PACE: Advancing Quality Improvement for Inflammatory Bowel Disease (IBD)
As part of the IMAGINE Network’s collaboration with Crohn’s & Colitis Canada and the Canadian Association of Gastroenterology (CAG), researchers developed PACE: A Quality Improvement initiative for patients with inflammatory bowel disease (IBD).  In the past year, a consensus process was conducted with Canadian IBD experts and patient-input to establish a list of 45 quality indicators (QIs). A quality indicator is essentially a “yardstick” against which an IBD clinic can assess the quality of its care delivery. The list of QIs established will be implemented across five IBD Centres of Excellence. This list of QIs will also be made available to other IBD centres across Canada, as well as community gastroenterology practices, to ensure that the maximum possible number of Canadians living with IBD have access to an acceptable standard of care. The manuscript on the quality indicators has been accepted for publication in a peer reviewed journal and will be published later in 2018.

In a related project, the QIs developed have also been used to help design a Global Rating Scale (GRS) tool for IBD. The IBD GRS is a web-based tool that will serve as a type of scorecard, giving a clinic the ability to evaluate its performance against standardized metrics, and highlight areas of care delivery that could be improved upon. The tool is currently in development, and is expected to be available through the Canadian Association of Gastroenterology’s (CAG) website by the end of 2018. More than 1,000 gastroenterologists, surgeons, pediatricians and nurses, who make up CAG’s membership, will have access to the IBD GRS. The manuscript describing the development of the IBD GRS tool has been drafted and will be published in a peer-reviewed journal later in 2018. Focus groups with IBD patients were completed in Toronto, Calgary and Montreal. The themes extracted from the focus groups were incorporated into the quality indicators and the IBD GRS tool. The creation of the web-based platform by CAG to host the IBD GRS tool has taken longer than anticipated. Further, negotiations on a funding agreement have delayed this collaboration.  Ultimately, the Quality Improvement Initiative for IBD will equip IBD healthcare providers from across Canada with the tools they need to engage in quality improvement in their clinics, and ultimately deliver better care to IBD patients.

Policy KT Project: Reducing Emergency-department Usage in People with Inflammatory Bowel Disease in Provincial Health Systems in Canada (January 2019)
Canada has one of the highest rates of inflammatory bowel disease (IBD) in the world, affecting approximately one in every 150 Canadians. Given the burden of IBD and complications associated with its care, there is a high utilization of emergency department healthcare services in Canada.  Therefore, this topic was prioritized by IMAGINE Network’s KT Working Group to serve as a powerful exemplar for policy-makers on how to systematically deal with issues pertaining to complex single conditions, instead of a one-size-fits-all approach to chronic-disease management. Specifically, in determining how to ensure appropriate, cost-effective services for IBD are available to those who need them, policy-makers will have the tools to think through how they can establish nimble health systems that are positioned respond to condition-specific issues.

The IMAGINE Network engaged McMaster Health Forum to convene two citizen panels on the subject of reducing emergency-department usage in people with inflammatory bowel disease in provincial health systems in Canada, followed by a stakeholder dialogue. The panels and dialogue – both informed by a pre-circulated synthesis of the best-available data and research evidence on the topic. The panels brought together a total of 23 citizens from across Canada, and the dialogue brought together 23 participants – 6 policymakers and managers, 2 healthcare professionals, 6 other types of stakeholders, and 9 researchers – from across Canada to examine the problem, elements of a potentially comprehensive approach for addressing it, and key implementation considerations.

In addressing some of these challenges facing patients with IBD, citizens expressed their collective desire for greater access to reliable and trustworthy sources of information and to patient-held records that include information on IBD to support self-management, front-line service enhancements in primary care and emergency departments for patients with IBD, and the use of remote consultations (by email, telephone or web-based platforms) with an IBD care team as an option for those living in rural and remote communities,  but also for those experiencing an IBD flare who may not be physically able to attend an in-person consultation.

Stakeholder dialogues participants also expressed concern about patients’ reliance on emergency departments as their treatment option ‘default,’ a lack of strong connections among care providers and ‘one-size fits all’ guidelines, and a lack of service integration and system-wide leadership. Therefore, recommended better enabling self-management and the establishment of IBD care teams as key solutions for challenges raised, and identified six overarching principles to guide efforts to reduce emergency-department use among IBD patients in provincial health systems in Canada.

