What was the research about?
In the United States, about 1.5 million people have Parkinson’s disease. This disease can cause
- Poor balance
- Shaking in hands, legs, or face
- Pain, fatigue, and depression
- Dementia, including memory loss, trouble doing daily tasks, and mood changes
In this study, the research team tested a palliative care program for people with Parkinson’s disease and their caregivers. Palliative care focuses on easing suffering and improving quality of life for people with a serious illness and their families. Care can include physical, emotional, social, and spiritual support.
The research team compared the palliative care program plus usual care with usual care alone. The team looked at patients’ quality of life and caregiver burden.
What were the results?
After six months, the two groups differed in quality of life. Patients who received palliative care plus usual care had improved quality of life. Patients who received usual care alone had worse quality of life. The two groups didn’t differ in caregivers’ ratings of burden. Both groups reported reduced burden over time.
Who was in the study?
The study included 210 patients with Parkinson’s disease and 175 of their caregivers. Patients’ average age was 70.
Among patients who received palliative care, 94 percent were white, 2 percent were Asian, 1 percent were African American, and 3 percent were another race; 61 percent were men.
Among patients who received usual care alone, 89 percent were white, 4 percent were Asian, 2 percent were African American, 2 percent were more than one race, 1 percent was Native American, and 2 percent were another race; 67 percent were men.
What did the research team do?
The research team assigned patients and their caregivers by chance to receive palliative care plus usual care or usual care alone. Usual care included care from a primary care doctor and a neurologist not trained in palliative care.
The palliative care team included a neurologist trained in palliative care, a nurse, a social worker, and a chaplain. Patients receiving palliative care had visits from the care team every three months in person, by phone, or online. They received check-in calls one week after each visit and again six weeks later. The care team sent notes from the visits to the patient’s primary care doctor.
Patients and caregivers answered surveys during clinic visits at the start of the study and then every three months for one year. Patient surveys had questions about quality of life, including physical health and quality of living situation. Caregiver surveys had questions about burden, such as having time for themselves.
Patients, caregivers, and advocacy groups gave input on the study.
What were the limits of the study?
Most patients and caregivers were white. Results may differ for people from other races. This study took place in three academic clinics. Findings may differ in other settings.
Future research could include more diverse patients and caregivers and look at ways to provide palliative care in community settings.
How can people use the results?
Clinicians can use the results when considering ways to help people with Parkinson’s disease and their caregivers manage their care.
To examine the effectiveness of usual care plus outpatient palliative care compared with usual care alone for improving quality of life for patients with Parkinson’s disease and reducing burden on their caregivers
|Design||Randomized controlled trial|
|Population||210 patients with Parkinson’s disease and moderate to high palliative care needs and 175 of their caregivers|
|Outcomes||Patient quality of life, caregiver burden|
|Timeframe||6-month follow-up for primary outcome|
This randomized controlled trial examined the effectiveness of usual care plus outpatient palliative care compared with usual care alone in improving quality of life for patients with Parkinson’s disease and reducing burden on their caregivers.
Researchers randomly assigned patients to one of two groups. Patients in both groups received usual care, which included care from a primary care provider (PCP) and a neurologist who did not have specialized training in palliative care. In one group, patients received additional care from an outpatient palliative care team. Visits occurred every three months either via telemedicine or at one of three university clinics, with telephone follow-up one week after each visit and again six weeks later. Palliative teams met daily to coordinate care and sent summaries of visits to the patient, caregiver, PCP, and neurologist. The study included 210 patients with Parkinson’s disease and 175 of their primary caregivers, including family members and friends who helped on a regular basis. Patients were 70 years old on average. Among patients who received usual care alone, 89% were white, 4% were Asian, 2% were African American, 2% were more than one race, 1% was Native American, and 2% were other races; 67% were male. Among patients who received usual care plus palliative care, 94% were white, 2% were Asian, 1% was African American, and 3% were other races; 61% were male.
Patients and caregivers completed surveys during clinic visits at study enrollment and then every three months for one year. Patient surveys assessed quality of life, including quality of living situation and physical health. Caregiver surveys assessed burden, such as how often caregivers had time for themselves.
Patients, caregivers, and advocacy organizations provided input on planning and conducting the study.
At six months, the two groups differed in quality of life (p=0.027); patients who received usual care plus palliative care reported improved quality of life, while patients who received usual care alone reported worse quality of life.
At six months, the two groups did not differ significantly in caregiver burden. Caregiver burden had decreased for both groups, but the change over time was only significant for those who received usual care plus palliative care (p=0.0001).
Most participants were white; results may differ for other races and ethnicities. The three academic health clinics that implemented the palliative care model served patients with high socioeconomic status, and staff had a high level of experience in palliative care. Results may differ in other settings.
Conclusions and Relevance
Compared with usual care alone, the addition of outpatient palliative care improved patients’ quality of life at six months, but did not affect caregiver burden.
Future Research Needs
Future research could examine palliative care in community settings and with more diverse patients and examine ways care can better address caregiver burden.
Final Research Report
View this project's final research report.
More to Explore...
Related PCORI Dissemination and Implementation Project
Article Highlight: This project compared the effectiveness of team-based outpatient palliative care to current standards of care for people living with Parkinson’s disease. The palliative care intervention included quarterly visits with a team that included a neurologist, social worker, chaplain, and nurse who used checklists to assess and manage palliative care. The project team reported in JAMA Neurology that, compared to usual care that used a neurologist and primary care practitioner, patients receiving palliative care at six months had improvements in their quality of life, symptom control, grief, and advance care planning. Caregivers had improved anxiety and spiritual well-being at six months and reduced caregiving burden at 12 months. A related editorial calls palliative care “the next frontier” in treating Parkinson’s disease.
Results of This Project
Related Journal Citations
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked for more examples of the interventions conducted in the palliative care arm of the study. The researchers included an appendix that detailed the clinical care checklists that the intervention team used. The researchers also added a reference to an article about the clinical model.
- The reviewers requested more information about the secondary outcomes, which were previously only listed by name. The researchers added a line about each scale used, giving examples of items from the scale and how they rated them.
- The reviewers found it interesting that the relative changes in the primary outcome, quality of life (QOL), in the two arms of the study occurred early on and then seemed to remain relatively stable. The researchers commented that they did not know why there was a change in QOL in both groups at the first time point, three months, that then stabilized. They said a larger longitudinal study would be needed to address that question.
- The reviewers recommended adding discussion and context about why participants in the study were generally white and of high socioeconomic status, despite the researchers’ efforts to recruit a broader sample. The researchers said that they did not collect demographic data for people who they deemed ineligible in the initial telephone screening phase of the study, but they believed that the people selected were demographically similar to those screened. So, they believed that lack of referrals or interest in the study, rather than study procedures, was the main barrier to recruiting a more broadly representative group. The researchers noted that in Parkinson’s disease care in general, African Americans are less likely to see a neurologist or a movement disorders specialist, and patients were less likely to hear about the study if they did not see such specialists. The researchers also added information to the report regarding their efforts to recruit participants from rural and inner-city populations, which were not very successful. They acknowledged that future studies would need to target these disadvantaged and minority populations to improve the diversity of the participant pool.
Conflict of Interest Disclosures
Study Registration Information
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