An observational study in Wounds and Injuries, Out-of-Hospital Cardiac Arrest and Traumatic Brain Injury, sponsored by Azienda Usl di Bologna. Active, not recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Azienda Usl di Bologna · Observational
This retrospective population-based cohort study uses linked administrative healthcare data from the Local Health Authority of Bologna (Italy) to describe the use of four classes of psychoactive drugs (opioids, antiepileptics, antipsychotics, and antidepressants) after hospital discharge in two populations, adults admitted urgently for trauma and adults surviving out-of-hospital cardiac arrest, and to evaluate whether post-discharge exposure is associated with low-acuity or incomplete emergency department visits and urgent hospital readmissions within one year. Exposure is derived from outpatient dispensing records and classified as naive (started after discharge), long-term (before and after), or interrupted, and as current or not current over follow-up. Associations are estimated with marginal count regression models adjusted for demographics, illness or injury severity, and comorbidity, separately for each cohort.
Follow-up starts at the discharge ending the index care episode (including transfers or readmissions within one day) and continues until death, loss of eligibility, or one year. Dispensings are chained into treatment episodes using a 60-day grace period (30- and 90-day sensitivity analyses). Post-discharge exposure requires treatment initiation, continuation, or restart within 30 days of discharge; exposure states are assigned using only information available at each time point. Outcomes are counts of low-acuity or incomplete ED visits (missing, non-urgent, or minor-urgency discharge code; leaving before visit or record closure; or missing or ICD-9-CM V-code diagnosis) and urgent ordinary-regime hospital readmissions, excluding scheduled or routine contacts. Outcomes are analysed with marginal count regression models (negative binomial or Poisson, as appropriate) with patient-clustered robust standard errors, adjusted for sex, age, severity (New Injury Severity Score and body-region AIS for trauma), Charlson Comorbidity Index, and an early post-discharge period indicator.
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
This study's planned enrollment of 52,720 is above the median of 135 across 1,603 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Azienda Usl di Bologna is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult residents of the Local Health Authority of Bologna, Italy, discharged alive after (1) an urgent hospital admission for trauma between 2014 and 2024, or (2) a hospital admission following out-of-hospital cardiac arrest.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adults resident in the Local Health Authority of Bologna discharged alive after an urgent ordinary-regime hospital admission for trauma (ICD-9-CM 800-999) between 2014 and 2024. Post-discharge exposure to opioids, antiepileptics, antipsychotics, and antidepressants is assessed from outpatient dispensing records.
Drug: Opioids (ATC N02A) · Drug: Antiepileptics (ATC N03A) · Drug: Antipsychotics (ATC N05A) · Drug: Antidepressants (ATC N06A)
Adults resident in the Local Health Authority of Bologna admitted to the emergency department after out-of-hospital cardiac arrest and discharged alive from hospital (ICD-9-CM 427.5). Post-discharge exposure to opioids, antiepileptics, antipsychotics, and antidepressants is assessed from outpatient dispensing records.
Drug: Opioids (ATC N02A) · Drug: Antiepileptics (ATC N03A) · Drug: Antipsychotics (ATC N05A) · Drug: Antidepressants (ATC N06A)
Post-discharge outpatient dispensing of opioids (ATC N02A), as prescribed in routine care; exposure is observed, not assigned by the study.
Post-discharge outpatient dispensing of antiepileptics (ATC N03A, including gabapentinoids and clonazepam), as prescribed in routine care; exposure is observed, not assigned by the study.
Post-discharge outpatient dispensing of antipsychotics (ATC N05A), as prescribed in routine care; exposure is observed, not assigned by the study.
Post-discharge outpatient dispensing of antidepressants (ATC N06A), as prescribed in routine care; exposure is observed, not assigned by the study.
Percentage of Patients With Post-discharge Exposure to Each Psychoactive Drug Class
Percentage of patients with at least one qualifying post-discharge treatment episode (treatment initiation, continuation, or restart within 30 days of discharge) for each drug class: opioids (ATC N02A), antiepileptics (N03A), antipsychotics (N05A), and antidepressants (N06A), derived from outpatient dispensing records and reported separately for each cohort.
Time frame: 1 year after hospital discharge
Percentage of Exposed Patients by User Type for Each Psychoactive Drug Class
Among patients exposed to each drug class (opioids, antiepileptics, antipsychotics, antidepressants) before admission and/or after discharge, percentage of naive users (exposure after discharge only), long-term users (exposure both before admission and after discharge), and interrupted users (exposure before admission only, not continued after discharge), reported separately for each cohort.
Time frame: 1 year after hospital discharge
Percentage of New Users by Duration of Post-discharge Treatment for Each Psychoactive Drug Class
Among naive users of each drug class (opioids, antiepileptics, antipsychotics, antidepressants), percentage whose qualifying post-discharge treatment episode lasted up to 30 days, 31-90 days, or 91-365 days (episode span, with dispensings chained using a 60-day grace period), reported separately for each cohort.
Time frame: 1 year after hospital discharge
Number of low-acuity or incomplete emergency department visits
Count of emergency department visits with a missing, non-urgent, or minor-urgency discharge severity code, with the patient leaving before the medical visit or before record closure, or with a missing or supplementary-classification (ICD-9-CM V code) diagnosis, excluding scheduled or routine contacts; analysed as incidence rate ratios by post-discharge exposure state.
Time frame: 1 year after hospital discharge
Number of urgent hospital readmissions
Count of urgent ordinary-regime hospital admissions, excluding scheduled or routine contacts; analysed as incidence rate ratios by post-discharge exposure state.
Time frame: 1 year after hospital discharge
Plan to share: No — Individual patient data derive from regional administrative health databases and cannot be shared under Italian and EU data protection regulations; aggregated data and analysis code are available from the principal investigator on reasonable request.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Azienda Usl di Bologna