The results of this project have been disseminated by IMAGINE Network and its patient advocacy partners including McMaster Health Forum, Crohn’s and Colitis Canada, Canadian Digestive Health Foundation and Gastrointestinal Society, which have a cumulative social media community greater than 70,000 followers. All products from the project can be downloaded from the website and links disseminated through Facebook, Twitter and e-newsletters. The next steps identified are informing ongoing conversations among participants about to how to improve systems across Canada. For example, Manitoba has revised its health care model to Shared Health Manitoba and Dr. Charles Bernstein, spurred by this KT policy initiative and armed with the evidence summaries, has since engaged with health administrators and policy-makers about strengthening regional efforts in Manitoba.

RECRUITMENT AND RETENTION PROJECT IMPLEMENTATION (Implementation completed June 2021, Evaluation on-going)
As reported in our last year’s annual report, our Network supported an innovative patient-led patient-oriented qualitative research project to understand the motivations and barriers to getting and staying involved in IMAGINE’s main research study, MAGIC study. Given the study’s ambitious recruitment target and long-term commitment, a group of IMAGINE Patient Research Partners (PRPs) co-led, co-designed and executed a qualitative study to better understand the motivations and barriers of healthy controls to participating in MAGIC to inform more effective recruitment and retention strategies. The findings were shared with MAGIC’s Site Directors and Research Coordinators during their monthly meetings to identify pragmatic solutions that could be implemented locally immediately. Furthermore, strategies that were deemed low-cost and high-impact were considered for a national roll-out. As such, this past year, IMAGINE embarked on creating new content to promote enrolment and retention for MAGIC.

(1) Recruitment Videos
A series of three short recruitment videos were created to promote and spark recruitment for the MAGIC Study (Sketch Video, Bacteria Video and Got Poop). These videos are animated and are only 30-seconds in length which make them ideal for distribution over social media platforms. Two out of three of the videos are targeted to healthy individuals which remains our greatest recruitment challenge. We submitted and received approval from our McMaster’s REB and have now disseminated these videos over social media and posted them on our website.  We have also shared them with our partners (including CCC, CDHF and GI Society) and encouraged them to distribute with their audiences. Furthermore, we have produced French versions of the videos for use with our Montreal recruitment sites and these are currently under review by the local REB before dissemination.

(2) Video Interviews
The “Get To Know Us Interview Series” is intended to increase engagement with our current study participants so that they remain excited and motivated to stay enrolled. We created of six different interviews with key stakeholders, including three patients (Kim Daley, Kate Mason, and Megan Marsiglio) and three investigators (Drs. Paul Moayyedi, Charles Bernstein, and Michael Surette).  These have been posted on our website but to increase their accessibility and longevity over social media, we have also broken down each video into short segments and added closed captioning.

These marketing assets were developed and implemented with the support of our patient partners. They will also contribute to the evaluation phase to determine the overall success of this initiative. To date, there have been more than 500 views for these videos over our website and Facebook posts. We are currently monitoring the impact of these videos on overall recruitment and retention rates and are hopeful that the online nature of these collateral materials will prove to more beneficial than traditional posters due to COVID restrictions.

Patient Monitoring App for IBD (completed Jan 2021)

Through IMAGINE’s partnership with Crohn’s and Colitis Canada, the PACE Health Services research projects (Telemedicine for IBD; HealthPROMISE Patient Monitoring App, Quality Indicators in IBD Care; and e-Clinical Care Pathways to reduce steroid use) continue to enhance healthcare delivery for IBD across key IBD Centres of Excellence in Canada. Of particular note this past year, the Patient Monitoring App Project was completed at McMaster University and results from the study were published online in the Journal of Medical Systems.

With the rapid rise of smart phones, electronic health (eHealth) monitoring platforms may be an important healthcare tool to provide patients with effective self-management strategies to complement outpatient care. HealthPromise involves the use of technologies that facilitate health-related communication between patients and health care providers. It also provides patients with a means of tracking their medical information, learning about their condition, and getting their questions answered.

