Substance-Related DisordersR2RINCT06639373
The Road to Recovery Initiative (R2RI)
An observational study of Substance-Related Disorders, run by BC Centre on Substance Use at 1 site in Canada.
Trial summary
Despite substance use causing significant harms and cost to our health care system, British Columbia's (BC) current addiction treatment system remains under-resourced and fragmented. To address this, Providence Health Care (PHC) is expanding clinical addiction services as part of the Road to Recovery Initiative (R2R). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Specialized clinical service access
- How many people
- 10,000 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2023to 5 Oct 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who have accessed or been admitted to any R2R service.
Who may be able to join
- Aged 18 years or older
- Able to provide written informed consent
- A resident of British Columbia
- Willing to comply with study procedures
- An individual who has accessed one or more R2R services
Who cannot join
- Individuals who have an acute, severe mental health condition (e.g., psychosis) precluding the opportunity to provide full informed consent
- Individuals who have an acute, severe medical condition (e.g., intubation) precluding the opportunity to provide full informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital - Providence Health Care
Vancouver, British Columbia, V6Z1Y6
Travis De Wolfe, PhD, 236-308-0183, travis.dewolfe@bccsu.ubc.ca
About this study
Official title: The Road to Recovery Initiative (R2RI): an Observational Study of a Novel Model of Substance Use Care in a Canadian Setting
Despite substance use causing significant harms and cost to our health care system, British Columbia's (BC) current addiction treatment system remains under-resourced and fragmented. To address this, Providence Health Care (PHC) is expanding clinical addiction services as part of the Road to Recovery Initiative (R2R). The proposed study aims to generate novel data to promote fully evidence-informed and coordinated substance use care in BC and beyond. This study will explore substance use treatment trajectories, identify challenges and areas for growth in addiction health services, characterize important features of patients accessing care, and improve our provincial capacity to promptly tailor approaches to care in response to the substance use crisis.
Read the detailed description
Since the declaration of a public health emergencies in Canada in 2016 and the United States in 2017 in response to rising overdose deaths, more than 400,000 Americans and 38,000 Canadians have died from drug overdoses. Within Canada, British Columbia (BC) shoulders a substantial burden of that loss, exceeding 13,000 overdose deaths since 2016. BC's unpredictable and toxic drug supply combined with the province's siloed and fragmented addiction treatment system are key contributors. The burden of disease, however, is not restricted to criminalized substances. The prevalence of alcohol misuse across Canada is at an unprecedented high, between 2015 - 2016 over 77,000 hospitalizations were attributed to alcohol related harms, with the highest rates again being observed in BC. Further, the substance use crisis has had a disproportional impact on Indigenous peoples as a consequence of colonialism and systemic racism. Accordingly, the provincial government and representative health organizations have urgently called for the development and implementation of a coordinated system of culturally safe substance use care that spans a continuum, ranging from harm reduction services to abstinence-based programming.
To address care gaps, Providence Health Care (PHC)-a regional health authority in the province of BC - in collaboration with the provincial government's Ministry of Mental Health and Addictions (MMHA), Vancouver Coastal Health (VCH) (another regional health authority) - is spearheading the Road to Recovery (R2R) Initiative, a first-of-its-kind model of substance use care. BC's existing substance use treatment system is comprised of both publicly- and privately-funded service providers in bed-based and outpatient settings. Quality and standards vary substantially between service providers, and inter-organizational communication is extremely limited. The R2R model of care seeks to address this by: (1) improving access to care through the creation of approximately 100 new substance use treatment beds; and (2) offering comprehensive substance use management along the entire care continuum (i.e., harm reduction, withdrawal management, bed-based recovery and outpatient longitudinal follow-up). A focus of the R2R model is inclusivity and honouring what matters most to individual patients to foster a safe recovery environment. Thus, close collaborations with Providence Health Care's Indigenous Wellness and Reconciliation (IWR) team and the BC Centre on Substance Use Indigenous Initiatives team has supported the integration of Indigenous cultural safety into the R2R model including through workflows and daily programming thereby meeting patients where they are at when they want and are in need of substance use care.
The proposed study will constitute a cohort of patients accessing substance use treatment services parallel to the phased operationalization of R2R in the VCH region. In this mixed-methods prospective cohort design, patients receiving R2R services will be observed through primary data collection at baseline and 12-month follow up via (1) interviewer-administered surveys and (2) semi-structured qualitative interviews over a 5-year study period. Participants will be asked to provide consent for the use of personal identifiers (i.e., a unique and persistent identifier issued to all provincial residents to access healthcare) to support secondary data-collection through (1) 30-day prospective follow-up from time of R2R admission using electronic medical record chart review, and (2) linkage annually to provincial health and administrative databases over a five-year follow-up period. A purposive sample of cohort participants will also be invited to participate in baseline and 12-month follow-up qualitative interviews.
