Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04604574 |
| Other study ID # |
6010991 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
March 31, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Health Sciences North Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: The negative health outcomes experienced by Indigenous peoples may be understood
as direct consequences of colonization. One of the key consequences of the colonial influence
on Canada's Indigenous peoples has been intergenerational trauma (IGT). Indigenous
communities in Canada face significant challenges with IGT, which often manifest in substance
use disorders (SUD). Indigenous communities have identified SUD as one of their greatest
health challenges(Maté 2009), with some Northern Ontario First Nations communities
experiencing SUD rates of 70% (Calveson 2010). Most Elders, traditional healers, and
Indigenous scholars agree that connecting treatment to culture, land, community, and
spiritual practices is a pathway to healing trauma and SUD for Indigenous peoples. Recent
work by Dr. Teresa Naseba Marsh has demonstrated that Indigenous Healing and Seeking Safety
(IHSS) model for trauma therapy can be effectively combined for the treatment of Indigenous
patients with a history of trauma and SUD. Seeking Safety incorporates the inclusion of the
mind, body, spirit, and self-awareness during treatment, and the perspective of Seeking
Safety is convergent with traditional Indigenous healing methods. Benbowopka Treatment Centre
is a residential treatment site operated by Mamaweswen, located in the North Shore Tribal
Council in Blind River, Ontario. Benbowopka's mandate is to provide treatment for Indigenous
clients with trauma and SUD. They are also implementing a culturally sensitive program
grounded in IHSS methodology for the treatment of Indigenous patients' trauma and SUD.
Through our current collaboration with Benbowopka and Mamaweswen the applicants have
collected baseline data from client files to establish historical outcomes going back three
years. In 2016, we began the collaborative implementation of the Indigenous Healing and
Seeking Safety (IHSS) model for trauma therapy for clients at Benbowopka.
Objective: The purpose of this proposal is to evaluate the effectiveness of the IHSS
intervention which blends Indigenous Healing Practices and a mainstream treatment model,
Seeking Safety for the treatment of Indigenous patients with a history of trauma and SUD.
Methodology: In collaboration with the North Shore Tribal Council and the Benbowopka
Treatment Center, we propose a prospective evaluation of IHSS treatment for Indigenous
patients with a history of trauma and SUD. Benbowopka treats approximately 90 patients per
year in a residential treatment program, and the program has high quality retrospective data
on their programming and outcomes. We propose to benchmark anonymized historical program
outcomes by evaluating program outcomes and the impact of program completion on health
systems usage. Impact of treatment on health system usage will be determined by linking
anonymized patient records with records at the Institute for Clinical and Evaluative Sciences
(ICES). ICES linkage will provide further insight into hospitalizations, interaction with
emergency, mental health, and primary care usage before and following the implementation of
the IHSS intervention. We will respect the Tricouncil Policy Statement, Chapter 9, which
highlights the importance of engaging with First Nations throughout all phases of the
research process. In addition, we will honour Indigenous knowledge by engaging with Elders
and the North Shore Tribal council. Through the data governance protocols established at
ICES, we will respect the First Nations principles of ownership, control, access and
possession of data (OCAP™). Dr. Jennifer Walker Canada Research Chair in Indigenous Health at
the Center for Rural and Northern Health Research and ICES Scientist will oversee the process
of data sharing and linking de-identified Benbowopka treatment data to anonymized health
system data at ICES. Benbowopka and the North Shore Tribal council will maintain complete
ownership over the study data and its subsequent dissemination. Anticipated Outcome: We
expect that patients who are treated in the IHSS treatment model will have improved outcomes
as compared to previous patients of Benbowopka treated under the abstinence based model of
therapy. Objectives measures will include treatment completion, substance use at program
completion, substance use at follow-up, ED visits, hospitalization, and death. Patient
satisfaction will be tracked using surveys administered at treatment completion and is
expected to improve with implementation of IHSS. Impact: We expect to demonstrate that the
IHSS is a culturally sensitive and effective treatment model for Indigenous patients who are
affected by trauma and substance use disorder.
