those LBP patients who received a PCP referral in the EHR or documentation in the EHR of a visit with a chiropractor. The denominator will be the total number of unique LBP patients seen by a PCP with an LBP diagnosis in the EHR.

Secondary outcomes

  1. Percentage of patient participants referred to physical therapy

    Time frame: 14 months

    Information for this outcome will be abstracted from the participants' medical records

  2. Percentage of patient participants referred to acupuncture

    Time frame: 14 months

    Information for this outcome will be abstracted from the participants' medical records

  3. Percentage of patient participants prescribed opioids

    Time frame: 14 months

    Information for this outcome will be abstracted from the participants' medical records

  4. Percentage of patient participants referred to magnetic resonance imaging (MRI)

    Time frame: 14 months

    Information for this outcome will be abstracted from the participants' medical records

  5. Percentage of patient participants that receive epidural injections

    Time frame: 14 months

    Information for this outcome will be abstracted from the participants' medical records

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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