HealthPROMISE was developed based on patient input and designed to promote patient participation. Its creation was guided by a study that found three parameters that characterized the needs of IBD patients. The investigators noted that patients complained of a lack of information dissemination by their providers, struggles with the social impacts of IBD, and called for a tool that facilitates symptom monitoring with physician feedback to patient input. Through the application, patients track their symptoms, medications, quality of life scores (measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ), quality of care scores (measured by IBD quality indicators developed by the Canadian Association of Gastroenterology), visits with physicians, emergency room (ER) visits, or hospitalizations. They can then access their personal data through an individual patient dashboard where they can view the details of their different ePRO domains and their longitudinal trends. Their physicians are also able to keep track of the data, suggest changes in lifestyle or treatment, or facilitate a clinic visit. Further, the application also permits the flagging of patients with suboptimal disease control, medication non-adherence, or extra-intestinal complications which may require further attention.

The purpose of this study was to investigate whether the use of an IBD digital health monitoring platform, HealthPROMISE, leads to better quality of care and improved health outcomes in IBD patients. IBD patients were recruited in gastroenterology clinics and asked to install the HealthPROMISE application onto their smartphones. Patient satisfaction, quality of care, quality of life, patient symptoms, and resource utilization metrics were collected throughout the study and sent directly to their healthcare teams. Patients with abnormal symptom/SIBDQ scores were flagged for their physicians to follow up. After one-year, patient outcome metrics were compared to baseline values. Overall, out of 59 patients enrolled in the study, 54% logged into the application at least once during the study period. The number of IBD-related ER visits/hospitalizations in the year of use compared to the prior year demonstrated a significant decrease from 25% of patients to 3%. Patients also reported an increase in their understanding of the nature/causes of their condition after using the application. This study demonstrated that digital health monitoring platforms may aid in reducing the number of ER visits and hospitalizations in IBD patients.

Fecal Microbial Transplantation in active Ulcerative Colitis with Antibiotic Pre-treatment  – Analysis Phase – October 2020

Ulcerative colitis affects approximately 80,000 Canadians and is thought to arise from a disordered immune response to gut contents in predisposed individuals.  Current therapies for UC remain expensive and imperfect with 50% of patients needing hospitalization and 20% requiring colectomy at some time during the course of their illness. Fecal Microbial Transplantation (FMT) is the administration of stool from a healthy screened to a patient and has shown effective in the treatment of C. diff.  IMAGINE investigators were the first in the world to conduct an RCT of FMT to induce remission in active ulcerative colitis (UC). The seminal study showed positive results and spurred growing interest from researchers, funders and patients. As such, the IMAGINE Network initiated the CRAFT study (Ulcerative Colitis Remission through Antibiotics & Fecal Transplantation) to investigate whether the effectiveness of FMT to induce remission in UC patients can be enhanced with an antibiotic pre-treatment. 

A total of 76 subjects were recruited and randomized to receive treatment or placebo.  The study had an initial target of 80 subjects however, due to challenges related to COVID it became difficult to collect and administer FMT preparations and so it was decided to close out the study. Analysis is currently underway and final results will be shared via publication in scientific meeting and journal.  However, interest in this study from the patient and research community has already been tremendous. Patients with UC from across North America were keen to participate and many even travelled as far as 4 hours to join the study. Dr. Tariq Iqbal (University Hospitals Birmingham, UK) is collaborating with Dr. Moayyedi to launch a complementary study in Europe evaluating the best route to administer FMT in UC patients. Dr. Paul Moayyedi and Dr. Michael Surette  participated in scientific podcasts by FutureTech to discuss the potential of FMT and microbiome. Furthermore, a lay podcast by Guts & Glory featuring Dr. Paul Moayyedi and Ziyaad Mia (a study participant) was also held reaching over hundreds of stakeholders.

Also noteworthy is that this research study is being complemented by several other studies. The Network is also supporting additional trials that are investigating the efficacy of FMT to treat Crohn’s disease, Pouchitis and Major Depression in patients with IBS. Also, a qualitative research study, led by IBD Nurse Practitioner and co-funded by Crohn’s and Colitis Canada, is looking into patient perceptions of FMT, specifically comparing experiences before and after treatment, and showing how expectations before the treatment administration measure up to real-life experiences. The results from this study will be indispensable in addressing major concerns that may be preventing more patients from seeking out FMT treatment, as well as providing recommendations for improving patient experiences throughout such treatments. Finally, another IMAGINE-supported study, led by Dr. Deborah Marshall, is conducting a Discrete-Choice Experiment (DCE) to quantify patient preference of FMT compared to other conventional treatment options. These complementary studies will better inform health policy-makers in making decisions regarding FMT coverage.