Description:
Background:
Indigenous Ways of Knowing coupled with Indigenous Healing provide the foundation for
achieving personal and community wellness. Specific health outcomes experienced by Canada's
Indigenous Peoples- including trauma and substance use disorders (SUD)-are seen as a direct
consequence of colonization. Most notably, these effects are seen in the multi-generational
trauma of the residential school system (Kirmayer, et al., 2009; Menzies, 2014; Thatcher,
2004; Stewart, 2008). The aspiration of healing and wellness is most effectively achieved by
using tools and methods that are both appropriate and effective for Indigenous Peoples and
communities. The evidence suggests that one of the key consequences of the colonial influence
on Canada's Indigenous Peoples has been intergenerational trauma, and high rates of
depression, suicide, and SUD (Bombay, Matheson, & Anisman, 2009; Kirmayer, et al., 2000;
Haskell & Randall, 2009). Intergenerational trauma is the most common term used to describe
the systematic trauma suffered by Indigenous Peoples (Evans-Campbell, 2008; Haskell, 2009;
Palacios & Portillo, 2009). Intergenerational trauma is now seen as a precursor to
depression, anxiety, post-traumatic stress disorder, re-enactment of trauma, suicide, and SUD
(Brave Heart, 2004; Duran, 2006; Menzies, 2014; Thatcher, 2004; Waldram, 2006). Indigenous
communities in Canada face significant challenges with intergenerational trauma, which often
manifest in SUD. Indigenous communities have identified SUD as one of their greatest health
challenges, with some Northern Ontario First Nations communities experiencing SUD rates of
70% (Calveson 2010). Between 2004 and 2009, the number of Indigenous patients seeking
treatment for SUD in Ontario increased threefold (Calverson 2010). In 2009, the Nishnawbe
Aski Nation declared a state of emergency for prescription drug abuse (Prescription Drug
Backgrounder; NAN, 2009), and the number of people seeking treatment continues to rise. Many
Elders, traditional healers, and Indigenous scholars agree that connecting treatment to
culture, land, community, and spiritual practices is a pathway to healing trauma and SUD for
Indigenous Peoples. To address SUD for Indigenous patients, Mamaweswen, The North Shore
Tribal Council operate the Benbowopka Treatment Centre. Benbowopka is a residential treatment
site in Blind River, Ontario with a mandate to provide treatment for Indigenous patients with
trauma and SUD. Historically, the treatment program at Benbowopka merged Indigenous Healing
with an abstinence-based residential treatment model. However, a 2015 program review
identified the need to modernize the program to address the increasing number of patients
with concurrent trauma and SUD. The skills required to heal from intergenerational trauma and
subsequent recovery of identity can be enhanced by cultural practices, Indigenous Healing,
the presence of Elders, and through traditional ceremony (Duran, 2006; Menzies, 2014;
Thatcher, 2004; Waldram, 2006). Similarly, Seeking Safety (SS) is a validated, manualized
psycho-educational counseling program that targets the unique problems resulting from SUD and
trauma (Najavits, 2009). Importantly, the perspective of SS is convergent with traditional
Indigenous Healing methods. Because of the content and delivery method of SS, the program
complements traditional teachings such as holism, relational connection, spirituality,
cultural presence, honesty, and respect (Gone, 2008; Lavallée, 2008; Menzies, 2014; Marsh et
al., 2016). Benbowopka staff work with the Client's Circle of Care Team to develop the
necessary support services to address the client's physical, mental health/addictions and
cultural needs as part of their aftercare services once discharged. In 2016, Benbowopka
worked with Dr. Teresa Marsh to integrate and implement SS into a novel treatment
intervention, known as Indigenous Healing and Seeking Safety (IHSS) (Marsh et al., 2015;
Marsh et al., 2016a; Marsh et al., 2016b). The IHSS intervention aims to increase the coping
skills of participants and reduce the chance of relapse by emphasizing values such as
respect, care, integration, and healing of self (Najavits, 2007). This community-led
initiative-with a novel IHSS clinical treatment framework-presents a unique opportunity to
study innovative approaches to Indigenous wellness.
