Description and Goals
Gateway’s long-term goal over three to five years is to establish an independent, community-based centre in Seaforth, Ontario dedicated to the investigation of health issues affecting rural communities in the Huron-Perth-Grey-Bruce region. The centre will support rural investigators in all aspects of clinical investigation including preparing research proposals, applying for funding, implementing studies, collecting and analysing data, and publishing results. Although the focus of the initial research activity will be on heart disease, stroke and diabetes, the centre will consider support of any research initiative considered relevant to the rural population.
Gateway plans to become a recognized centre of excellence for clinical research that generates new knowledge necessary to develop and implement policies designed to improve the health status of Canadians living in rural areas.
The initial goal (1 to 2 years) is to implement a strategy that involves:
1. Creating a network of clinical investigators (physicians, nurses, pharmacists, dieticians, physiotherapists).
2. Obtaining certification for clinical investigators and research coordinators.
3. Establishing partnerships with academic centres and industry to participate in large research projects.
4. Writing grants application to Heart and Stroke Foundation of Ontario and other agencies.
5. Promoting Gateway in the community
6. Implementing initial research projects:
* Health status of orphan-patient population in underserved sub-populations
* State of cardiovascular health in a rural population
* Diabetes intervention program
An outline of each of these goals and the strategy for achievement follows.
1. Network of clinical investigators
In Huron, Perth, Grey and Bruce counties, there are 17 community hospitals, 14 internists, 228 physicians and approximately 54 private family practices in addition to 24 newly-formed family health teams. There are also several community-based programs providing basic services including 6 Community Care Access Centres. CCACs engage health professionals including nurses, physiotherapists, pharmacists and dieticians who actively provide basic health care to rural residents. There are also 38 long term care residential facilities with 2,600 residents.
Gateway will contact selected professionals of the various health care organizations and formally invite them to participate in the centre as clinical investigators. This work will require (a) development of appropriate written material and visual aids, (b) making presentations to potential investigators, and (c) organizing and conducting investigators meetings to discuss research priorities and new research initiatives and obtain feedback on overall research goals. Efforts are underway to recruit at least two internists and an investigator (physician, nurse, pharmacist, or dietician). In Huron County, for example, recruits will come from each of the four new family health teams in addition to four family physicians in private practice. It is estimated that these medical practices alone have a patient population of about 10,000 people, a significant number to begin research on prevention programs. The long-term goal is to have an extensive network of community-based physicians and other professionals across all four counties actively engaged in clinical research.
Any new young physician recruited into the area, especially those with strong research backgrounds, will be invited to participate in clinical research from the outset. The centre will provide an immediate network and support to implement their research interests. Clinical research is a rewarding experience. We strongly believe that the centre will be an important tool to attract and retain physicians to the area helping indirectly to fight the critical shortage of physicians affecting these rural areas.
2. Certification for clinical investigators and research coordinators
Clinical investigation has become a highly regulated activity as the complexity and size of research projects increase. Regulatory agencies have developed training protocols to provide standardization to the process of clinical research in an effort to guarantee good quality data. An early goal is to encourage investigators and research coordinators to obtain formal certification as clinical investigators as this will be essential to attract both academic- and industry-sponsored research projects. The availability of several on-line courses will facilitate this process. The goal is to attain certification of at least four new investigators during the first year. Gateway will provide training for new research coordinators in clinical research and encourage them to obtain their certification.
3. Establish partnerships with academic centres
The geographic location of the Huron-Perth-Grey-Bruce region offers a great potential for active collaboration with several world-renowned academic research centres from McMaster University, York University, the University of Western Ontario and the University of Toronto. Gateway will pursue research projects that can help to sustain long-term collaborations with centres involved in population health studies, studies in outcome research, evaluation of health programs, and clinical trials.4
These academic centres will benefit from a well-established community-driven clinical research centre with qualified investigators and willing primary care and preventive care patients. In turn, investigators from the rural communities will have the opportunity to participate in large academic projects, interact with peers from other regions or countries and with world-renown medical investigators.
4. Grant applications
During the Gateway startup, a significant amount of time and effort will be dedicated to preparing grant applications to fund building infrastructure, fund an operations budget and finance initial research projects. Efforts are underway to identify appropriate government and non-government granting agencies and prepare and submit grant applications. Potential agencies include the Heart and Stroke Foundation of Ontario (HSF), the Canadian Foundation for Innovation (CFI), Rural Community Development, Canadian Institutes for Health Research (CIHR), the pharmaceutical industry, all government levels and private foundations.
5. Promoting the research centre in the community
Gateway’s success will depend in large part on the collaboration and acceptance of the centre not only by health care professionals but also by the broader community at large. Presentations are underway discussing the goals and benefits of clinical research at community gatherings such as City Council meetings, churches and school meetings across the area. The efforts are in keeping with the marketing and communications plan outlined below.
6. Research projects
A number of possible initial research projects have been considered in order to exemplify the prime purpose of the Gateway centre. Four projects have been identified.
Project 1 – Investigate the demographics and health status in under-served rural sub-populations
Project 2 – Investigate cardiovascular health (heart disease and stroke) in the Project 1 population.
Projects 1 and 2 –
Recent nation-wide health surveys have consistently shown that the health status of Canadians living in rural areas is worse than that of their urban counterparts. For example, the average frequency of ischemic heart disease, stroke, and diabetes in the Huron-Perth-Grey-Bruce region is among the highest in Ontario and Canada. The stroke rate is about 30% higher in Huron County than in cities such as London Ontario. These comparisons are based on average values representing all county populations; however, there is no data on the actual health status in rural sub-populations such as low literacy groups or rural populations without access to continuous comprehensive medical care (orphan patients).
Funds will be sought for a grant for (a) completion and expansion of the Huron (and area) Health Survey designed to determine cardiovascular risk profile, and (b) implementation of a community-based cardiovascular disease prevention program in a rural context: the Mentor project.
Although no formal sample-size calculation has been made yet for these studies, based on similar studies, it is estimated that two groups of 300 patients (N=600 subjects) will provide enough data to observe statistically significant differences (10,11).
The goals for the above projects are to establish collaboration with the Population Health Research Institute at McMaster University to discuss project details, prepare and submit the grant application, establish a theoretical model for mentor selection and training, obtain feedback from community members, and promote programs in the community. The inclusion of the first patient into the programs is planned to occur during the fall 2008.5
Project 3 - Depression in rural women
Community surveys indicate that general depression is a major problem for women, more so for women in rural areas, and especially older women with disabilities. Women in general experience depressive symptoms twice as often as men, and twice as many rural women experience depression compared with their urban counterparts. A recent report showed that about 75% of women with disabilities living in a rural area in the USA experience moderate to severe depressive symptoms (7). In Canada, there is very little research on depression in rural women or depression in rural communities in general.
Project 4 - Diabetes Intervention Program
Investigators from the Lawson Research Institute and the University of Western Ontario are organizing a large comprehensive diabetes prevention program that requires patients from community-based practices. This program is particularly appropriate for Huron and neighboring counties as the frequency of diabetes in Huron is one of the highest in Ontario. According to the Community Health Survey of 2001, the rate of diabetes in Huron County is 8.0% whereas the average rate for the province of Ontario is 5%. In addition, this project offers the opportunity to establish formal collaboration with another academic centre.
Gateway is prepared to ensure that all aspects of conducting these research projects will be in place from protocol submissions to an ethics review board, in addition to personal training to data collection and data management.
