An Observational Study of Integrated Chronic Pain Management in a Community Health Center

This was a prospective observational study with the primary objective of quantifying a change in pain scores after 6-12 months of two separate interventions within the study site (pain team and chiropractic team). Target enrollment was 30 participants for each intervention. The primary outcome was a change from baseline of the Pain Disability Questionnaire (PDQ), the study tool. Secondary outcomes were reduction of opioid dose by morphine equivalent daily dose, and its effect on PDQ scores.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Spine Disease
• Intervention / Treatment: Other: chronic pain team; Other: chiropractic team

Detailed Description

Data collection After participants were enrolled, they completed a baseline PDQ while waiting for their appointment. Participants continued to see the intervention group, PCP, and other medical providers as determined by their health providers independent of this study's protocol. Another PDQ was collected at an intended 6 - 12 months later. Demographic information was collected by manual chart review in the electronic medical record NextGen (NextGen EHR, Nextgen Healthcare, Inc. Irvine, CA, USA).

Variables collected included age, sex, race, BMI, insurance type, preferred language, presence of another pain diagnosis (e.g. knee pain), active mental health diagnosis (including substance abuse), diagnosis of hypertension or diabetes, and morphine equivalent dose (MED); one post-hoc variable was recorded: timing of follow-up survey in relation to the 2019 coronavirus (COVID-19) pandemic, defined as before/after March 1, 2020. Intervention type was analyzed as an independent variable since the study was not designed as a comparison of interventions. All data was stored in an encrypted Excel database on a password-protected laptop. Consent forms were stored in a locked cabinet accessible only to the PI.

Stata 16.0 (StataCorp, LLC, College Station, TX, USA) was used for statistical analysis. PDQ scores at baseline and follow-up were tested for statistical significance using paired t-tests. Univariate analysis was performed on individual categorical variables and change in PDQ using two-sample t-tests. Multivariate linear regression was used to determine associations of these factors to the outcome. Variables were excluded from regression models if there was a subgroup size of six or less.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63118
      • Affinia Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

active patients at an urban federally-qualified health center

Description

Inclusion Criteria:

• referred by PCP to either intervention at study site

Exclusion Criteria:

• active cancer diagnosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Pain Disability Questionnaire (PDQ) score	6-12 month follow up pain score - (minus) baseline. scores range from 0 (no pain or disability) to 150 (severe pain and disability)	6-12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prescription opioid weaning	ability to successfully wean off opioid prescription	6-12 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Logan University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): May 25, 2020
• Study Completion (Actual): May 25, 2020

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: community health center; integrated pain team
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Bone Diseases; Chronic Pain; Spinal Diseases
• Other Study ID Numbers: RD04240531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: methodology and data will be available
• IPD Sharing Time Frame: after publication, available indefinitely
• IPD Sharing Access Criteria: by request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No