A framework for the organization and delivery of systemic treatment.

BACKGROUND
Increasing systemic treatment and shortages of oncology professionals in Canada require innovative approaches to the safe and effective delivery of intravenous (IV) cancer treatment. We conducted a systematic review of the clinical and scientific literature, and an environmental scan of models in Canada, the United Kingdom, Australia, and New Zealand. We then developed a framework for the organization and delivery of IV systemic treatment.


METHODS
The systematic review covered the medline, embase, cinahl, and HealthStar databases. The environmental scan retrieved published and unpublished sources, coupled with a free key word search using the Google search engine. The Systemic Treatment Working Group reviewed the evidence and developed a draft framework using evidence-based analysis, existing recommendations from various jurisdictions, and expert opinion based on experience and consensus. The draft was assessed by Ontario stakeholders and reviewed and approved by Cancer Care Ontario.


RESULTS
The poor quantity and quality of the evidence necessitated a consensus-derived model. That model comprises four levels of care determined by a regional systemic treatment program and three integrated structures (integrated cancer programs, affiliate institutions, and satellite institutions), each with a defined scope of practice and a specific organizational framework.


INTERPRETATION
New models of care are urgently required beyond large centres, particularly in geographically remote or rural areas. Despite limited applicable evidence, the development and successful implementation of this framework is intended to create sustainable, accessible, quality care and to measurably improve patient outcomes.


INTRODUCTION
In Canada, cancer is a major cause of morbidity and mortality, and the leading cause of potential years of life lost. Increasing demands for cancer services relate directly to annual cancer incidence increases of 3%, resulting mainly from population growth and aging 1 . Medical oncology consultations are increasing by 10%-20% annually, and systemic treatment has increased at an annual rate of 7%-10%, fuelled by new evidence-based therapies that improve survival and quality of life 2 . Even more enhanced treatments are 5 5 5 5 5 CURRENT ONCOLOGY-VOLUME 16, NUMBER 1 predicted 3 . These treatments are often more complex than those they replace, and they are delivered for longer periods as the survival time with cancer-now increasingly a chronic disease-lengthens.
Several provincial and national bodies have convincingly demonstrated that ongoing clinical human resource shortages limit funding and filling of new oncology positions 2,[4][5][6][7][8][9] . For example, the November 2005 Canadian Post-MD Education Registry revealed that only 34 medical oncology residents and 8 fellows are in oncology training for the entire country 5 . Exacerbating this problem are the numbers of retiring physicians 6 and registered nurses 8

anticipated in Canada.
Given such changes, Canadian provinces need to devise innovative ways to deliver safe and effective systemic treatment in an ambulatory care setting for people with cancer. The risks of not pursuing a revised and sustainable model of systemic treatment delivery include adoption of ad hoc and inconsistent local solutions; cessation of service in some jurisdictions; and inequalities in access to, and standards of, care.
The purpose of the present work was to provide a practical framework to guide standardized delivery of evidence-based systemic treatment in hospitals outside regional cancer centres, with special consideration for geographically dispersed regions. The primary goal of the framework is to provide safe, evidence-based systemic cancer treatment while maximizing the efficient use of resources and implementing the principle of patient-centred care provided as close to home as possible. Service provision; complexity of care; safety, accessibility, and quality across all care levels defined from the patient, organization, and system perspective; and appropriateness, transparency, and accountability were all taken into consideration. Quality, research, and education are interlinked and integral parts in the regional delivery of safe systemic treatment, ensuring the dissemination of new or improved evidence-based standards in this rapidly changing field.

Evidence Base
We used two core methodologies to develop this framework: • a systematic review of scientific and clinical research evidence and • an environmental scan of systemic treatment models developed in other jurisdictions.  (OVID, 1996through June 2006, and HealthStar (OVID, 1996 through June 2006). The terms used were "anti-neoplastic agents," "chemotherapy," "infusions intravenous," and "neoplasms," combined with "health facilities," "organizational policy," "continuity of patient care," "outpatient clinics," "ambulatory care facilities," "hospitals rural," "hospitals community," "hospitals general," "health care facilities," and "health care policy". Article bibliographies and personal files were also searched for relevant evidence.
The environmental scan retrieved published and unpublished sources (June 25-July 4, 2006) documenting systemic treatment delivery at hospitals outside a larger cancer centre. Documents from countries with health care systems similar to Canada's (United Kingdom, Australia, and New Zealand) were considered. In addition, a free keyword search was conducted through the Internet Google search engine, and a search was made for documents mentioned in the text or references of identified reports.
The inclusion criteria were kept purposefully broad. Any study design was considered if it provided evidence on ways to deliver systemic treatment within ambulatory care institutions. Outcomes of interest included health care provider roles and education, service type and complexity, service volumes, quality assurance, facility requirements, and administrative and organizational responsibilities. Specific details of the development of the evidence base can be found online at www.cancercare.on.ca/pdf/pebc12-10s.pdf 10 .