Employing a convergent parallel design, quantitative and qualitative data collection will occur in parallel, of which results are later compared and related to one another. This will be an iterative process, as findings from each convergent analysis will inform adaptations and additions to data collection processes across implementation phases of R2R. The data will be leveraged to promote evidence-informed and coordinated substance use care through the integration of population and administrative data From cohort participant questionnaires, the investigators will gain an understanding of substance use treatment trajectories, identify challenges and areas for growth in addiction health services, characterize important features of patients accessing care, and improve our provincial capacity to promptly tailor approaches to care in response to the substance use crisis. Engaging with Indigenous participants for each study outcome will be critical to understanding the impact of building Indigenous cultural safety into the R2R model on relevant outcomes, and is supported by the IWR. Lastly, this work will support surveillance of evolving substance use trends, identify fixed and modifiable risk factors impacting substance use trajectories, as well build local, regional, and provincial partnerships to promptly respond to health challenges associated with the dynamic landscape of the substance use crisis. Collaboration with IWR throughout this work ensures that the collection and use of Indigenous data respects and upholds the principles of Indigenous data governance.
- Conditions
- Substance-Related Disorders
- Being tested
- Specialized clinical service access
- Keywords
- addiction, substance use, alcohol, opioids, harm reduction
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized clinical service accessOther
A new model of addiction care that will offer comprehensive and coordinated service delivery
| Study group | Role | What they receive |
|---|---|---|
| R2R Service Access | Individuals with a substance use disorder who access or are admitted to an R2R service Receives: Other: Specialized clinical service access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use patterns following R2R access
Metrics include frequency of use in the 12-months following R2R access
Measured: 1 year
Health care utilization patterns following R2R access
Metrics include the count of hospitalizations, readmissions, and emergency department visits.
Measured: 1 year
Substance use treatment trajectories
Metrics include completion status of substance use treatment programs within 12 months after R2R access.
Measured: 1 year
Health among study participants over time
Metrics include count of comorbidities in the 12 months following R2R access.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Oct 2023
- Primary completion5 Oct 2028 (estimated)
- Study completion5 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BC Centre on Substance Use
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seonaid Nolan, MD, FRCPC, Principal investigator, BC Centre on Substance Use
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639373
- Sponsor's protocol ID
- BCCSU-R2RI
- Acronym
- R2RI
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Road to Recovery Initiative (R2RI): an Observational Study of a Novel Model of Substance Use Care in a Canadian Setting
- ClinicalTrials.gov ID
- NCT06639373
- Acronym / sponsor ID
- R2RI / BCCSU-R2RI
- Conditions
- Substance-Related Disorders
- Keywords
- addiction, substance use, alcohol, opioids, harm reduction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- BC Centre on Substance UseUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 5 Oct 2028 (estimated)
- Study completion
- 5 Oct 2033 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite substance use causing significant harms and cost to our health care system, British Columbia's (BC) current addiction treatment system remains under-resourced and fragmented. To address this, Providence Health Care (PHC) is expanding clinical addiction services as part of the Road to Recovery Initiative (R2R). The proposed study aims to generate novel data to promote fully evidence-informed and coordinated substance use care in BC and beyond. This study will explore substance use treatment trajectories, identify challenges and areas for growth in addiction health services, characterize important features of patients accessing care, and improve our provincial capacity to promptly tailor approaches to care in response to the substance use crisis.
Detailed description
Since the declaration of a public health emergencies in Canada in 2016 and the United States in 2017 in response to rising overdose deaths, more than 400,000 Americans and 38,000 Canadians have died from drug overdoses. Within Canada, British Columbia (BC) shoulders a substantial burden of that loss, exceeding 13,000 overdose deaths since 2016. BC's unpredictable and toxic drug supply combined with the province's siloed and fragmented addiction treatment system are key contributors. The burden of disease, however, is not restricted to criminalized substances. The prevalence of alcohol misuse across Canada is at an unprecedented high, between 2015 - 2016 over 77,000 hospitalizations were attributed to alcohol related harms, with the highest rates again being observed in BC. Further, the substance use crisis has had a disproportional impact on Indigenous peoples as a consequence of colonialism and systemic racism. Accordingly, the provincial government and representative health organizations have urgently called for the development and implementation of a coordinated system of culturally safe substance use care that spans a continuum, ranging from harm reduction services to abstinence-based programming.
