Results Summary
What was the research about?
Hospice care aims to keep patients comfortable and reduce their pain in the last weeks or months of life. In this study, the research team wanted to reduce pain for patients with cancer in hospice care. The team created PAINRelieveIt, a software program for patients and their caregivers to use on a tablet. Caregivers are family members or friends who help a patient on a regular basis.
The PAINRelieveIt program had three parts:
- Patients entered information about their pain and pain medicine.
- Patients and caregivers got information about how to manage pain.
- Nurses reviewed patients’ entries to help manage patients’ pain.
The research team compared patients who used PAINRelieveIt as part of hospice care with patients who got regular hospice care only.
What were the results?
The study found no differences between patients who used PAINRelieveIt and patients who got regular hospice care in
- How often patients took their pain medicine as prescribed
- How well patients understood how to manage pain
- How satisfied patients were with their pain levels
Caregivers who used PAINRelieveIt understood more about how to manage pain than caregivers who didn’t use the program.
Who was in the study?
The study included 234 patients with cancer getting care at home from two hospice services in Chicago. The research team expected all patients to live at least 10 days. Among patients, 49 percent were white, 35 percent were black, 14 percent were another race, and 18 percent were Hispanic. Patients’ average age was 68, and 51 percent were women.
The study also included 231 caregivers of patients in the study. The average age of caregivers was 53, and 74 percent were women. Among caregivers, 44 percent were white, 36 percent were black, 12 percent were another race, and 20 percent were Hispanic.
What did the research team do?
The research team assigned patients by chance to get either usual hospice care or hospice care plus the PAINRelieveIt program. All patients had a tablet computer. They used the tablets to record information about their pain and pain medicine each day for six days.
Patients in the PAINRelieveIt group and their caregivers could also learn how to manage pain on their tablet. Patients in the usual care group could play games on their tablet.
Before and after the study, patients filled out surveys about their pain, and patients and caregivers filled out surveys about how to manage pain.
What were the limits of the study?
Because of changes to how the research team asked patients to take part in the study, more patients ended up getting usual hospice care than PAINRelieveIt. Results may differ in a study with similar numbers of patients in each study group. Nurses didn’t always have access to patients’ pain reports. This may have affected how they managed pain.
Future research could continue to look at ways to help patients in hospice care manage pain.
How can people use the results?
People who work in hospice care may use these results when deciding how to help patients and caregivers manage pain.
Professional Abstract
Objective
To compare the effects of hospice care plus PAINRelieveIt tablet-based software versus usual hospice care only on pain and pain management for patients receiving home hospice care for cancer
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 234 patients receiving home hospice care and 231 caregivers of patients enrolled in the study |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient adherence to prescribed pain medication Secondary: patient worst pain intensity, satisfaction with pain levels, and misconceptions about pain management; caregiver misconceptions about pain management; and appropriateness of pain medication prescribed by nurses |
| Timeframe | 7-day follow-up for primary outcome |
This randomized controlled trial compared usual hospice care with hospice care plus PAINRelieveIt, a tablet-based software program with patient-reported pain measures, decision support for clinicians, and education tailored to patients and caregivers. Usual care included pain assessment, appropriate medication, and access to a tablet for recording patient-reported pain and for recreation.
Researchers recruited patients from two Chicago-area hospices. Patients who enrolled in the study had cancer, spoke English or Spanish, were receiving hospice care at home, had a lay caregiver at home, and had a life expectancy of at least 10 days at the start of the 7-day study period. Caregivers were those whom patients designated as their primary lay caregiver.
The study included 234 patients and 231 caregivers. Among patients, 49% were white, 35% were black, 14% were another race, and 18% were Hispanic. The average patient age was 68, and 51% were female. Among caregivers, 44% were white, 36% were black, 12% were another race, and 20% were Hispanic. The average age among caregivers was 53, and 74% were female.
Researchers assessed adherence to pain medication instructions for six days and measured appropriateness of pain prescriptions using patients’ daily reports of pain intensity. Immediately before and after the study period, the team measured patients’ satisfaction with pain levels and administered a survey to assess patient and caregiver misconceptions about pain management.
To plan and conduct the study, researchers worked with physicians and nurses with experience in hospice, palliative, and oncology care, as well as with hospice volunteers.
Results
Medication adherence. Over the course of the study period, medication adherence did not change in either group. Across groups, the adherence rate for prescribed pain medication was 63% before the study period and 70% after (p=0.43, 95% confidence interval [CI]: -0.10, 0.04).
Pain management. Patients in the PAINRelieveIt group reported pain intensity that was statistically, but not clinically, worse than the pain reported by the control group (6.63 ± 2.12 on a 0-10 scale versus 6.05 ± 2.24, p=0.02, CI: 0.12, 1.27).
Satisfaction with pain level before and after the study period was the same in both groups (p=0.36, 95% CI: 0.27, 1.61).
Misconceptions about pain management. Caregivers in the PAINRelieveIt group had fewer misconceptions about pain management than caregivers in the usual care group (p=0.01, 95% CI: -0.38, -0.08). Patients’ misconceptions about pain management did not change from before to after the study period in either group (p=0.32, 95% CI: -0.18, 0.55).
Appropriateness of pain medication. At baseline, patients in both groups had appropriate pain medication prescribed and available; therefore, the research team did not analyze this variable further.
Limitations
Changes to recruitment and randomization procedures to balance demographics led to more patients being in the control group than originally planned. Study results may have been different if referral patterns had been more consistent between study arms. Nurses in the study did not always have access to patients’ pain reports from PAINRelieveIt, which may have affected care decisions.
Conclusions and Relevance
PAINRelieveIt did not improve medication adherence or pain intensity compared with usual care.
Future Research Needs
Future research could continue to examine ways to improve medication adherence and pain management for patients receiving hospice care.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
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. The comments and responses included the following:
- Reviewers asked for additional information on how researchers handled comorbid conditions in this study. The researchers responded that because they assumed that all hospice patients would have many comorbidities, they did not control for these comorbidities in their analyses.
- Reviewers noted that the report’s background did not discuss the psychosocial, sociopolitical and sociomoral components of pain experience. The researchers responded that they did address these but used different language that referred instead to the patient and physician barriers to adequately assessing pain.
- Reviewers lauded the researchers’ 20-year history of engaging patients and stakeholders in research but requested more specificity about the patient and stakeholder engagement activities that influenced this study. The researchers provided additional detail about the engagement activities that were part of and contributed to this study.
- Reviewers noted that the seven- to nine-day assessment period was unlikely to be long enough to get good control over neuropathic pain and could explain the lack of significant impact of the intervention. The researchers acknowledged that the study period was brief but explained that this was the result of the short, median hospice stay of 19 days.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^Diana J. Wilkie, PhD, MS, BSN, was the original principal investigator for this project.