Name of Project: Phase III Study of Palliative Care Program
Institution: University of Michigan – Hospice of Michigan, Ann Arbor, MI
PI: Kenneth J. Pienta, MD
Abstract (as described by Project staff)
The Palliative Care Program is a Phase III trial randomizing patients to a new hospice model of care versus standard medical care. The project aims to evaluate the quality of life of patients enrolled into hospice while receiving palliative treatments for their illness, versus patients who receive standard medical care; evaluate health outcomes, including pain, dyspnea, performance scale measures, emergency room visits, hospital admissions, and place of death, in the same group of patients; evaluate the cost of health care in the same group of patients; evaluate the caregiver burden for individuals. The Palliative Care Program targets terminally ill patients with advanced breast, lung, prostate, colorectal, bladder, pancreatic and metastatic melanoma and involves multiple academic and community based hospitals, as well as private physician offices and a VA center.
Brief Synopsis of Program Characteristics, Successes and Challenges
Project materials state: “The Palliative Care Program is a new model of care that incorporates the best practices in cancer care with the supportive care provided by an interdisciplinary hospice team. The care provided under this new model of care is coordinated by a palliative care coordinator that is involved in screening and identifying eligible patients for the study, collecting quality of life, health outcomes, caregiver burden and economic data on both groups of patients (control and intervention), and provides the key component in establishing the communication link between the primary health care team and the supportive care team.”
The project at the University of Michigan is a Phase III, randomized, controlled study that extends a clinical model developed in preceding phases. As such, the delivery model has already been developed and found to be both feasible and acceptable to stakeholders – principally patients, their families, clinicians and healthcare institutions – and the current evaluation emphasizes clinical and system effects of the intervention.
To date, 116 patients have been enrolled. All patients have met the rigorous eligibility criteria for the study and represent both intervention (N = 58) and control (N = 58) arms of the trial. They have had some difficulty in that physicians have been reluctant to break bad news and are correspondingly hesitant to refer patients to an end-of-life project. Staff has addressed this by dedicating additional time to talking to physicians one-on-one about the project, and they have produced an instructional video for physicians on communicating bad news to patients.
The Project staff writes: “Currently the hospice model of care makes the assumption that a patient, upon being told they have a terminal diagnosis, will elect the supportive services offered by our current model of hospice care. This assumes that patients will no longer hope for cure or prolonged survival and seek the acceptance and “comfort only” approach of today’s hospice programs. It is our experience that most patients nearing the end of life will continue to seek options that include disease-modifying therapies. The Palliative Care Program supports patients and families who desire the option of disease modifying and comfort-enhancing treatments simultaneously.”
Exportable Products/Tools
Policy Issues
Project staff reports “reimbursement and regulatory agencies continue to drive the manner in which care is provided and delivered. Without changing the current system under which we are working on, the efforts of this project may dissipate.”
Communications
Project staff reports that they have discovered important data about how the Palliative Care program decreases caregiver burden, and they are in the process of disseminating these preliminary findings. The American Society of Clinical Oncology (ASCO) and the American Academy of Hospice and Palliative Medicine (AAHPM) have accepted the project’s abstract, “A Palliative Care Program That Decreases Caregiver Burden” for presentations at their 2001 annual meetings. A storyboard featuring the measurement outcomes used in the study was accepted and presented at the IHI End of Life Congress in February 2001. Staff has talked about initiating a public engagement campaign.
The staff is very articulate about the regulatory and reimbursement barriers in providing palliative care.
Sustainability
When project staff was asked, “What will it take to sustain what you have learned?” they replied:
Generalizing the Model
The NPO sponsored Integrating Cancer Care and Palliative Care: A Strategic Retreat in June 2001 that brought together a select group of leaders from cancer centers across the country that are building innovative approaches to providing palliative care. The agenda was designed for the day to conclude with the development of strategic, actionable recommendations for short, mid and long-term steps necessary to build upon the work of these innovators.
When project staff was asked, “What will it take to generalize what you have learned?” They replied: “To generalize what we have learned relies heavily on the ability to provide the hard data necessary to make changes in our current health care system. The palliative care coordinator is essential and is the necessary component to be successful in the delivery of this model. The palliative care coordinator functions as communicator, educator, advocate, resource, and integrator for bringing the best in cancer care efforts with the supportive nature of hospice.”
Words of Wisdom from the Project
Project staff was asked, “Knowing what you know now, if another institution or project team in another community were to attempt a project similar to yours, what advice would you give them?” They replied: “Achieving the ‘buy-in’ necessary to be successful is the first step in planning and executing a project of this magnitude. Directly dealing with collaborating partners versus dealing with institutions would be the best advice we can provide in getting the project off the ground. The second piece of advice is to be sure that all partners appreciate and understand the risks involved and agree to commit fully to the effort. Often ‘surprises’ are not foreseen, and it becomes necessary to be flexible and willing to be an active participant in problem solving. Of course, it is imperative to have a funding source to support patient care that is currently not a covered benefit under the current reimbursement stream.”