To address care gaps, Providence Health Care (PHC)-a regional health authority in the province of BC - in collaboration with the provincial government's Ministry of Mental Health and Addictions (MMHA), Vancouver Coastal Health (VCH) (another regional health authority) - is spearheading the Road to Recovery (R2R) Initiative, a first-of-its-kind model of substance use care. BC's existing substance use treatment system is comprised of both publicly- and privately-funded service providers in bed-based and outpatient settings. Quality and standards vary substantially between service providers, and inter-organizational communication is extremely limited. The R2R model of care seeks to address this by: (1) improving access to care through the creation of approximately 100 new substance use treatment beds; and (2) offering comprehensive substance use management along the entire care continuum (i.e., harm reduction, withdrawal management, bed-based recovery and outpatient longitudinal follow-up). A focus of the R2R model is inclusivity and honouring what matters most to individual patients to foster a safe recovery environment. Thus, close collaborations with Providence Health Care's Indigenous Wellness and Reconciliation (IWR) team and the BC Centre on Substance Use Indigenous Initiatives team has supported the integration of Indigenous cultural safety into the R2R model including through workflows and daily programming thereby meeting patients where they are at when they want and are in need of substance use care.
The proposed study will constitute a cohort of patients accessing substance use treatment services parallel to the phased operationalization of R2R in the VCH region. In this mixed-methods prospective cohort design, patients receiving R2R services will be observed through primary data collection at baseline and 12-month follow up via (1) interviewer-administered surveys and (2) semi-structured qualitative interviews over a 5-year study period. Participants will be asked to provide consent for the use of personal identifiers (i.e., a unique and persistent identifier issued to all provincial residents to access healthcare) to support secondary data-collection through (1) 30-day prospective follow-up from time of R2R admission using electronic medical record chart review, and (2) linkage annually to provincial health and administrative databases over a five-year follow-up period. A purposive sample of cohort participants will also be invited to participate in baseline and 12-month follow-up qualitative interviews.
Employing a convergent parallel design, quantitative and qualitative data collection will occur in parallel, of which results are later compared and related to one another. This will be an iterative process, as findings from each convergent analysis will inform adaptations and additions to data collection processes across implementation phases of R2R. The data will be leveraged to promote evidence-informed and coordinated substance use care through the integration of population and administrative data From cohort participant questionnaires, the investigators will gain an understanding of substance use treatment trajectories, identify challenges and areas for growth in addiction health services, characterize important features of patients accessing care, and improve our provincial capacity to promptly tailor approaches to care in response to the substance use crisis. Engaging with Indigenous participants for each study outcome will be critical to understanding the impact of building Indigenous cultural safety into the R2R model on relevant outcomes, and is supported by the IWR. Lastly, this work will support surveillance of evolving substance use trends, identify fixed and modifiable risk factors impacting substance use trajectories, as well build local, regional, and provincial partnerships to promptly respond to health challenges associated with the dynamic landscape of the substance use crisis. Collaboration with IWR throughout this work ensures that the collection and use of Indigenous data respects and upholds the principles of Indigenous data governance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R2R Service Access | – | Other: Specialized clinical service accessIndividuals with a substance use disorder who access or are admitted to an R2R service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have accessed or been admitted to any R2R service.
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Able to provide written informed consent
- A resident of British Columbia
- Willing to comply with study procedures
- An individual who has accessed one or more R2R services
Key exclusion criteria (2 listed)
- Individuals who have an acute, severe mental health condition (e.g., psychosis) precluding the opportunity to provide full informed consent
- Individuals who have an acute, severe medical condition (e.g., intubation) precluding the opportunity to provide full informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized clinical service accessA new model of addiction care that will offer comprehensive and coordinated service delivery | Other | R2R Service Access |
Primary outcome
Substance use patterns following R2R access
Time frame: 1 year
Metrics include frequency of use in the 12-months following R2R access
Health care utilization patterns following R2R access
Time frame: 1 year
Metrics include the count of hospitalizations, readmissions, and emergency department visits.
Substance use treatment trajectories
Time frame: 1 year
Metrics include completion status of substance use treatment programs within 12 months after R2R access.
Health among study participants over time
Time frame: 1 year
Metrics include count of comorbidities in the 12 months following R2R access.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seonaid Nolan, MD, FRCPC principal investigator
BC Centre on Substance Use
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance-Related Disorders, run by BC Centre on Substance Use at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seonaid Nolan, MD, FRCPC (604-682-2344 ext. 62360, seonaid.nolan@bccsu.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use patterns following R2R access (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.