Improving Access to Chiropractic Care in Community Health Centers

Sponsor

Boston Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06104605

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

107

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Back Pain	Other: Institutional interventions Other: PCPs interventions Other: Patient interventions	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

107 participants

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.This is a stepped-wedge design. CHCs will be randomized to receive the intervention either first, second, or third two months apart.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Change in PCP Chiropractor Referrals for LBP [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 DC. The denominator will be the total number of unique LBP patients seen by a PCP with an LBP diagnosis in the EHR.

Secondary Outcome Measures

Percentage of patient participants referred to physical therapy [15 months]
Information for this outcome will be abstracted from the participants' medical records
Percentage of patient participants referred to acupuncture [15 months]
Information for this outcome will be abstracted from the participants' medical records
Percentage of patient participants prescribed opioids [15 months]
Information for this outcome will be abstracted from the participants' medical records
Percentage of patient participants referred to magnetic resonance imaging (MRI) [15 months]
Information for this outcome will be abstracted from the participants' medical records
Percentage of patient participants that receive epidural injections [15 months]
Information for this outcome will be abstracted from the participants' medical records

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Eric J Roseen, DC, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boston Medical Center

ClinicalTrials.gov Identifier:

NCT06104605

Other Study ID Numbers:

H-41930
K23AT010487

First Posted:

Oct 27, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Boston Medical Center

Chiropractic care

Primary care provider

Chiropractor referrals

Chronic pain

Non-pharmacologic treatment

Community health centers

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Oct 30, 2023