Pain Clinical Trial
Official title:
Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice
The study purpose is to compare usual hospice care and PAINRelieveIt groups for effects on: (1) patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250 cancer patient-caregiver dyads receiving hospice care; and (2) nurse outcomes (obtained appropriate analgesics for patient) in a sample of hospice nurses. The investigators hypothesize that at posttest, controlling for pretest data and compared to the usual care group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a larger proportion who report satisfaction with pain intensity and whose nurses obtained appropriate analgesics for the patients' pain.
Unrelieved cancer pain at the end of life is a major health problem and is inconsistent with
patient-centered goals for their last days. Building on a successful approach researched in
outpatient oncology settings, the investigators propose a study testing PAINRelieveIt, a
system-level intervention of computerized tools with patient-reported pain outcomes (in
English, Spanish, Chinese languages), decision support for clinicians (English) and
multimedia education tailored to each cancer patient and lay caregiver.
Using a 1-week pre-test/post-test randomized design in patients receiving home level hospice
care provided by two Chicago-area hospices, we will compare effects of usual hospice care
with PAINReportIt Summary and usual hospice care with PAINRelieveIt on pain outcomes. The
tablet-based PAINRelieveIt includes valid and reliable pain tools (PAINReportIt), a summary
of the patient's pain data with decision support for hospice nurses to obtain
recommendations for algorithm-based analgesic therapies (PAINConsultN), and multimedia
education tailored to the patient's and lay caregiver's pain management misconceptions
(PainUCope). Patient's/caregiver's answers are automatically stored in an electronic
database, from which the system generates a PAINReportIt Summary (usual hospice care control
group); PAINConsultN and PainUCope (experimental group). All patients will receive usual
hospice care. All patients/caregivers will complete PAINReportIt at pretest and 1-week later
(posttest); patients also complete parts of PAINReportIt daily. Via daily e-mail updates,
the control-group hospice nurses will receive a PAINReportIt Summary and experimental-group
hospice nurses will receive a PAINConsultN. Additionally, experimental group
patients/caregivers will view multimedia educational materials via PAINUCope to help
patients report pain and adhere to prescribed analgesics.
Specific aims are to compare usual hospice care and PAINRelieveIt groups for effects on:
1. Patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and
misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of
250 cancer patient-caregiver dyads receiving hospice care.
2. Nurse outcomes (obtained appropriate analgesics for patient) in a sample of hospice
nurses.
The investigators hypothesize that at posttest, controlling for pretest data and compared to
the usual care group, the PAINRelieveIt group will: a) report decreased scores for worst
pain intensity and pain misconceptions; b) have increased analgesic adherence (primary
outcome); and c) have a larger proportion who report satisfaction with pain intensity and
whose nurses obtained appropriate analgesics for the patients' pain.
Findings will guide future system-level research to implement PAINRelieveIt in a multi-site,
longitudinal trial that will test the effect of disseminating this technology on clinical
decisions for managing pain and patient/caregiver pain outcomes in a national sample of
hospices. This approach offers improved pain control for dying patients and other
populations.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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