Unrelieved cancer pain at the end of life is a major health problem that interferes with patient-centered goals for their last days. Building on a successful approach researched in outpatient oncology settings, we tested a system-level intervention (PAINIt) that included an internet-based tool with patient-reported pain outcomes (in English and Spanish languages), decision support for clinicians (English), and multimedia education tailored to each cancer patient and lay caregiver (in English and Spanish languages).
Specific aims were to compare usual hospice care with PAINIt groups for effects on (1) patient outcomes (analgesic adherence [primary outcome]; worst pain intensity; satisfaction; and misconceptions about pain and pain management) and lay caregiver outcomes (misconceptions about pain and pain management, known as pain control barriers) in a diverse sample of cancer patients receiving hospice care and their lay caregivers; and (2) nurse outcomes (obtained appropriate analgesics for patients) in a sample of hospice nurses.
Using a 1-week pretest/posttest, stepped-wedge randomized design in 234 patients receiving home-level hospice care provided by 2 Chicago-area hospices and 231 of their lay caregivers, we compared effects of usual hospice care and PAINIt on pain outcomes. The average age of the 234 patients was 68.4 (SD, 14.0) years; 49% were male and 51% were from ethnic or racial minorities. The 231 caregivers were younger (mean, 53.2 years, SD; 15.0 years) and predominately minority (54%) and female (74%). The tablet-based PAINIt included valid and reliable pain tools (PAINIt, which includes analgesic adherence in the past 24 hours, and Barriers Questionnaire-13 [BQ-13]); a summary of the patient's pain data (PAINIt Summary); a summary of the patient's pain data with decision support for hospice nurses to obtain recommendations for algorithm-based analgesic therapies (PAINN); and multimedia education tailored to the patient's and lay caregiver's misconceptions about pain and pain management (PainCope). Patients' and caregivers' answers were automatically stored in an electronic database, from which the system generated a PAINIt Summary (control group: PAINN and experimental group: PAINCope). All patients received usual hospice care. All patients/caregivers completed PAINIt and BQ-13 at pretest and 1 week later (posttest); patients also completed parts of both tools daily. Via daily email updates, the control group hospice nurses received access to a PAINIt Summary and experimental group hospice nurses received access to a PAINN. Additionally, experimental group patients/caregivers were asked to view multimedia educational materials via PAINCope to help patients report pain and adhere to prescribed analgesics (analgesic adherence from PAINIt).
At posttest, neither analgesic adherence nor satisfaction with pain level differed significantly between the usual care group and experimental group. The posttest worst pain intensity was 6.05 ± 2.24 for the control group and 6.63 ± 2.12 for the experimental group, which was statistically significantly higher for the experimental group; the difference (0.70 [95% CI, 0.12-1.27]) is not clinically meaningful. There was nearly universal availability of prescriptions for strong opioids and adjuvant analgesics for neuropathic pain in both groups. Lay caregivers' pain control barriers ( = .01) were significantly lower in the experimental group compared with the usual care group (mean difference controlling for baseline is 0.38; 95% CI, 0.08-0.67), but the patients' pain control barriers did not differ significantly by study group.
Unanticipated imbalance in study group size occurred given the ever-changing clinical environment of hospice care. Other limitations included the nurses' low access to the intervention reports for their patients and the ceiling effect for appropriateness of the analgesics for type of pain that may have occurred because medications were placed in the home at admission for use during active dying.
Over the 1-week study, both intervention groups had high availability of appropriate prescriptions, yet in both groups a high proportion of patients were not satisfied with their pain levels, reporting moderate to severe worst pain, and were not completely adherent to their opioid analgesics (primary study outcome). Better understanding of the lack of change in the patient outcomes is important for improving patient-centered care of the patient with cancer who is dying.
