Outcome | Rationale and description | Data sources |
Primary outcomes | ||
Incidence of SARS-CoV-2 infection | According to the initial impetus for the RMG | Public Health Laboratory system |
Incidence of fatal overdose* | Coroner’s record with laboratory testing confirming presence of a range of substances. Concordance of these classifications will be confirmed with linked vital statistics data. | BC Coroner’s service database, BC vital statistics database |
Incidence of non-fatal overdose* | ED visit or hospitalisation for drug-related causes | NACRS and DAD databases |
Secondary outcomes | ||
Incidence of all-cause mortality | We will consider all-cause mortality to account for the uncertainty in attribution of illicit drugs in mortality records and otherwise acknowledge the secondary role of drug use in deaths due to other causes. | BC Coroner’s service database, BC vital statistics database |
Incidence of all-cause acute care visits to hospital, ED† | We will consider all-cause acute care visits to account for the uncertainty in attribution of illicit drugs in health administrative records and otherwise acknowledge the secondary role of drug use in causes of other hospitalisations. | NACRS and DAD databases |
OAT retention among PWOUD | We will consider variations of definitions, including (but not limited to) OAT episode discontinuations§, missed doses¶ and sustained disengagement.** | PharmaNet and DAD databases |
Retention/continuity of care for other chronic medical conditions | The medical conditions under consideration will include HCV, mental health disorders and potentially other conditions cited in consultations with community stakeholders. | PharmaNet, MSP and DAD |
Uptake of COVID-19 protective measures | Differences in ability to maintain physical distancing and self-isolate when needed, based on RMG exposure | Longitudinal survey data |
Health-related quality of life | Differential change (over 10 weeks) in scores on the EQ-5D-5L, based on RMG exposure | Longitudinal survey data |
Mental health | Differential change (over 10 weeks) in scores on the Patient Health Questionnaire-2/Generalized Anxiety Disorder 2-item, based on RMG exposure | Longitudinal survey data |
Substance use and related harms | Differential change (over 10 weeks) in use of illicit opioids, stimulants, and benzodiazepines (without a prescription), and in binge drinking, based on RMG exposure | Longitudinal survey data |
Income source | Differential change (over 10 weeks) in sex work and acquisition crime as income source, based on RMG exposure | Longitudinal survey data |
Implementation Outcomes | ||
Number of people who receive an RMG prescription‡ | Measure of access to RMG (CFIR domain: characteristics of the intervention) | PharmaNet |
Number of prescribers writing RMG prescriptions | Measure of access to RMG (CFIR domain: characteristics of the intervention) | PharmaNet |
Extent to which access varies by geography and population subgroup | Measures of variability in access to RMG (CFIR domain: characteristics of individuals receiving and delivering the intervention) | PharmaNet |
Extent to which delivery differs across the province | Service provider descriptions of who is eligible for RMG and models of delivery (CFIR domain: process of implementation) | Qualitative interviews, longitudinal and cross-sectional survey data |
Extent and types of barriers encountered in accessing RMG | Descriptions by people who use substances of barriers encountered in accessing RMG (CFIR domains: intervention characteristics, inner and outer context) | Qualitative interviews, longitudinal and cross-sectional survey data |
Extent to which providers feel ready and able to implement RMG | Descriptions of perceived knowledge, skills, training, organisational and system support (CFIR domains: all) | Qualitative interviews, longitudinal and cross-sectional survey data |
*Drug-related causes classified through ICD-9/10 codes presented in online supplemental table A1.
†Our ED data did not have complete coverage for all visits in BC. The estimated ED coverage in NACRS was 72% from 29 ED facilities submitting to NACRS.
‡According to both definitions 1 and 2.
§≥ 5 consecutive days of missed methadone doses or ≥6 consecutive days of missed buprenorphine/naloxone doses.
¶Any missed doses within a continuous episode.
**OAT disengaged ≥3, 6 or 12 months.
DAD, Discharge Abstract Database; ED, emergency department; EQ-5D-5L, 5-Level Euro-Qol 5 Dimension; MSP, Medical Services Plan; NACRS, National Ambulatory Care Reporting System; OAT, opioid agonist treatment; PWOUD, people with opioid use disorder; RMG, Risk Mitigation Guidance.