Indigenous Healing and Seeking Safety (IHSS) Intervention: Initial 90-minute meetings will be
conducted with the participants; during these meetings, participants will receive information
about IHSS, traditional healing, sharing circles, sweat lodge ceremonies, and program
details. The sharing circles will take place at Benbowopka Residential treatment Centre in
Blind River, Ontario. Each of the sharing circles will be cofacilitated by two Indigenous
health-care workers. These facilitators will organize and lead sharing circles daily
throughout the 28-day treatment cycle. Each sharing circle will be two hours long. The
Seeking Safety program consists of up to 25 treatment topics that aim to teach participants a
variety of skills. The majority of topics address the cognitive, behavioral, interpersonal,
and case management needs of persons with SUD and posttraumatic stress disorders (PTSD)
(Najavits, 2002a). To adhere to the concept of Two-Eyed Seeing and cultural sensitivity, the
material will be conveyed verbally. The facilitators will encourage a language that respects
the participants' cultural values and beliefs. To encourage a holistic view of mental health
and substance use (which includes connection to community), Indigenous healing practices will
be incorporated into the sharing circles. Each sharing circle will be opened and closed with
smudging, ceremonial drumming, and singing. Tobacco-a herb recognized in Indigenous culture
for its healing powers-will be prepared in bundles in advance of the sharing circles. It will
be offered to each participant for protection and healing. The cultural coordinator and
facilitators will introduce their sacred items and sacred bundle during the sharing circles.
A sacred bundle can consist of one or many items. It can be a tobacco or sacred medicine
pouch worn around the neck, or it can be an item such as a sacred pipe that the spirits have
given to a person to carry for the people. The sacred bundle is considered a very precious
possession that represents a person's spiritual life (Hart, 2010; Menzies, 2010). The
participants will be invited to bring their bundles, and will be encouraged to place their
sacred bundles or items at the center of the circle. Participants will also partake in at
least three sweat lodge ceremonies held once a week during the four-week cycle of the
intervention period. Sweat lodge ceremonies will provide a powerful way to bring forth
Two-Eyed Seeing as an Indigenous decolonizing methodology. The sweat ceremonies help repair
the damage done to the spirits, minds, and bodies of the participants. During the sweat
ceremonies, the cultural coordinator will give teachings about Aboriginal traditional healing
and its restorative power. Participants will also be invited to share their stories and
experiences. Also, participants will attend at least two Sacred Fire ceremonies with the
staff and cultural coordinator with the purpose of helping them let go of past traumas and
substances. Mamaweswen North Shore Community Health Services currently provides a range of
physical and mental health/addictions pre-treatment and aftercare services to the seven
Member First Nation communities in our area. Each First Nation community in our area also
provides some pre-treatment and aftercare services. All of these services work closely with
Benbowopka Treatment Centre around the referral and transitioning of clients between required
mental health and addiction services. Mamaweswen North Shore Community Health Services has
continued on with its community opiate withdrawal program on Sagamok Anishnawbek and has now
established an additional partnership with the Sault Ste. Marie Indian Friendship Centre to
offer community opiate withdrawal to First Nation individuals who are living in Sault Ste.
Marie.
Objective: This proposal aims to evaluate the effectiveness of the treatment model Indigenous
Healing and Seeking Safety (IHSS) for the treatment of Indigenous patients with a history of
trauma and SUD. Study findings will be used to inform trauma and SUD residential treatment
programming and implementation for Indigenous communities across Canada. Our work will
contribute to the field of community-based trauma and addiction programming by addressing
objectives that consider:
i) the patient perspective; does patient satisfaction improve when IHSS methodology for
treatment of trauma and SUD replaces an abstinence-focused approach? ii) the program
perspective; do program completion rates improve following the implementation of IHSS
intervention? iii) the community perspective; do health system outcomes in the year following
treatment completion decrease following IHSS implementation?
Hypothesis: We expect that patients who are treated with the IHSS model will have improved
treatment satisfaction (increase of 10% over pre-intervention rates), improved treatment
completion (increase of 10% over pre-intervention rates), and a greater reduction in health
system usage for addiction-related services at one-year follow-up compared to those treated
within the abstinence-based model (decrease of 10% over preintervention rates).
Community Partnership:
The Mamaweswen (North Shore Tribal Council) and the Benbowopka Treatment Centre represent
seven member communities (Batchewana, Garden River, Thessalon, Sagamok, Mississauga,
Atikameksheng, and Serpent River) on the North Shore of Lake Huron. Mamaweswen and our
research group began collaborating on the evaluation of the IHSS protocol in the fall of
2016. The primary research questions and the research approach were developed and supported
at the community level. Improving care for community members who are affected by trauma and
SUD is a priority for Mamaweswen, the North Shore Tribal Council; it is also a shared
research interest with collaborators from the Northern Ontario School of Medicine (NOSM) and
the Institute for Clinical and Evaluative Sciences (ICES). Together, Mamaweswen, NOSM, and
ICES are aiming to build reciprocal capacity building processes that enable academic
collaborators to understand the context of community priorities and allow the community to
build capacity for future research and quality improvement initiatives.