Development of the Framework
The Regional Models of Care Systemic Treatment Working Group, comprising medical oncologists, a Cancer Care Ontario regional vice president, a regional cancer program administrator, a systemic treatment satellite nursing administrator, oncology nurses, administrators, pharmacists, and other professionals, reviewed the evidence and used a combination of evidence-based analysis, existing recommendations from various jurisdictions, and expert opinion based on experience and consensus to develop the framework. Given that the quantity and quality of evidence was generally poor, the panel agreed upon the framework elements through consensus of expert opinion.
A draft framework document was circulated to 191 stakeholders in Ontario for feedback, with 89% of respondents endorsing the framework and document recommendations. More details regarding the feedback obtained can be found at www.cancercare.on.ca/pdf/ pebc12-10s.pdf 10 . The document was also reviewed and approved by Cancer Care Ontario's Clinical Council, Provincial Leadership Council, and Executive Team.

Evidence Base
Evidence on the current organization and delivery of systemic treatment across Canada, the United Kingdom, 6 6 6 6 6 Australia, and New Zealand was gathered through a systematic search of the literature and a scan of documents from organizations concerned with systemic treatment quality practice. In Canada, the provinces of British Columbia, Saskatchewan, and Nova Scotia have instituted important initiatives [11][12][13] . More details of the evidentiary base considered by the panel can be found at www.cancercare.on.ca/pdf/pebc12-10s.pdf 10 .

Regional Models of Care for Systemic Treatment
The Regional Model for Quality Systemic Treatment ( Figure 1) consists of a key set of fundamental elements and regional programs designed to implement, monitor, and evaluate quality indicators related to the delivery of safe, evidence-based, and patient-centred care. The model is an organizational framework for the delivery of systemic treatment within a regional systemic therapy program (RSTP). The main goal of the model is to facilitate the provision of appropriate care in the appropriate setting within the appropriate time frame for all patients, regardless of the geographic location in which a patient receives systemic treatment.
The model is composed of three integrated structuresintegrated cancer programs (ICPs), affiliate institutions, and satellite institutions-each with a defined scope of practice. The ICPs are multidisciplinary organizations that provide complex cancer care and that conduct cancer site-specific multidisciplinary care conferences (MCCs). The MCCs discuss unusual cases, oversee quality assurance, and provide assistance on cases seen at the RSTP level 1-4 facilities in their own ICP region. The MCCs include surgical, radiation, and systemic therapy oncologists, nurses, pharmacists, social workers, pathologists, and radiologists. The ICPs provide leadership in the development of local guidelines for their region; they collect and assist in the analysis of outcome measures and quality indicators for funding, patient safety, and program organization and efficiency; and they may provide academic leadership, including educational support and access to research.
Affiliate institutions have their own systemic treatment programs, although they are linked through formal agreements with the RSTP. Satellite institutions have fewer oncology-related resources and have a formal linkage to the RSTP for support in delivering systemic treatment.
All regional partner institutions will participate in the development of their RSTPs and will collaboratively determine the appropriate configuration for their model, including the formal linkages that will be required among institutions. The complexity of care delivered in each type of institution may vary; standards encompassing four institutional levels of care (levels 1-4) are recommended for the delivery of systemic treatment, with the level of complexity and the availability of services differentiating one level from another. The RSTP determines the appropriate level of care for each institution. Levels are hierarchical, with the satellite responsibilities being encompassed within the affiliate and ICP levels. The designation of a level requires that an institution meet all the standards for that level. As individual institutions expand or focus their services, the configuration of the model and the designation of institutional levels may change, after consultation between the RSTP and the institution.
The successful implementation of the framework is intended to create sustainable, accessible quality care and to measurably improve patient outcomes. The four levels and their standards are these: • Level 4 (Satellite) • Ambulatory facilities, nursing, pharmacy, and physician support provided for the administration of low-risk to high-risk intravenous systemic treatment under the direction of an oncologist from an ICP or an affiliate level 3 institution • Systemic treatments given under the supervision of a physician with appropriate oncology training • Access to specialized services and to providers with a formalized linkage to the RSTP are ensured CURRENT ONCOLOGY-VOLUME 16, NUMBER 1

Defining Features for Each Level in the Framework
The goal of the RSTP is to ensure safe, standardized, evidence-based care across the regions and equitable access to systemic treatment. Tables I-VIII delineate the defining features by level in the areas of type of care, health care providers, education, service type and complexity, volumes, quality assurance and safety, facility requirements, and administrative responsibilities. Definitions for key terms are provided in Appendix A.

