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The University of Michiganís Comprehensive Cancer Centerís Palliative Care Program took the form of a Phase III clinical trial that compared advanced cancer patients receiving standard cancer care to those receiving standard cancer care plus hospice services. In addition to providing information on the impact on quality of care, this project is contributing much-needed data on the cost of providing concurrent hospice services and cutting-edge cancer treatment.
Preliminary data show that adding palliative services improves quality of care and reduces caregiver burden. Intriguing findings from this study also suggest that the hospice intervention may reduce the cost of care. Another exciting - and unexpected - finding is that patients who receive palliative care may actually live longer.
The Michigan experience also carries sobering implications that extend beyond the positive impacts of concurrent care. While it has shown what is possible, it also reveals how current reimbursement and regulatory policies present substantial barriers to realizing those gains.
The trial was a partnership of the NCI-designated University of Michigan Comprehensive Cancer Center and Hospice of Michigan (HOM). This Phase III trial built on an earlier pilot study at Wayne State University that found improvements in comfort and patient satisfaction among advanced prostate cancer patients who received concurrent palliative services. Phase III trials evaluate the effectiveness of a new treatment against existing treatments.
A total of 167 patients with advanced cancer of the prostate, breast, lung, colon, bladder or pancreas, or with metastatic melanoma, were enrolled. They came from multiple sites across the state, including private physician offices and community-based hospitals as well as the University of Michigan Comprehensive Cancer Center. All patients met hospice criteria of a life expectancy of six months or less, yet all were determined to continue life-extending treatment, including trials of experimental therapies.
Nurses trained as palliative care coordinators (PCCs) identified patients who met the study criteria and then approached the patientís oncologist to see if he or she would introduce the study to the patient. The PCCs obtained informed consent from patients wishing to participate. Patients were then randomized to receive either standard oncology care or standard care plus palliative services.
Eight palliative care coordinators worked closely with the study group patients. They served as liaisons to a hospice team from HOM that provided round-the-clock palliative services. Although similar to a case management approach, the coordinators were more closely involved with their patients, communicating frequently, monitoring their progress and attending physician appointments with them.
Because the trial involved patients with many types of cancer and involved many types of care settings and oncologists, the results were intended to be widely generalizable, according to Jeanne Parzuchowski, R.N., M.S., O.C.N., who was vice president for research at HOM during the trial and project director. Parzuchowski also ensured that the nurses who were trained to be palliative care coordinators represented a range of educational backgrounds to make the program easier to replicate in various settings.
Hospice of Michigan directly provided the palliative care services to the patients enrolled in the trial and covered all costs of the study group, billing Medicare or private insurers when possible. Therefore, HOM bore the greatest financial risk.
"Even though providing these services is the right thing to do, we have
stopped because we canít afford to do it. There is no reimbursement stream
for what we are doing."
One of the early lessons of the program, especially for the hospice staff, was how many patients with incurable cancers hold out hope for cure or improvement. "We cannot underestimate patientsí and familiesí desire for ongoing treatment despite the odds," said Dr. John Finn, the programís co-principal investigator and chief medical director of the Maggie Allesee Center for Quality of Life at HOM. This became clear early on when about two-thirds of eligible patients chose not to enroll in the study.
One factor was that patients still fighting their disease were uncomfortable with the idea of getting care from hospice workers, said Finn. "Hospice doesnít sell,Ē he said, ďbecause it symbolizes dying and death to patients not wanting to face that." According to Finn, many patients wanted palliative services, but they wanted to be identified as palliative care patients, not hospice patients.
Confronting death was a problem for physicians as well as patients. The first line of the consent form stated, "I have been told that I have an incurable disease," and that forced a discussion about death that was difficult for many oncologists, said Parzuchowski.
