Study design and data
allergic, anxiety/depression, OUD, psychosis, abscess, depressive, psychiatric
ACTIVE TUBERCULOSIS, ABSCESS, ADVERSE EFFECTS, SECONDARY, CHRONIC PAIN, SEIZURE DISORDER
We conducted a secondary analysis of HRQoL among persons with OUD who were transitioning from incarceration to the community. Our analysis focused on the determinants of specific EQ-5D HRQoL domains, as well as the overall preference/utility score (please see description in Introduction), over the first 12 weeks post-release, with the first measure taken just before release, and treatment groups collapsed across condition.Data were obtained from the aforementioned Woody, et al. study, a 1:1 randomized trial, where participants with OUD who were incarcerated in the Philadelphia Department of Prisons were selected to receive either XR-NTX before release, with referral for continuing XR-NTX at a nearby community program after release (n = 74), or referral to start XR-NTX post-release, and receive continuing care at the same nearby program (n = 72) [Participants for the study had to meet the following inclusion criteria: be 18 years of age, or older; have a DSM-V diagnosis of OUD; be interested in and not allergic to XR-NTX treatment; plan to reside in Philadelphia for the next 6 months; be eligible for Medicaid or other third-party health insurance; anticipate release from incarceration within 3–4 months, with no subsequent sentence longer than 30 days scheduled at a different carceral facility; no residential treatment stay for over 30 days after release; give consent to be contacted; be proficient in English (speaking and reading); provide contact information of 3 references that could help locate the participant; not pregnant or breastfeeding; be eligible for treatment at the community treatment provider (NET Steps); be able to answer 9 out of 10 items on a study quiz,with three attempts allowed; no neurological, cardiovascular, renal, or hepatic conditions that could make participation hazardous; no active tuberculosis; not experiencing psychosis, suicidal thoughts, or homicidal tendencies; no uncontrolled seizure disorder; not on opioid therapy for chronic pain; and were not already sentenced to naltrexone.Data were collected from participants at baseline (pre-release), and at 12- and 24-weeks post-release. However, of the 146 randomized participants, 60 were lost after randomization due to unforeseen facility transfer, withdrawing consent, release prior to scheduled study induction, or becoming otherwise ineligible for study participation, leaving a final analytic sample of 86 (n = 38 pre-release XR-NTX; n = 48 referral only) [The parent study measured HRQoL via the EuroQol 5D (EQ-5D-5L) [Our outcome variables were the following longitudinal measures: a) categorical HRQoL measures of mobility, pain/discomfort, and anxiety/depression (usual activities and self-care were excluded because 97% and 98% of participant responses indicated “minimal difficulties” in these areas, respectively); and b) the previously-described preference/utility score associated with the participant’s health state. For ease of interpretation, the EQ-5D domain values were recoded such that an increase in values aligned with an improvement in the relevant health condition, similar to the utility score. As mentioned above, our analysis focused solely on the first two data collection timepoints, baseline and 12 weeks post-release, as the purpose of this study was to conduct an in-depth evaluation of the factors that influence HRQoL over this critical transition period for persons with OUD.Regression covariates included baseline sociodemographic variables (age, race, gender, high school completion, health insurance status), lifetime and past 30 days incarceration, randomization arm, and time-varying composite scores from the Addiction Severity Index (ASI) Lite (medical, employment/support, alcohol, drug, legal status, family/social relationships, psychiatric) [Additional predictors included injection drug use, and time free from opioids (measured in weeks). History of injection drug use was included in the analysis since prior studies have found significant associations between it and depressive components of various HRQoL scales, as well as between HRQoL and other adverse effects of injection drug use (e.g. abscess) [