Improving Access to Chiropractic Care in Community Health Centers

Lower Back Pain Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06104605
• Other study ID #: H-41930
• Secondary ID: K23AT010487
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: February 2025

Study information

• Verified date: December 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 107
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PCP Chiropractor Referrals for LBP	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 DC. The denominator will be the total number of unique LBP patients seen by a PCP with an LBP diagnosis in the EHR.	During the fourteen month study period
Secondary	Percentage of patient participants referred to physical therapy	Information for this outcome will be abstracted from the participants' medical records	15 months
Secondary	Percentage of patient participants referred to acupuncture	Information for this outcome will be abstracted from the participants' medical records	15 months
Secondary	Percentage of patient participants prescribed opioids	Information for this outcome will be abstracted from the participants' medical records	15 months
Secondary	Percentage of patient participants referred to magnetic resonance imaging (MRI)	Information for this outcome will be abstracted from the participants' medical records	15 months
Secondary	Percentage of patient participants that receive epidural injections	Information for this outcome will be abstracted from the participants' medical records	15 months