Clinical trial NCT04490291: An Observational Study of Integrated Chronic Pain Management in a Community Health Center
Official title: An Observational Study of Integrated Chronic Pain Management in a Community Health Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Spine Disease
Keywords: community health center
integrated pain team
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Logan University
First posted: 2020-07-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: active patients at an urban federally-qualified health center

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* referred by PCP to either intervention at study site

Exclusion Criteria:

* active cancer diagnosis

Primary outcomes:
measure: change in Pain Disability Questionnaire (PDQ) score
timeFrame: 6-12 month
Secondary outcomes:
measure: prescription opioid weaning
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Affinia Healthcare
state: Missouri
Study officials:
References: