SUPPORT Units – Application instructions

Table of contents

1. Background
2. Overview
3. Vision
4. Description
5. Core components
6. Governance
7. Performance measurement
8. Iterative review process
9. Available funding
10. Business plan requirements
11. Section instructions
12. Contact information

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1. Background

Patient-oriented research, the cornerstone of evidence-informed health care, refers to a continuum of research, from initial studies in humans to comparative effectiveness and outcomes research, and the integration of this research into the health care system and clinical practice.

Canada’s Strategy for Patient-Oriented Research (SPOR) is a pan-Canadian research strategy that puts patients first. It was created after extensive consultation with national and international partners and is led by the National Steering Committee: a coalition of federal, provincial and territorial partners with broad representation from patient advocates, policy makers, researchers and clinicians. SPOR reflects a commitment to deliver high quality care in Canada by providing patients, health professionals and policy makers with the best available information to make decisions about health care. It aims to strengthen support for clinical trials and intervention studies as well as research that compares the effectiveness, benefits and harms of existing treatment options. The strategy also endeavours to improve the translation of innovative preventative, diagnostic and therapeutic approaches into the health care setting by expanding research in implementation science and incorporating these methods into day to day practice.

The vision of the strategy is that Canada will demonstrably improve health outcomes and enhance the health care experience for patients through the integration of evidence at all levels of the health care system.

Two key components of the SPOR strategy are: National Research and Knowledge Translation Networks and nationally distributed specialized support units called Support for People and Patient-Oriented Research and Trials (SUPPORT) Units. The focus of this document is the creation of the SUPPORT Units.

2. Overview

SUPPORT Units will develop jurisdictional centres of expertise to enhance patient-oriented research and facilitate studies involving patients and/or patient records.

SUPPORT Units are intended to:

• Identify the needs of patients and knowledge users and facilitate research that addresses these needs.
• Provide a critical mass of highly specialized and multi-disciplinary methodological expertise in patient-oriented research and its application.
• Assist decision makers and investigators to identify and design relevant research studies, conduct biostatistical analyses, manage data, provide and teach project management skills and ensure studies meet all relevant regulatory standards.
• Advance methods and training in comparative effectiveness research and develop the next generation of methodologists.
• Provide timely access to linked data and integrate existing or new databases.

Figure 1

Figure 1 long description

3. Vision

The vision is that SUPPORT Units will:

• Support the priority setting mechanism for the jurisdiction.
• Conduct and support implementation science and integrated knowledge translation (KT) approaches.
• Support the design and conduct of clinical and health services studies that address jurisdictional priorities.
• Support systematic evidence reviews.
• Have data systems in place to accelerate the conduct of clinical and health services research.
• Develop new and innovative methods.
• Provide training and career development in health services research methods.
• Leverage and integrate existing SUPPORT-related resources.

4. Description

SUPPORT Units will be established across Canada to develop jurisdictional centres of expertise to enhance patient-oriented research and facilitate large-scale national and international studies involving patients and/or patient records. Working collaboratively with their knowledge user partners, the SUPPORT Unit should help to address the research questions/knowledge needs of the knowledge users by producing solutions-focused answers and supporting the knowledge users to apply these solutions. Examples include policy makers at the provincial/territorial or federal level; managers and administrators of the health care system/ jurisdictional health authority/ hospital or community sector, health care providers; patients and the public.

Each SUPPORT Unit will be developed in partnership with the jurisdictional partners to ensure that the design is appropriate to the jurisdiction and capable of achieving the intended impact. The proposal process will commence based on the ‘readiness’ of the jurisdictions and it is anticipated that funding will begin in fiscal year 2013-14.

5. Core components

The SUPPORT Units are each expected to include six components covering core functions. Jurisdictions will be asked to demonstrate how the core components are expected to meet their needs and how existing resources will be leveraged and integrated. It is expected that some core components may be phased in over time.

Figure 2

Figure 2 long description

5.1 Data platforms and services

Proposed requirements for this component includes linkage of administrative data to clinical data, linkage of clinical feeder system to consent-based and legislated registries and providing timely access to usable data within a three to four month timeframe. More specialized services may include use of electronic health/medical records, computerized clinical decision support protocols, linking biobanks and clinical registry and administrative data systems, and advanced technologies and methods including qualitative and patient-reported outcomes.

5.2 Methods support and development

This component would provide timely services in areas such as biostatistics, epidemiology and health economics to the community in the jurisdiction. Scientific leadership in applied methods could focus on a pre-determined priority area, develop advanced methods and provide leadership and mentorship for students. Services could also include data management and computing for small to moderate scale databases, cohorts and multi-site studies. More specialized services could focus on advanced methodological innovations and services, e.g. for genetic bioinformatics, adaptive clinical trials, high content trials, patient-reported outcomes, international cohorts and multi-site studies.

5.3 Health systems research, implementation research and knowledge translation health systems research

SUPPORT Unit funding will support Applied Health Services Research (HSR) scientific leadership to lead the engagement of decision-makers and build HSR research capacity. Areas of focus may include evaluation of clinical and program interventions, financing and funding models and governance/accountability mechanisms; comparative effectiveness research, comparative policy and health systems research. Programs would take into account the jurisdictional or local needs of knowledge users and support decision making within the catchment area.

• Knowledge translation (KT) – KT will be a requirement of SUPPORT Units. Specialized functions could include conduct of knowledge synthesis and/or science of knowledge synthesis, and primary implementation studies on the science of KT.
• Implementation research - is critical to promote the discovery of more effective approaches to implement clinical and health research findings and other evidence-based practices into routine practice, and hence to improve the quality (effectiveness, reliability, safety, appropriateness, equity, efficiency) of health services.

5.4 Real-world clinical trials as part of a strategy to change health outcomes

As a core service, SUPPORT Units will provide expert assistance in areas such as innovative trial design, data management, statistical analysis, ethics approvals and multi-site management for clinical trials that change health outcomes and can support decision-makers in all aspects of Canadian healthcare. In particular, clinical trials that compare effectiveness and/or the comparative safety of treatments in the real-world healthcare environment will be emphasized. Outcomes of such trials will be used as inputs into clinical practice guidelines, computerized decision-support tools, cost-effectiveness economic models, educational modules for healthcare providers, and by other decision-makers, from patients and their caregivers to provincial reimbursement plans. Partnerships may allow for clinical trials supporting commercialization of products; however, emphasis is placed upon clinical trials supporting improvements in real-world health outcomes.

5.5 Career development in methods and health services research

Training, mentoring and career development for clinical, health services and systems research and methodological patient-oriented researchers is a core responsibility of SUPPORT Units.

SUPPORT Units will be expected to provide an environment that will foster the development of the next generation of specialized and multi-disciplinary methodological expertise, and clinical, health services and systems researchers engaged in patient-oriented research.

It is expected that research institutions would be essential partners in the SUPPORT Unit training and mentoring program and would be involved in the development of a sustainability plan for long-term innovative training and mentoring.

5.6 Consultation and research services

Consultation services could focus on design, measurement, methods development, data analysis, economic evaluation, literature review and scientific writing. Services could also include data management and computing for small to moderate scale databases, cohorts and multi-site studies. Clients of the SUPPORT Unit could have access to highly qualified research personnel including data managers, data analysts, research coordinators and nurses. These services could be contracted by teams or individual investigators to assist in the management and conduct of health systems research and multi-site clinical trials.

In addition, project management services of a SUPPORT Unit could provide expertise related to the management of small-scale to multi-site study teams such as development of business plans, tracking/evaluation of deliverables, and coordination of project components, communications strategies and project implementation. More specialized services could include a comprehensive (turnkey) service to develop and manage projects on a large national & international scale and could include, for example, qualitative research methods, survey methods, adaptive assessment of patient-reported outcomes and meta-analysis. The consultative services could be provided on a fee-for-service, which could generate infrastructure and operational funds for the unit.

6. Governance

Integral to the success of a SUPPORT Unit, it is expected that a collaborative leadership and governance approach will be used to integrate all individuals crucial for changing practice, implementation of evidence and sustainability. This would include the involvement of knowledge users such as policy makers at the provincial/territorial or federal level; managers and administrators of the health care system/ jurisdictional health authority/ hospital or community sector, health care providers; patients and the public.

7. Performance measurement

A core set of performance measurement indicators (approximately 15-20), covering all six core components, will be jointly developed and discussed at the Strengthening and Development Workshop. Jurisdictions will have the flexibility to add indicators based on their jurisdictional needs.

At this time, jurisdictions are asked to think about a potential performance measurement framework, including relevant milestones across the six components to be reported throughout and at the end of the funding period.

8. Iterative review process

Business plans will be evaluated using a two-phase, iterative review process, designed to provide jurisdictions with feedback during business plan development and implementation. This will be followed by a third phase designed to facilitate networking and continuous improvement of SUPPORT Unit activities.

Phase 1 – Draft business plan

Jurisdictions will have the opportunity to submit a draft business plan from November 1, 2012 onwards. All jurisdictions will be invited to present their vision for their SUPPORT Unit at a Strengthening and Development Workshop, regardless of when they are submitting their business plan. The goal of the workshop will be for jurisdictions to learn from each other, share ideas and best practices and strengthen business plan proposals.

Intended outcomes resulting from the workshop are:

• Improved understanding of the vision, aims and jurisdictional priorities.
• Strengthening of initial ideas leading to stronger final business plans.
• Emergent learning, monitoring and evaluation framework.

Phase 1 will be repeated periodically as jurisdictions become ready to submit their proposals.

Phase 2 – Final business plan

Through an iterative review process, an expert international panel will evaluate the final business plans. Jurisdictions will have the opportunity to answer questions raised by the panel during the evaluation process.

Jurisdictions may submit their final business plans when they are ready to do so. It is anticipated that this will occur 1-6 months after the workshop. Funding decisions will be available 6-12 weeks after submission.

Phase 3 – Continuous development

To ensure continuous improvement and on-going learning, jurisdictions will have the opportunity to network and share ideas on a regular basis. It is anticipated that this will occur annually.

9. Available funding

The total annual budget for a SUPPORT Unit is likely to vary depending on the needs and capacity of the jurisdiction. CIHR will match financial commitments invested by the jurisdictions with an estimated range of $2-6 M per year per SUPPORT Unit over a period of five years.

10. Business plan requirements

To ensure proposals contain all pertinent information, jurisdictions are asked to include the following sections in their business plan:

1. Overview of Vision
2. Description of Key Components of the Support Unit
3. Summary of Participants
4. Alignment with Jurisdictional Priorities and National SPOR Strategy
5. Governance
6. Performance Measurement
7. Stakeholder Engagement
8. Appendices
   1. Expenditure Requirements
   2. Governance Chart
   3. Bio-sketches of key participants
   4. Letters of Participation and/or Support

11. Section instructions

Once completed, the following sections will make up the business plan for the SUPPORT Unit. The number of pages specified for each section is intended as a guide rather than a prescriptive instruction.

Section 1: Overview of vision (1 page free form)

In the form of an executive summary, describe the jurisdiction’s vision and expected outcomes for the SUPPORT Unit.

Section 2: Description of key components of the SUPPORT Unit (maximum 10 pages free form)

Provide information on how the jurisdiction is going to establish and implement the six core components of the SUPPORT Unit. If it is not feasible to establish all six at the time of submission, include a plan for future attainment.

For each of the six core components, provide:

• details of the proposed activities and/or services;
• an overview of the budget requirements for the proposed activities (see appendix);
• a summary of how these core components will meet the needs of the jurisdiction;
• a description of how existing resources will be leveraged and integrated;
• a scalability plan (adaptability to increased or decreased demand and or for core components that are not fully developed a plan/approach that will be taken to phase them in over time);
• an overview of key risks to the successful realization of the described activities and/or services in the core component, including a risk mitigation strategy; and
• a sustainability plan.

Section 3: Summary of participants (maximum 4 pages free form)

In table format, provide a list of all jurisdictional participants, including their expertise, planned activities and role in ensuring the success of the SUPPORT Unit. Bio-sketches should be provided in the appendix.

To facilitate communication with CIHR, a primary contact representing the jurisdiction must be identified. The contact must be designated by and endorsed by the jurisdiction.

Section 4: Alignment with jurisdictional priorities and National SPOR strategy (2 pages free form)

Describe the value added of establishing a SUPPORT Unit in the jurisdiction based on jurisdictional needs and priorities. Include how existing projects can access the SUPPORT Unit.

Describe how the vision and expected outcomes of the SUPPORT Unit align with the National SPOR strategy.

Section 5: Governance (2 pages free form)

Provide a governance structure including key roles and decision-making processes. It should be noted that the model should be based on a collaborative leadership approach, including key decision makers, designed to support the achievement of the SUPPORT Unit’s vision. A governance chart should be provided in the appendix.

Section 6: Performance measurement (2 pages free form)

Propose a performance management framework for the SUPPORT Unit to assist in the monitoring and evaluation of key outcomes.

*Note that during Phase 1 of the process, jurisdictions are asked to submit initial thinking about a performance management. A core set of indicators (approximately 15-20), covering all six core components, will be jointly developed and discussed at the Strengthening and Development Workshop.

Section 7: Stakeholder engagement (2 pages free form)

Provide an overview of the stakeholder engagement and collaboration plan. The plan should include patients and the public.

Section 5: Appendices

Appendix A: Expenditure requirements

Using the table provided as a guide, include budget expenditures required from all sources of funding (per funding year). All expenditures entered into the table must be justified in detail in the business plan.

Jurisdictions should review the Use of Grant Funds section of the Tri-Agency (CIHR, NSERC and SSHRC) Financial Administration Guide for a complete listing and description of CIHR allowable costs and activities.

Appendix B: Governance chart

Illustrate the organizational governance structure for the management of the SUPPORT Unit activities.

Appendix C: Biosketches of key participants (free form – 2-4 pages per bio-sketch)

Provide bio-sketches of all key participants. This may include Board and Subcommittee members (or equivalents), operational management personnel, scientific leaders, subject matter experts, etc.

Appendix D: Letters of participation and/or support (no limit)

Letters of participation and/or support confirm the commitment of participants and partners to the SUPPORT Unit and its activities. It is expected that the SUPPORT Unit will receive letters of participation and/or support from key participants, relevant stakeholders and partners detailing support and/or commitments (including financial, if applicable). It is vital to the success of the SUPPORT Unit that the ministry/health authority and other decision/policy makers are included as key participants.