Benbowopka Treatment Centre employs a culturally-based residential substance use treatment
program, following the Seven Grandfather Teachings. Through these Aboriginal teachings and
principles, individuals will learn to understand and accept that they are out of
balance-according to the Medicine Wheel-as a result of their SUD. As patients move along the
road to recovery, they will learn how to maintain balance and harmony in their mental,
physical, emotional, and spiritual health. Individuals will participate in individual
counselling, group educational sessions, and talking circles; they will also learn relaxation
techniques (through yoga and drumming), the importance of addressing their physical health
through proper nutrition and exercise, and how to address their spiritual health through
cultural activities and teachings. Benbowopka also endorses medication-assisted treatment
with buprenorphine/naloxone for patients with opioid use disorder.
The Northern Ontario School of Medicine (NOSM) is a made-in-the-North medical school that has
an innovative model of community-engaged medical education and research, while staying true
to its social accountability mandate of improving the health of the people and communities of
Northern Ontario. NOSM brings together over 90 community partners, over 1,400 clinical,
human, and medical sciences faculty, and more than 200 employees. NOSM's success is very much
a result of partnerships and collaborations with individuals, communities, and organizations,
including Indigenous communities. The Institute for Clinical and Evaluative Sciences (ICES)
is a not-for-profit research institute encompassing a community of research and clinical
experts, and a secure and accessible array of Ontario's health-related data. ICES has a
special focus to enhance the health of Indigenous peoples through a collaboration with the
Chiefs of Ontario.
Methodology:
Design: We plan to conduct a pre/post intervention matched comparison group study. We will
compare historical treatment outcomes for past Benbowopka patients to outcomes following IHSS
treatment for Indigenous patients with a history of trauma and SUD. All patient data will be
anonymized at the time of data entry. Propensity matching will be undertaken for patient
characteristics, including sex/gender, age, and substance use type. The National Native
Alcohol and Drug Abuse Program (NNADAP) tool will be used to analyze the program objective;
that is, whether completion rates improve following the implementation of the IHSS
intervention. Additionally, a Client Quality Assurance Survey will be utilized to determine
patient satisfaction.
Sample and Study Window: The pre-IHSS intervention study window will span the 36 months prior
to the implementation of the IHSS intervention (April 1, 2013 - March 31, 2016; n=343), and
the Post-IHSS intervention study window will span the 27 months post-IHSS implementation
(January 1, 2018 - March 31, 2020; n>300). We will only include data from patients initiating
treatment at Benbowopka during the study window. Patient follow-up will occur in the one year
following treatment completion and/or discontinuation. Anonymized patient records will be
linked via Ontario Health Insurance Plan (OHIP) number, or Indian Registry Number, to the
administrative health data at the ICES, and we will query data in the one year following
completion or discontinuation of IHSS at Benbowopka to ascertain impact of substance use on
health outcomes including hospitalization, ED visits and opioid-related overdose. For
patients with multiple admissions, the date of first admission will serve as the index date
for health outcomes evaluation. Treatment Setting: Benbowopka treats approximately 100
patients per year in a residential treatment program, and the program has high quality
retrospective data based on standardized assessment screening tools routinely used by the
Drug and Alcohol Treatment Information System and the National Native Alcohol and Drug Abuse
Program. For the 343 patients admitted between April 1, 2013 and March 31, 2016 86% were
Indigenous, 57% male, 84% had alcohol as the primary substance and 38% had opioids as the
primary or secondary substance with 65% of patients completing the program.
Access to Linked Administrative Health Data: We propose to link de-identified patient data to
record-level provincial health systems data at ICES. ICES routinely links partner data to its
core health systems data holdings. ICES linkage will enable virtual follow-up of Benbowopka
patients for health systems usage. The main data required for this analysis are available at
ICES.
Data Governance: We will respect the Tri-council Policy Statement, Chapter 9, which
highlights the importance of engaging with First Nations throughout all phases of the
research process. In addition, we will honour Indigenous knowledge by engaging with Elders
and the Mamaweswen Council. Anonymized data collected at Benbowopka will be linked in
accordance with data governance protocols and data-linkage process established at ICES in
consultation with the Chiefs of Ontario. All parties involved in the study will respect
Indigenous principles of OCAP.
