Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639373
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
The Road to Recovery Initiative R2RI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Road to Recovery Initiative R2RI an Observational Study of a Novel Model of Substance Use Care in a Canadian Setting
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R2RI
Brief Summary:
Despite substance use causing significant harms and cost to our health care system British Columbias 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 400000 Americans and 38000 Canadians have died from drug overdoses Within Canada British Columbia BC shoulders a substantial burden of that loss exceeding 13000 overdose deaths since 2016 BCs unpredictable and toxic drug supply combined with the provinces 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 77000 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 governments 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 BCs 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 ie 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 Cares 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 ie 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
To address care gaps Providence Health Care PHC-a regional health authority in the province of BC - in collaboration with the provincial governments 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 BCs 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 ie 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 Cares 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None