Other cultural differences between oncologists and hospice staff also were apparent. "Even oncologists who we thought were hospice-friendly had a great deal of difficulty with notions of comprehensive palliative care," said Finn. "Palliative care means different things to different people. When an oncologist thinks of palliative care, he thinks Ďif I can reduce some of the cancer cell burden, it will make the patient more comfortable.í"
All these issues complicated the way physicians introduced the trial to eligible patients and slowed recruitment into the trial. Another reason patients seemed reluctant, said oncologist Dr. Frank Worden, was that enrolling in this trial seemed like one more thing to deal with for worried and overwhelmed patients who were in other protocols that they hoped would be life-extending. To improve the recruitment process, project staff made a video of a physician skillfully talking with a potential trial participant. This video "role model" helped physicians introduce patients to the study in a non-threatening manner. The team also provided other training and guidance in presenting the study. Recruitment improved following those interventions.
Although there were also other difficulties in bridging the cultures and operating the program, the positive effects of providing the services gradually won over participating physicians. "As the project progressed," said Finn, "oncologists were disappointed when their patients were randomized to the control arm because their perception was that care was so much better on the experimental arm. It was also easier for them to take care of the patients because there were far fewer phone calls, and emergency room visits in the middle of the night were rare. The hospice nurse could usually handle problems at home."
Dr. Finn said the program also appealed to oncologists because it affirmed their primary role in the patientís care and eliminated the need for the doctor to effectively discharge patients from their practice in order for them to receive hospice services.
"Oncologists were disappointed when their patients were randomized
to the control arm because their perception was that care was so much better
the experimental arm. It was also easier for them to take care of the patients
because there were far fewer phone calls, and emergency room visits in the
middle of the night were rare."
Data from the Michigan trial are still being analyzed but preliminary data from 55 subjects suggest that the project has achieved impressive results in both the quality of care and cost arenas. Early data show that patients receiving palliative services had significantly less decline in quality of life compared to the group receiving standard care only. Caregivers of patients in the palliative care group also reported a lower degree of burden, especially in the first month. In addition, an unexpected finding is that patients in the palliative care group had a longer length of life - 266 days compared to 227 days.
Project staff are using the most sophisticated cost models available to compare the cost of caring for the patients in the study and control groups, said Dorothy Deremo, president and CEO of Hospice of Michigan. One challenge is developing standard costs for procedures being provided across the various settings. For example, a community hospital may charge less - or more - than a tertiary care center for a specific procedure but traditional cost accounting methods will assign a single cost.
Preliminary data show striking cost savings for the patients receiving palliative care services. The average total cost per patient of the study group was $12,682, compared to $19,970 per patient for the control group receiving standard care only. Average cost of hospitalizations for the study group was $8,974 per patient, compared to $13,126 for the control group. These data do not include prescription drug costs for either group or some other costs. When those are added in, economists think the gap will close but there will still be a savings, said Deremo.
Some of the cost savings resulted from the reduced use of the emergency room and hospital by the palliative care group:
Deremo also cited national studies showing that caregiver stress increases morbidity and use of health services so the reductions in caregiver burden may well translate to additional cost savings.
"Our preliminary results indicate that providing palliative services is certainly improving quality, probably decreasing costs and possibly extending lives," said Demero. If the findings hold up, some staff wonder whether oncologists would feel ethically comfortable in enrolling patients in cancer trials in the future knowing that patients who simultaneously receive palliative care do so much better.
Ironically, despite these positive findings, including overall financial savings, access to concurrent hospice services ended when the Promoting Excellence grant was complete because of uncompensated costs of care. Medicare does not reimburse for hospice care while patients receive disease-modifying treatment. Although total health care costs for patients who received hospice care appear to be lower than for those who received standard care only, those savings went to Medicare and other payers and did not accrue to HOM, which assumed the costs for patients enrolled in the study arm. By the end of the trial, HOM had spent more than they expected - about $1.5 million.
Parzuchowski worked with Medicare, insurers and managed care organizations to get them to share the costs for their patients in the study group. "It took tremendous effort with mixed results," she said. She encountered restrictive payment caps and coverage gaps and questions about why patients who were dying were getting aggressive treatment.
"Even though providing these services is the right thing to do, we have stopped because we canít afford to do it," said Deremo. "There is no reimbursement stream for what we are doing."
It is regrettable, she adds, "We have let the reimbursement tail wag
the dog and have not looked at the patient experience based on need."
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