Planned Analysis:
Using anonymized Benbowopka/ICES-linked data, we propose to evaluate the pre/post-IHSS
intervention outcomes. This analysis strategy will provide insight into i) patient
satisfaction, ii) program completion, iii) and health systems outcomes for Benbowopka
patients. A detailed schematic of the analysis plan is provided in adjacent figure. Baseline
metrics will be established for April 1 2013 - March 31 2016 (n = 343) and will be compared
to January 1 2018 - March 31, 2020 (n>300) with a one year follow up for health systems
outcomes. Specific variables to address patient wellbeing will be captured in the patient
satisfaction survey and structures assessments at patient enrollment. Anonymized linked data
outcomes from ICES will include primary care visits, mental health visits, initiation of
opioid agonist therapy, ED visits, hospitalizations, and all cause mortality.
Training:
Wellness, training, and capacity building are cornerstones to the application. Clinicians at
Benbowopka have been trained in the IHSS methodology (beginning January 2016), and IHSS is
now routinely delivered to patients. The investigators have worked with Benbowopka team to
digitize the data collection and maintenance of their health record system. Establishing a
digital health record has enabled efficient data capture and evaluation for quality
improvement, research, and reporting purposes. Benbowopka staff, patients, and the Mamawesen
communities will benefit from this training and technology enhancement going forward.
Importantly, the reciprocal training and skills developed by the community and research team
will strongly position collaboration for future community-based research studies, and it will
materially increase the capacity for high-quality Indigenous Wellness research in Northern
Ontario. Community-based trainees will include three clinical staff, a community-based
graduate student, and a research assistant based in the community. The academic research team
will also benefit from enhancing its understanding of Indigenous Healing, unique community
perspectives, and Indigenous ways of knowing.
Anticipated Outcome:
We will evaluate the results of the IHSS intervention against three distinct primary
outcomes. The lens applied to these outcomes will consider:
i) the patient perspective; we will use Client Quality Assurance Survey tool to assess the
appropriateness and satisfaction of the intervention ii) the program perspective; we will use
the structured assessments at admission to characterize changes in the patient population and
the program completion rate as primary outcome to assess the effectiveness of the IHSS
intervention iii) the community perspective; we will use the change in substance use related
health system usage between the year prior and the year following treatment completion as an
indication of the impact of the admission on health system outcomes. We believe our study
findings may validate an innovative approach for effective and appropriate care for patients
with intergenerational trauma and SUD. We expect that patients who are treated in the IHSS
treatment model will have improved satisfaction and outcomes as compared to previous patients
of Benbowopka who were treated under the abstinence based model of therapy. Objective
measures will include pattern of substance use at admission (to characterize changes in the
patient population), treatment completion, and reduction in health system outcomes in the
year following treatment compared to the year prior to admission.
Impact and Knowledge Translation:
A material benefit for the community partners will be the digitization of data collection
process. For Benbowopka, digitization will enable enhanced ease of program evaluation,
reporting, and future quality improvement and research initiatives. Outcomes of the proposed
collaboration will use a push, pull, and exchange strategy to benefit the Mamaweswen,
Benbowopka, and stakeholders who have an interest in programming and implementation of trauma
and SUD treatment.
Push Strategy: Collaboratively, we will actively disseminate the study findings to
stakeholders, including Indigenous Health Authorities, Provincial and Federal funding
agencies, and community-based treatment programs. Specifically, we will organize in-person
presentations to the Chiefs of Ontario and Mamaweswen North Shore Tribal Council. Data will
be provided to stakeholders via print, digital, and social media (Facebook/Twitter) via
presentation, infographic and explainer video format.
Pull Strategy: We also propose to make study findings freely available on the Benbowopka,
Mamaweswen, and other partner websites. Detailed study findings may also be made available
via open source peer-reviewed publication. Social media hashtags and user groups will target
those who may wish to 'pull' the freely available study findings.
Exchange: To ensure that the necessary knowledge users are directly engaged, a
multidisciplinary team of stakeholders will be assembled for in-person meetings and webinars
to discuss study outcomes and recommendations for planning and implementation. These
stakeholders will include community members, leaders in the field of Indigenous Health,
provincial and federal healthcare funders, and academic researchers. In addition to
internet-based knowledge translation, we will also organize a series of in-person
presentations for communities who are served by Benbowopka.