DISCUSSION AND CONSENSUS
The Regional Models of Care Systemic Treatment Project Team used the modest evidence that was available from the published literature and the environmental scan and the expert opinion of the membership to reach consensus on the defining features for the organization and for delivery of systemic cancer treatment.
For several years, Cancer Care Ontario regional networks delivered systemic treatment, particularly in rural areas, under a hub-and-spoke model; however, this delivery was accomplished without regional governance or management authority 17 . The provincial standard of care now is the new integrated regional systemic treatment model, with all its defining elements (Figure 1), which is being implemented with the goal of improving equitable access to appropriate evidence-based and coordinated cancer services. Existing regional cancer programs and new ones currently being developed in Ontario will be expected to meet the model requirements.   Where the standard identifies that services are to be provided in a multidisciplinary environment, all providers required for the service at a particular level are available or readily accessible. All patients being considered for systemic treatment must be assessed by an oncologist. All treatment plans are recommended by and parenteral systemic treatment is prescribed by the consulting oncologist. Individual treatments as part of an approved course may be ordered by a family physician or internist with oncology training. Ongoing care must be coordinated with the consulting oncologist. Only registered nurses with appropriate chemotherapy certification may administer parenteral drugs. Only pharmacists or pharmacy technicians will prepare systemic treatment.

Oncologists
Level 4 (Satellite) Access to oncologist from a level 1, 2, or 3 hospital is required to determine and recommend the treatment plan, to manage disease status, and to discuss patient management issues with the health care team. CURRENT ONCOLOGY-VOLUME 16, NUMBER 1   All levels The location has sufficient patient volume to maintain competency and skills of professional providers to address the of care acuity and complexity of the treatment modalities and to provide cost-effective use of resources and drugs. The number of patients that can be treated will be affected by the complexity of the treatment regimens. Staffing must be sufficient to provide safe, quality care at all times, including during vacation, illness, and so on. 11 11 11 11 CURRENT ONCOLOGY-VOLUME 16, NUMBER 1 Although developed in the Ontario context, this model may, we believe, be useful in other provinces. The goal of the model is to ensure that, regardless of where in a province a patient receives systemic treatment, the same standard of care is guaranteed: the patient receives appropriate care in the appropriate setting within the appropriate time frame by clinicians with the expertise to offer the services. A regional program model replaces a traditional hub-and-spoke model and better reflects the relationships between all partners delivering systemic treatment.
In the new model, the RSTP assumes regional leadership for the delivery of systemic treatment, with support from the provincial cancer organization. Although most regional authorities in Canada (for example, local health integration networks, district health councils, health authorities, or health regions) have ICPs, it is important to acknowledge that, to best meet patient needs, cross-regional collaboration must also be considered in the planning of RSTPs. In addition, regional authorities without ICPs also exist, and therefore regional cancer services must be planned through a neighbouring ICP. Under the RSTP, systemic treatment ICPs, affiliates, and satellites would work collaboratively to ensure safe, evidence-based care that maximizes the capacity of care given across the region, while ensuring appropriate high-quality care.

CONCLUSIONS
The structure for systemic treatment delivery in ambulatory centres provides a comprehensive regional and provincial framework. This framework has been formed through a combination of evidence and expert consensus. Consensus was achieved through a small working group and the larger Regional Models of Care Systemic Treatment Project Team. The framework outlines the four levels (institution types) of care that are recommended for the delivery of systemic treatment. A hospital is not prevented from moving up to 12 12 12 12 12 the next level, provided that all the model requirements are met and that the RSTP agrees to the move. The present work provides a framework for all hospitals to meet the same standards and, at the same time, to achieve quality care and service when administering systemic treatment. Although the present article has been created to sustain the Ontario Cancer Care network in providing safe and accessible care, we believe that it is applicable to, and useful for, other jurisdictions. May also measure regional indicators as defined by the regional cancer program. Leadership Level 4 (Satellite) Physician and administrative leads identified, with defined roles to manage strategic and operational issues through regional forums. Formal linkage to a regional systemic treatment program. Nursing and pharmacy administrative leads identified, with defined roles to manage strategic and operational issues through the regional systemic treatment program. pediatric oncology nursing), or registration in and completion of the certification exam offered by the Canadian Nurses Association and attainment of the distinction Certified in Oncology Nursing (Canada). The specialized oncology nurse works in a specialized inpatient setting such as an oncology unit or bone-marrow transplant unit, an ambulatory setting focused on the delivery of cancer care, a screening program, or a supportive care setting or community setting offering palliative care. The individual's enhanced specialty knowledge and skill can be utilized in many environments to manage symptoms and side effects of treatment, to counsel patients in coping strategies, to teach self-care behaviours, and to monitor responses to treatment and nursing interventions 15 .